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India's Top Regulator Prepares for a Future Without Branded Medicines

Posted 16 October 2012 | By

The Times of India reports that India's top regulatory official, the drug controller general of India, Dr. G N Singh, eventually wishes to do away with branded or patented medicines in favor of a generics-only system he says will benefit the public before all others.

"We want to gradually move towards a future where we will not issue any brand or trade names," The Times reported Singh as saying.

"Gradually" may come faster than some pharmaceutical companies may like.

"We have sent the order to all state health secretaries asking them to instruct their drug licensing issuing authority to issue licenses only on generic names and not on branded or trade names, which is the usual practice now," Singh is reported as saying. He noted that the cost of brand-name pharmaceutical products can be many times greater than their branded counterparts, which can make them unaffordable to Indian patients.

The statements, made at a meeting of the Drug Consultative Committee on 20 July 2012, but reported by The Times on 16 October, come as the country has moved to aggressively implement a number of cost-cutting measures in the form of compulsory licenses under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement.

A September 2012 decision by India's Intellectual Property Appellate Board (IPAB) upheld a controversial compulsory license for a high-cost medicine with little impact on public health-the stated goal of compulsory licenses granted under TRIPS.

The combination of both the new legal environment and Singh's statements may be enough to give some international companies pause. Companies such as Bayer have in the past argued that such actions harm pharmaceutical research and may have the effect of reducing the introduction of new medicines into the country.

Read more:

The Times of India - Health ministry pushes for end to sale of branded drugs

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