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PROPOSED LAW WOULD LIMIT ACCESS TO GENERIC ARVS

July 26, 2006

India's plans to change its drug approval system could put the price of antiretroviral (ARV) drugs out of reach of developing countries in Africa.

India, under pressure from the United States and drugmakers, is considering a law that could grant a monopoly to the developer of a new drug for several years without a patent.

Manufacturing and exporting generic ARVs has been easy in India, for once a new drug is approved for sale, other drug companies only need to prove that theirs is identical to the original. But brand drugmakers argue that this reduces the incentive to research and develop new drugs.

As a member of the World Health Organization, India is being hard pressed to make a law giving brand companies exclusive rights to their investment for several years under the Trade-Related Aspects of Intellectual Property Rights (TRIPs).