GENERIC DRUGS AND

PRADHAN MANTRI
BHARTIYA JANAUSHADHI
PARIYOJANA
PRESENTED BY: DR. ATHIRA K.R.
RESOURCE FACULTY: DR RENU SHAHRAWAT
 CONTENTS
1) GENERIC DRUGS
2) ROLE OF INDIAN PHARMACEUTICAL INDUSTRY IN GENERIC DRUG MARKET
3) INDIAN SCENARIO ON MEDICINES
4) PMBJP
5) OTHER GOVERNMENT INITIATIVES
6) CHALLENGES
7) WAY FORWARD
GENERIC DRUGS
 WHAT IS A GENERIC DRUG?
A medication created to be the same as an
already marketed brand-name drug in dosage
form, safety, strength, route of administration,
quality, performance characteristics, and
intended use.

These similarities help to demonstrate

bioequivalence

Source: https://www.fda.gov/drugs/questions-answers/generic-drugs-questions-answers
 BIOEQUIVALENCE OF GENERIC
PRODUCT AND A REFERENCE
PRODUCT

Bioequivalence of a generic product (B) and a reference product (A). Product A is the reference product. Product B is the test (generic) product. The
relevant parameters are: Drug A: Cmax=8.1 μg/ml; Tmax=2.6 h; AUCo-∞=124.9 μg.h/ml Drug B: Cmax=7.6 μg/ml; Tmax=2.1 h; AUCo-∞=112.4 μg.h/ml
The ratio of areas (generic:reference), and therefore the relative bioavailability, is 0.9 To be accepted as bioequivalent, the 90% Confidence Intervals for
the area ratio would need to fall within the 0.8–1.25 range.Source:Al-Jazairi AS, Bhareth S, Eqtefan IS, Al-Suwayeh SA. Brand and generic medications:
are they interchangeable? Ann Saudi Med. 2008 Jan-Feb;28(1):33-41. doi: 10.5144/0256-4947.2008.33. PMID: 18299655; PMCID: PMC6074234.
 Generic medicines use the same active ingredients as brand-name medicines and work
the same way

Have the same risks and benefits as the brand-name medicines.

Small amount of natural variability, not medically important

FDA limits the variability

A study - approximately 3.5% in absorption into the body between generic and the
brand-name medicines
Source:Davit et al. Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration.  Ann
Pharmacother. 2009;43(10):1583-97.
 WHY GENERIC DRUG COST LESS?
Reduction in upfront research cost - Do not have to repeat animal and
clinical (human) studies that to demonstrate safety and effectiveness

Unlike brand name drugs – multiple generic companies are approved to

market a single product

Competition in the market

According to the IMS Health Institute, generic drugs saved the U.S.
healthcare system $1.67 trillion from 2007 to 2016
Source: imshealth.com. Quintiles IMS Institute: Reports. Available from: http://www.imshealth.com/en/thought-leadership/quintilesims-institute/reports
DEMAND FOR GENERIC DRUGS
ON A RISE
• Treatment is long & repetitive
NCDs on a rise • Cost of NCD medicines
• Increase in aged populations

Patent expiration  • Promotion of generics

• In developed - To reduce costs

Rise in healthcare • In developing – To make drugs
expenses affordable and accessible

Source: https://www.imarcgroup.com/generic-drug-manufacturing-plant
 GLOBAL GENERIC MARKET
The global generic drugs market reached a value of US$ 386 Billion in 2020

Cardiovascular diseases (CVDs) are the leading therapy area, accounting for the
majority of the total market.

On a regional basis, the United States represents the biggest market, accounting
for the largest market share.

China, Brazil, Germany, France, India, United Kingdom, Japan, Canada, Italy.

Source: https://www.imarcgroup.com/generic-drug-manufacturing-plant
 IMPORTANCE OF GENERIC DRUGS
SDG 3.8: “Achieve universal health coverage, including financial risk protection,
access to quality essential health-care services, and access to safe, effective, quality
and affordable essential medicines and vaccines for all.”

A key element of any UHC essential medicines strategy will be the promotion of
generic medicines

Affordability and access to medicines can be increased

Effective cost containment strategy - reduce government expenditure on medicines
– generic prescribing & generic substitution.
LMICs could consistently save 60-80% of their medicines expenditures on
off-patent originator medicines through the use of unbranded generic
equivalents.

Accounting for approximately 90% of prescription in the US, generic

medicines are essential to increasing patient access to important drug
therapies.

Source: The world health report . Health systems financing: the path to universal coverage. Geneva: World Health Organization; 2010,
https://www.usp.org/our-impact/generics/timeline-of-generics-in-us
 USA AND GENERICS
FDA – Authority for approval of applications for generic versions of drugs.
Generic substitution policies – Pharmacy Practice Act.
Measures to encourage use by patients by making them pay significantly
less co-payment when selecting generic medicines as most pharmacy plans
& designs & insurers adopted formularies for 3 – tier co-payment.
At federal level – the approved products and therapeutically equivalent
generic medicines are listed in Orange book.
Promotion & Education of health care professionals and consumers to
increase their confidence
 USA AND GENERICS
• Simplifying generics applications
• The Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) is signed into law, allowing
the FDA to approve applications for generic versions of brand-name drugs released after 1962 through an ANDA
1984 without repeating efficacy and safety research

• Generics growth phase

• FDA receives approximately 1,050 applications for new generics, with a projected annual savings of $1 billion, in
1985 the first year following enactment of the Hatch-Waxman ANDA approval pathway

• Increasing generic substitutions

• The substitution rate at pharmacies for FDA-approved generic drugs jumps from 12% to 22% by the second
1986 year after the Hatch-Waxman Act

• Requiring more quality data

• Generic Drug Enforcement Act requires generic drug manufacturers to include more scientific data about quality
1992 and bioequivalence and establishes penalties for including false information in ANDAs
 • Tripling generics
2007 • The proportion of prescriptions filled with generics grew to 63% from 18.6% in 1984

• Savings surge
• The generic substitution rate at pharmacies reaches 86%, with an estimated savings of more than
2014 $230 billion

• Savings continue to build

• Generics save US consumers more than $265 billion for the year
• FDA's focus on competition
2017 • FDA announces its Drug Competition Action Plan to encourage generic drug development

• New pathways for approvals

• FDA approves first generic drug under new “Competitive Generic Therapy” (CGT) pathway aimed at
2018 enhancing market competition for sole-source drugs.
 BRANDED GENERICS
Generic drugs that have been given a proprietary market name

Marketed in a similar way as branded drugs

To drive recognition and promote consumer loyalty

13 times more expensive than unbranded generics

More common in low and middle income countries like India

Source:
https://www.drugpatentwatch.com/blog/branded-generics-what-they-are-and-why-theyre-profitable/#:~:text=Branded%20generics%20are%20generic%20drugs,known
%20by%20their%20chemical%20name
 EXAMPLE
Atorvastatin – LIPITOR 10MG –
Innovator drug – 183 dollar for 30 tablets

Atorvastatin – CADITOR 10 MG –
Branded generic – Rs.149.83 for 30 tablets

ATORVASTATIN – GENERIC –
Rs.15 for 30 tablets at JA stores.
ROLE OF INDIAN
PHARMACEUTICAL INDUSTRY
IN GENERIC DRUG MARKET
 INDIA
India ranks 3rd worldwide for pharmaceutical production by volume and 14th by value.

An established domestic pharmaceutical industry, with a strong network of 3,000 drug
companies and ~10,500 manufacturing units.

Operates more than 250 US food and drug administration (FDA) and UK medicine and
healthcare products regulatory agency (MHRA) approved plants

Over 80% of the antiretroviral drugs used globally to combat aids are supplied by Indian
pharmaceutical firms.

Supplies over 50% of global demand for various vaccines, 40% of generic demand in US and
25% of all medicine in the UK.
Source: https://www.ibef.org/industry/pharmaceutical-india.aspx
 Largest provider of generic drugs in the world – 60%

Indian firms accounted for 35-40% of the global USFDA 971

approvals in 2018

Sun Pharmaceutical Industries Ltd, Lupin Limited, Aurobindo

Pharma Limited, Cipla, Dr. Reddy’s – among leading generic
producers

Source: https://www.imarcgroup.com/generic-drug-manufacturing-plant
Generic competition needed to drive prices down:
the example of AIDS medicines
INDIAN SCENARIO ON
MEDICINES
 An estimated 469 million people in India do not have regular access to
essential medicines, according to the WHO.

Indians are the sixth biggest out-of-pocket (OOP) health spenders in the
low-middle income group of 50 nations, as in May 2017.

Around 70% of the overall household expenditure on health is on medicines

Source:https://www.indiaspend.com/why-indias-poor-buy-essential-medicines-from-private-pharmacies-86299/
 HEALTH EXPENDITURE IN INDIA
Total health expenditure (THE) as percentage of GDP – 3.8%

Government Health Expenditure (GHE) percent of THE – 32.4%

Out of Pocket Expenditures (OOPE) as percent of THE – 58.7%

Medicines as percent of OOPE – 43% (Inpatient – 18%, Outpatient – 82%)

Source: MoHFW, NHA Report 2016-17, Available at http://nhsrcindia.org/category-detail/national-health-accounts/ODU=

 AVAILABILITY OF MEDICINES IN PUBLIC SECTOR
FACILITIES OF TWO NORTH INDIAN STATES
PUNJAB HARYANA
TYPE OF PHC CHC DH MC TOTAL PHC CHC DH MC TOTAL
MEDICINES

Anti- 50.8 52.5 54.2 12.5 50.7 59.1 59.8 59.7 62.5 59.6
bacterial
Anti- 60.5 61.4 61.7 0 59.1 59.7 58.6 55.0 60.0 58.5
hypertensiv
e

Anti- 35.2 54.5 63.3 0 44.1 38.2 49.1 76.7 40.0 47.0
diabetic
Thrombolyti 0.0 4.3 20.0 0 9.9 0.0 10.2 46.7 50.0 26.6
c
Anti-cancer 0.0 0.0 4.2 25 4.4 0.0 9.1 4.2 25.0 7.7
medicines

Source:Prinja, S., Bahuguna, P., Tripathy, J.P. et al. Availability of medicines in public sector health facilities of two North Indian States. BMC Pharmacol Toxicol 16, 43 (2015). https://doi.org/10.1186/s40360-
015-0043-8
 HOW TO IMPROVE GENERIC MEDICINE USE
National Drug Authority – registration of generic medicines via a rigorous scientific based
registration system to ensure quality, safety, efficacy and bioequivalence.
Generic medicine promotion programmes
Health care professionals – communication & co-operation
Acceptance of generic medicines by health care professionals
Acceptance of generic medicines by patients
Evidence based reference of therapeutically substitutable medicines
Medicine pricing and pricing systems
Reimbursement system and financial incentives
 REGULATIONS AND GUIDELINES
Central Drugs Standard Control Organization (CDSCO), licensing
authority in India, MoHFW – release guidelines for Bioequivalence /
Bioavailability studies for generics in 2014

National Pharmaceutical Pricing Authority (NPPA) - Drugs (Price

Control) Order 1995 and other orders enforced.

The Drugs & Cosmetics Act, 1940 - regulates the import, manufacture,
distribution and sale of drugs in India – Amended in 2008
 NATIONAL HEALTH POLICY 2017
14.4
◦ A strong and transparent drug purchase policy for bulk procurement of drugs
◦ Facilitating spread of low cost pharmacy chain such as Jan Aushadhi stores linked with ensuring
prescription of generic medicines.
◦ Education of public with regard to branded and non-branded generic drugs.

14.7
◦ Timely revision of National List of Essential Medicines (NLEM) along with appropriate price control
mechanisms for generic drugs shall remain a key strategy for decreasing costs of care for all those patients
seeking care in the private sector.

16

◦ Making available good quality, free essential and generic drugs and diagnostics, at public health care

facilities is the most effective way for achieving the goal of UHC
 PRADHAN MANTRI BHARATIYA
JANAUSHADI PARIYOJANA
Started as Jan Aushadhi Scheme in 2008 by Dept of Pharmaceuticals, Ministry of
Chemicals & Fertilizers.

Implementing Agency – BPPI - Bureau of Pharma Public Sector Undertakings of

INDIA – set up on 1st December, 2008

1st Jan Aushadhi Kendra was opened

on 25th Nov 2008 at Amritsar in Punjab

Renamed as PMBJP in 2015

 • Launched as Jan Aushadhi scheme
2008

• Only 157 kendras could be opened by 31st March 2012 & only 130/370
medicines available
2008- • 3rd party evaluation by PHFI – Rapid Assessment and Potential Scale up of
2012 PMBJP scheme

• New Business plan on Aug 2013

• By end of financial year 2014-15 only 99 kendras were functional with
2013 only 200 medicines

• Strategic Action plan 2015 approved by Ministry of C & F in September

2015
 IMPLEMENTING AGENCY AND
FUNDING OF PMBJP - BPPI
Under the administrative control of Dept Of Pharmaceuticals, Ministry of Chemicals and
Fertilizers

Established with the support of all pharma PSUs for coordinating procurement, supply
and marketing of generic drugs through PMBJKs.

Registered as independent society in 2010.

Full financial support by Govt Of India during initial years

Later BPPI should recover its expenses through trade margin

To bring down the healthcare budget
of every citizen of India by providing
quality generic medicines at
affordable prices
 Create awareness among public regarding
generic medicines
 Create demand for generic medicines
through medical practitioners
 Create awareness through education and
awareness programs that high price need
not be synonymous with high quality
 Provide all the commonly used generic
medicines covering all the therapeutic
groups
 Provide all the healthcare products too
under the scheme
• Making quality medicines available at affordable prices for all, particularly the poor
and the disadvantaged, through exclusive outlets ‘Pradhan Mantri Bharatiya Jan
Aushadhi Kendras, so as to reduce out of pocket expenses in healthcare
 PRADHAN MANTRI BHARATIYA
JANAUSHADHI KENDRAS
State govts or any organization/ Reputed NGOs/ Trusts/ Charitable associations/
Doctors/ Unemployed pharmacists/ Individual entrepreneurs are eligible to apply

Applicants have to employ one B pharma / D pharma degree holder as pharmacist

Can be located within Govt/ Private hospital premises or anywhere outside

 In addition to medicines and surgical items supplied by BPPI, PMBJKs can sell
allied medical products to improve the viability of running
 PROCUREMENT AND SUPPLY
Procured through an open tender system from private manufacturers as well as CPSUs
(Central Public Sector Undertakings).

PSUs have the first right to supply

Only through e-tendering

Receipt of goods at warehouses- four modern warehouses at Gurugram, Bengaluru,

Guwahati and Chennai for storage and distribution of drugs.

Each batch of medicine is tested at NABL empaneled laboratories and distribution

network.
Only after quality certification the goods are dispatched to Carrying & Forward
agents at different locations & distributors in all states or UTs

Drugs are made available to all kendras across the country from these warehouses.

Information Technology enabled End-to-End supply chain system with Point-of-Sale

(POS) application for value added services has been implemented in PMBJP.
 QUALITY OF MEDICINES UNDER
PMBJP
Procures medicines only from WHO – Good Manufacturing Practices (WHO-GMP)
certified suppliers for ensuring the quality of the products.

Apart from this, each batch of drugs is tested at laboratories accredited by ‘National
Accreditation Board for Testing and Calibration Laboratories’ (NABL).

Only after passing the quality tests, the medicines are dispatched to PMBJP Kendras.
 Any individual entrepreneurs is
extended an incentive of 15% of
monthly purchases subject to a
ceiling of 10,000/- per month up
to a total limit of 2.5 lakh

Individual SC/ST and Compensation against

differently abled expired medicines for
entrepreneurs are PMBJK & Distributers –
also provided 2% of total sales or
medicines worth of actual loss whichever is
lower. Expired goods at
Rs. 50,000/- in FINANCIAL C& F levels – entire loss
advance
SUPPORT BY by BPPI
BPPI
For the north eastern
states, Naxal affected area Credit facility-
and tribal areas, the rate of all PMBJK for 30days
incentive is 15% of monthly against postdated cheques
purchases subject to a Distributers – 60 days
ceiling of Rs. 15,000/- per
month up to a total limit of C & F agencies – security
Rs. 2.5 lakh. deposit upon business.
 MONITORING OF THE SCHEME
Progress of implementation of the project and the target achieved shall
be monitored by the steering committee.

Steering committee-
Secretary (Pharma),
Joint Secretary (Pharma),
Director (Pharma),
all the MDs/CMDs of Pharma PSUs,
President, Secretary and CEO of BPPI.
 COVERAGE

• 6068 PMBJP Kendras functional across the country in 696 districts

• Product basket comprises of more than 800 drugs and 154 surgical
instruments
Source: http://janaushadhi.gov.in/Data/Annual%20Report%202019-20_21052020.pdf
 AWARENESS & PUBLICITY
Print Media
Radio advertisement
TV advertisement
Cinema Advertisement and Outdoor publicity like Hoardings
Bus Queue Shelter branding
Bus branding,
Auto wrapping
BPPI also educates the public about the usages of Jan Aushadhi generic medicines through social
media platforms like Facebook, twitter, Instagram, YouTube, etc. on regular basis.
 NEW INITIATIVES
“Janaushadhi Suvidha” sanitary pads - made available for sale @ Rs 1.00 per pad since
27th August, 2019 in more than 5800 PMBJP kendras.

More than 60.25 lakh pads have been sold @ Rs. 1.00 per pad since 27th August, 2019.

313 new kendras were opened across the nation.

Modern warehouse was inaugurated in Chennai for better logistics in Southern India.
TECHNOLOGY ORIENTED
INITIATIVES
PROGRESS ENVISIONED – 31 March st

2024
Coverage: cover all districts of the country by opening at least one PMBJK in every district, so that a
total of 10000 kendras

Basket of medicines: Target is set to enhance it up to 2000 medicines and 300 surgical products, so
that all essential medicines covering therapeutic groups.

Storage & Logistics: Establishment of an effective IT-enabled logistics and supply-chain system for
ensuring real time distribution of medicines at all outlets to avoid stock out situation.

Planned to open two more warehouses in Western and Central India

 OTHER GOVERNMENT
INITIATIVES FOR GENERIC
DRUGS
Free Drugs Service Initiative

AMRIT Stores
 FREE DRUGS SERVICES
INITIATIVE

WHO – 65% of the Indian population lacks regular access to essential

medicines.

Provision of free drugs - most important interventions towards

mitigating the burden of health care costs

Announced in Budget 2014-15

KEY FEATURES Robust IT backed
procurement , quality
assurance, warehouses
and supply chain
management

Workshop for Doctors

State policy for All drugs procured,
to promote
universal access distributed and
prescription of
to essential prescribed should be
generics and rational
medicines generic drugs
drug use

A Grievance Redressal
Mechanism
OPERATIONAL FRAMEWORK
Centralized Procurement Standard Treatment Prescription Audit
Body at State Level with guidelines
sub committees

Monitoring & Grievance Redressal

Financing through NHM
Evaluation of the System
initiative

Tendering
Procurement of drugs
IEC, Training &
Debarring of defaulter Supply chain Management
Orientation
drug companies system for drugs and
vaccines
District Drug Warehouse
Transportation of from
DDW to health facilities Quality Assurance
Storage at Health facilities
 Key Characteristics of a
Reliable & Efficient Medicine Supply Systems,
Tamil Nadu and Rajasthan
Atleast 15% allocation of public funds to drugs;
An autonomous procurement agency for drugs, vaccines & diagnostics;
State must procure all EDL medicines;
Separate traditional EDL and centralized procurement at state level;
A two-bid open transparent tendering process;
Quality generic drugs ensured;
Warehouses at every district level;
An empanelled laboratory for drug quality testing;
Prescription & Dispensing through STGs;
Enactment of Transparency in Tender Act;
Prompt payments.
 AMRIT STORES
Affordable Medicines & Reliable Implants for Treatment

Objective - To reduce the out-of-pocket expenditure especially through pharmacies,

MoHFW

Run by HLL Life care limited, Govt Of India

Offers more than 5200 drugs, implants, surgical disposables and other consumables at
average discounts up to 60% of maximum retail price (MRP).

First outlet - on 15th November 2015 at AIIMS, New Delhi

153 AMRIT stores in 23 states/ UTs

CHALLENGES
 HURDLES IN THE WAY OF JA
STORES
Drug related
Unavailability of common drugs / their multiple combinations
Unavailability of newer or costly drugs like Anti-cancer drugs or drugs mentioned in
the website

Supply related – Poor/irregular/insufficient/delayed supply

Practitioner related – Unawareness/ Misguiding/Non interest by both Govt and private

practitioners
 Other chemist related – Competition or misguiding by other chemists

Additional hurdles
 Insufficient awareness of public regarding the generics
 Improper location of JAS
 No association between physicians and chemists

Fewer drugs for NCDs such as diabetes, hypertension, asthma, cancer, and
hypercholesterolemia.
Fewer PMBJP kendras are found in poorer, less developed, and rural districts.

Lack of coordination between state schemes and PMBJP.

KAP study towards Jan Aushadhi Scheme conducted in Jammu in 2017 among physicians –
even though all the physicians were aware of the scheme only about 16% of them
prescribed generic medicines.
Source: Deshpande PR, Sheriff MK, Pawar AP. Functioning and productivity of Jan Aushadhi stores in India: The owners' perspective. CHRISMED J Health Res
[serial online] 2018 [cited 2021 Feb 24];5:28-37. Available from: https://www.cjhr.org/text.asp?2018/5/1/28/223122
Extensive patent protection delays onset of generic competition
Intellectual Property Rights in free trade agreements cause an increase in price
Irrational prescription practices
Lack of timely rationalized updation of NLEM
Perception of public regarding quality of generic drugs
Proportion of fake/substandard/spurious drugs in India is 3-4%.
Indian pharmaceutical firms present a pattern of differentiating drug quality
depending on the final destination.
High API dependence on other countries - Over 63% of India’s pharmaceutical
imports are API and intermediates and almost 70 per cent of it comes from China.
Branded generics with high prices

Source: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/279148/Oxfam.pdf
 WAY FORWARD
PMBJP
◦ Coordination between state specific schemes and PMBJP kendras

◦ Strengthen the supply chain by establishing more additional regional warehouses

◦ Ensure supply by connecting the stores to a real time software and different stock level
recommendations based on volume of sales

◦ BPPI should provide more incentives to open more PMBJP kendras in rural less developed areas

◦ Current medical stores in all the government hospitals (in the whole nation) may be converted
to JAS. It may bring uniformity among the JAS.
Generic medication – Outreach and safety.

Centralized manufacturing licensing system.

Quality checks should be boosted at manufacturing sites and at warehouses.

More strategic price controls on drugs which are used to treat new prevalent diseases.

Generic prescription and generic substitution acts.

Draft Pharmaceutical Policy 2017

1.
REFERENCES
US FDA generic drugs, available at https://www.fda.gov/drugs/questions-answers/generic-drugs-questions-answers
2. PMBJP scheme, Available at janaushdhi.gov.in
3. Al-Jazairi AS, Bhareth S, Eqtefan IS, Al-Suwayeh SA. Brand and generic medications: are they interchangeable? Ann Saudi Med. 2008 Jan-Feb;28(1):33-
41. doi: 10.5144/0256-4947.2008.33. PMID: 18299655; PMCID: PMC6074234.
4. Davit et al. Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug
Administration. Ann Pharmacother. 2009;43(10):1583-97.
5. imshealth.com. Quintiles IMS Institute: Reports. Available from: http://www.imshealth.com/en/thought-leadership/quintilesims-institute/reports
6. IMARC group report, Available at https://www.imarcgroup.com/generic-drug-manufacturing-plant

7. The world health report . Health systems financing: the path to universal coverage. Geneva: World Health Organization; 2010,
https://www.usp.org/our-impact/generics/timeline-of-generics-in-us

8. Source: Deshpande PR, Sheriff MK, Pawar AP. Functioning and productivity of Jan Aushadhi stores in India: The owners' perspective. CHRISMED J Health
Res [serial online] 2018 [cited 2021 Feb 24];5:28-37. Available from: https://www.cjhr.org/text.asp?2018/5/1/28/223122

9. Sadiq S, Khajuria V, Khajuria K. Knowledge, Attitude and Practices towards Jn Aushadhi scheme.Nat J Physiol Pharm Pharmacol 2017;7(9):977-982,

10. OXFAM report, available at https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/279148/Oxfam.pdf

11. Prinja, S., Bahuguna, P., Tripathy, J.P. et al. Availability of medicines in public sector health facilities of two North Indian States. BMC Pharmacol Toxicol 16, 43 (2015).
https://doi.org/10.1186/s40360-015-0043-8

12. https://www.drugpatentwatch.com/blog/branded-generics-what-they-are-and-why-theyre-profitable/#:~:text=Branded%20generics%20are%20generic%20dru
gs,known%20by%20their%20chemical%20name
.
13. Indian Pharmaceutical Industry , available at https://www.ibef.org/industry/pharmaceutical-india.aspx

14. MoHFW, NHA Report 2016-17, Available at http://nhsrcindia.org/category-detail/national-health-accounts/ODU=

THANK YOU