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In Bow to WTO, India Targets Drug Copying

Aid Groups Fear Drop in Supply

By John Lancaster
Washington Post Foreign Service
Thursday, March 24, 2005; Page E06

NEW DELHI, March 23 -- India's parliament gave final approval Wednesday to legislation barring drugmakers from producing low-cost versions of patented medicines from the United States and elsewhere. Public health groups condemned the move, saying it would restrict the supply of anti-HIV drugs in Africa and other developing regions.

The measure passed the upper house of parliament a day after it cleared the lower house with support from the Congress Party-led government of Prime Minister Manmohan Singh and party leader Sonia Gandhi. It now goes to President Abdul Kalam, who is expected to approve the change.

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Government officials said the law was a condition of India's membership in the World Trade Organization. They secured its passage after granting concessions to left-wing parties, whose support Congress needs to stay in power, aimed at keeping drug prices in check.

The concessions were not enough to satisfy more than two dozen aid organizations, led by Paris-based Doctors Without Borders, which said in a letter to Gandhi: "We are deeply disturbed and concerned that you are failing to listen to the voices of your people who have entrusted you with their welfare, not to mention the poor in the developing world who rely on affordable medicine from India."

The Paris group estimates that about 700,000 people in Africa and other developing nations rely on generic anti-retroviral drugs from India to stay alive. Such drugs generally are sold for about 5 percent of the cost of name-brand anti-retrovirals sold in Europe and the United States. About 5.1 million people are infected with HIV in India, the second-largest number in any nation, after South Africa.

"Prices are a concern for all of us," Trade Minister Kamal Nath told lawmakers in remarks quoted by Bloomberg News. "This patent bill does not make anything happen tomorrow. No patent will come into being for the next couple of years."

For more than three decades, Indian drug companies have skirted patent rules -- and infuriated pharmaceutical firms in other countries -- by means of a loophole that allows them to copy foreign medicines by altering the processes used to manufacture them.

The practice has fueled the rapid growth of India's $5 billion pharmaceutical industry while providing its people and those of other developing nations with reliable and advanced generic medicines at far lower cost than would otherwise be possible.

The measure passed by the upper house Wednesday will not cut off the supply of existing generic medicines. It permits continued production of drugs that are already on the market as long as their manufacturers pay royalties to the patent holders.

The biggest concern centers on new medicines. The measure requires that generic Indian companies wait three years before they can apply to produce a new drug, according to an analysis by Doctors Without Borders. Such patent restrictions could be overridden in the event of a national emergency.

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