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THE PHARMA REVIEW (JUNE 2008)

Generic Drugs in India - Whether an Affordable Alternative
to Branded Drugs : A Critical Study

Singal G. L. and Arun Nanda

Abstract: Generic drugs are considered to be the cheaper alternative to the costly patented / branded products, by providing precisely the same medical benefits to the suffering mankind at lower price as these are certified to be perfect substitute for the original branded product. The generic drugs contain the same active ingredient as the original branded product on which they are based. A branded product, for all purposes, is identical to & hence interchangeable with the branded product. They must contain same active ingredients with same strength as the innovator drug product and must meet same pharmacopoeial standards.

Internationally, drugs patents and exclusive marketing rights associated therewith are awarded for a period of 20 years, during this time, no other drug company is allowed to manufacture or market the same drug. After expiry of the patent, other companies are permitted to manufacture and market the drug; their brands are known as generic versions.

The quality requirement for the generics is by and large same as for the corresponding branded product. The generics are considered to be bio-equivalent to a branded drug. Thus generics are identical to their branded counterpart in dose, strength, route of administration, safety, efficacy and intended use. Generics also go through a rigorous scientific review to ensure both safety and effectiveness. Sometimes generic versions of a drug have different colors, flavors or inactive ingredients and also does not look alike the branded one because of trade mark laws. Some of the generics are manufactured by the same pharmaceutical company that make brand drug; others are produced by pharmaceutical companies specializing in the manufacturing of generics. All prescription drug manufacturers must meet rigid FDA, WHO & GMP approvals, as and where applicable.

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