ISSN (Print) - 0012-9976 | ISSN (Online) - 2349-8846

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The Myth of Branded Generics

The pharmaceutical market in India is unique in that it is dominated by "branded" generics which enjoy a price premium though they are not superior to "unbranded" generics in either pharmacopoeia or therapeutic value. Aggressive marketing of branded generics has led to higher prices, irrational fixed dose combinations and concentration in the industry. It is high time India moved towards a de-branding of generic drugs.

This article is written in the author’s personal capacity and the views expressed are his own and not that of the Government of India.

Generics have made drugs more affordable the world over because of the intense competition they bring along with them. Unlike a brand name drug, which is protected by exclusive marketing rights under a commercial patent, its generic version, which is usually manufactured and marketed by several competitors after expiry of the originator patent, sells at a fraction of the original price, thereby benefiting the consumer immensely.

In pharmacopoeia, a generic drug has the same active pharmaceutical ingredient(s) (API) as the originator drug and works alike in dosage, strength, performance and use. In the United States (US), bioequivalence measures of generic drugs approved by the Food and Drug Administration over a 12-year period of 1996-2007, involving 2,070 bioequivalent studies, were found comparable with those of their corresponding innovator counterparts. In India, the position is no different. All drugs, including generic versions, are subjected to identical statutory requirements, inspections and approvals. All drug manufacturers have to conform to the Schedule M Good Manufacturing Practices prescribed under the Drugs and Cosmetics Act, 1940. They must also meet the same labelling requirements and quality standards, and possess necessary manufacturing and sale licences. Any drug that fails to meet the pharmacopoeia specifications, including quality standards, is treated as a spurious drug and is not allowed to be sold in the market.

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