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[NEW DELHI] India's pivotal role in supplying cheap anti-HIV medicines to developing countries has been quantified for the first time.

The detailed assessment found that India is supplying 80 per cent of the cheap anti-retroviral drugs (ARVs) bought by low- and middle-income countries. The authors say their work reveals the scale of the damage that could be done to these countries should the supply be cut off by new trade agreements.

The research, published last week (14 September) in the Journal of the International AIDS Society, contained data from more than 17,000 donor-funded purchases of ARVs made by 115 low- and middle-income countries between 2003 and 2008.

In niche areas, such as those for children and those that prevent the HIV virus from multiplying, Indian ARVs accounted for about 90 per cent of the market, the study found.

During this period the number of Indian firms supplying ARVs rose from four to ten; while the number of drugs supplied rose from 14 to 53.

The Indian ARVs used in the first line of treatment were "consistently and considerably" less expensive than the "branded" drugs produced by other countries.

Key new drugs recommended recently by the WHO were up to four times more expensive than the older drugs.

Not only India, but also its trade partners, international organisations, donors, civil society organisations and drug firms should ensure "sufficient policy space" for Indian drug firms to continue making cheap generic versions of ARVs, the study concluded.

Sub-Saharan African countries, and India itself, rely heavily on cheap Indian generic drugs.

This has been possible as Indian laws did not grant patents on a product, but only on a process to make it, which helped its drug firms to make cheaper versions and improved formulations using alternative methods. 

But India's signing of the Trade Related Intellectual Property Rights (TRIPS) agreement under the World Trade Organization in 2005 means that the country now has to grant patents on products as well as processes, for any drugs patented after this date.

Meanwhile, India and the European Union have been holding talks on a free trade agreement since 2007; while India and Japan are expected formally to sign one during Indian prime minister Manmohan Singh's visit to Japan in October.

"Now, there is a threat that the limited policy space that remains will be further constricted by bilateral or regional free trade agreements" that have even more stringent clauses than TRIPS, said the authors.

"This report is very welcome," said Shamnad Basheer, professor in intellectual property law at the National University of Juridical Sciences, Kolkata. "It helps us move away from emotional rhetoric to hard facts and data on which sensible policy can be built."

Experts engaged in HIV treatment in Africa told SciDev.Net that they expect the first big squeeze to be felt with a delay, or inability to access, generic versions of a class of HIV drugs called protease inhibitors, launched after 2005. 

Marcus Low, a researcher at Treatment Access Campaign, an activist group engaged in universal access to cheap medicines, said: "The proposed EU/India free trade agreement ... will be catastrophic. It will deprive hundreds of thousands or even millions of people in developing countries from having access to new life-saving medicines — a problem that will become even more acute as resistance to currently used antiretrovirals increases."


Journal of the International AIDS Society doi:10.1186 (2010)