INDIA: Govt ARV programme hits stumbling block

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INDIA: Govt ARV programme hits stumbling block

[This report does not necessarily reflect the views of the United

Nations]

Second-line ARVs are still too expensive

NEW DELHI, 26 January (PLUSNEWS) - 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 . " 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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http://www.plusnews.org/aidsreport.asp?reportid=6659