Legislation Unit 5

PHARMACEUTICAL LEGISLATION
Pharmaceutical jurisprudence- Pharmaceutical jurisprudence is a

science of laws and fundamental principles related to pharmacy
profession it covers laws, rules and regulations on medicines, drugs,
pharmaceuticals, cosmetics, allied substances and pharmacy
profession.
Pharmaceutical legislation-_Pharmaceutical legislations are laws
related to pharmacists, pharmacy profession, drugs, medicines,
cosmetics, practices and substance affecting health of human beings
and animals.
Various pharmaceutical legislations time to time amended and
enforced in India-
The drug and cosmetic act 1940 and rules there under
The pharmacy act, 1948 and various rules, regulations
The drug and magic remedies (objectionable advertisements) act
1954 and rules there under
Hygia Group of Institutions Lucknow, Approved by AICTE, PCI & Affiliated to AKTU
Prabandh Nagar, IIM Road, Lucknow-226013
The medicinal and toilet preparations (excise duties) act, 1955 and
rules there under
and psychotropic substance act 1985 and rules
The narcotic drugs
there under
Drug prices control orders time time to
enforced under the
provision of essential commodities act 1955
The drug prices control order 1970, 1979 and 1987
O Scope and obiectives-_Various pharmaceutical legislations are
enacted with the following objectives
To control over practice and profession of pharmacy
To control and regulate manufacture, import, distribution and sale
of drugs, pharmaceutical and cosmetics
To regulate use of alcohol in medicinal and toilet preparation
andto
levy excise duties on preparation containing alcohol or/ narcotic
drug
To control and regulate import, possession and sale of poisons
Hygia Group of Institutions Lucknow, Approved by AICTE, PCI& Affiliated to AKTU

DRUG ENQUIRY COMMITTEE
Forensic phormacy-_The word forensic is derived from the latin

term forencis meaning forum, which signifies a public place market
place or a place of assembly for judicial and other business
Forensic pharmacy may accordingly be construed as the application
of pharmaceutical knowledge to legal problems
Drug enquiry committee- The government of India responded to a
strong public opinion on the subject of drugs and in pursuance
thereof and that of the resolution of 1927 appointed the drug
enquiry committee (also known as the chopra committee ) under
the chairmanship of Col R.N chopra and Dr. B. Mukherjee as its
assistant secretary. Dr. B. Mukherjee was later appointed the
director of the central drug laboratory and subsequently of the
central drug research institute following were the terms of
reference to the drug enquiry committee.
Hygia Group of Institutions Lucknow, Approved by AICTE, PCI & Affiliated to AKTU
Prabandh Nagar, lIM Road, Lucknow-226013
To enquire into the extent to which drugs and chemicals of impure
quality or defective strength particularly those recognized by the
british pharmacopoeia were imported manufactured and sold in
british india and the necessity in public intrest of controling of such
importation, manufacture and sale and to make recommendations.
To report how far the recommendation made under (1) above may
be extended to known and approved medicinal preparations other
than those referred to above , and to medicines made from
indigenous drugs and chemicals
To enquire into the necessity of legislation to restrict the profession
of pharmacy to qualified persons and to make recommendations
The report of the committee was published in 1931thecommittee
finallyrecommended:
Central legislation to control drugs and pharmacy the legislation
may consist of either a combined drug and pharmacy act or
separate drugs act and separate pharmacy act
Hygia Group of Institutions lucknow, Approved by AICTE, PCI &Afilated to AKTU
Prabandh Nagar, lIM Road, Lucknow-226013
Setting up of testing laboratories in all state to control the quality of
production of drugs and pharmaceuticals and a control laboratory
to control the quality of imported drugs and also to act as expert
referee in case of disputed samples sent by local governments
Appointment of an advisory board to advise the government in
making rules to carry out the objects of the act
Setting up of courses for training in pharmacy and prescribing
minimum qualification for registration as a pharmacist
Registration of every patent and proprietary medicine of
undisclosed formula manufactured in India or imported from
outside the country
The crude single drugs as well as compounded medicines used in
the indigenous system of treatment should be brought under
control
The drugs industry in India should be developed
The manufacturing in medical stores depots should be gradually
Teduce.
Hygia Group of Institutions lucknow, Approved by AICTE, PCI & Afiliated to AKTU
HEALTH SURVEY AND DEVELOPMENT COMMITTEE
This committee was appointed by the government of India in October

1943 under the chairmanship of sir Joseph Bhore to make a survey of
the existing position in respect of health organizations in then British
India and to make recommendations for future developments
Some oftherecommendations ofthe committeeare as follows
The establishment of an all India pharmaceutical council and
provincial pharmaccutical council representing the pharmaceutical
trade, education and other phamaceutical interests.
Enactmcnt of legislation designed to protest the public from
incompctence, to safeguard the interests of qualified pharmacists and
to rise the professional standing of pharmacists cngaged in the
handling of drugs.
H y Ciroup of
lastitutioas l.acknow. Aprorad by AlKTE. PC1
Prabandh Nagar. IIM Road. Lucknow-226013
&Amilated to AKTU
Mcasures of registration of pharmacists
Measures of maintaining disciplinary control
profcssion of pharmacy
over the practice and
Revised courses of study for i) licentiate

pharmacists ii) pharmaceutical tochnologists
phamacists ii) graduate
Setting up ofcentral drug laboratory
The drug act 1940 should be brought into opcration throughout the
country and rigidly enforced
The questions of the requirements of the country in drugs and of the
medical requisites should be examined by a small committe.
Mudaliar committee
A health survey and planning committee was appointed in June 1959
under the chairman ship of Dr. A Lakshmanswamy Mudaliar . the
committee submitted its report in 1961 and among other
recommendations, it recommended the inclusion of indigcnous system
of medicince under the preview of the drug and cosmetic act 1940.
Hygia roup of Institutions Lacknow, Approved by ATE. RI& AMilated to AKTU

fHathi committee- Jaisukhlal hathi committee was appointed by the
government of India to monitor various factors of the drugs industry in
order to promote the growth of drug industry
Following are the terms of relerence of the committee:
I t recommends measures to ensure that the public sector achievers a
leadership role in the manufacture of basic drugs, formulations and in
rescarch and development
It recommends measures to support the growth of the drug industry,
that of the Indian and small scale industrial sector
especially
It examines the arrangements for the flow of new technology into the
and make
industry commendations
necessary
Itforrecommends measures for effective quality control of the drugs and
helping the small scale units
I t examine the step taken to decrease the price for the consumer and to
recommend more such measures to rationalize the prices of basic drugs
and formulations
Hya Group of Intituttons l.ucknow, Approved by AlCTE. PCI& Ailated

to AKTU
The summary of the recommendations of the hathi committee report is
as started belon-
Around 20% of the total sales of drugs and pharmaceuticals carried out
by small fims and by multinational units over the world similar pattern
was developed by the hathi committee
The success of large units in the modern pharmaceutical industry
depends on their ability to develop new products based on rescarch and
to create and sustain a demand for their product
The committee recommends providing information related to

production, stock, costs, sales on a regular basis to allow the
govermment to act in an efficient and rapid way
I t also recommends developing an effective and continuing monitoring
system for the industry in order to attain the essential objectives
Hypa iroup of Institutions l.ucknaw. Approved by ACTE. PKC1 &Afiliated

to AKTU

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PHARMACEUTICAL LEGISLATION

Pharmaceutical jurisprudence- Pharmaceutical jurisprudence is a

Hygia Group of Institutions Lucknow, Approved by AICTE, PCI& Affiliated to AKTU

Forensic phormacy-_The word forensic is derived from the latin

This committee was appointed by the government of India in October

Revised courses of study for i) licentiate

Hygia roup of Institutions Lacknow, Approved by ATE. RI& AMilated to AKTU

Hya Group of Intituttons l.ucknow, Approved by AlCTE. PCI& Ailated

The committee recommends providing information related to

Hypa iroup of Institutions l.ucknaw. Approved by ACTE. PKC1 &Afiliated

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