Generics

What are Generic Drugs?

A generic drug is identical or bioequivalent to a brand name drug in
dosage form, safety, strength, route of administration, quality,
performance characteristics and intended use. Although generic drugs
are chemically identical to their branded counterparts, they are
typically sold at substantial discounts from the branded price.
How are Generic Drugs approved?
• Drug companies must submit an abbreviated new drug application
(ANDA)
• The Drug Price Competition and Patent Term Restoration Act of 1984,
more commonly known as the Hatch-Waxman Act, made ANDAs
possible
• New drugs, like other new products, are developed under patent
protection.
• The ANDA process does not require the drug sponsor to repeat costly
animal and clinical research
Global Generics Scenario
• Expected to grow at a CAGR of 10.53% from 2016 through 2020
• The global generic drugs market will benefit from the patent expiry of
drugs worth $150 billion by 2020.
• In 2020, the largest volume of medications will be generics
• The global generic drugs market is fragmented with the top vendors
accounting for about 26% of the global generic sales.
Key players in the global generic drugs market
Indian Pharmaceutical Market
Indian Generics Market
• Increase in Exports in last 10 years
• Growth from API bulk exporters to drug makers
Indian Generics Market
• India constitute around 8% of total global generics market by volume,
indicating huge untapped opportunity in the sector
• India is the largest producer of generics, accounting for 20% of global
export in terms of volume
• Indian pharmaceutical industry has been eyed as the key contributor
with a CAGR of 13 percent during the period of 2008-2013.
• The year on year growth has taken a promising growth since 2008
with an incremental increase in the range of $ 1-1.5 billion each year.
• Pharmexcil Data generics consumption data
Key players in the Indian generic drugs market
Jan Aushadhi Campaign
• Generics in India 1500cr in 1980 to 119000cr in 2012
• Govt. initiatives to make affordable medicines:
A. Price control of Scheduled Drugs through NPPA
B. Price regulation of Non-Scheduled Drugs
C. Uniform VAT of 4% on medicines
D. Reduction in Excise duty
• Govt Dissatisfaction
• ‘Jan Aushadhi’ launched
 Jan Aushadhi Campaign
Make available quality drugs at affordable prices through dedicated stores
selling generic medicines which are available at lesser prices but are
equivalent in quality and efficacy as expensive branded drugs.
Promote greater awareness about cost effective drugs and their prescription.
• Make available unbranded quality generic medicines at affordable prices
through public-private partnership.
• Encourage doctors, more specifically in government hospital to prescribe
generic medicines.
• Enable substantial savings in health care more particularly in the case of
poor patients and those suffering from chronic ailments requiring long
periods of drug use.
 Market
Segments

Branded
Generics OTC
Products

Branded Generic Authorized

Generics Generics Generics
Authorized Generics
• Authorized generics are prescription drugs produced by brand
pharmaceutical companies and marketed under a private label, at
generic prices.
• Authorized generics v/s generics
• Marketing after and during 180 days exclusivity