Campaign to Stop Monopoly of Clinical Trial Data [India]

Author: Keya Acharya, Inter Press Service, Published on: 14 February 2007

Under the drug regulatory process any drug, whether patented or not, must pass safety, efficacy and quality tests for marketing from the Drug Controller-General of India (DGCI)...the DGCI can [currently] rely on previous test data to approve subsequent generic versions of the same drug. This allows generic drug manufacturers to circumvent expensive repeats of clinical trials that translate into cheap and quick drug availability in the market. But in 2005, the powerful Pharmaceutical Research and Manufacturers of America, (PhRMA) lobbied the United States Trade Representative to impose data exclusivity on drug trial submissions...Public health groups...protest...that this is yet another move by MNCs to monopolise the drug market in India, to the detriment of public health and the market for essential generic drugs [refers to PhRMA members Novartis, Pfizer, GlaxoSmithKline, Merck]

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Related companies: GlaxoSmithKline Merck Novartis Pfizer