Biotechnology in Developing Countries

000y3
BIOTECHNOLOGY
IN DEVELOPING
COUNTRIES
Research Advances
and Applications
Edited by
William Edwardson
Michael Graham
For additional copies, or for further information about this

document, please contact the authors at the following address:
INTERNATIONAL DEVELOPMENT RESEARCH CENTRE
ENVIRONMENT AND NATURAL RESOURCES DIVISION
P. O. Box 8500
OTTAWA, ONTARIO
CANADA, K1G 3H9
TEL: (613) 236-6163

FAx: (613) 567-7749
February, 1994
Biotechnology in Developing Countries
Acknowledgments
Special thanks are given to the authors of the original papers both for their contributions
and for their active participation in the conference. Their papers are reproduced in
unedited form in this book, and their ideas have been used in the synthesis and the
discussion summary.
Thanks are also extended to Chusa Gines for her assistance with the coordination of the
presentations and the organization of the seminar.
Research Advances and Applications
Contents
Foreword
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Pal ......................
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William Edwardson
Major Issues in Biotechnology for Developing Countries:

Michael Graham
A Synthesis of Presentations
Discussion Summary
Biotechnology in India
25
Gaston Grenier
29
G. P. Talwar and Rahul
Development of Biotechnology in Asia
Setijati D. Sastrapradja
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55
- C.J. Chetsanga ...........
81
Biotechnology for Developing Countries: The Mexican Case

Role of Biotechnology in Development of Zimbabwe
- Jose
41
Luis Solleiro
Foreword
Biotechnology is being applied in ways that will affect agriculture, health, the environment,
and many other aspects of science and industry in the decades to come. Most current
applications are centred in the developed countries and, as a result, priorities for research
and development are, in general, established by these nations.
As the number of biotechnology-derived products increases, they can be expected both to coexist with conventional products and to replace them. The development of new products, and
the competition and new opportunities they will create, has serious implications for
developing countries.
Biotechnology processes depend on sources of raw materials that can be processed into new
products with a much higher value. These biological resources are found naturally in many
developing countries, but are at risk due to ever-increasing populations, agricultural
expansion, logging, and resettlement programs. Without a sustained conservation effort,
many species of plants and animals will disappear. Continued loss of biodiversity would be a
serious blow to biotechnology and this situation begs for cooperation between countries that
are rich in biological resources but poor in technological resources, and countries that are
rich in technological resources but poor in biological resources.
Developing countries must prepare now to take advantage of the coming opportunities that
biotechnology will provide. For this reason, the International Development Research Centre
invited leading developing country scientists to prepare papers expressing their views on the
opportunities, progress, and problems of biotechnology in their regions of the developing
world. Christopher Chetsanga from Africa, Jose Luis Solleiro from Latin America, and
Setijati D. Sastrapradja and G.P. Talwar from Asia presented their views first at a seminar in
Industrial Biotechnology
Ottawa and then at a larger forum, the Bio-Recognition
Conference in Montreal (June 1992). Gaston Grenier, from Africa, acted as moderator and
provided a summary of the discussions. This publication presents their papers along with a
synthesis of the major elements of their presentations. We are indebted to them for their
efforts.
They make a strong case for attention to alternative applications of biotechnology for the
related more to agricultural and
specific needs and constraints of developing countries
food, tropical diseases, and public health than to the high-value pharmaceutical product
orientation of biotechnology in developed countries.
IDRC in its new strategy will be addressing key issues presented in Agenda 21, the action
document resulting from the Rio Conference on Environment and Development, which took
place at the same time as the Montreal meeting. Agenda 21 allocates an entire chapter to
highlighting the importance of environmentally sound application of biotechnology for
development. IDRC therefore will draw on the recommendations and ideas presented at the
Montreal meeting to identify and implement its program of support for biotechnology over
the next few years.
Given the importance of the issues and the complexity of the problems confronting the
development of biotechnology in the developing countries, greater understanding among all
nations, both developing and developed, is required. It is our hope that this publication will
help governments, development agencies, and the private sector to adjust their policies and
programs so that developing country populations, particularly the poor, will gain access to
the benefits that will flow from new applications of biotechnology.
William Edwardson
Senior Program Officer
Environment and Natural Resources
International Development Research Centre
Major Issues in Biotechnology for

Developing Countries: A Synthesis of
Presentations
Michael Graham
What is Biotechnology?
Biotechnology is a field of study that seeks to generate new products and processes using the
concepts and methods of modern biology. It blends the principles and practices of
biochemistry, genetics, and microbiology. Recent breakthroughs in molecular biology have
transformed biotechnology into a science that has produced refinements to areas such as
protein chemistry, nucleic acid biochemistry, fermentation, and immunology. These advances
are having an impact in agriculture, aquaculture, animal productivity, and health care.
Although the roots of this technology are ancient and have been employed in fermentation
processes for hundreds of years, "biotechnology" as a new science was rejuvenated by
developments in molecular biology, genetic engineering, and cell chemistry. Over the past 15
years, biotechnology has provided opportunities to create and support many new industries in
the countries of the North, but these bioindustries are just now beginning the profitable phase
of their life cycle.
For developing countries, the promise of biotechnology is particularly strong. Problems

associated with population pressures, food insufficiency, and nutritional deficiencies,
environmental degradation, and the need to create employment could well be partially solved
by new technological innovations presented by advances in biotechnology. However, to face
these challenges, governments in developing countries must develop appropriate plans and
policies, and invest in capacity building. Otherwise, much of this potential may be lost. It is
crucial that countries be able to define their own priorities and devise ways in which these
emerging technologies will enhance resource exploitation.
Biotechnology promises many positive benefits. At the same time, it poses some potential
negative consequences. Among the projected positive outcomes of advances in biotechnology
are:
(1) Increases in farming productivity and in food production by the use of plant
biotechnology to complement conventional technologies..
(2) Improved nutrition brought about by increases in farming and agro-industrial production,
and the use of fermentation techniques in food processing.
(3) Better integration of food production with the production and consumption of bioenergy,
especially in small rural communities.
(4) Improved production of livestock, and better health of domestic animals.
(5) Improved diagnosis and prevention of human diseases, as well as improvements in public
health.
(6) Increases in income and employment opportunities.
(7) Improve pollution control.
Some of the potential negative consequences of advances in biotechnology include:

(1) Shifts in trade patterns between developing and developed countries due to changes in
productivity brought about by improvements in farming and agro-industrial activities and the
marketing of new biological products that will have a tendency to displace raw materials and
products from developing countries (i.e., substitution of agricultural products).
(2) An expansion in the area devoted to cash crops in developing countries at the expense of
traditional food crops.

(3) The strengthening of large farming operations and the subsequent displacement of small
farmers and its effect on the economic sector.
(4) Possible reduction in genetic diversity as a result of the broad distribution of new crops
varieties, and the potential for increased soil erosion.
(5) Increased privatization of the results of research, which could reduce access to them by
developing countries and force them to pay fees for the use of seeds and plant varieties
developed by the industrialized countries.
(6) Greater possibilities of risk to health and therefore a need for emphasis on biosafety.
All these factors will have far-reaching consequences. New biotechnologies are likely to be
adopted by developing countries in the sectors of their economies with the greatest potential
8
for growth. As a result, there will be a trend toward centralization of ownership of farmland.
Under these circumstances, small producers and hired labourers are likely to suffer and the
trend of migration from rural to urban areas can be expected to accelerate.
Developing countries also fear that they may not be able to obtain appropriate technologies
from the industrialized countries. Given the barriers erected against the transfer of
biotechnology, Third World countries will have to concern themselves with maximizing their
natural, scientific, and technological resources to define problems and seek solutions that will
benefit broad sectors of their populations.
Faced with this prospect, the only way to confront these risks while taking advantage of
existing opportunities, will be for developing countries to gain greater control over
biotechnology. To a great extent, success in using biotechnology will depend on the level of
scientific and technological knowledge that these countries are able to develop in this
emerging field.
Why the Enthusiasm?

Every year the World Resource Institute, together with United Nations Development
Programme (UNDP) and the United Nations Environment Programme (UNEP), produces a
publication on world resources. The most recent figures make it clear that the world's
population continues to grow at an alarming rate. Two-thirds of this growth is in the
developing world. In India alone, the population increases by 69,000 each day. Increases of
this magnitude place great pressures on governments to find innovative ways to provide food,
health, shelter, and jobs for their citizens.
Food production in developing countries has increased remarkably during the past two
decades. This success was achieved, in large part, through the application of fertilizers and
pesticides as well as the planting of high-yielding crop varieties. Moreover, arable land was
available to expand the area under cultivation. Food production today faces ever-increasing
challenges created by increasing populations. Under present agricultural practices, there are
signs that production of high-yielding varieties is beginning to level off. Arable land can no
longer be found easily in most developing countries and this is forcing farmers onto marginal
land. Meanwhile, excessive applications of fertilizers and pesticides degrade the environment.
These challenges require new approaches.
For many developing countries, agriculture produces food as well as earns foreign exchange.
For centuries, many developing countries have exported agricultural commodities. In these
countries, large areas are occupied by plantations of oil palm, tea, coffee, cacao, sugar cane,
and cotton. Production technologies for those commodities are well developed. However, to
continue to compete in the world market, technologies for processing need to be refined
because competition from new products produced through biotechnology continues to grow.
For example, the market for natural vanilla has been reduced by the in vitro production of
vanillin and the use of sugarcane has been reduced because of the extraction of fructose from
maize. The next crops likely to be affected are cacao and tomato.
The need to increase food production and to meet the challenges of new products has made
many developing countries eager to grasp the potential of biotechnology to increase the
production and value of their commodities.
Many Third World countries are rich in biological resources, including plants with medicinal
properties. These species have been used for centuries to maintain health and cure illness.
Pharmaceutical industries process the products from these species into high-value substances.
Many other tropical species are also used in the cosmetics industry. Both of these industries
are likely to grow in the coming years under the control of multinational corporations.
Many crop and animal species in the tropics have received little attention from biologists
because they often have limited distributions and are valuable only to local communities. But,
the characteristics that have adapted these traditional varieties to local conditions are very
important inputs when scientists seek to develop new varieties for specific purposes.
Biotechnology can help identify these characteristics and shorten the time needed to
incorporate the desired characteristics into new varieties. However, developing countries will
need to establish their own programs to improve these varieties as they may not be of interest
to countries and companies in the North due to small markets. For example, the Institut
International de Recherche Scientifique pour le Developpement en Afrique QIRSDA) has
focused work on yams, which are locally important, but have no industrial agricultural
applications in developed countries. This situation is in contrast to the work that has been
done in Africa on cassava, which has contributed in large part to dairy production in
Holland.
The myriad of plants, animals, and microbes that live in tropical forests are an important
component of the world's biological resources. They are an important resource for
developing and developed countries alike. These forest resources have declined at an
accelerated rate throughout the 1980s due to agricultural expansion, wood extraction, and
resettlement programs. This reduction in forest areas has an effect on endemic species of
both plants and animals. Reforestation programs are thus becoming a priority in many
nations. This, in turn, requires the production of massive amounts of planting material.
Traditional means of propagation are insufficient to meet the demand. Biotechnology offers
the potential of rapid selection and multiplication of the desired species. For some trees, such
as wild fruit trees, overexploitation can cause their total elimination if rapid propagation
systems and new management systems are not developed.
10
What has been Achieved?

Some Third World governments saw the potential for the application of biotechnology in
industry, health, and agriculture and made research and development in biotechnology a
priority. Countries with advanced infrastructure and sufficient resources are now ready to
absorb new techniques developed in this field. Countries with limited resources are struggling
to keep pace with developments.
The most widely used technique in agricultural biotechnology in these countries is tissue
culture. Commercially, it is used in the production of potatoes and flowers, palm trees,
bananas and plantains, and coffee. On a laboratory scale, success has been achieved in the
rapid multiplication of forest tree species, such as teak, acacia, and casuarina. More
sophisticated techniques, such as cell and protoplast fusion, gene cloning, gene transfer,
DNA-finger printing, and cell immobilization are at various stages of application.
In the field of medical biotechnology, Third World governments are developing diagnostic
kits and vaccines for major tropical diseases, such as hepatitis B, dengue fever, malaria, and
amoebiasis. Vector control programs, such as the onchocerciasis control program in West
Africa, use thousands of tonnes of Bacillus thuringiensis per year (which is produced in
developed countries).
In many cases it is the more technologically advanced countries, such as the United States
and Japan, that are playing a leading role. However, other countries have also made
significant advances. Developing countries are far behind; however, a Chinese institute has
offered monoclonal antibodies against human T lymphocytes. In India, tissue culture
techniques have been used for mass propagation of bamboo saplings, strains of algae are
being developed and tested as sources of nitrogen in traditional planting systems, genetically
improved fish are being used in aquaculture projects, embryo transfer technology is being
used to improve cattle herds, new methods are being developed for fertility control in
humans, vaccines are under development to treat leprosy, and a diagnostic kit is being
developed for Salmonella. In Zimbabwe, efforts have been directed mostly at improvements
in agriculture. For example, micropropagation techniques are being used to produce diseasefree seedlings, efforts are being made to isolate and characterize milk-fermenting bacteria to
improve traditional milk fermentation, investigations are continuing to develop a fast method
to detect strains of bacteria that cause abortions in cattle, and work is being done on the
genome of the hepatitis B virus that is responsible for causing primary liver cancer in people.
Also in Africa, 22 nitrogen-fixing trees have been identified and used in Kenya,
cryopreservation of coconut tree embryos and rapid micropropagation of improved palm trees
are in use in C6te d'Ivoire, Rhizobium inoculant is being produced in a dozen centres in
Africa, and many national institutes have designed and used systems for in vitro preservation
11
of many vegetatively reproduced domestic plants. In Latin America, fermented beverages and
milk products are produced using inputs from biotechnology as are antibiotics, amino acids,
organic acids, and biofertilizers. Efforts to engineer new characteristics into local plant
varieties are also being conducted in some countries of the region. However, it is important
to underline the fact that most of these applications do not employ the advanced techniques of
new biotechnology, rather they build on improvements in traditional biotechnology. Most
developing countries have little experience or access to the new knowledge.
Although many research activities are being conducted, a much smaller number of
applications have been developed through the use of biotechnologies in the developing world.
Efforts are needed to understand how various policies and practices influence the
development and commercialization of these products.
The Role of the Public and Private Sectors

In developing countries, the public sector plays a dominant role in the launching of
biotechnology activities. Recently, new institutions have been established for biotechnology
in many countries. In Asia, a Department of Biotechnology in the Ministry of Science and
Technology was set up in 1986 by the Government of India; Indonesia has established a
Centre for Research in Biotechnology under the Indonesian Institute of Sciences; the Federal
Ministry of Education of Pakistan has organized a National Centre of Excellence in
Molecular Biology, and in Thailand a National Centre for Genetic Engineering and
Biotechnology (NCGEB) was organized in 1983. In Mexico, biotechnology has been in the
operating budget of the National Council of Science and Technology since 1984. Efforts in
Zimbabwe saw a Master's Degree program initiated in biotechnology in 1991 and a National
Biotechnology Research Institute is under construction.
The driving force behind the commercialization of biotechnology is financial profit. In some
developed countries, a part of biotechnology research starts in both the private and public
sectors. However, it soon transfers to the private sector once there are signs of market
opportunities. Today, two-thirds of biotechnology spending in developed countries comes
from the private sector. Transnational corporations are by far the leading spenders.
But in most developing countries, the private sector is weak. There are only a few industries
capable of acquiring and assimilating new biotechnologies and then producing and
commercializing new products in the global market. Indigenous industries generally prefer to
buy technologies from the world market. Industries affiliated with transnational corporations
draw most of the research and development needed for their manufacturing activities from
their headquarters. This situation creates a climate in which transnational corporations have
no urgent need for new technologies to be derived from research and development work
12
supported by the public sector. Unless this condition is altered by developing better
relationships between the public and private sectors, the results of biotechnology research
produced by the private sector may not be made available to the public sector corporations.
There are also a number of structural problems that must be resolved as well. For example,
the over-valued currency in a country like CW d'Ivoire makes it more attractive to import
the raw material at a disguised subsidized price than to prepare this raw material locally for
further processing and marketing on the local market.
The privatization of biotechnology products and processes has fuelled the international debate
on intellectual property rights. A few developing countries (i.e., Korea, Mexico, Venezuela,
Colombia, and Chile) have intellectual property rights on crop varieties and plant products
and many others are analyzing modifications to their patent laws. In principle, these
biological resources are a common heritage and should be freely accessible. Biotechnology
is, on the other hand, a technology whose results are being patented and made available only
for a price.
Control of Innovations
Obtaining patent rights for biotechnology inventions has become a fundamental objective of
companies seeking to commercialize biotechnology. The main beneficiaries of the patenting
process are the large multinational corporations. These companies seek to patent their
products or processes in a given country, with the primary objective of restricting the wider
use of the technology. They would prefer to export it and eliminate possible competition.
As the number of potential applications for biotechnology has risen, a race has developed for
control of the resulting innovations and the markets they will dominate. This control is
increasingly being exercised by large international corporations.
European, American, and Japanese companies currently compete in the open market. Success
in this market is difficult because several entry barriers must be overcome. These barriers
can be particularly daunting for developing nations.
The first difficulty is that research in biotechnology requires a solid interdisciplinary

scientific team with expertise in such areas as molecular genetics, immunology, protein
chemistry, biophysics, industrial microbiology, computer sciences, and engineering.
The resources necessary to undertake biotechnology research and development can also be a
serious obstacle. Resource requirements go beyond the exclusive scope of the research
activity. In fact, the greater the scale of the biotechnology operations to be undertaken, the
greater the relevance of the availability of such material resources as equipment, process
13
control instruments, and standardized raw materials. For this reason, new suppliers of the
special inputs, such as super-producing fermentation strains, required by biotechnology
companies continue to spring up.
Even when developing countries develop technological capacity, this does not guarantee
successful commercial and economic biotechnology operations. Efforts to distribute and
market biotechnology products may encounter barriers that are far more complicated than
those posed by the technical problems. Many start-up companies therefore have no alternative
than to grant the marketing rights for their products to other well-established companies.
These factors limit access by developing countries to biotechnologies, as well as their

capacity to adapt processes developed elsewhere.
To benefit from the potential applications in the biotechnology field, developing countries
need to confront the problem of technological information dissemination and define policies
and practices that will make it possible for them to use biotechnology to find solutions to
their specific needs.
This means that efforts must be made to develop local capacities to select, acquire, develop,
and promote biotechnology products and processes in sectors where the country has clear
comparative advantages. Countries must therefore be selective and make honest analyses of
their strengths and weaknesses to realistically identify their comparative advantages.
Establishing a Biotechnology Policy

As developing nations establish national biotechnology strategies it is essential that they
develop appropriate legal and regulatory frameworks as part of their biotechnology policies.
Complying with regulatory requirements in biotechnology is a critical factor affecting the

time and cost necessary to market a product. All applications of biotechnology should include
an assessment of the possible dangers to ensure the health and safety of workers, consumers,
and the environment.
Industrialized countries currently have regulatory procedures for biotechnology products.
Consequently, approvals are time-consuming and costly. If a developing country does not
have such regulatory procedures, they may become the experimental ground for the release
of genetically engineered organisms by foreign industries. In cases of collaboration between
developed and developing country laboratories, developing countries should insist that any
field tests conducted in their test stations follow the guidelines established in the developed
country for the handling of the organism.
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The Commission on Plant Genetic Resources of the Food and Agriculture Organization
(FAO), in its Fourth Session (1991), devoted considerable discussion to the development of
legal and regulatory procedures. The handling and release of genetically modified organisms
and intellectual property rights over plant genetic resources has become a focus of attention.
The regulatory system must also build confidence, make economic sense, and be compatible
with international regulations. The system must permit long-term development planning and
marketing of new products, while being flexible enough to adapt itself to the characteristics
of each new development.
It is also important that efforts be made to ensure that poor farmers on small plots of land in
the developing world are able to benefit from biotechnology inputs. It is these farmers who
have developed, in many cases, the traditional varieties that are the raw materials for
biotechnology. After several years of discussion, the concept of Farmer's Rights is now
recognized by FAO. These rights provide for farmers all over the world to be compensated if
their materials are developed into high-value products. However, it will take time for this
concept to be worked out and put into routine practice.
Developing countries face problems when trying to establish biotechnology policies. To start
with it can be difficult to define and classify biotechnology. Often there is also a lack of a
reliable information on biotechnology in these countries, and a lack of knowledge about
biotechnology and its importance among various executive levels of government due to poor
links with the country's scientists. Biotechnology as a science can be limited by: (1) the
application of inadequate methodologies; (2) a lack of mechanisms to use the results of
research; and (3) limited numbers of scientists.
However, in view of the positive and negative effects that biotechnology can have, countries
must make efforts to develop and consolidate the development of biotechnology. This will
mean that countries need to increase investments in research and development to increase
their scientific capacity and to improve their abilities to adopt and assimilate biotechnologies
developed abroad. They must also develop a monitoring system to keep pace with global
developments and to be aware of potential suppliers of technology. In those regions where
countries are too small or too poor to develop their own biotechnology sector alternative
regional mechanisms may be needed.
When a country is developing a comprehensive policy for biotechnology, it is important that
this be done in such a way that other policy areas, such as science, technology, industry,
finance, export, and regional development become complementary. Certain prerequisites are
necessary before a biotechnology policy can be established. These prerequisites include:
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(1) A strong scientific establishment must be in place that is able to develop technology of its
own or to negotiate or adapt technologies originating in other countries.
(2) A solid technological and scientific infrastructure is indispensable and will require a
significant increase in research and development expenditures by both the government and
the private sector.

(3) Because the most important production factor is qualified human resources, a definite
training policy in both the basic sciences and engineering is crucial.
(4) Human resources and capital are scarce; therefore, priorities must be established for
biotechnology developments, otherwise resources will be spread too thinly.
(5) Biotechnology policies must be linked with macroeconomic policies, and with other
policies that impact on other sectors of the economy.
(6) When policies are being formulated, they should be developed in a sequence that: (a)
establishes long-term strategic objectives and defines priorities; (b) defines opportunities and
requirements for different regions and/or sectors; (c) selects or designs policies for each
priority in the biotechnology field; and (d) defines roles, action plans, and agreements among
different participants.
As these conditions are met, defining a biotechnology development plan should become a
national priority. The options and priorities identified in the national plan must take into
account the country's strengths and weaknesses, as well as the opportunities and challenges
that are presented. The following issues are likely to be part of a comprehensive national
plan.
Financing and Evaluation

Funding for biotechnology should cover the development of infrastructure, basic research,
contribution of venture capital (for technological development and investment), scholarship
programs, and exchanges with other countries. Funds should be allocated in accordance with
established priorities.
However, although many countries have made biotechnology one of their top priorities in
their research and development agenda, there are large differences in the commitment of
resources.
Research in biotechnology can cover a wide range of topics and be undertaken at different
levels of sophistication. In many developing countries these activities have led to the
16
mastering of new techniques in biotechnology. Quite often, however, this capability is

scattered throughout different research units.
It is important that as programs in biotechnology are developed the potential benefits are
evaluated. Biotechnology has been shown to have applications in industry, medical care, and
agriculture. But in developing countries, human and financial resources are limited in all
three areas. Because of this limitation, priorities must be set if biotechnology is to contribute
to development. This means that within research programs, economic returns and social
implications should be addressed at the same time as technical matters are evaluated. This is
an area that requires research to develop new tools to do this adequately, in particular when
the contemplated products are to be directed at the poorest people.
Training of Human Resources

Biological resources are the raw materials used by biotechnology processes. Of these, it is
the plant genetic resources that are most widely used in biotechnology. Alone, these
resources mean little to a country. They require human skills and the appropriate
technologies to achieve their potential. Included in the required technology is a delivery
system.
There is a widespread agreement that modern biotechnology requires the development and
application of biochemistry, microbiology, molecular biology, and genetics. As a result, any
biotechnology program will have to assign high priority to strengthening human resources
training in these areas. An associated difficulty is "brain drain", which is particularly
important in biotechnology. For this reason, training should take place, when possible, at
centres of excellence in the developing country of origin or another developing country.
Expert human resources in general are rather limited in the developing world. Trained
personnel often have many duties (such as administration) and are left with no time to do
research. However, it is research that enhances technology acquisition, adaptation, and
development.
Information
Access to technical information enhances access to new technologies and can strengthen a
country's negotiating position with outside agencies. A network of libraries and technical
documentation centres that incorporates the latest advances for retrieval, storage, and
dissemination of information should be provided. As well, scientists need to attend regional
meetings to share ideas.
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Links with Developed Countries

Although there are many signs that new technologies are more closely guarded than ever, the
door is not yet closed. Developing countries should use all means of international cooperation
at their disposal. Sponsoring students to attend first-class universities and research centres on
scholarships is an important means of accessing new knowledge. However, other kinds of
collaboration such as technology transfer, investments, and alliances are also needed.
Enterprise Development
An efficient mechanism for biotechnology dissemination is the creation of so-called
knowledge enterprises. In key areas, national or regional companies can be promoted and
protected until they become established in the market.
Fiscal Incentives
It is important that the private sector make a contribution to national research and
development. For this reason, governments should provide incentives for research and
development activities, for the creation of infrastructure and information, and for the training
and development of human resources.
Purchasing Policies of the Public Sector

The public sector is the largest buyer in any country. Therefore, it can promote national
technologies by purchasing goods produced by means of new biotechnologies.
Safety
The application of biotechnology is not free from danger. Training courses should be
organized on safety measures and supported with manuals and other training materials.
Links Between Research and the Productive Sector

Research and development activities are carried out in universities, research institutes, and to
some extent in industries. In modern biotechnology, interactions between research centres
and the productive sector are critical. In sub-Saharan Africa, the critical mass can only be
achieved through subregional research centres. It is necessary that means be developed to
encourage research centres, industry, and government institutions to work together. Several
countries have a centralized policy, which helps to coordinate efforts. In other countries,
each research unit has its own interests and these are not necessarily related to solving
domestic problems. Such fragmentation prevents the pooling of scarce resources.
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Industrial Property
Modern industrial property laws should be developed because they help promote
biotechnology inventiveness. However, it is also important to place special care on the
information aspects of patents so that inventors can reveal their invention in exchange for
legal protection. For this measure to fulfil its objective of promoting the flow of knowledge,
the patent office must communicate information on patents through an active dissemination
system. However, many countries do not have the resources to implement such regulations.
For example, in 1989, Kenya adopted a patent law similar to British law. However, because
of lack of funds, there is no registering system and no employee to implement the system.
Development Assistance
When building a national capability for biotechnology, developing countries often receive
external donor support. Several programs have been established to assist Third World
countries to develop this national capability. When these programs are implemented it is
important that they have a clear focus so their effectiveness can be measured. As well, it
important to heed several lessons have been learned from the past: (1) biotechnology research
requires a long-term commitment by donors; (2) an enlightened "smart" human resources
management process is needed; (3) at least a minimal amount of infrastructure is essential;
(4) a thorough assessment of the needs of the target group is needed; and (5) it must be
flexible to allow for a multidisciplinary approach.
The United Nations System

Several UN agencies assist their members to develop human resources for biotechnology and
other closely related subjects. For example: United Nations Industrial Development
Organization; Food and Agriculture Organization; United Nations Environment Programme;
and United Nations Education, Science, and Cultural Organization.
The Consultative Group on International Agricultural Research

Because research is required to sustain what was achieved in grain production during the
"green" revolution, this consultative group (CGIAR) was established jointly by FAO, UNDP,
and World Bank. Within this system, there are now 17 research institutes in which
biotechnology is applied.
Through the crop improvement programs of these international agricultural research centres,
research programs are tackled with biotechnology and other appropriate techniques. Such
19
cooperation develops new capabilities and skills in the partner countries while developing
new varieties and agricultural techniques.
Bilateral Assistance
New techniques in biotechnology are derived mainly from cellular and molecular biology.
Because molecular biologists are scarce in most developing countries, it is difficult to tap into
existing applications, let alone develop new applications for local purposes. Technical
assistance programs cover many areas including biotechnology. These government to
government arrangements cater to the individual needs of each country. Both degree and nondegree training enhances human resources development. Often coupled with these programs
is the inclusion of the equipment necessary to establish laboratories.
Other Sources
International foundations and other donor organizations such as IDRC support the
development of biotechnology for developing countries. For example, a world-wide network
on rice biotechnology is sponsored by the Rockefeller Foundation. Transnational corporations
also have strong programs in biotechnology. Developing countries can take advantage of
these opportunities. It is clear that cooperation with the private sector is desirable, however,
caution should be exercised to ensure that concerns about biosafety and the control of new
technologies are taken into account.
Potential for Biotechnology

Biotechnology has the potential to modify and improve the economic and social conditions of
the populations living in the developing world. In the long run, it will create a new
worldwide "revolution" in agriculture. Biotechnology may well generate a greater impact in
this sector than the so-called "agro-chemical" or "green" revolution of the 1960s and 1970s.
It could allow developing countries to improve their self-reliance in both the quality and
quantity of the food they produce, to increase their competitiveness on the international
commodity markets, and to produce products to satisfy specific needs.
Biotechnology also has the potential to produce improvements in the health and energy
sectors of many developing countries and to help resolve difficult problems such as
population growth. However, to produce these benefits, it is essential that developing
countries themselves promote research, development, and the transfer and marketing of
technologies to end-users.
20
Limitations
The reduced per capita purchasing power of potential users of new products in most
developing countries stands in contrast to the availability of very lucrative markets in the
developed countries. This situation makes it less attractive for companies involved in
biotechnology research to establish research facilities or subcontract research in developing
countries. A few developing country governments, for example India and Brazil, have
supported the public research apparatus to produce relevant products from biotechnology.
They have been able to create and stimulate a scientific critical mass to capture the
opportunities offered by the new scientific breakthroughs in biotechnology. In these
countries, the emergence of an active private sector for the implementation of a sustainable
research and development system based on entrepreneurship is still at an incipient stage. The
development of business linkages between developed and developing countries remains a
difficult and challenging task.
The absence in most of the developing countries of the necessary policy framework and the
accompanying measures and regulations to promote biotechnology research and development
is an area that limits the transfer of technology and business linkages. A small number of
countries have recently adopted biosafety and intellectual property protection regulations. In
most of these countries, these measures and regulations have been copied from the outside.
Sometimes these regulations have been adopted without satisfactory participation from the
local industrial and scientific community. In some of these countries, the approved measures
and regulations have proven to be too costly to implement.
The high costs associated with biotechnology research, the lack of venture capital or public
funding to support the development of the appropriate infrastructure, and the operating costs
of the research itself in the developing countries are major limitations. It is clear that there is
a tremendous gap between the amount spent on the development of products for the
wealthiest people and the amount spent on products for the poor in developing countries. The
Official Development Assistance (ODA) devoted to biotechnology through multinational
instruments like the CGIAR centres in agriculture and the Tropical Disease Research (TDR)
program in the health sector, although not negligible, is far from being sufficient to
compensate for the lack of private capital.
The shortage of well-trained and experienced scientists is felt across the developing world.
Often new Doctoral graduates are unable to find the necessary physical and intellectual
environment to promote professional development and to acquire the necessary scientific
experience. Successful scientists are often those who have adopted an aggressive
entrepreneurial approach to obtain the resources necessary to achieve scientific results. Most
of the trainees who have conducted their thesis work in developed country universities have
21
had no exposure to enterprise development. In some cases, they have worked on themes of
limited relevance for their own environment and are poorly prepared to face the realities of
their own country.
Future Options
The development of a critical mass of high-level motivated scientists is crucial in all
countries. More resources from the development assistance agencies should be devoted not
only to the training of these scientists but also to the building of appropriate physical
environments where they can conduct their research. However, when a small country's
economy is too small to generate the necessary critical mass of scientists, every effort should
be made to generate multi-country initiatives to achieve efficient pooling of resources for the
benefit of all countries involved. Great effort is needed to develop imaginative solutions that
will reduce the negative impact of the brain drain and brain underemployment.
Entrepreneurs able and willing to capture the new opportunities offered by biotechnology
must be encouraged and supported. It is the responsibility of the governments and their
external assistance counterparts to create and support appropriate measures for
entrepreneurial involvement in biotechnology research and development.
Within the context of scarce resources, it is important that research institutes and academic
institutions take the necessary steps to identify the most relevant products for the target
population. When defining policies, government officials should favour a participatory and
dynamic process to define priorities and one that enables them to convert scientific results
into industrial uses. A supply-led type of entry into biotechnology has been most common in
developing countries and private sector involvement has generally been very low. With ongoing structural adjustment programs in many developing countries and trends toward
liberalization, there seems to be more interest in a market-led industry.
The stringent regulatory requirements in the developed countries contrast greatly with the
weak or even non-existent regulatory requirements in the developing countries. This prevents
developing countries from selling finished products to the developed countries or from
participating actively in the field testing of products directed mainly at developed country
clients. On the other hand, the shorter delays encountered in dealing with the regulatory
system in developing countries could help accelerate the commercial production of products
developed and marketed in and for developing countries. However, when the requirements
for industrial production are too complex, many developing countries may not be able to
manufacture at a low cost and may be forced to terminate their projects. Developing
countries will likely find it advantageous to promote product innovation from less costly and
less complex, but efficient, technologies.
22
External assistance programs should devote more resources to biotechnology in developing

countries. However, the effectiveness of this assistance should be closely monitored
particularly in terms of the impact and relevance of the research programs and projects.
External assistance will be necessary for long-term as well as short-term programs if the
increasing gap between North and South is to be reduced. Otherwise, biotechnology will
continue to marginalize Third World economies. New international frameworks like the
international agreement on the preservation of biodiversity should be adopted. This will help
free some financial resources for biotechnology in the South where most of the biodiversity
in the world is found.
Biotechnology can help resolve problems in the health sector of developing countries because
health is the area in which most work is now taking place. Biotechnology can also have a
great impact in agriculture, nutrition, and environment. Recent trends demonstrate that much
of the gain in agricultural productivity in the developed world today originates from
biotechnology. Another area that is still very much neglected and where a tremendous
potential for progress exists is the energy sector. Biotechnology for energy should be given
more attention. Nitrogen fixation, urban waste cycling, solar energy transformation, forest
conservation, and many other areas pertaining to the energy sector should receive more
attention.
23
24
Discussion Summary
Gaston Grenier
IIRSDA, B.P. V-51, Abidjan,
Me
d7voire
Developmental Recognition
Biotechnology has the potential to modify and improve the economic and social conditions of
the population living in the developing world. On long term, it will create a new "revolution"
in the agriculture worldwide. Biotechnology may well generate a greater impact in this sector
than the so-called "agro-chemical revolution" in the 1960s and the 1970s. It will give the
possibility to the developing countries to improve their self-reliance on adequate quantity and
quality of food and to increase their competitiveness on the international commodity markets.
Biotechnology has also the potential to resolve difficulties in the health as well as the energy
sector of many developing countries or to help in the resolution of difficult problems such as
the reduction of the population growth in some of the countries. However, in order to
produce all these benefits, it is essential that appropriate policies and instruments be adopted
in the developing countries themselves to promote research, development, and transfer of
technologies and their marketing to the end users.
Limitations to the Extension of Biotechnology in

Developing Countries
The reduced per capita purchasing power of the potential users of new products in most of
the developing countries stands in contrast with the availability of very lucrative markets in
the developed countries. The situation in developing countries prevents the large
multinational companies as well as the small ones involved in biotechnology research from
implementing research facilities or sub-contracting research works in these countries. A few
number of developing country governments such as India and Brazil have supported the
public research apparatus to produce relevant products from biotechnology. They have been
able to create and stimulate a scientific critical mass to capture the opportunities offered by
new scientific breakthroughs in biotechnology. In these countries, the emergence of an active
private sector for the implementation of a sustainable research and development system based
on entrepreneurship is still very slow. The development of business linkages between
developed and developing countries remains a difficult and challenging task.
25
The absence in most of the developing countries of the necessary policy framework and the
accompanying measures and regulations to promote biotechnology research and development
is another difficult area which limits largely the transfer of technology and the business
linkages. A small number of countries have recently adapted biosafety and intellectual
property protection regulations. In most of these countries, the measures and the regulations
have been copied from outside. Sometimes these regulations have been adopted without
satisfactory participation from the local industrial and scientific community. In some of these
countries, the approved measures and regulations have proved to be too costly to be
implemented.
The high costs associated with biotechnology research and the lack or venture capital or
public savings to support the development of the appropriate infrastructure and the operating
costs of the research itself in the developing countries are other major limitations. Although,
no figures have been mentioned, the evidence exists of a tremendous gap between the amount
of financial resources devoted to the development of products for the wealthiest population of
the planet and the poor who live in the developing countries. This reflects the fact that the
public opinion is more preoccupied by the rescue of its savings than by the social
restructuring and rehabilitation of the world. The Official Development Assistance (ODA)
devoted to biotechnology through multilateral instruments like the CGIAR centres in
agriculture or the TDR programs in the health sector, although not negligible, are far from
being sufficient to compensate for the lack of private capital.
The shortage of well trained and experimented scientists is felt across all the developing
world. Often the new PhD graduates will be unable to find the necessary physical and
intellectual environment to complete the development of their knowledge and acquire the
necessary scientific experience. The successful scientists have often adapted an aggressive
entrepreneurial approach to obtain the necessary resources to achieve scientific results. Most
of the trainers who have conducted their thesis work in developed country universities have
had no exposure to enterprise development. In some cases, they have worked on themes of
limited relevance for their country environment and are poorly prepared to face the realities
of their own country.
Options for Better Benefits to the Developing Countries

The development of a critical mass of motivated scientists is a crucial element in all the
countries. More resources from the development assistance agencies should be devoted not
only to the training of these scientists but also to the building of appropriate physical
environments where they can execute their research works. However, where the country
economy is too small to generate the necessary critical mass of scientists, every effort should
be made to generate multi-country initiatives in order to achieve an efficient pooling of the
26
resources for the benefit of all the countries involved. Every effort and imaginative solution
has to be found to reduce the negative impact of the brain drain and brain unemployment.
The development and support of new entrepreneurs able and willing to capture the new
opportunities offered by the biotechnologies must take place. It is the responsibility of the
governments and their external assistance counterparts to create and support the appropriate
measures for entrepreneurial involvement in biotechnology research and development.
In a context of scarcity of resources, it is important that the research institutions and the
academic institutions take the necessary steps to identify the most relevant products for the
largest population. In their process to define the policy framework and the accompanying
measures, the officials of the government should favour a participatory and dynamic process
for priority delineation and for the conversion of scientific results into industrial use. The
supply-led type entry into biotechnology has been the most common in developing countries
and the private sector involvement has generally been very low. With the likely influence of
the many on-going structural adjustment programs in developing countries and other trends
toward liberalization, there seems to be more interest for an industry and a market-led type
entry.
The stringent regulatory requirements in the developed countries contrast greatly with the
weak or even non-existing regulatory requirements in the developing countries. The situation
prevents the developing countries from selling finished products to the developed countries or
to participate actively in the field testing of products directed mainly at developed country
clients. On the other hand, the shorter delays encountered in dealing with the regulatory
system in the developing countries could help accelerate the commercial production of
products developed and marketed in and for developing countries. However, when the
requirements for industrial production are too complex, the developing countries may not be
able to manufacture at low cost and may be forced to terminate their projects. The
developing countries will find advantageous to promote product innovation from less costly
and complex technologies.
The external assistance programs should devote more resources to biotechnology for
developing countries. However, the effectiveness of this assistance should be closely
monitored particularly in term of the impact and the relevance of the research programs and
projects. External assistance will be necessary for long term as well as short term programs
if the speed at which increase the gap between the North and the South has to be reduce.
Biotechnology will continue to marginalize the Third World country economies. New
international frameworks like the international agreement on the preservation of biodiversity
should be adopted to free some financial resources for biotechnology in the South where is
located most of the biodiversity of the planet. There is a very close link between biodiversity
and biotechnology.
27
Biotechnology can help resolve problems in the health sector of the developing countries.
Health is the sector where most of the action is taking place. Biotechnology can also be of
great help in agriculture and nutrition. As recent trends demonstrate, a great part of the gains
in productivity of agriculture in the developed world today originates from biotechnology.
Another area which is still very neglected and where there exist a tremendous potential for
progress is the energy sector. Biotechnology for energy should be given more attention.
Nitrogen fixation, urban waste recycling, solar energy transformation, forest conservation
and many other areas pertaining to the energy sector should receive more attention.
Given the importance of the issues at stake and the complexity of the problems confronting
the development of biotechnology in the developing countries, it was the panel opinion that
IDRC should keep open the possibility of assembling a more permanent small group of
experts to help reflect on how IDRC and other similar bodies could adjust their policies and
programs to let the developing country populations, particularly the poor, access some of the
benefits of the new biotechnology.
28
Biotechnology in India
G. P. Talwar and Rahul
Pal
National Institute of Immunology, New Delhi, India, 110067
Abstract
Biotechnology, which seeks to generate new technologies using the concepts and tools of
modern biology has wide ramifications, with applications, amongst others, to agriculture,
biomass production, aquaculture, animal productivity, and human health care. The nature
and dimensions of problems in the developing countries are such that they call for new
technological solutions, where biotechnology can play an important role. Biotechnology is
nonpolluting and environmentfriendly. While it demands sophisticated scientific inputs, its
applications in many instances do not call for huge layouts. The benefit, say in agriculture, is
spread to large populations. It can help increase incomes and improve living standards.
Biotechnology development in India is for the time being entirely state supported. The
organization and the working of a new Department under the Ministry of Science and
Technology will be briefly described. During its brief existence (6 years), notable
achievements have been made in several fields.
Two new National Institutions devoted to Immunology and Tissue Culture have been
established. Also established are seven units in existing Institutions offering facilities for
oligonucleotide synthesis, blue-green algae collection, microbial type and fermentation

technology and supply of animals of defined genetic traits. Nineteen Institutions offer 2 year
course leading to Masters in Biotechnology. A chain of Informatics Centres equipped with
appropriate computers has been established in several Institutions, which are interlinked and
connected through Satellite to International Data bases and Libraries.
In the agriculture field, emphasis is on selection of good varieties and large scale availability
of biofertilizers, algae, rhizobium. Biopesticides for control of cotton destroying insects and
bacilli secreting larvicides for mosquito control are infield trials with beneficial results.
Culture of oil palm is now spread on 1000 hectares in more than one district as
demonstration plantation. Better varieties of tissue culture grown cardamom has enhanced the
yield several times. Elite tree plantlets of eucalyptus, teak wood, bamboos are being made
available in large number to promote biomass production and of orestation. Experimental
29
approaches have been refined to induce breeding offishes by LHRH analogues, and the
cultivation ofprawns with biotechnology inputs has enhanced the yield to 8.5 to 10
tonnes/hectare/year.
Cattle herd improvement is being achieved by a two pronged strategy. An injectable
=SUR) has been developed which sterilizes male bulls without loss of vigour for draught
and traction purposes. This will help stop the proliferation of low genetic stock poor
productivity animals. At the same time, these bulls act as sensors for detection of estrus,
enhancing success of insemination with high genetic stock semen. Employing super ovulation
and non surgical embryo transfers, a nursery of elite animals can be created. Of interest is
the standardization of Desi stray cows to serve as surrogate mothers for gestation of high
quality calves.
Employing hybridoma technology, highly accurate and simple to use diagnostic kits have been
developed for amoebiosia, typhoid, filariasis, and hepatitis besides indigenous low cost kits
for pregnancy, blood groups. Kits are under development for tuberculosis, leprosy, malaria,
and Streptococcus A. These are expected to be of great help in correct and early diagnosis of
widely prevalent diseases and provision of timely rational treatment.
A vaccine with remarkable immuno-therapeutic properties for leprosy is in
Phase III field

trials. It shortens not only the period for cure of multibacillary patients, thereby saving cost
of medical care, drugs and better patient compliance, but it also upgrades the immune
responses of these deficient patients to resist relapses on reinfection.
major problem of India (and all developing countries) is the rate of population growth,
which decimates largely the increase in food production and other amenities. India has
currently 16 % of the World Population with only 2 % of global area. To the 875 million,
69, 000 people are added every day. A novel category of vaccines for control offertility are
being developed. One of these, directed against the pregnancy hormone, has just completed
the first leg of Phase II clinical trials, in which its ability to protect against pregnancy has
been demonstrated. Earlier the safety, reversibility and lack of side effects of this vaccine
were determined by a series of Phase I clinical trials in India andfour other countries.
Although much more work remains to be done before the vaccine reaches general public use,
the first birth control vaccine is on the horizon. Incidentally these researches received critical
grant support from the IDRC of Canada. Ancillary developments, namely two potential
products for control offertility by use ofpurified extracts of Neem, which have contraceptive
and also antimicrobial and anti viral action are of conjoint interest. A recombinant version of
the birth control vaccine is also under development, which would be considerably cheaper
and amenable to mass scale use.
A
30
Biotechnology seeks to generate new technologies using the concepts and methods of modern
biology. It has wide ramifications with applications of benefit to agriculture, aquaculture,
animal productivity and human health care. Although the roots of this technology are ancient
and have been employed in fermentation processes for many years, the "new biotechnology"
has emerged only about 15 years ago. With its immense potential and useful applications, it
has attracted world wide attention. It is of particular benefit to developing countries where
the nature and dimensions of problems call for new technological solutions. Biotechnology is
multidisciplinary and interactive; its practice. however, in many. instances does not require
huge layouts.
In India, the biotechnology effort is primarily supported by government funds. The
Government of India constituted the National Biotechnology Board in 1982. and the
Department of Biotechnology (DBT) was started as part of the Ministry of Science and
Technology in 1986. The Prime Minister is the Union Minister for science and Technology.
DBT is headed by a Secretary who is an eminent scientist. The Department has the usual
government structure, although many positions are manned by scientists over and above those
handling administrative responsibilities. The Department has constituted national and overseas
Scientific Advisory Committees. It has set up 13 Task Forces in the areas of (i) Plant
Molecular and Agriculture Biotechnology, (ii) Biological Pest Control, (iii) Fuel, Fodder,
Biomass, Horticulture, Plantation Crops and Sericulture, (iv) Environmental Biotechnology,
(v) Aquaculture and Marine Biotechnology, (vi) Veterinary Biotechnology, (vii) Medical
Biotechnology, (viii) Biochemical Engineering, Downstream Processing and Instrumentation,
(ix) Microbial Biotechnology, (x) Industrial Biotechnology, (xi) Basic Research, Emerging
Areas and R&D Facilities, (xii) Bioinformatics, and (xiii) Integrated Manpower
Development. DBT started with a budget of Rs. 142 crores in the 7th Plan (1985-1990). The
projected budget for the period 1992-1997 is Rs. 650 crores (a crore = 10 million).
The Department has undertaken and supported several programmes. Two Institutions have
been established with the core budget from DBT. These are the National Institute of
Immunology (NII), New Delhi and the National Facility for Animal Tissue L Cell Culture
(NFATCC). Pune, which are both premier institutions of the country.
Infrastructural facilities have also been set up for oligonucleotide synthesis at the Indian
Institute of Science, (IISC) Bangalore, the CSIR Centre for Biochemicals, New Delhi and the
Centre for Cellular and Molecular Biology (CCMB), Hyderabad. National Facilities on
Microbial Type Culture Collection a; the Institute of Microbial Technology (IMTECH)
Chandigarh, and on Blue Green Algal Collection at the Indian Agricultural Research Institute
(IARI), Delhi, have also been set up. A National Animal House Facility has been established
at the Central Drug Research Institute (CDRI), Lucknow and the National Institute of
Nutrition (NIN), Hyderabad. These facilities have been created or upgraded in existing
institutions.
31
For manpower training, DBT has started MSc. Biotechnology courses in 19

universities/institutions of the country. These programmes attract some of the brightest
students in India. The course content and training programmes are of an inspirational and
stimulatory nature. DBT has also instituted short term training courses, of 2-4 weeks
duration, in biotechnology with the aim of providing hands-on experience in areas of modern
biotechnology to mid-career scientists. About 1200 scientists have so far been trained in
various techniques. In addition. the Department awards 20-25 Post Doctoral Associateships
every year, enabling scientists to undergo training at other National Institutes on relevant
research projects. Short term (3 months) and long term (1 year, extendible to 2 years)
overseas Associateships are also awarded to scientists holding regular positions, for
pursuance of advanced research in high priority areas.
DBT has established a national network for information relating to biotechnology which
connects several important centres in the country. The Apex Centre of the Biotechnology
Information System is located at DBT and is associated with nine Distributed Information
Centres (DICs) established at various R&D laboratories, which store and disseminate
information in the areas of (i) Genetic Engineering, (ii) Animal Cell and Virology Culture,
(iii) Plant Tissue Culture, Photosynthesis and Plant Molecular Biology, (iv) Oncogenes,
Reproduction Physiology, Cell Transformation, Nucleic Acid and Protein Sequences, (v)
Immunology, (vi) Enzyme Engineering, Immobilized Biocatalysts, Microbial Fermentation
and Bioprocess Engineering. DICs also interact with Distributed Information Sub-Centres
established at different locations of the country. All DICs are inter-connected via satellite
through the National Informatics Centre Network (NICNET). Besides providing access to
databases such as MEDLAR, as well as updated information on international patents,
NICNET also provides on-line access to international databases such as the Brookhaven
protein Data Bank and the Cambridge Structural Data Base on X-ray and Neutron Studies.
This set-up has in a short time revolutionized the access of the scientist to biotechnology
related information within and outside the country.
Research projects supported by DBT are located in various institutes of the country. Progress
is monitored by Scientific Monitoring Committees meeting at least once a year and
sometimes more frequently. Site visits are conducted for major projects. Some of the
achievements made during the last five years of the existence of DBT are summarized below,
particularly those which bear relevance to problems of developing countries.
Agriculture
The current production of food grains is about 170 million tonnes/year. Based on current
trends of population increase, the requirement by the year 2000 is projected to be 250 million
tonnes/year. This would call for evolving strategies for the integrated management: of water
32
and soil resources. While the Indian Council of Agricultural Research (ICAR) is primarily
involved with the development of new varieties of seeds, several important elements
contributing to our efforts to achieve the requisite target of food production are being
supported by DBT. These pertain to the development of biofertilizers, biopesticides and to
the cultivation of oil palm. DBT has also supported programmes that aim at increasing the
production of cardamom and other cash crops.
Biomass Production
The forest cover of India has dwindled and currently stands at 11 %. For ecological reasons,
as well as for the provision of wood for fuel and for meeting industrial need for paper, an
intensive programme of biomass cultivation has been initiated. Biotechnology offers a unique
opportunity in this are - the ability to cultivate an elite tree in a test tube. Two pilot plant
units for research and development in plant tissue culture techniques and for mass production
of saplings have been set up at the National Chemical Laboratory (NCL), Pune and the Tata
Energy Research Institute (TERI), New Delhi. Plantlets of two species of bamboos,
Dendrocalamus strictus and Bambusa arundinacea have been grown using these techniques.
7000 plantlets have been transferred to field status in the states of Uttar Pradesh, Orissa,
Karnataka and Delhi and are being evaluated with regard to their growth characteristics.
Tissue culture technologies are also being developed for mass propagation of important forest
trees like. eucalyptus, teak and sandalwood.
Cardamom
This spice has a high export potential, but yields in the country have only been of the order
of 60 Kg/hectare, about a quarter of what has is achieved in some other areas of the world.
Field trials using elite tissue culture developed clones have been initiated in several
cardamom growing regions.
Edible Oils
The country's requirement for edible oils far exceeds production, necessitating imports worth
several hundred crores of Rupees per year. Palm oil constitutes a major portion of these
imports. Oil palm yields are the highest amongst the edible oil producing crops, being about
4-6 tonnes/hectare. Imported and indigenous seeds have been planted over areas of a 1000
hectares each to demonstrate the feasibility of oil palm cultivation under irrigated conditions.
In addition, efforts to propagate oil palm using tissue culture techniques are also underway.
33
Bidertilizers
To achieve high yields, adequate nutrients have to be supplied to crops. Nitrogen, essential
for sustained growth, has conventionally been provided by chemical fertilizers, made using
expensive, energy-intensive processes. The use of biologically-fixed nitrogen thus has
obvious appeal. About 140 million tonnes of nitrogen are added annually to the earth's
surface by nitrogen fixing organisms. The National Facility for Blue Green Algal Collection
at New Delhi collects, screens and identifies new nitrogen fixing blue-green algal
(Cyanobacteria) strains which can be used to enrich soils used for cultivation of rice, pulses
and oil-seeds, with the ultimate aim of reducing dependence on chemical fertilizers. Research
in this area is also being carried out at the Madurai Kamaraj University, Madurai, the Tamil
Nadu Agricultural University, Coimbatore, the College of Agriculture, Pune, the Council of
Science and Technology, Lucknow and the Sri Ramakrishna Ashram, Nimpith.
Blue-green algae have been tested for their ability to provide nitrogen inputs in the rice
ecosystem. Inoculation of the algal culture is normally done seven days after transplantation.
Field trials have shown that algal inoculation contributes to an increased yield of 5-14 %.
Studies have shown that the amount of chemical fertilizers required for optimum yields is
considerably reduced in fields where algal inoculations have been carried out. Algae have
several other ecological advantages. They have the ability to concentrate nutrients such as
Nitrogen, Phosphorus, Carbon and other trace elements. They can also scavenge sodium and
are therefore beneficial in salt-affected soils.
Rhizobium strains are being developed and tested at the National Facility for Rhizobium
Germplasm Collection, New Delhi and will be supplied to different laboratories for field
trials. Success has been achieved in growing some of these strains in fermenters. Laboratory
testing for nodulation in a variety of pulses, groundnut and soyabean are in progress.
Biopesticides
Insects and crop diseases result in significant drops in yields. Chemical insecticides and
pesticides, in addition to being expensive, are frequently absorbed by plants and transmitted
down the food chain, with potentially harmful consequences. In addition, a certain degree of
tolerance often develops to many of these agents, necessitating the use of higher doses. The
search for new, environmentally-friendly agents is therefore of paramount importance.
biological control agents have been developed and field tested, with the aim of selectively
destroying crop pests. These are: (i) Baculoviruses - Nuclear Polyhedrosis Viruses (NPVs,
for the control of Heliothis armigera and Spodoptera litura); (ii) Parasites and predators Chysopa (for the control of aphids, white flies and bollworms); Trichogramma (for the
control of Lepidopteran pests; and (iii) Fungal/Bacterial Antagonists - Trichoderma, T.
harzianum, T. koningi, Gliocladium virens and B. subtilis.
34
These biocontrol agents, alone or in combination, have shown promise in cotton, chickpea,
sugarcane, groundnut, cauliflower and tobacco cultivations in field trials carried out over a
total plantation area of 1000 hectares. In particular, the sequential release of Trichogamma,
Crysopa and the two NWs resulted in higher yields of groundnuts.
Aquaculture
In order to increase significantly the breeding of freshwater fish, a hormonal approach
involving the use of synthetic GnRH analogs has been developed at the National Institute of
Immunology (NII), New Delhi. Injection of microgram quantities of such analogs which can
be synthesized in abundant quantities, induced breeding of cat fish, carps. and major carps.
The hormonal treatment can be repeated every few months in temperature and photoperiod
controlled hatcheries, making possible the off-season breeding of these fishes in large
numbers. These technologies have been field-tested in fish farms in Tuticorin and
Manimuthar, Tamil Nadu.
Biotechnological inputs have helped increase prawn yields to 8.5 tonnes/hectare/year in
Andhra Pradesh and Orissa, using semi-intensive farming techniques. The project aims at
obtaining yields of 10 tonnes/hectare/year for two successive years. Future plans include
standardization of in vitro fertilization techniques and long-term cryopreservation of prawn
larvae.
A programme for the development of growth hormone transgenic fish is underway at

Madurai Kamaraj University in efforts to achieve an enhanced growth rate, using Tilapia and
Zebra fish as model systems.
Cattle Herd Improvement

India has nearly 300 million cattle. More than two-thirds of this vast number are low
productivity animals. Religious beliefs do not permit their slaughter. An injectable agent has
been developed at NII which sterilizes male animals without loss of libido. This invention has
received the New Drug Authorization and has been recently licensed to a company in
Bangalore. It is being marketed under the trade name "Talsur". Talsur renders the bulls
azoospermic. As testosterone levels do not fall, these animals can be employed as biosensors
or "teaser" bulls to detect females in heat. This is particularly useful in buffaloes where the
estrus is silent. As the fertile life of the egg is one or two days, detection of ovulation is
35
important for timely insemination. The availability of such teaser bulls will therefore be of
special utility for animal husbandry of buffaloes which constitute the backbone of the white
revolution. Talsur has thus the dual benefit of controlling the proliferation of scrub animals
and of being an important additive to A.I. programmes.
Another programme launched by the DBT is in embryo transfer technology (ETT) for cattle
herd improvement. The programme has been conducted as a Science and Technology
mission, with participation of National Dairy Development Board (NDDB), the National
Dairy Research Institute (NDRI), Indian Veterinary Research Institute (IVRI), and the
National Institute of Immunology (NII). The objective of the project was to create a nursery
of elite animals. By this technology, high milk-yielding cows or buffaloes could engender up
to 150 calves instead of 6 - 8 achievable by traditional breeding practices. The technology
comprises of hormonally superovulating elite donor animals, obtaining embryos nonsurgically
by flushing and their non-surgical transfer to animals of low genetic quality. Another
important benefit of ETT is the employment of local stray cows of low productivity as a
surrogate mothers to produce high genetic stock animals. The project has been highly
successful. Embryo banks have been established at several places. Techniques have been
developed for obtaining higher yields of embryos per flush in both cows and buffaloes.
Genetically identical twins have been obtained by transfer of embryos split by
micromanipulation, doubling in a way the overall yield. The project would seek in the next
five years to develop technologies for obtaining eggs without the use of exogenous hormones,
their in vitro maturation and fertilization. Transgenic animals will be developed by insertion
of genes far desirable products such as erythropoeitin. Techniques will be further refined and
evaluated for sexing and cloning of embryos.
Human Health
Biotechnology has ushered in new possibilities for products and processes additive to human
health care. Human growth hormone (hGH) has been prepared in abundant quantities by
recombinant DNA techniques. The hormone from beef or pork is not usable in humans due
to species restrictions. Before it was available from the genetic engineering route, the only
source was extraction from cadaver pituitaries, evidently a meagre source for general supply.
A genetically engineered vaccine to prevent Hepatitis B infection is also in the market after
due clinical and safety trials. Other recombinant DNA products which have already reached
the market are human insulin, a and 7 interferons, tissue plasminogen activator,
erythropoeitin etc. The list is growing. Much of this progress has for the time being taken
place in industrially developed countries. The developing countries are also entering this
arena. At NII, we have obtained the B chain of cholera toxin/heat labile enterotoxin in large
yields, employing a mutant bacterial expression system. Work is at an advanced stage for
obtaining hGH as well buffalo growth hormone. The latter increases the milk yield of
36
buffaloes by about 20% and also results in a better feed conversion quotient. We are also
working on efficient expression of the u and P subunits of human chorionic gonadotropin
(hCG) in an insect expression system.
Immunodiagnostics
Hybridoma technology enables the production in unlimited amounts of antibodies of defined
characteristics. These in turn are the key reagents for developing accurate, sensitive but
simple to use methods for diagnosis. At NII, diagnostic kits have been developed for both
invasive and enteric amoebiasis. The tests are rugged, with a shelf of about a year. The
diagnosis is available in the form of a colour change on a dip-stick in 35 minutes, employing
a drop of finger prick blood. According to the WHO, 10% of the world population carries
amoeba and 1/10th of these individuals suffer from clinical disease. Another unique test
developed at NII is for the diagnosis typhoid. Hitherto, the Widal test commonly employed
in laboratories could provide indications only 8-10 days after the onset of pyrexia. Our new
test provides the right diagnosis on day 1, enabling the quick initiation of chemotherapy.
What is more, the kit combines a drug sensitivity test which provides indications on the
optimum choice of drug(s) for treatment of a given patient. The drug sensitivity test is now
becoming necessary in view of the wide spread resistance of Salmonella to habitual drugs.
Both these tests have been licensed to Industry after extensive Institutional and field testing.
They would be useful not only in India but also in other parts of the world where these
diseases are rampant. Other kits which have been developed can help in diagnosis of filaria
and leishmania. The NII has also developed highly specific tests for the detection of M.
tuberculosis and Hepatitis B, employing DNA probes +/- PCR. Tuberculosis is the major
disease in India, with 2 million new patients and half a million deaths every year.
An Immunotherapeutic/Immunoprophylacdc vaccine for Leprosy: India has the world's
largest number of leprosy patients. These 4 million patients are spread all over the country
and cannot be logistically isolated on an island, as could be done in Japan. The disease
manifests itself as a clinical spectrum related to the immune status of the patient.
Multibacillary lepromatous leprosy (LL) patients have the extreme deficit and do not exhibit
cell mediated immune responses to M. leprae. The bacilli proliferate in their tissues and
spread' as an infection to others. For all practical purposes, these patients constitute the
reservoir of the infection. Like small pox, it is theoretically possible to eradicate leprosy if
the immune responses of these patients can be upgraded so that they do not serve as
hospitable territory for bacterial growth. In fact, 99% or more of humans in endemic ares
with normal immune apparatus can resist infection.
About 14 years ago, we were able to develop a candidate vaccine which could invigorate
immunity in deficient LL patients. The vaccine employs a killed suspension of a non-
37
pathogenic soil mycobacteria which shares antigens with M. leprae and M. tuberculosis. This
vaccine is currently in large scale Phase III trials. In two hospitals in Delhi, it has been used
for the treatment of multibacillary patients as an adjunct to multi drug therapy (MDT).
Multibacillary LL patients take 2-5 years of treatment with MDT to become bacteriologically
negative. Inclusion of the vaccine once every 3 months shortens the recovery period
significantly. What is more, vaccination converts 80% of these patients to a status of
lepromin positivity, which drugs alone do not bring about. The vaccine has also been
effective in drug resistant patients. This vaccine is currently in field trials in Kanpur District
in a population of 362,000, in collaboration with the National Leprosy Eradication
Programme.
New Methods for Fertility Control

India's population is increasing at the rate of 2.1 %, which means that more than 17 million
are added every year to an already large figure of 876 million. 69,000 people are added
every day. Control of population is a priority of the country and for that matter, of the entire
developing world. Several factors such as education, status of women, regulation of child
labour, general level of economic development would no doubt influence the acceptance of
family planning methods. However, there is also need for socio-culturally acceptable methods
with low user-failure risk. Our group has been involved with the development of birth
control vaccines. These methods would require periodic intake and if properly designed,
would not interfere in the normal physiology of the non-pregnant female. Steroidal
contraception, though highly effective, blocks ovulation and provides synthetic female
hormones exogenously.
The vaccine which is at present at the most advanced stage of development is directed against
hCG, a hormone which is made in appreciable amounts only in situations of pregnancy or
some cancers. If is an early signal of conception and is important for the establishment and
sustenance of pregnancy. The rationale of the vaccine is to induce the formation of antibodies
which can inactivate hCG as and when it is formed. Thus, corpus luteum function is not
sustained and the woman menstruates even if fertilization has taken place. hCG is self
hormone and would not by itself cause the formation of antibodies. It was rendered
immunogenic by tagging the P subunit of hCG to a carrier such as TT (the a subunit is not
employed for vaccination purposes for fear of undesirable cross-reactivity to follicle
stimulating hormone and thyroid stimulating hormone, which share this subunit). This
structured vaccine engendered antibodies against both hCG and TT, the latter providing
protection against tetanus. a largely prevalent mortal infection at the time of delivery.
The vaccine has undergone extensive safety studies. Being the first vaccine of its type, a
series of toxicology studies. including life-long toxicity studied in monkeys, were carried out
to establish the safety and reversibility of the vaccine. phase I clinical trials with this vaccine
38
were conducted in 9 centres in India, Finland, Sweden, Chile and Brazil. These studies
demonstrated that the vaccine was immunogenic. Menstrual regularity was maintained and
ovulation remained undisturbed. Clinical chemistry and haematological parameters in
immunized women were normal and there was no evidence of immunopathological
reactivities. The vaccine was reversible in every case.
Phase II efficacy trials have been carried out in 3 major Institutions of the country. The main
objective of these trials is to determine whether women of proven fertility can be protected
from pregnancy by immunization with this vaccine. If so, the trial seeks to determine the
level of antibody titres necessary to prevent pregnancy. As on March 31, 1992, 752
protected cycles were recorded in highly fertile women, with only one pregnancy having
taken place at antibody titres greater than 50 ng/ml. Several women were exposed to the risk
of pregnancy for periods ranging from 12-22 months. This is first time anywhere in the
world that a birth control vaccine has been clinically tested to be effective in preventing
pregnancy.
These trials have demonstrated that the vaccine is protective in principle. To make it a
logistically usable product, however, further refinements would be necessary. The following
strategies are under investigation:
(i) During primary immunization, a woman has to receive 3 injections of the vaccine at 6
weekly intervals to attain antibody titres beyond the protective threshold. It is necessary to
provide reliable contraception during this period by an ancillary approach which does not
interfere with the immunological response against the vaccine. Our group has prepared a
purified extract from the Neem tree (Praneem), which, after a single application in the
uterus, prevents pregnancy for at least 3 months without effecting ovulation and hormonal
profiles. The treatment is akin to a vaccine, inducing locally cell mediated immunity
(VILLI). Acute and subacute toxicology studies have been completed with VILLI. An
application has been made to the Drugs Controller of India for permission to start a Phase Ub
clinical trial combining VILLI and the hCG vaccine. Research on Praneem has also given
rise to a polyherbal vaginal cream and pessary with dual properties of contraception and antimicrobial and antifungal action. These preparations have entered Phase I clinical trials in
China, Nigeria and Brazil under the South-to-South Collaborative Programme.
(ii) It would be desirable to administer multiple doses of the vaccine at a single contact point.
Biodegradable microspheres are under development, which can release the entrapped vaccine
over a period of time to generate antibody responses similar to or better than those obtained
by conventional multiple immunizations.
(iii) A vaccinia virus based anti-hCG vaccine has also been developed which is highly
immunogenic in rodents and primates. The use of vaccinia or related viruses for anti-hCG
39
immunizations in women may not only help reduce the frequency of injections, but will also
bring down considerably the cost of the fertility control vaccine. Clinical trials of a
recombinant vaccinia hCG vaccine virus have started in patients of non-small cell carcinoma
of the lung. This cancer makes hCG and its subunits which are autocrine growth factors for
the proliferation of tumour cells. No effective chemotherapy exists for this type of the
disease at present.
Although vaccinia based vaccines for HIV have been approved for Phase I trials in humans,
and vaccinia rabies and rinderpest vaccines are in use in animals, it may be necessary to
develop a recombinant vaccine that does not replicate in humans. Fowl pox viruses are
worthy of investigation as vectors for a recombinant fertility control vaccine.
It may be appropriate to acknowledge that the International Development Research Centre

(IDRC), Canada provided supported for the development of the hCG vaccine from the early
stages when it was a novel and venturesome idea. Thanks to this support, the work could
proceed and reach the present stage where the hCG vaccine appears to be a reality.
Many laboratories all over the world are today engaged in the development of fertility
control vaccines. Besides hCG, vaccines are also under development against follicle
stimulating hormone (FSH, for the control of male fertility), luteinizing hormone releasing
hormone (LHRH. as a post partum contraceptive for the extension of lactational
ammenohorea) and against sperm and zona pellucida antigens. The LHRH vaccine has
undergone early Phase I trials; the FSH vaccine is due to enter Phase I trials soon. Other
vaccines are currently at the experimental stage. Hopefully, many of them would become
workable propositions.
In view of the fact that immune responses are genetically regulated. no single vaccine may
work in all recipients. To obtain near to 100% response, it may be necessary to employ
poly-vaccines which target more than one reproductive tract antigen.
40
Development of Biotechnology in Asia

Setijati D. Sastrapradja
Center for Research in Biotechnology, Jalan Juanda 18, P.O. Box 323, Bogor, Indonesia
Abstract
National development of the developing countries in Asia is challenged with similar problems
in the decades to come. Population pressure, food and nutrition insufficiency, environmental
degradation, job creation, are just a handful of realities that most of them should face.
Therefore, any energy technology which promises hopes such as that of biotechnology, is
greeted with enthusiasm. This paper is reviewing what happened in Asia as far as
biotechnology is concerned. Of the many opportunities shown in various international and
regional fora, it seems that the region of Asia has comparative advantages in developing
agricultural biotechnology. Lack of trained manpower in the field of molecular biology and
financial resources are identified as common phenomena. Another serious constraint is the
weak linkages among research institutes. In most countries, the public sector is the leading
actor with little participation from the private sector, if any. Development assistance has been
received from various donors. The effectiveness of such assistance, however, should be
evaluated if biotechnology is aimed at its application. Linked with this application is the
question of the Intellectual Property Rights and the issues of biological material ownership.
Finally, it is hoped that sustainable efforts should be attempted to guarantee its long time
results.
Introduction
In recent years new cluster of technologies have emerged propelling further the progress of
industries in the developed countries. Biotechnology is identified as one of that cluster which
plays a leading role (Colombo, 1991). With biotechnology, low volume high cost new
products, clean and faster bioprocesses and environmental services are promised. Because of
its bright application potentials and because of its intense advertisement, biotechnology is the
topic of the day discussion, not only in the developed countries, but also in the developing
countries. Asian region is not exempted from such an enthusiasm.
41
In term of economic development, the status of the countries in Asia varies. Some are
considered as well developed, but some belong to the lowest income group. Population wise,
three countries in Asia are among the four largest nations in the world. Many countries in
Asia, fortunately, are rich in biological diversity. Traditionally, this diversity has been
employed to fulfil the basic needs of the people. Moreover, part of the states income derives
from agricultural commodities which are nothing but biological resources. In employing the
biological resources, technologies are indeed important. On the contrary, certain technologies
such as that of biotechnology need biological resources for their advancement. The reciprocal
dependency of biotechnology and biological resources is sometimes overlooked.
Several regional fora of biotechnology have been organized in Asia. The topics for discussion
vary ranging from policy development, technical matters, to public awareness. This paper
reviews what have been done in Asia as far as biotechnology is concerned, the opportunities
it offers and the limitations it has. Special reference is given to the most populated countries,
i.e. China, India, and Indonesia, in which agriculture plays an important role on their
economy.
Why the Enthusiasm?

Every year the World Resource Institute, together with UNDP and UNEP, produces a
publication on World Resources. Based on the data presented for 1990 - 1991, it was obvious
that the world's population is still growing. Compared to other regions of the world, Asia is
the most populated region. The estimated figures for 1985 were: China 1,000.9 million,
India 754.6 million, and Indonesia 166.0 million (WRI, 1990 - 1991). Further it was stated
that the annual rate of increase for Asia was 1.85 %, which is higher than the world average
(1.73%). The projected figures for 2025 are: China 1,492.6 million, India 1,445.6 million,
and Indonesia 263.3, with the average annual population changes are 1.39%, 2.08%, and
1.62%, respectively for the period of 1985 - 1990. The average of Asia for that period is
1.85 %. It means that India is above the Asian average and thus its projected number for
2025 is closer to China. The increase of the number of population is not necessarily followed
by the increase of the quality of life.
One of the indicators of development is life expectancy at birth. In all countries of Asia, life
expectancy has risen from 53.3 in 1965 - 1970 to 61.1 in 1985 - 1990. However, there are
countries which are under this average. India, Indonesia, Nepal, and Pakistan are among
these countries. Another indicator is income. Caring for the Earth (1991) lists 160 countries
with lower income, middle income and upper income. Most countries in Asia fall into low
income or lower middle income. Only a few are categorized into high income countries.
Among the last group, belong Japan, Hongkong, Singapore, and Brunei. Though quality of
life has risen in Asia, poverty has not been washed out completely. It is true that world food
42
production, especially in developing countries, has increase remarkably during the past 23
years. The success was achieved, among others, through the application of high yielding
varieties and the fertilizers/pesticides they required. Moreover, arable land was available for
the expansion of land under cultivation. Food production to meet the needs of the increasing
population faces new challenges (Brady, 1990; Swaminathan, 1991). Under present
agricultural practices, there is a sign that production of high yielding varieties is beginning to
level off. Arable land in some developing countries is no longer easy to be found, forcing the
farmers to use more marginal land. Meanwhile, excessive application of fertilizers and
pesticides in many developing countries has degraded the environment. To meet with these
challenges, new appropriate technologies are required; hence, the enthusiasm of the
developing countries to join the world community in their endeavour to speed up the
application of biotechnology for agricultural development.
For many developing countries in Asia, agriculture is not only to produce food, but also to
earn foreign exchange. For centuries, countries like India, Indonesia, Sri Lanka, and
Malaysia are the exporters of agricultural commodities. Large area in Asia are occupied by
plantation of oil palm, tea, coffee, cacao, sugar cane, cotton, etc. Production technology for
those commodities are well developed. To compete in the world market, however,
technology for processing should be refined from time to time. The market of natural sugar
is greatly reduced due to the application of biotechnology for sweetener production
(Hobbelink, 1991). The next target is cacao market. Realizing the threat, the developing
countries in Asia are more than eager to grasp biotechnology to increase the added value of
their commodities.
Asia is also home of medicinal plants which have been used traditionally to maintain health
and cure illness. Pharmaceutical industries are in the need of the products of those species to
be processed further into high value substances. In addition to this group of species, there are
species which are sought for cosmetic industries. Industrial application for pharmaceutical or
cosmetic products will certainly affect the developing countries either positively or
negatively.
That many countries in Asia are rich in biological resources was highlighted recently when
the world community expressed their concern on their fast erosion. Of the twelve Vavilovian
centers of economic plants, four are located in Asia (Zeven and Zhukovsky, 1975). Many of
these species have not been improved scientifically. Several of them have limited distribution
and valuable only to the local communities. The adapted values of the traditional varieties to
local condition are important component to developing new varieties for specific purposes.
Biotechnology is of a great help to identify the desired characters. Moreover, biotechnology
shorten the period needed for incorporating the characters into a new combination. Such a
specific goal may escape from the global interest. Besides, the problems can only be solved
where they exist.
43
Linked with the biological resources are the forest resources in which myriads of plants,
animals and microbes live. It is well noted that the world's forest has declined with time
especially that in the tropics. Agricultural expansion, wood extraction, resettlement program
are among the causes of the decline. Accelerated change in forest areas of the tropics has
occurred throughout the 1980's. In Asia, the notable reduction of forest areas are in India,
Indonesia, Myanmar, the Philippines, and Thailand (WRI, 1991). Indonesia and Malaysia,
for example, are the home of dipterocarps - timber species - which many of the species are
endemic to this region. Species endemism is also true for animals. With the go of the
dipterocarp family, also gone the animal species and others which economically are unknown
yet. What left behind is the barren land needed to be reforested. This, in turn, requires
millions of planting materials, which through traditional propagation means are hardly
sufficient. The potential of biotechnology for rapid multiplication of the desired species give
hope. Moreover, through biotechnology the early selection of the species in which seeds are
produced without difficulty can be accomplished. In short, Asia - together with the rest of
the world - is welcoming the era of biotechnology with enthusiasm. There are many
problems existing in Asia which biotechnology is expected to be of use in solving them.
Therefore, activities in research have been initiated two decades ago mostly in the public
sector.
What Has Been Achieved in Asia?

Governments in Asia do believe that the application of biotechnology in industry, health and
agriculture will soon be a reality. Therefore, research and development in biotechnology has
been put as one of the priorities. Accordingly, every country in Asia, rich or poor, has
initiated activities in biotechnology. Those countries which have advanced infrastructure and
sufficient resources are ready to absorb the new techniques developed in this field. In no time
the scientific community in these countries was able to master techniques such as gene
cloning, gene transfer, DNA-finger printing, cell immobilization, etc. Other countries with
much limited resources are struggling to make themselves not to be left behind.
To get an idea how strong the countries in Asia in biotechnology, Greenfield (1991)
presented a table as follows:
44
A PERCEPTION OF RELATIVE COMMERCIAL AND RESEARCH STRENGTH IN
BIOTECHNOLOGY
HIGH
USA
WESTERN EUROPE
AUSTRALIA
JAPAN
CANADA
RESEARCH STRENGTH
IN BIOTECHNOLOGY
REPUBLIC OF KOREA
SOUTHEAST ASIA
HIGH
LOW
COMMERCIAL STRENGTH IN BIOTECHNOLOGY
From the figure given, it is obvious that most Southeast Asian countries fall into low
research strength and low commercial strength in biotechnologies. Japanese, being an
industrial country, is comparable in rank to USA. There were 143 products in various stages
of development were of biotechnology derived pharmaceutical products which were processed
by a group of Japanese companies. Korea, on the other hand, has high commercial strength
but its research strength is low. To improve this condition, a tripartite system of research and
development, involving universities, government research institutes, and industries, has been
developed (Chung, 1991). As many as 19 companies join efforts to conduct research and
development in industrial biotechnology. Singapore, realizing that the world market is
difficult to enter, through its Institute of Molecular and Cellular Biology (IMCB) has yet a
joint venture research with GLAXO (Sercovich, 1991). In the field of medical biotechnology,
Asia is aiming at the development of diagnostic kits and vaccines for major tropical diseases,
such as hepatitis B and dengue fever. Research on various aspects of medical biotechnology
has taken place in the public sector, especially in developing countries in Asia, in conjunction
with the public health care. The Japanese institutes are again leading in this endeavour. A
Chinese institute offered monoclonal antibodies against human T lymphocytes, for example
(Biotechnology and Development Review, 1991). Most widely used technique in agricultural
biotechnology is tissue culture. Commercially, it is used in the production of potato and
flowers. Success in rapid multiplication of forest tree species, such as teak, acacias, and
casuarinas, has been reported within the laboratory scale. The drawback of applying tissue
culture for mass production of oil palm seedlings has also been reported. More sophisticated
techniques, i.e. cell/and protoplast fusion, gene cloning, genetic engineering are at various
45
stages of application. Japan, for example, has succeeded in regenerating 73 species from
protoplast culture and 25 inter-species or intergeneric combination from fused cells. China is
leading in the creation of new rice varieties through biotechnology (Zhensheng, 1991). He
emphasized the need to combine biotechnology technique with conventional plant breeding
practices.
Member countries of FAO regional Asia and Pacific in their 20th Conference (1990) had
urged FAO to establish a regional cooperation network in plant biotechnology. To follow up
that desire, FAO convened a regional expert consultation on the Role of Biotechnology in
crop production the following year (1991). In this meeting, activities on plant biotechnology
in the member countries were received. Despite the many research activities, only a small
number of matured technologies generated through the use of biotechnologies could be shared
at the regional level (Singh, 1990). Two priorities were identified: 1. micropropagation of oil
palm, coconut, and date palm; and 2. development of Bt - technology in identified
laboratories.
In addition to the two areas mentioned, improvement of grain legumes and oil seed crops
through biotechnology was also discussed in detail. Among the progress made were distant
promising hybrids in groundnut, diagnostic kits for identification of viruses in soybean and
groundnut, as well as RFLP mapping in Brassica and soybean.
One important observation was made regarding the general notion that in developing
countries, the region of Asia-Pacific is no exception, there were poor linkages among the
different actors in biotechnology activities. These actors are research institutions,
universities, government departments and industry. In the developed countries, most
industries are in the hand of the private sectors. If research in biotechnology should be
expected to reach the receiving ends, the complexity of the flow from research to
commercialization should be realized. Such a complexity was highlighted by using maize
research as an example (Brenner, 1991).
The Role of the Private Sector

In developing countries, public sector plays dominant role in biotechnology activities. Almost
in every country a national effort is aimed and quite often new institution was established just
for biotechnology. To mention a few, a full-fledged Department of Biotechnology in the
Ministry of Science and Technology was set up in 1986 by the Government of India;
Indonesia has established a Center for Research in Biotechnology under the Indonesian
Institute of Sciences; the Federal Ministry of Education of Pakistan has organized a National
Centre of Excellence in Molecular Biology, and in Thailand a National Center for Genetic
Engineering and Biotechnology (NCGEB) was organized in 1983. The driving force behind
46
the commercialization of biotechnology is financial profit. From the history of commercial

biotechnology we learned that the public sector was the place where biotechnology research
started. The transfer to the private sector happened as soon as there was a sign of marketing
opportunities (Hobbelink, 1991). No less than two-thirds of biotechnology spending comes
from the private sector. The transnational corporations are the leading private sector in the
field of biotechnology at present. In most developing countries in Asia, the private sector is
weak. Indigenous industries prefer to buy technologies from the world market. Those
belonging to transnational corporations draw most of the research and development needed
for their manufacturing activities from their headquarters. There then is no urgent need for
new technologies from the public sector, unless that condition is altered, allowing a better
relationship between the public and private sector. The privatization of biotechnology
products and processes leads to international debate on Intellectual Property Rights (FAO,
1991; UNEP, 1991; Keystone, 1991). None of the developing countries in Asia has
Intellectual Property Rights on crop varieties and plant products. It was realized that
biological resources are often considered a common heritage of mankind and thus should be
freely accessible. Biotechnology is, on the other hand, a technology which can be patented
and accessible only with cost. The developing countries are demanding the transfer of
technology, including biotechnology in exchange of the biological materials they have
(UNEP, 1991) free of charge. While the debate of IPR is still going on in UNEP, many
believe that biotechnology will revolutionize agriculture production the way the Green
Revolution did in early 1970's. To avoid the same mistake that the Green Revolution
showed, i.e., it could not benefit the poor farmers, a dialogue on Biotechnology in
Agriculture - Reaching the Unreached, was held in India in early 1991 (Swaminathan, 1991).
Deo (1991) doubted the promise of biotechnology will mean much to small farmers in the
developing world. These farmers are the ones who developed traditional varieties over times
and this type of varieties are the raw materials for biotechnology. After several years of
discussion, finally the concept of Farmer's Rights is officially recognized in FAO. With these
rights, farmers all over the world will be compensated if their materials were developed into
high value products. How this concept can be worked out and put it in practice, it certainly
needs time. Another issue associated with biotechnology is the concern about the release of
the genetically engineered organisms to environment (Riley, 1989). While it is true that the
risks have not been, yet the assessment of the possible dangers should be taken into account.
The industrialized countries are ready with the regulatory procedure for biotechnology
products. Consequently, to obtain approval from the government is time consuming in the
developed countries. Many developing countries in Asia, however, have not developed such
regulatory procedures. There was fear that these countries may become the experimental
ground for releasing the genetically engineered organisms by foreign industries. Therefore, it
was recommended that in cases of collaboration between developed and developing countries
laboratories in the field of biotechnology and field tests should be done in developing
countries, the guidelines in handling the organism of that of the developed countries should
prevail. Commission on Plant Genetic Resources of FAO, in its Fourth Session (1991),
47
devoted its discussion on the development of legal and regulatory matters, in which the
handling and release of genetically modified organisms and Intellectual property rights over
plant genetic resources become the focus.
Lessons Learned
In reviewing the development of biotechnology in Asia, the following points are worth
noting:
National Policy on Biotechnology

Most countries in Asia put biotechnology as one of the top priorities in their research and
development agenda. However, in putting resources countries differ in their commitment.
Institutional Arrangements
Research and development in biotechnology are carried out in various universities, research
institutes and to some extent in industries. Several countries has centralized policy and in so
doing more or less coordinated efforts are in place. In others, each research unit within a
country has its own interest and that is not necessarily related to solving the domestic
problems. Such fragmentation prevents the pooling of the scarce resources.
Resources
Biological resources, plant genetic resources in particular, are the raw materials for
biotechnology precesses. Let alone, these resources will not mean much to a country. They
require the skilled man power and the appropriate technologies to their potentials. Included in
those technology resources are the delivery system. Both types of resources are rather limited
in the developing world of Asia. The trained man power are often loaded with multiduties
leaving them with no time to do research, which is important for the basis of technology
adoption, adaptation and development.
Programmes
Research activities on biotechnology cover a wide range of topics and are done at various
levels of sophistication. In developing region of Asia these activities have lead to the
mastering of new techniques in biotechnology. Quite often, however, the capability scattered
in different research units. Further question is necessary if development will get benefit from
biotechnology: what will we do with the techniques? The potential application of
biotechnology in industry, medical care and agriculture have been shown. In either of the
48
three areas mentioned, human resources and financial resources are limited in developing
countries of Asia. Because of this limitation, priority should be set up if biotechnology is
expected to contribute to development. Within the research program then not only the
technical matters should be the concern, but also the economic return and the social
implication should be addressed.
Development Assistance
In building the national capability for biotechnology, quite often the developing countries of
Asia received supports from outside. Sometimes supports in the form of soft loan were
exercised. Without a clear focus on the program, it is difficult to measure the effectiveness
of the foreign aids.
Developing countries in general lack scientific infrastructure and financial resources to carry
out new biotechnology activities. There are ways to develop the national capability, among
others through:
The United Nations System

Several agencies under the UN system are in the position to assist their members in
developing human resources for biotechnology or closely related subject:
a. United Nations Industrial Development Organization (UNIDO) has launched International
Center for Genetic Engineering and Biotechnology (ICGEB) in 1980 with the headquarters in
Italy and India. The main purpose of the establishment was to set up a center of excellence
for biotechnology research for developing countries' needs.
b. Food and Agriculture Organization (FAO) is developing a sound proposal for Asia-Pacific
networking in biotechnology. If accepted by the United Nations Development Program
(UNDP) then national capability in agricultural biotechnology will be developed through
regional networking using matured technology as the driving force.
c. United Nations Environment Programmes (UNEP). A convention on biotechnology is
expected to be signed by the number countries of UNEP in Brazil in June 1992. If this
convention is materialized, developing countries will be in position to exchanging their
biological resources with technology, including biotechnology. Unfortunately, however, the
negotiation went slow because there was a fundamental difference in perception between the
developed and the developing countries concerning the transfer of biotechnology and its
related issues.
49
d. United Nations Education, Science and Culture Organization (UNESCO) Since its
inception, UNESCO has assisted its member countries, specifically the developing countries
with training and education in sciences. One strong component of its programmes is in the
field of biology, microbiology in particular., With the advancement of microbiology into
molecular and cellular biology, UNESCO is confronting with new challenges to supporting
the new area of biology.
The Consultative Group of Agricultural System

Maintenance research is required to sustain what have been achieved in grain production
through green revolution. Under the joint sponsorship of FAO, UNDP, and IBRD, a
Consultative Group of International Agriculture was established (Swaminathan, 1991). Within
this CG System, now there are 17 research institutes in which biotechnology in one way or
another is applied. The involvement of private industries in developing biotechnology for
food production and their partnership with the institutes within the CG System have created
worry among the non government organization (Hobbelink, 1991). On the other hand, the
developing countries are cooperating with the IARCs long before the issue of biotechnology
and the patenting problems. Through IARCs crop improvement with the associated activities
are tackled with biotechnology where appropriate by the developing countries. Such
cooperation develops capability in Asian countries as well.
Bilateral Assistance
New techniques in biotechnology deal mainly with cellular and molecular biology. Many
developing countries in Asia lack of molecular biologists to enable them to tap the application
of biotechnology, let alone by develop it for certain purposes. Recent technical assistance
granted by developed countries to developing countries covers among others biotechnology.
Government to government arrangement caters individual needs of each country. US-AID,
for example, organized a panel of experts to set up program which US-AID might fund
(NRC, 1991). The same hold true for United Kingdom, Japan, the Netherlands, Australia,
etc., through their appropriate agency include biotechnology in their technical assistance.
Both degree and non degree training enhance the human resources capability. Coupled with
this program sometimes the needed equipments are included.
Bilateral Sector
Large international foundations, such as that of Rockefeller, show interest in the development
of biotechnology for the developing countries. A world-wide networking on rice
biotechnology is sponsored by the Rockefeller Foundation. Meanwhile, transnational
corporations have strong programmes on biotechnology. Developing countries may take
advantage of it. However, concerns have been expressed that not only the biosafety should be
50
taken into consideration, but also the control of the new technology (Development Dialogue,
1988). It is clear that cooperation with the private sector is desired, however, cautions should
be taken.
Toward More Sustainable Efforts

Information technologies bring the countries in the world closer and closer. What happens in
Latin America or Europe in a matter of seconds has been widely known to Asia. Easier and
faster transportation between countries enables man to travel from one corner of the world to
the others. The era of globalization affects every country and in consequent, it requires a
more understanding between nations both developed and developing. Biotechnology
development is only one of the many global issues that the world community are confronted
with. The beauty of biotechnology is that it is closely related to other issues, such as
biodiversity conservation, food products, health, or pollution. Though biotechnology is
generally understood to be of politically and target wise neutral, yet many are concerned with
whether or not the developing countries are in position to go along with the developed
countries in its applications. Realizing that the world population is increasing every year
despite of the success of family planning program and the fact that the misery of its effects
can no longer be confined to a given territory, it is logical that biotechnology application
should be aimed at a wider target than the monetary term. Private industries are no doubt
driven by profit motivation and looking for a big market. Without a big market, they cannot
possibly pay the cost for effective biotechnology research and development. The question
becomes, how can the public sector benefit from this situation? Biotechnology needs raw
materials to be processed into new products with much higher value. The raw materials are
found naturally in many developing countries. Unfortunately, these resources are at stake of
erosion, because of the fact that populations are concentrated in these countries. What more,
the number of poor families are higher in these countries compared to those of the developed
regions. Without a sustainable effort to conserving the wealth, before too long the raw
materials for biotechnology will be depleted. This situation needs considerable cooperation
between countries which are rich in biological resources but poor in technological resources
and the countries which are rich in technological resources but poor in biological Resources.
Sustainable efforts are required if long term effects are expected.
Competitions between countries do always exist. Secrecy is the trait of biotechnology
application. They have got to be balance between the urgency to compete and the need to
cooperate if biotechnology is to be useful for mankind. Without a long term commitment of
countries to work together, the problems we face to day will be a disaster to all of us. This
is the issue confronting the countries in Asia where 50% of the world population live.
51
References
Biotechnology and Development Review, 1991.
Brenner, C., 1991. Biotechnology and changing comparative advantage: lessons from maize.
In: Sasson, A. and Vivien Cestarinir: Biotechnology in Perspective: 101-112. UNESCO.
Chung, Hong-Ik, 1991. Biotechnology research and development in the Republic of Korea.
Colombo, Umberto, 1991. The role of technology building in development. In:
Swaminathan, M.S.: Biotechnology in Agriculture: 3-14. McMillan.
Deo, S.D., 1991. Implication of biotechnology for Third World Agriculture: lessons of the
past and prospects. In: Sasson, A. and Vivien Cestarinir: Biotechnology in Perspective:
19-25. UNESCO.
Greenfield, P.F., 1991. Developing public sector-private enterprise links in biotechnology:

experience in South East Asia and Australia. In: Sasson, A. and Vivien Cestarinir:
Biotechnology in Perspective: 93-100. UNESCO.
Hobbelink, Henk, 1991. Biotechnology and the Future of World Agriculture. Zed Book Ltd.
London and New Jersey. 159 p.
IUCN/UNEP/WWF, 1991. Caring for the Earth. Gland, Switzerland. 228 p.

Keystone International Dialogue Series on Plant Genetic Resources. Oslo Plenary Session.
Oslo, Norway, 31 May - 4 June 1991.
Riley, R., 1989. Plant biotechnologies in developing countries: the plant breeding
perspective. In: Sasson, A. and Vivien Cestarinir: Plant Biotechnology for Developing
Countries. CTA/FAO: 85-94.
Sercovich, F.C., 1991. Industrial biotechnology policies: guidelines for developing countries.
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Bangkok. In press.
Swaminathan, M.S., 1991. From Stockholm to Rio de Janeiro. M.S. Swaminathan

Foundation. 68 p.
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UNEP, 1992. Intergovernment Negotiating Committee for a Convention on Biological

Diversity. Nairobi, February 5-15, 1992.
US-NRC, 1990. Plant Biotechnology Research for Developing Countries. National Academy
Press. 44 p.
Zeven, A. C. and P.M. Zhukovsky, 1975. Dictionary of Cultivated Plants and their Centers
of Diversity. Centre for Agr. Publishing and Doc. Wageningen.
Zhensheng, Li, 1991. Biovillages and agroindustry in developing countries. In:
Swaminathan, M.S.: Biotechnology in Agriculture. McMillan: 325-326.
53
54
Biotechnology for Developing Countries:

The Mexican Case
Jose Luis Solleiro
Centre for Technological Innovation, Autonomous National University of Mexico
Abstract
In the opinion of many specialists, biotechnologies have in general kept their promise with
regard both to results expected from research and to their potential applications over the last
ten years, in particular in the industrialized countries. This decade will witness the marketing
of an increasing number of biotechnology-derived products, which will co-exist with
conventional products or will replace them.
The control of innovation in biotechnology is increasingly falling in hands of large
multinational firms and consortia. Developing countries have begun to pay attention to the
positive as well as the negative impacts of biotechnology in all areas of development and
some of them are supporting biotechnological research. Nevertheless most of these countries
have followed an imitative pattern to select their research programs and, as a consequence of
this, they have found a lot of obstacles to generate innovations capable to reach the
commercialization stage. This reflects a lack of sound methodologies for setting priorities of
development which are essential in order to allocate effectively limited human and financial
resources, to avoid a disarticulation of research from its practical application, concentrate on
realistic opportunities and reduce duplication of effort.
This paper analyzes past experiences in the priority setting process related to biotechnological
research as well as in the development of biotechnology-based companies in Mexico. Doing
so it is attempted to identify and describe the main factors influencing the possibility of
diffusion of biotechnologies in the country.
Finally, the paper presents a set of recommendations to overcome barriers, limitations and
difficulties for the development and application of biotechnological innovations, including
some relating the design of a suitable policy framework for the promotion of biotechnology.
This policy framework derives from the priority areas which have been found by recent
studies.
55
Introduction
In the opinion of many experts, biotechnology is viewed as a possible technical and scientific
revolution developing towards the end of the present century, bearing in mind the
expectations resulting from research and its applications, particularly in the industrialized
countries.
During the present decade we shall witness the marketing of an ever increasing number of
biotechnology derived products. These will either coexist side by side with traditional
products, or will end up displacing them (Sasson and Costarini, 1991).
Increasing interest in biotechnology has given rise to a large number of definitions. For our
purposes in this document, by biotechnology is meant the "overall number of technological
innovations which are based on the use of microorganisms and microbiological processes
with which to obtain goods and services and the development of scientific research activities"
(Bull et al. 1982).
The range of applications created by the new biotechnology includes new possibilities for its
use in the most diverse fields (from farming and health up to and including mining), all of
which has awaken remarkable economic expectations, some of them excessively optimistic.
It is very obvious that biotechnology is a phenomenon that in all likelihood will require the
introduction of structural changes in our society. For this reason, the different elements
impacting on this technical change must analyze their own roles, while avoiding falling into a
participatory action full of enthusiasm but lacking in talent and prudence. It is, therefore,
necessary to ponder many economic, commercial, technical, social, ecological and political
factors in order to make appropriate decisions.
Taking the case of Mexico as an example, this work analyzes some of the factors that must
be taken into account when defining biotechnological policies in the developing countries.
(Examples of current work are presented in the case studies at the end of this paper.)
Biotechnology for the Developing Countries

There is no doubt that biotechnological sciences offer a large number of flexible techniques
which can be applied to many areas, although it is also true that these techniques have not
emerged in a vacuum, in addition to their not being inert as regards their socio-economic and
political consequences.
56
During the last few years, an optimistic literature has appeared according to which
biotechnology is seen as the panacea that will solve the problems of the developing countries.
There are also authors who attest precisely to the contrary. At the outset, it can be said that
the best position from which to make decisions in this field in the developing countries will
be one that excludes extreme positions.
To this end, the possible positive or negative effects of biotechnology upon the following
aspects must be borne in mind (Sasson and Costarini, 1991):
Increase in farming productivity and in food production, through the direct use of
plant biotechnology, complementing conventional technologies.
Nutrition, through improvement in farming and agro-industrial production, and
techniques of fermentation in food processing.
A better integration of food production with the production and consumption of
bioenergy at the household and small settlement levels.
Improvement in livestock production and in the health of domestic animals.

Correctness in diagnosis and prevention of diseases, as well as upon public health.
Commercial exchange patterns between developing and industrialized countries, as a

result of differences in dynamics in the introduction of productivity improvements
both in farming and agro-industrial activities; also, of the marketing of new biological
products which have a tendency to displace raw materials and products from the
developing countries, depriving them of an important source of revenue.
Income and employment.
The possible expansion of cash crops at the expense of food producing crops.
Strengthening of large farming operations, with the subsequent displacement of small
farmers.
Possible reduction in genetic diversity as a result of the broad distribution of new

crops.
The increasing privatization of the results of research, to which the developing

countries do not have easy access, being forced to paying fees for the use of seeds
and plant varieties developed by the industrialized countries.
57
We can see that the preceding factors can have far reaching consequences. In addition, we
expect that the adoption of new biotechnologies by the developing economies will be
concentrated in the sectors of greatest economic development potential, will increase internal
social differences and concentration of ownership of farmland, and bring greater poverty to
small producers and hired manpower. This will also bring about an acceleration of
migrations from rural areas, while increasing the cost of medicines and other health products,
etc. (Hidalgo y Monge, 1989).
Faced with this perspective, the only way to confront the above risks while taking advantage
of existing opportunities, will be by having a greater control over biotechnology in the
developing countries, which will depend to a great extent on the level of scientific and
technological knowledge already attained in this area.
The developing countries must not believe that they will be able to go "shopping" to the
technology supermarkets of the industrialized countries (Deo, 1991). On the contrary, given
the barriers erected against the transfer of biotechnology, third world countries will have to
concern themselves with maximizing their natural, scientific and technological resources with
which to define problems and seek solutions for the benefit of broader sectors of their
respective societies.
Erection of Barriers and Control of Biotechnological

Innovation
As previously mentioned, the expectations created by biotechnology have given rise to a race
for control of the resulting innovations and new markets (Correa, 1991). This control is
increasingly being exercised by large corporations and multinational consortia.
At present, there are three large categories of institutions carrying out research and
development (R&D) in the biotechnology field. The first encompasses the universities and
not-for-profit R&D centres that carry out both basic and applied research. The close
connections established between universities and large and small biotechnology companies are
very numerous. (See Table 1, where the biomedical R&D is illustrated).
The second category of institutions involved in biotechnological R&D projects are venture
capital companies and R&D companies; the latter are usually small, although somehow
related to large multinational corporations. The third category embraces the transnational
corporations themselves.
Thus we see that the multinational corporations have undertaken a strategy enabling them to
maintain all their options open, ensuring their preferential access to the results of research
58
that offer some marketing potential, transferring the development risks to third parties while
trying to maintain monopolistic positions in the world market (Dembo et al. 1988).
In this manner, European, American and Japanese companies, frequently interfacing through
strategic alliances, compete among themselves in the open market. However, success in this
market is not an easy matter, because several entry barriers must be overcome.
The first difficulty lies in that biotechnology requires for its development solid
interdisciplinary scientific teams in such areas as molecular genetics, immunology, protein
chemistry, biophysics, industrial microbiology and computer sciences (Correa, 1991).
However, the greatest problems are not found at the scientific level: the main bottleneck, in
the majority of the countries, arises as a result of the low engineering level in product
recovery processes, this being the basic element for the industrial application of these
techniques (Sercovich and Leopold, 1991).
The resources necessary to undertake biotechnology R&D may also be a serious obstacle
towards its inception. Also, resource requirements go beyond the exclusive scope of the
research activity. Different type of inputs are required; in fact, the greater the scale of the
biotechnological operations to be undertaken, the greater the relevance of the availability of
such material resources as equipment, process control instruments, standardized raw
materials, etc.
In addition, we must also bear in mind that certain types of inputs are highly specialized and
are not massively available (for example, superproducing fermentation strains). In response
to this fact, entirely new companies are appearing as specialists in the supply of special
inputs for biotechnology companies.
Unfortunately, technological capacity in itself does not guarantee a successful commercial

and economic biotechnology operations. Distribution and marketing of biotechnology
products may encounter barriers far more complicated than those posed by reasons of a
technical nature. On account of this fact, many starting-up companies have had no other
alternative than to grant marketing rights of their products to other well established
companies (Correa, 1991).
Therefore, from all that has been said it is obvious that access by developing countries to
biotechnologies, as well as their capacity to adapt them, are fairly limited.
To really benefit from some of the potential applications of the biotechnology field,
developing countries need to confront the problem of technological dissemination and define
policies and practices that will make its use possible.
59
Table 1. Cooperation in Biomedicine Between Universities and the Corporate Sector.

Pharmaceutical
Company
Institution
Field
$ Volume
(million)
Merieux Inst.
Univ. of Toronto
Vaccines
15
Hoechst
MG H
Molec. Biology
78
Monsanto
Washington Univ.
Biomedical Res.
100
Upjohn
Univ. of London
Central Nervous
System
Roche
Harvard Med. Sch.
Immunology
10
Smith Kline
Beecham
Oxford University
Neurobiology
10
Shieseido
MG H
Dermatology
85
Eisai
Univ. of London
Central Nervous
System
100
Nova
Johns Hopkins
Cancer
Ciba-Geigy
Cal. Univ. S.D.
Arthritis
28
Source: Haber, E. (1991) Biological Concepts as the Basis for Pharmaceutical Development.
Association of University Technology Managers; San Francisco (February).
This specifically means that efforts must be made to develop local capacities enabling to
select, acquire, develop and implement biotechnological products and processes in those
sectors where the country has clear comparative advantages upon others. This requires that
we be selective and that we start from a very honest analysis of strengths and weaknesses, in
order that we may be able to realistically identify these comparative advantages.
Biotechnology in Mexico: A Brief Diagnosis

In Mexico, biotechnology is represented by a mixture of industrial and promotional R&D
activities which are carried out at different levels of technological and scientific complexity.
To asses their development and status in the country, and to estimate their possibilities and
60
potential, it is necessary to define and delineate this sector, using the available information
(Quintero, and Gonzalez, 1989).
Mexico incorporated the technology field into its industrial, technological and scientific plans
during the 80's. Until now, all actions taken in teaching, research, technological development
and industrialization in this field have been interconnected. Lacking an explicit biotechnology
promotion policy, seems to be a consequence of this, although at the discourse level it has
already been considered as a priority area.
Thus, the first generation of the biotechnology industry is the most important category, in
terms of market size. Its main products are fermented beverages, milk products, bread
yeasts, alcohol and edible mushrooms. Companies involved are very much oriented toward
the domestic market, their R&D activities being thus very limited.
With regard to second generation biotechnologies, several companies produce antibiotics,
aminoacids, organic acids and biofertilizers. A large share of the biotechnology employed by
these companies is foreign. In this field, there are some groups of R&D, concentrated in
universities and public research centres, that very seldom have interfaced with commercial
enterprises, without having marketed any commercial product.
With respect to biotechnologies of the third generation, manipulation of microorganisms has

been restricted to universities and public R&D centres. We have some high quality research
groups, but these are not closely connected with the productive sector, by the mere fact that
companies working in these technologies in Mexico are exceptionally rare.
A recent diagnosis carried out by Erossa et al (1989), includes a qualitative assessment of the
biotechnology industry in Mexico. The main conclusions of this study are:
a)
b)
The food industry shows signs of disarticulation in the productive chain giving rise to
scarcities; insufficient and occasionally defective infrastructure in warehousing, supply
and transportation cause losses in the range of 30% in fruit and vegetables and 50%
in fish and seafood products; consumption and industrial concentration; low
competitiveness caused by technological obsolescence of machinery and equipment, as
well as inadequate economies of scale; all this is compounded by an insufficient
technological development that exacerbates our dependency from abroad.
With regard to the pharmaceutical industry its integration is very rare, in the majority
of cases being carried out during the last stages of the productive chain, and being
dependent upon the importation of the intermediary products the country requires for
the manufacture of its pharmaceutical products, as well as of the corresponding basic
technologies.
61
c)
In the case of the biotechnological industries, most of them are under the control of
foreign investors. The national industry performs little research: It does not adapt or
improve imported biotechnologies, depending again upon raw materials, equipment
and qualified personnel of foreign origin.
d)
In addition and with regard to the agricultural industries, a study carried by Solleiro
et al (1991) shows that their level of global competitiveness is lower than that of other
countries with similar level of development as Mexico's, with the presence of many
companies very different among themselves as regards their marketing power,
productivity and technological efficiency.
e)
With regard to livestock, national experts are of the opinion that the new
biotechnology is still far from being applied to the Mexican livestock sector. For the
time being, its use is confined to the country's largest breeders. The infrastructure for
industrial and domestic research does not have economic capacity to invest in costly
and long term studies as required by this type of activities (Solbrzano, 1989).
To the preceding conclusions it should be added that biotechnological markets have not been
sufficiently assessed as no system exists to monitor and analyze the international technical
and market information available in the biotechnology field.
We can advance the conclusion that short of a substantial increment in the technological
capacity of the industries of the sector, any policy initiative shall be in danger of being an
exercise in rhetorics.
Research and Human Resources in Biotechnology

There is no doubt that biotechnology R&D, although circumscribed within the general
scientific and technological development of the country, it presents the characteristic of being
a fundamental element, especially because the main applications of biotechnology are yet to
arrive.
A study of the biotechnological status of the Latin American countries has been recently
carried out (Jaffe, 1991). The study reported that the main problems confronting the region
in the field of R&D are the following:
Insufficient R&D funding
-
Lack of priorities
Lack of human resources
Deficient infrastructure and equipment
Importation difficulties.
62
In the case of Mexico, the study of Ana Irene Soldrzano (1989) explains that research
activities are disarticulated. There is no a biotechnology domestic plan for which priority
areas of research have been defined. Interinstitutional relationships are very limited, thus
causing a duplication of efforts.
Even though it has been asserted that biotechnology is an essential area, the number of R&D
projects in biotechnology or connected with it in 1987 were only 1.4% of the total number of
R&D projects being carried out in the country.
Basic research is not very innovating; almost invariably it follows a pattern imitating foreign
studies, and most of the time it does not respond to domestic socio-economic interests and
requirements.
Applied research is chiefly oriented towards the health, environment and the food farming
sectors. This type of research is oriented towards two extremes. On the one hand, there is a
good number of projects looking for the development or adaptation of "simple processes",
seeking to create an impact through reductions in production costs, and not through the
transformation of the productive process or the creation or development of new products.
This is the case of projects aimed at the farming and livestock sectors -which together have a
greater specific weight than the industrial sector in financing biotechnological R&D - in
which the objectives of research are not to increase efficiency or speed in crop propagation,
production of virus free plants, production of new vegetal varieties or animals with better
characteristics of reproductivity and resistance to disease or to environmental adversity, as
these are the basic ways by which it is expected biotechnology will impact upon the livestock
sector (Soleiro et al. 1991).
On the other hand, there are research groups that seek applications for the new
biotechnology, using in the process well equipped laboratories generally located in university
settings. Within these groups the imitation pattern is repeated once again, as many of them
seek to develop products which, although they are offshoots of new technologies, they are
already on the market under the control of very powerful corporations. It is obvious that
given the existing entry barriers, the industrial viability of these projects ought to be
questioned.
To the problems previously mentioned, we must add that a great part of the process
generated by research centres is arrested on account of their low profitability, or simply
because it is not possible to demonstrate their economic viability (Casas, 1987). Besides, in
spite of the applied orientation and the commercial motivation of the projects, our short
experience in large scale production problems and in the marketing of final products, does
not allow for the application of results. (Eastmond, 1987).
63
This last point reflects the fact that biotechnological research projects in our country lack a
corporate orientation, thus reducing radically their success probabilities, in as much as the
technology user will always be a corporation.
For its part, the domestic productive sector has not assumed an adequate participation in
biotechnological development, leaving the initiative in the hands of the universities and public
research centres, or even in the hands of transnational corporations.
If we are not able to change this situation, it is very likely that any initiative will fail.
Finally, another characteristic of biotechnological development during the last few years is its
strong concentration in just few States, particularly in Mexico City and in very few research
centres, adding further difficulties to the dissemination of results.
As far as human resources and training are concerned, there is a high consensus with regard
to the fact that there is a shortage of qualified personnel in the biotechnology field.
According to Erossa, in 1989 there were 848 researchers working in biotechnology; about
650 belonged to institutions of higher learning, 20% to public research centres and the rest to
the productive sector. Sixty percent of these researchers has undertaken postgraduate work.
The post-graduate national system has the capacity to train about 65 biotechnologists per
year. Besides, another 4 or 6 can be trained abroad. Although this supply is rather low, it
exceeds the requirements of the country's biotechnology industry, which until recently has
only required personnel with medium to high qualifications. Under these conditions, the
employment possibilities are limited to teaching and research in public institutions, where
salaries are so low that detract from undertaking training in this field. We have proof of this
in the fact that in 1989 all post-graduate students in biotechnology, bioengineering and
bioelectronics represented only 0.2% of all post-graduate enrolment (Sol6rzano 1989).
In addition, this structural problem is made more acute by the fact that no program
incorporates guidelines towards the design of equipment and industrial or laboratory
instruments, and this causes the expectations for industrial process development to be low.
Regulations and Intellectual Property

Another point of consensus amongst experts in the establishment of biotechnological policies
is that which refers to the appropriate legal and regulatory framework (National
Biotechnology Advisory Committee, 1991) towards establishing a national strategy.
64
On the one hand, complying with regulatory requirements in biotechnology is a critical factor
affecting the time and cost necessary to market a product. In general terms, the need for
regulations ensuring the health and safety of workers, consumers and the environment is
amply recognized.
Emphasis is also put on the fact that the system must, while building confidence, possess
economic rationality and be internationally compatible. This system must permit long term
development planning and marketing of new products, while being flexible enough to adapt
itself to the characteristics of each new development. The jurisdiction of each regulation must
also be clarified in order to prevent duplication, focusing the whole process on principles of
risk evaluation.
Mexico does not as yet have a regulatory framework that includes all the previous
characteristics. The General Law of Ecological Balance and Protection of the Environment
(I.ey General de Equilibrio Ecol6gico y de la Protecci6n del Ambiente) that was enacted on
January 1988, stipulates some regulations for the prevention and control of contaminants and
for the rational use of water.
There is also a Health General Law (Ley General de Salud) which includes regulations for
the research in the health field, and a Law concerning Production, Certification and
Marketing of Seeds (enacted in 1982), as well as a Law for Phytosanitary Protection.
Nevertheless, an all encompassing regulatory body does not exist, and there is a great lack of
knowledge on the importance of its proper application, and this either deprives technological
development projects of the required momentum, or places our country in such liberal
position that Mexico may be used as "test territory".
With regard to intellectual property, it is worth noting that obtaining patent rights for
biotechnological inventions has become a fundamental objective of companies seeking the
commercialization of biotechnology. It is obvious that the main beneficiaries of the patenting
process are the large multinational corporations. These patent their products or processes in a
given country, not with the primary objective of transferring technology, but in order to
export it from their country of origin, thus eliminating all possibility of competition.
In spite of this, in June 1991, the Congress approved a new Law for the Development and
Protection of Industrial Property, which inaugurated the patentability of biotechnological
inventions in Mexico. Thus, new plant varieties, microorganisms, biotechnological products
and processes can also be protected.
The enactment of said Law was preceded by great pressures by the United States. In fact,
almost nine months after its publication in the Official Gazette, we have not been able to
65
know as yet the details of the pertinent regulations outlining how new patent rights may be
applied for. This is just a reflection of the lack of preparation in the country for such an
important step as that taken by Mexico.
Mexican Experience in Establishing Biotechnology Policies

and Priorities
It has already been said that biotechnology began to receive priority attention in Mexico at
the beginning of the 80's.
In fact, towards the end of 1982 biotechnology in Mexico received political support by being
included as a research priority area in the 1983-1988 National Development Plan;
subsequently, in the 1984 Annual Operating Program of the National Council of Science and
Technology (CONACYT), three of its 28 indicative programs were related to biotechnology.
In 1984, Banamex's Industrial Co-investment Program included biotechnology in its strategic
plan. Also in 1984, in order to increase the contribution of technological, administrative and
financial resources from abroad and to build Mexican companies with participation of foreign
capital, foreign investment guidelines were issued.
Said guidelines sought to channel foreign investment towards selected industrial activities,
particularly complex and of high technological level, which included biotechnology.
Since 1983 several attempts have been made to develop a Biotechnology National Plan
defining research and development priorities in this field. Although this idea has been
examined at the scientific, political and industrial levels, efforts made have not been
successful, and for practical purposes no changes have taken place in the national
biotechnology development (Soldrzano, 1989)
The 1989-1994 development plan (PLANADE), envisages the promotion of biotechnological

development and the consolidation of progresses made in the country. PLANADE's basic
structure includes directly or indirectly those economic activities upon which biotechnology
may have determinant effects.
One of the actions proposed by PLANADE to bring about economic recovery, price
stabilization and improvement in the living standards of the population is the economic and
technological modernization of the primary activities sector, and of the industrial and service
sectors.
66
PLANADE also proposes to support the export of non-petroleum products, foreign

investment, technological transfer, international cooperation and protection of the
environment. Of the medium-term programs defined in PLANADE under the items of health,
nutrition, supply and hygiene, protection of the environment, water conservation, energy
modernization, updating and modernizing primary activities and mining, etc., biotechnology
is considered as a priority technology. Nevertheless, an explicit program promoting
biotechnology continues undefined.
In spite of not having this explicit policy, research projects are being carried out in Mexico
which involve a broad range of applications. This is the result of several decades of efforts
made in human resources training and in the development of biotechnology, but it is also a
consequence of the lack of well defined priorities that would have avoided dispersal of
research efforts.
About 10 studies on perspectives for determining research priorities in biotechnology have

been carried out in Mexico (see Table 2).
This experience, together with that of Latin America, shows that most of these studies have
been commissioned by groups that assign economic resources for development or
dissemination of biotechnology, and clearly illustrates the fact that developers and users of
the research have not shown great interest in finding said priorities, or even opportunity
areas.
Some of the most important aspects derived from the Mexican experience are: Difficulties in
defining and classifying biotechnology; problems in having a reliable information source on
the biotechnology situation in the country; lack of knowledge on the subject and its
importance among the various executive levels; application of inadequate methodologies; lack
of mechanisms to use the results of the studies; reduced number of experts; and the lack of
connection between the conclusions and the decision makers so as to promote a definite
policy.
Even though important efforts have been made in spite of this situation, it has not been
possible to articulate policies starting from priorities outlined, as these have not been
adequately defined or have been concentrated in generating recommendations that were
overly general, therefore vague.
If these difficulties are not overcome, it is very likely that Mexico may be compelled to
follow internationally recognized research lines, and even this at a minor scale. Should the
same pattern continue of industrial sector participation and financial support, it is most
probable that our country may be prevented from using its own biotechnology in industry as
well as in agriculture both in the short and medium term.
67
Table 2. Mexico. Experience in Determining Biotechnology Applications

(Prepared as per data from R. Quintero, (1991)).
Year/
Duration
1981/ 18
months
Study
Sponsor and
Executor
Objective
Vague
objectives. Low
budget. Lack of
methodology.
Lack of
information.
Identification of
areas and R&D
priority projects
to be financed by
CONACYT.
Consulting group
prepared documents
on eight application
areas. Evaluation of
documents by
scientist groups,
corporation execs.
and public
foundations.
Bibliographic Rev.
Examination of 107
projects. Ident. three
application areas
(Health, agriculture,
chemical products).
Ident. limiting
factors: financing,
patents, and
University-Industry
linkage. Participation
of 150 people in
meetings. Book
on...(sic)
There were na
mechanisms to
implement
results. Umited
budget. Umited
participation of
experts in new
areas. Deficient
analysis and
evaluation of
available
documents.
Identification and
classification of
nationally
developed
biotechnological
projects, for their
eventual
industrialization
and marketing.
Examine state-of-theart national and

international. Visits
and interviews with
national and
international
companies (U.S. and
Canada).
Classification of 30
projects as per 10
10 high potential
projects selected for
national development.
New vision on
biotech marketing and
interned competition.
Compiling info on
industrial biotech
in...(sic)
economic criteria.
Difficult to
obtain economi
information on
biotech. Expert
little experience
in selecting
potential
industrial
products. Well
defined method
but difficult to
(Classif. 1-10).
apply.
To establish a
1984/12
months
Biotechnology
in Mexico.
Opportunity
evaluation.
CONACYT.
Barros Sierra
Foundation.
(Centre for
Prospective
Studies)
1984/6
months
Biotech.
perspective and
its implications
for the national
BANAMEX.
Barros Sierra
Foundation
Biotech
company in
government
sector
SEM1P
Project
Evaluation
Centre
Limitations
Inventory of
biotechnological
activities.
Classification of
biotechnology in four
groups. A book on it.
Programs and
Budget Section.
Private
consulting firm.
1986/6
months
Results
A group of five
experts prepared
documents on their
areas of expertise.
Bibliographic Rev.
Analysis and
expectations of
biotechnology
in Mexico
productive
sector.
Methodology
national
biotechnology
strategy
Proposal to
create a new
biotech state
company to carry
out mainly State
projects
(PEMEX, SSA,
FERTIMEX,
PIPSA,
CONASUPO,
etc.)
68
Examination of
present and future
applications in State
controlled companies.
Individual
consultations with
national and
international experts.
Design of a mullpurpose biotech

company.
Identification of a
lack of a
technological
development policy in
the State sector.
Unit or no
participation of
State controlled
companies in
study. Lack of
tech and
commercial inf
in State
companies.
Umited
knowledge of
biotechnology
and its
applications.

TABLE 2. (Cont'd).
198816
months
Strategic study
for the
CYDSA group
in the biotech
field.
CYDSA (private
group) Private
consulting firm.
Identification of a
group of biotech
projects and their
priorities
according to the
interests of the
company.
Nati and internatl

State-of-the-art
examination of
biotech. Analysis of
biotech by sector.
Select projects and
products using criteria
(type of client, raw
material producers,
interest in same
Selection of 12
projects. The first of
these gave rise to a
new company within
the industrial group.
At a corporate level,
a search for
opportunities for its
companies was
initiated.
Little knowledge
of biotech within
the company
group.
Conservative
attitude. Search
for business
with results at
short
and medium
term.
sectors). Classify
projects/products
using the potential
methods with
chemical industry
standards (qualif. 14).
1991/6
months
Priorities in
biotech
for
international
technical
cooperation
E UNAM
Biotechnology
Institute
S R
Establishment of
a list of biotech
priorities for
their promotion
by SRE, aiming
at international
technical
cooperation
(Scholarships,
exchange of
academics, joint
projects,
information
exchange).
8 experts prepare
documents and
propose priorities in
four application areas.
10-15 experts
examine proposed
priorities (decide by
consensus). Exam of
the country's S&T
state-of-the-art as it
applies to biotech
Lists priorities
research, training,
cooperation products.
Ident of outside
groups with which
advisable to establish
cooperative
relationships. Ident
national capacity that
can be offered
abroad.
Change in
relative
importance of
project for SRE.
Difficult to find
group to
perform the
study. Deficient/
outdated info on
status of biotech
in country.
It is for this reason that priority determination must be considered as a dynamic and
participatory process, valid within a given time frame (as a function of available elements
when priorities are defined), which must made periodically (in keeping with the dynamics of
the sector, area or field under consideration).
This tool must not be considered as a universally applicable process, as it will vary as a
function of the values, preferences, needs, capacities, resources and opportunities of the
institutions for whom the work is performed (national, sectorial and institutional public or
private). Besides, determination of priorities is rarely ever placed at the first level of policy
definition.
It will also be essential that the priorities determination process be integrated with those from
whom the demand will originate, namely the productive sector.
69
Methodologies based on the opinion of experts indicate that it is important to establish the
expert's profile. This must not be "married to his discipline", as the process under discussion
must be as open as possible in order to identify the clearest opportunities and to present
competitive technological packages to the international market.
Basic Aspects Towards Establishing a Biotechnology Policy

In view of the positive and negative effects biotechnology can have for a country such as
Mexico, important efforts must be made to enable the country to develop and consolidate its
bioindustrialization; "this implies creating conditions favouring the promotion of a process to
accumulate different capacities that will allow to generate, acquire and use biotechnology"
(Avalos, 1990). We must underscore that it is not only a question of increasing investments
in R&D in order to have greater scientific capacity. It is also important to develop abilities to
adopt and assimilate biotechnologies developed abroad. Therefore, in addition to the
scientific capacity and the quality of the educational system, it is fundamental to have a
monitoring system of the state-of-the art of biotechnology, of its suppliers and of the
evolution of the international market in this field.
Summing up, in the biotechnology field we should seek the development of an innovation
national system; this concept designates the existence of organizational devices and functional
mechanisms to achieve a greater linkage between science, technology and the market, thereby
fostering processes for generation, dissemination and use of innovations. "In other words, it
refers to an institutional organization framework allowing to link different capacities
(information, abilities, equipment, financial resources, etc.) located in different institutions
(public laboratories, university research centres, consumer goods companies, machinery
manufacturers, engineering firms, etc.) so that to facilitate innovation processes." (Avalos,
1990).
To develop a policy that articulate this Innovation System, the State must manage agreements
of a different nature in order to integrate resources around common objectives, giving
cohesiveness and complementariness to different policies having a bearing on biotechnology
innovation. These policies are:
*
*
*
*
*
*
*
Scientific policy
Technological policy
Industrial policy
Financial policy
Export policy
Regional integration policy
Regulatory policy
70
With this framework in mind, following are some basic recommendations towards the
establishment of a biotechnology policy for a country such as Mexico.'
It is not our intention to present a detailed plan here, as this could only be developed starting
from a rational analytical process of the strengths, weaknesses, opportunities and challenges
and from decisions based on the participation of the productive, academic and government
sectors.
First of all, it should be noted that to formulate a policy one must start off from certain basic
premises (Arroyo and Waissbluth, 1988):
1)
The country must have a strong scientific establishment in place, able to develop a
technology of its own or to negotiate or adapt that originating in other countries,
taking into account all economic, technical, social and ecological aspects having to do
with biotechnology.
2)
Creating a solid technological and scientific infrastructure is an indispensable

requirement to confront international competition. This requires a significant increase
in R&D expenditures. But this effort must not be an exclusive responsibility of
governments. The public sector must make a significantly greater contribution (about
50% of the total expense).
3)
In modern biotechnology, the most important production factor is qualified human

resources. Without a definite training policy, both with regard to basic sciences as
well in practical matters (such as handling laboratory techniques and pilot plants), any
mechanism that may be established will have, from its inception, a great risk of
failure.
Scarcity of human resources and capital are factors that should be administered in a
rational way, being therefore indispensable that biotechnological development
priorities be established. Trying to cope with all fields and all possible applications
would entail dispersion of efforts that would tend to neutralize them.
5)
It is also indispensable that biotechnological policies be linked with macroeconomic

policies, and with those impacting on other sectors, in order to achieve consistency
and compatibility (Redgrave, 1991).
'This section is based on the article by Solleiro and Arriaga entitled "Biotechnology Patents, challenges
and options for Latin America"; Revista de Comercio Exterior, 40-12.
71

6)
The policy definition process should agree with certain minimum regulations imposing
a certain order.
Thus, the general sequence should be:
Phase 1. Establishing long term strategic objectives, and definition of priorities.

Phase 2. Definition of opportunities and requirements for the different regions and/or sectors.
Phase 3. Selection or design of policy instruments pertaining to each priority in the

biotechnology field.
Phase 4. Definition of roles, action plans and agreement among different participants.
Once all these basic premises have been taken into account, the country ought to define a
biotechnology development plan as a national priority. The identification of options and
specific priorities of said national plan must be a product of a detailed analysis of strengths
and weaknesses, as well as opportunities and challenges.
Upon completion of the analysis of strengths and weaknesses of the present biotechnology
development, as well as of challenges and opportunities for the future, and upon
identification of areas to be considered as having priority in keeping with this diagnosis, it is
advisable to identify all government and institutional policy instruments required to push said
priorities forward.
The purpose of this work is not to present an in depth study of promotion instruments,
although those mentioned hereafter would constitute a suitable structure:
Financing
A special biotechnology fund must be created to finance the development of infrastructure,
basic research, contribution of venture capital (for technological development and
investment), scholarship programs and exchanges with other Latin American countries. The
assignment of funds must correspond to priority areas.
Training of Human Resources

There is a widespread agreement that modern biotechnology requires the development and
application of knowledge of biochemistry, microbiology, molecular biology and genetics. As
a result, any biotechnology program will have to assign a high priority to the strengthening
of higher learning units responsible for training human resources in these areas. This requires
72
that teaching programs include the latest developments, that the academic infrastructure be
considerably improved, that new experimentation facilities be created for molecular
biotechnology and genetics (subjects on which the new technology is based), that teaching
programs of biological sciences be adopted based on the interdisciplinary concept, and that
intensive use of computational equipment for teaching and research be promoted.
Information
An essential instrument to improve access by all countries to the new technologies and to
strengthen their negotiating position is to promote access to technical information. A network
of libraries and technical documentation centres must be created incorporating the latest
advances for retrieval, storage and dissemination of the information contained. The costs of
this infrastructure should be considered as an investment, having a very favourable
cost/benefit ratio. Limiting access to information would reduce the chances of making correct
biotechnological decisions.
Communication and Interfacing with the Developed Countries

Even though privatization of knowledge is an increasing phenomenon, the door is not yet
closed for the developing countries. Having recourse to the different international cooperation
mechanisms should be an immediate priority. And within these mechanisms, preference
should perhaps be given to sending students on scholarships to first class university and
research centres.
Advantage should be taken of the support opportunities offered by international centres and
institutions (such as the International Genetics Engineering Centre), where access to
knowledge should be primarily sought.
Support to Enterprise Development

It has been demonstrated that an efficient mechanism for biotechnology dissemination is
through the creation of so-called knowledge enterprises. In key areas, selected through
economic and technical analysis, the birth of national companies or even Latin American
companies could be promoted.
These companies should be given a non-frivolous protection (Fajzylber, 1983), but that
which would enable them to consolidate their position in the market place, following an
apprenticeship trajectory.
73
Fiscal Incentives
It is an indispensable requirement that the productive sector provide a greater contribution to
the national research and development effort. This idea may be considered as indispensable
to foster self-determination in biotechnology. For this reason, the Government must provide
the necessary take-off impulse through fiscal incentives in recognition of R&D activities, for
creating the corresponding infrastructure and for information, as well as for the training and
development of human resources.
Purchasing Policies of the Public Sector

It is worth considering that the main "promoter" of technological development is the market
place and, in as much as the State is the largest buyer in any country, its role as a promoter
of national technologies would be of the first magnitude, guiding its purchases towards those
goods produced by means of these technologies.
Quality Regulating Institutions

It has been demonstrated that biotechnology application is not free from dangers. On the face
of this, it is imperative that governments should have an "alertness" attitude.
Courses should be organized on the safety measures in this new industrial area; manuals and
procedures of quality and safety should also be written and disseminated.
On the other hand, it might be advisable to create a network of quality centres in support of
the above actions, with the ability to provide certifications guaranteed and recognized by the
different governments.
This last point may even lead to the creation of a "national certificate of quality", to be
obtained by every company wishing to sell biotechnological products. Thus, the countries
would gain in experience and would control those products to be marketed in their territories.
Besides, research on the subject matter should be clearly regulated.
Biotechnological Development Support Services

Technology development, its adaptation and assimilation frequently require interaction of
technological agents providing the engineering aspects of the project, specialized information
and design of equipment. With respect to Mexico, and from the standpoint of the supply,
engineering firms have developed a technical capacity in branches such as civil engineering
and certain fields of the chemical industry.
74
We have achieved excellence in detailed engineering and process design. However, lack of
capacity in industrial and basic engineering continues. To correct this, linkages between
engineering firms and national research centres should be promoted and strengthened, in such
a way that demand for basic engineering and equipment be increasingly oriented towards
supplying the domestic requirements.
Also, with the increase in demand for their services, a trend would develop towards a greater
specialization of consulting and engineering firms, thus increasing their quality and
reliability, as critical factors in the installation of biotechnological industries.
Connection Between Research and the Productive Sector

It has been shown that, in modern biotechnology, interaction between research centres and
the productive sector is critical. This interaction in Mexico is just beginning. It is necessary
that research centres, industry, as well as government institutions promote this connection.
Industrial Property
Mexico already has a modern industrial property law, adapted to the legislation of the more
advanced countries. Consequently, it cannot be delayed that researchers, producers,
corporations and the bulk of society be informed not only about the benefits, but also of the
risks involved in granting temporal patent monopolies.
In addition to promoting biotechnology inventiveness, special care should also be placed on
the information aspect of the patent. In exchange for the legal privilege, the inventor must
reveal his invention. For this measure to fulfil its objective of promoting the flow of
knowledge, the patent office must actively disseminate information on patents. This implies
establishing a powerful technical information dissemination system incorporating all the latest
advances in telecommunications and computational sciences (Solleiro and Arriaga, 1990).
Final Comments
Biotechnological development entails many difficulties for the developing countries, but the
benefits that may be obtained from its appropriate application more than cover the risks
involved.
One of the main problems to be resolved is the identification and timing of markets to be
developed. This opportunity detection cannot be based only on moments of inspiration. The
developing countries must understand the dynamics of the techniques involved and of the
75
biotechnology markets, and this will only be achieved through the concerted action of
universities, research units, government institutions and corporations.
The apprenticeship process will be long and must incorporate, not only an accumulation of
scientific, technological and manufacturing capacity, but also a close interaction with social
needs and realities of the marketplace.
Case Studies
Anaerobic Treatment of Waste Waters
The situation with regard to the infrastructure for the prevention and control of the
contamination of water in Mexico is alarming, due to the limited number of treatment
plants which exist and their low efficiencies. Most plants are aerobic, which in themselves
lead to health and environmental problems. The newer anaerobic processes can contribute
to environmental protection at reasonable cost. In Mexico it is now possible to design,
build, start-up and operate anaerobic treatment plants. A team of researchers based at the
Institute of Engineering at the National Autonomous University has transferred the
technology, trained specialists and developed basic and applied research to support the
establishment of anaerobic technology in Mexico. A private company has developed the
technology package incorporating the reactor and microbiological cultures. Several sources
of funds from national and international bodies as well as local industry supported these
developments.
Medical Diagnostics
Mexico, like many developing countries, urgently is seeking new methods to be able to
identify, at an early stage, and rapidly., the major diseases affecting its people- cholera,
malaria, AIDS etc. In Mexico success has been achieved in the technology of production
of monoclonal antibodies and their conservation and more recently on hybridoma
technology, so that now there is a variety of monoclonals available for clinical and
therapeutic diagnostics. A major centre for this work is the Institute of Biomedical
research at UNAM which has developed diagnostics for detecting amoeba, tapeworm and
malaria.
Other major developments underway in Mexico are in the production of human insulin,
aspartame and bovine somatotropin.
76
Aticropropagation of Fruits and Ornamental Plants

The technology of tissue culture for the micropropagation of plants has been worked on in
the public sector for many years. Only recently has the private sector become interested
and has promoted research to overcome difficulties of scale-up, quality control and inputs.
Biogenetica Mexicana, began in 1989 to produce ornamental plants using tissue culture in
a pilot plant in borrowed premises. It is now one of the largest micropropagation
companies in Latin America, with well equipped tissue -culture laboratories and
infrastructure. The Centre for Peasant Training and Demonstration, started by the Banco
de Mexico, has been set up to train small-scale farmers in micropropagation through short
courses, so that they could apply these techniques in their farming practices.
Acknowledgement
Rosa Luz GonzIlez and Sonia Zamudio contributed with valuable ideas and information to
the preparation of this work, which was financed with funds provided by the International
Development Research Centre. Fidela Rangel contributed with the heavy typing work.
To one and all my most sincere thanks.
The opinions expressed are the exclusive responsibility of the author.
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80
Role of Biotechnology in Development of

Zimbabwe
C.J. Chetsanga
Department of Biochemistry, University of Zimbabwe, Mount Pleasant, Harare, Zimbabwe
Abstract
This paper presents a brief analysis of the role that biotechnology can play in promoting
agricultural, biomedical and industrial sector development in developing countries. It is
argued that the mastering of clonal propagation techniques can be an effective approach to
be used in entering the field of biotechnology by developing countries.
The paper gives a prioritisation of the principle fields that have been identified for focus in
the Zimbabwe biotechnology programme. A summary of some of the resources and facilities
available for biotechnology research and some of the current applications of biotechnology in
Zimbabwe are outlined.
Among the items highlighted for Zimbabwe are the launching of the M Sc degree in
biotechnology in 1991 at the University of Zimbabwe, and the decision by Government to
establish a national Biotechnology Research Institute.
Introduction
The recent breakthroughs in molecular biology have transformed biotechnology into a
precision science. These developments have brought in further refinements to areas like
protein chemistry, nucleic acid biochemistry, fermentation and immunology. Biotechnology is
an applied science which represents a blending of the principles and practice of biochemistry,
genetics and microbiology.
The applied nature of biotechnology makes it an attractive field for developing countries
because its results readily lend themselves to commercialisation. Expert manpower shortages
constrain developing countries from significantly exploiting the opportunities offered by
81
biotechnology. For these countries a strategy for embracing biotechnology is to begin by

investing heavily in capacity building.
Developmental Role for Biotechnology in Zimbabwe

Agriculture is the mainstay of the Zimbabwe economy. Some crops are grown for their
commercial value while others are grown for food security.
The main draw back to agriculture in Zimbabwe is the frequent occurrence of drought
periods. An important role that biotechnology can play in Zimbabwe is its application in
developing drought resistant plants. Such a development would enhance the agricultural
productivity of the country. If the application of biotechnology were directed at crops that are
grown by small scale farmers, this group of farmers would benefit from biotechnology in a
major way.
Biotechnology Priority Fields in Zimbabwe

The priority setting process has been catalysed by the Research Council of Zimbabwe (RCZ)
which has convened workshops at which leading scientists participated. The discussions at
these meetings highlighted the importance of the acquisition of biotechnology skills by the
country.
The first project recommended for implementation was the launching of the M Sc
Biotechnology in 1991. The first group of trainees will complete the degree at the end of
1992.
The second project launched was the establishment of the Biotechnology Research Institute.
The construction phase will start in 1992 with completion expected in 1994.
The principle fields that have been identified for the Zimbabwe biotechnology focus are:
Crop Production; Livestock Production; Horticulture; Food Processing; Vaccine Production;
and Fermentation Technology
Resources and Facilities for Research

The facilities currently available for biotechnology research are located at the University of
Zimbabwe (Departments of Biochemistry, Biological Science and Crop Science). These
82
facilities are being used for both research and teaching. The equipment inventory includes: 8
sets of electrophoresis apparatus; 4 ultracentrifuges; 4 laminar flow hoods; 4 shaken water
baths; 3 MP-4 Polaroid cameras and transilluminators; 2 PCR machines; several
microcomputers; several microscopes; 2 CO2 incubators; several freezers; several
refrigerators; 2 liquid scintillation counters; and 2 tissue culture rooms.
The amount of funds available for biotechnology per year is about US$200,000. The amount
varies from year to year. The funds are used for purchasing equipment radioisotopes,
restriction enzymes, Taq polymerase, electrophoresis expendables, and paying research staff
salaries.
Biotechnology Applications
In my view, the most practical entry point into biotechnology for a developing country is cell
biotechnology. The most promising early applications of biotechnology are in
micropropagation. This involves the dissociation of tissue cells and culturing them to achieve
the production of disease-free seedlings by clonal propagation.
The Tobacco Research Board is establishing a Biotechnology laboratory. They are interested
in developing varieties of tobacco seedlings enriched in specific properties (pest-resistance or
drought-resistance). Most of the research at the agricultural Department of Research and
Specialist Services under the Ministry of Agriculture is based on traditional biotechnology.
A lot
of biotechnology mileage can be gained by the use of micropropagation techniques to
produce uniform plant material for protoplast fusion experiments, export and for establishing
industrial plantations. Micropropagation can be fruitfully used in developing seedlings for
agro-forestry. This approach was used in developing orchid clones. A companion technology
to be acquired is tissue culture. One can isolate cell clones of the needed crops in a virus-free
state.
After successfully developing a country's cell biotechnology programme to the point of

routinely applying it in micropropagation of plant material, the next stage is to gradually
move into molecular biotechnology. (Examples of current work are provided in the case
studies at the end of this paper.)
The entry into molecular biology based biotechnology (recombinant DNA technology) to
create genetically modified organisms (GMOs) can come in the next phase. The tooling up
for capability in gene cloning is a long and expensive process. There is a need for a critical
mass of trained molecular biologists. The choice of projects on which to focus is critical.
83
There are a number of projects currently underway in which biotechnology is being applied
in health and industrial research. Most of these projects are being pursued at the University
of Zimbabwe. A project in Dr Feresu's laboratory is focused in isolating and characterising
milk fermenting bacteria. The aim is to optimise the traditional process of milk fermentation
and improve its acceptability to the Zimbabwe consumer.
Another project is investigating the cattle aborting bacteria occurring in the Zimbabwe
natural environment. The aim is to develop a DNA diagnostic probe that can be used as an
easy and fast assay for detecting the strains of Leptospira interrogens that causes abortions in
cattle.
Dr Gopo's laboratory has developed a Salmonella DNA probe for screening food, animal
feed and water for Salmonella contamination. This probe is being optimised for field
applications.
Dr Robertson's laboratory is using the clonal propagation technique to produce potato

seedlings. He hopes to provide a service for supplying potato seedlings to small scale
farmers.
My laboratory is studying the genome of hepatitis B virus. We are focusing on developing a
database on the polymorphism of the nucleotide sequence of the S-gene (encoding the surface
antigen HBsAg) responsible for immunogenicity in people. We are also working to produce
s-gene constructs that give greater genetic activity in HBsAg production.
These few examples show the wide variety of biotechnology projects being carried out in
Zimbabwe. As we get more trained biotechnologists, there is great scope for creating a
critical mass of biotechnologists in the next five years. We expect to have expanded our
biotechnology equipment during this time period.
Government Support and Policy Guidelines

Biotechnology has been highlighted as a critically needed technology in Zimbabwe's national
Science and Technology (S&T) Policy Statement. The policy proposes that the early focus of
the national biotechnology be directed at crop and livestock improvement. The main objective
will be to develop high yield varieties.
In recent months, there has developed a recognition of the importance of making provisions
for biosafety. This has been influenced by a rapidly developing awareness in Zimbabwe.
84
The RCZ is engaged in an effort to develop biosafety guidelines. It is hoped to develop a

system of voluntary compliance. There are only two laboratories involved in recombinant
DNA technology work. The power of this technology is not fully understood by the majority
of this largely peasant population. It is expected that there will be more calls for greater
control of recombinant DNA work when the level of awareness increases. In the meanwhile
scientific leaders are emphasising the importance of best laboratory practice in the conduct of
work in biotechnology as the required approach to biotechnology.
The area of intellectual property rights (IPR) is beginning to receive attention. This arises in
part from the fact that Zimbabwe is a member of the African Regional Industrial Property
Organisation (ARIPO). Many African countries belong to ARIPO.
The issues that were considered when the early ARIPO discussions addressed industrial
property rights are very much relevant in biotechnology. Government has not yet got down
to the point of designing legislation to deal with biotechnology IPR.
My own laboratory is studying the S gene of hepatitis B virus (HBV) DNA. We have cloned
both the pre-S region and the S gene region in vector pIBI31. We are currently comparing
nucleotide sequences of the combined pre-S plus S gene sites from a number of Zimbabwean
HBV isolates. We want to determine whether the nature of the sequences in this region
influences the immunogenic efficacy of the HBsAg protein encoded by this region.
Constraints to Flourishing of Biotechnology Applications

Although biotechnology has great potential for promoting sustainable socio-economic
development in developing countries in Africa, its benefits are still hard to realise because of
a number of constraints.
The major constraints are in the area of shortages of skilled manpower, equipment and
facilities including funds for recurrent expenditures. For a country to benefit from
biotechnology, it must first invest in these areas. In my view the most important investment
in tooling up for biotechnology is in manpower development. As training is currently
available almost exclusively overseas, and African countries are experiencing their hardest
times economically, the only viable access to this technology is one funded by donors.
One would like to encourage the launching of special scholarships by the international
community to enable African trainees to acquire biotechnology. If such a programme were
launched and carefully targeted, it would take about ten years for a significant number of
African countries to acquire biotechnology.
85
Case Studies
Cassava Study
As cassava is not used much as a food item in Zimbabwe, the main interest in growing it
on a large scale is its industrial processing for plastics, carbohydrates, etc. Dr Ian
Robertson's laboratory at the University of Zimbabwe is initiating the expanded research
on cassava breeding in conjunction with some rural community groups. Government
extension agencies are promoting the growth of cassava so that it can serve as a hedge
against the impact of drought years.

Use is being made of micropropagation techniques. The technical problems associated with
attempts to use molecular gene transfer techniques are well known by experts in this field.
Thus the use of molecular gene cloning in cassava breeding has not yet been achieved.
The results from introducing cassava are likely to benefit a wide cross-section of the
Zimbabwe community as the country's extension system is being mobilised to ensure a
wider distribution of the results. It is hoped that wider cassava growing can eventually
lead to its acceptance as a food crop in Zimbabwe.
Hepatitis B Virus and Liver Cancer

Primary liver cancer is the leading cause of cancer related fatalities in Zimbabwe. Its early
diagnosis can result in prolongation of the life of the victim. Hepatitis B virus is
implicated in liver cancer carcinogenesis. The hepatitis B virus (HBV) study has used a
DNA probe to screen the blood of a large segment of the Zimbabwe population for the
prevalence of HBV infection. Blood samples served as sources of HBV, which was cloned
and its surface antigen gene sequenced to identify its nucleotide sequence structure.
The work is being done in Professor C.J. Chetsanga's laboratory at the University of
Zimbabwe. Current work seeks to clone the isolated gene in an expression vector from
which significant surface antigen proteins can be purified for use in vaccine trials.
Successful production of recombinant DNA HBV vaccine would provide an opportunity
for going into other pharmaceutical study applications.
86
Salmonella Probe
Salmonella food poisoning is a common medical problem in developing countries and to
some extent in developed countries. It has long been recognised that methods of detecting
Salmonella in food samples can be very effective in preventing food poisoning by this
pathogen.
Dr Gopo's laboratory at the University of Zimbabwe has been working on developing

DNA probes for diagnosing food contamination by Salmonella. They have identified a
DNA probe isolated by fractionating restriction digests from the Salmonella genome. The
fragment isolated has proved to be a sensitive probe for screening foodstuffs for
contamination by Salmonella.
Dr Gopo and his colleagues have been actively using the DNA probe to assist butcheries
and restaurants in screening meat and foodstuffs for Salmonella contamination.
References
Brown, A.H.D., Frankel, O.H., Marshall, D.R. and Williams, J.T. (eds) (1989) The Use of
Plant Genetic Resources. Cambridge University Press, Cambridge.
Kenny, M. and Buttel, F. (1985) Biotechnology: Prospects and Dilemmas for Third World
Development. Development and Change, 16: 16.
Persley, G.J. (ed.) (1990) Agricultural Biotechnology: Opportunities for International
Development. CAB International, Wallingford, U.K.
87

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