India's data exclusivity law could be delayed

29 April 2007

In a symptom of what local commentators are describing as "the Mashelkar effect," referring to the recent fiasco involving a withdrawn report into India's 2005 Patent Law which was hit by an accusation of plagiarism (Marketletters passim), a government-sponsored investigation into the issue of drug company data exclusivity is stalling.

The Satwant Reddy Committee is considering the merits of allowing research-based drugmakers, mostly foreign-heaquartered, to safeguard clinical data from local copycat drug firms. As with the Mashelkar Committee, the data exclusivity case is being fiercely resisted by a coalition of local generic drugmakers and activist groups, including Leftist political parties, according to the Economic Times of India.

Mrs Reddy, the committee's chairperson, is due to retire at the end of May from her position as Chemicals and Fertilizers Secretary. Like her predecessor, Pratyush Sinha, Mrs Reddy appears likely to pass the decision to a successor, in a move that suits the government, which would prefer not to face the controversy at this time. The government is reportedly split over the issue.

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