As India grapples with one of the world's largest HIV/AIDS caseloads, the government faces the challenge of rapidly scaling up the provision of first-line antiretroviral (ARV) drugs to people who need them, while a growing number require more expensive second-line medication.
Uma Shankar Pandey, a printing machine operator in the western state of Gujarat, has been taking first-line medicine since 1997, but he recently developed resistance to these drugs and has had to switch to a more costly second-line combination therapy.
He told IRIN/PlusNews that the cost of the newer drugs - around INR9,000 (about US$200) - was nearly as much as his monthly salary. "I am deep in debt and often don't know where I will find the money to buy the medicines in the coming months."
Pandey, who is also president of the Kachch Network of HIV-positive people, a nongovernmental organisation (NGO), said his situation was not unique and confirmed that 20 of the group's 475 members were in urgent need of second-line therapy, but only three could afford it.
Second-line treatment is not yet available from the Indian government's free ARV programme, which has been running since 2004.
According to Sujatha Rao, director-general of the National AIDS Control Organisation (NACO), the government's main priority was "to provide the basic treatment for millions of HIV-positive people. The second line of treatment is very expensive and we cannot afford to provide it free at this point," he told The Indian Express newspaper recently.
An estimated 50,000 of more than 5 million people living with the HI virus in India are accessing first-line drugs via the national programme. In December 2006, HIV/AIDS advocacy groups filed a complaint in India's Supreme Court, charging that the government was making little headway in its treatment programme, having failed to reach its own target of providing 100,000 HIV positive people with ARVs by the end of 2005.
There are no official figures on how many people need second-line ARVs, but the Indian Network of People Living with HIV and AIDS (INP+) has estimated there are at least 5,000. Since the treatment programme is still at an early stage, few HIV-positive patients have developed resistance, but as resistance to first-line drugs inevitably builds up, there will be a need for a second generation of medicines within a few years.
"It is a matter of life and death for those who are suffering," said INP+ spokesman Jacob John. "We believe the government has to factor in the inevitable progression of first-line patients to second-line regimens, but we do not see sufficient concern about the pressing nature of the problem."
India is perceived as being in an ideal position to scale up efforts against first-line resistance because of its flourishing pharmaceutical industry, which already provides affordable generic versions of patented anti-AIDS drugs to the developing world, including much of Africa.
The 1970 Indian Patents Act allowed pharmaceutical companies to produce generic versions of patented drugs by slightly modifying the manufacturing process to obtain a new patent for the product. Indian companies were therefore able to offer HIV drugs at a fraction the cost of brand-name versions.
India joined the World Trade Organisation in 1995, which meant it had to adhere to the trade-related aspects of intellectual property rights (TRIPs). In December 2004 the President issued an ordinance requiring a 20-year patent on all new medications, which went into effect on 1 January 2005.
A major change was that patent rights would no longer be determined by the manufacturing process but by the end-product. Generic drugs already in production are not affected and can still be exported.
The new legislation could, however, have the effect of slowing or even reducing the development of new products, including second-line medication, as the patent-holders of brand-name medications can now apply for a patent in India and prevent generic formulation of the medicine. The patent law also allows anyone to submit comments in opposition to a patent before the patent office decides to grant or reject it.
The INP+ has maintained that more could be done to provide ARVs, and has recommended that government bolster its efforts by reallocating funds granted by the Global Fund to Fight AIDS, Tuberculosis and Malaria to buy second-line anti-AIDS drugs, and also initiate negotiations with pharmaceutical companies to lower prices.
"Three years ago, NACO felt that introducing first-line ARVs was not possible because it was afraid that the costs might be quite huge," said INP+ president K.K. Abraham. "We hope [the government] can devise ways to move forward and introduce second-line ARVs as soon as possible."
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