Generic Medicines

Introduction

The generic drugs are also a pillar of affordable healthcare, as they provide the same therapeutic value as branded drugs at much lower prices, which is important in the case of India with a large population that fights with high out of pocket medical costs.

Definition and Fundamentals

• Innovator (branded) medications are the pharmaceutical copies of generic drugs; they are similar in terms of pharmaceutical active ingredient (API), dosage form, strength, route of administration and intended use.
• The biggest difference is bioequivalence: generics must demonstrate that they include the API to the blood with a similar rate and concentration as the original one, with equal efficacy and risk without undergoing intensive clinical testing.
• The other inactive ingredients like fillers, colors, flavors etc may vary, but they do not impact on performance since they are verified by the government agencies like the US FDA and the CDSCO in India.
• Legally, generic products cannot be displayed in the market till the expiry of the patent of the originator that is, 20 years, which then creates the chance to compete and lower the price.

Historical Development in India

• India started the tryst with generics with the Patents Act, 1970 that was only enabling process patenting but not product patenting because the locally based company could reverse engineer the drugs and make India the pharmacy of the world.
• By 1990s it had achieved a 20 percent of global quality volume of generics exported to over 200 countries.
• In 2005, the compliance of WTO TRIPS Agreement brought patents on products onto board, though access was preserved through force by compulsory licensing (e.g. Nexavar, 2012).
• This has changed its policy in 2008 with the introduction of Jan Aushadhi scheme which has been furthered in 2015 as Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP).

Regulatory Framework

• It is based on Drugs and Cosmetics Act, 1940 (with a number of amendments, one of the most significant was made in 1982, and again in 2008), which was and continues to be implemented by the Central Drugs Standard Control Organisation (CDSCO).
• Good Manufacturing Practices (GMP) must be followed by the manufacturers, bioequivalence studies must be done as per the Schedule Y and approvals be obtained through the New Drug Application route of generics.
• The Price Control Order (Drug Price Control Order 2013 (2024) regulator of prices; National Pharmaceutical Pricing Authority (NPPA)) has a limit on the price of the essential medicines found in the National List of Essential Medicines ( National List of Essential Medicines 2022).
• The prescription of generic prescriptions after 2023 is encouraged, and the quality is followed by the implementation of the Janaushadhi portal. It increases its credibility with international standards like USFDA certifications of 200 or more Indian locations.

Key Advantages

• This is because the generics can save 50100 percent of money by eliminating the costly research and development ( 800-1,000 crore per drug) and advertising which is significant as in India 60-70 percent of health spending is out-of-pocket.
• They are synonymous with branded safety and efficacy and studies show 95+ rates of equivalence.
• PMBJP had distributed over 10 crore prescriptions and saved 1.7 lakh crore and 2,500 and above prescription including oncology drug prescription.
• The SDGs 3 (Good Health) and universal health coverage in Ayushman Bharat is supported by the improved access.

Major Challenges

• The 10-20 percent of the generics are linked to quality variations due to the random regulation by 28 state drug controllers and haphazard drugs (5-10 percent of the market).
• There are 5-15 cases when generics are used with the help of the pharmaceutical rewards, mistrust and unsuitable packaging.
• Jan Aushadhi Kendras uptake in rural regions is poor (below 20%), because the supply chain has its gaps and is not well-known.
• Reliance on China 60-70% APIs exposes one to vulnerability as was the case with COVID disruptions. The lawsuits and additional stalling builds by patent evergreening.

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