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India Plans Free AIDS Therapy
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By AMY WALDMAN
NEW DELHI, Nov. 30 India has decided to expand substantially its program to provide antiretroviral therapy to people with H.I.V. and AIDS, government officials say.
By April of 2004, the government hopes to begin providing free antiretroviral therapy to all H.I.V.-positive new parents, all children under 15, in the six states with the highest rates of H.I.V. and AIDS.
Eventually, all people in those states with full-blown AIDS are to be treated.
The decision amounts to a significant policy shift for India, which has not previously tried to offer antiretroviral treatment on any significant scale, though it does provide drugs to try to prevent AIDS transmission from mothers to babies in childbirth.
But several obstacles must be overcome by spring. The government must still reach a final agreement with the country's pharmaceutical companies, which manufacture generic versions of antiretroviral medications, to reduce their prices, as these companies recently agreed to do in Africa and the Caribbean.
The government has yet to identify "budgetary support," the money to pay for drugs for as many as 100,000 people, the number it estimates would be served in the first year.
It also will have to recalibrate its weak public health system to provide for far broader testing, and train doctors and nurses to monitor the dosage and effects of antiretroviral therapy.
India is estimated to have at least 4.6 million people with H.I.V. the second highest number in the world, after South Africa. More than 600,000 new cases occurred in 2002.
Doctors in India prescribe antiretroviral therapy, but at $1 a day, it costs too much for most people. India's per capita income is less than $500 a year.
Providing the drugs will also challenge India's underfinanced health system. The great majority of financing for India's programs to prevent or treat AIDS comes from outside donors like the World Bank and the Bill and Melinda Gates Foundation.
Sushma Swaraj, India's Union Minister for Health and Family Welfare, said she would approach the Finance Ministry for the money. The Geneva-based Global Fund to Fight AIDS, Tuberculosis and Malaria also has agreed to provide India with $100 million over five years for prevention, treatment, voluntary testing and counseling, although technical disagreements have delayed the signing of a final agreement. The fund's director, Dr. Richard Feachem, said that it was possible that more of the money could be committed to treatment to support the new venture.
But that reducing the price of the drugs would be critical.
Cipla, Ranbaxy Laboratories Ltd. and Matrix Laboratories now joined by a fourth Indian company, Hetero Drugs Ltd., and a South African company, Aspen Pharmacare Holdings recently reached an agreement with the William Jefferson Clinton Foundation to provide the drug to four African and nine Caribbean countries for about 37 cents per patient per day.
Under the agreement, the companies will increase production in return for a guaranteed customer base. The companies will supply the therapy to at least 1.5 million patients during the next five years, and the price of their raw materials will be pre-negotiated with the government. They will sell directly to the foundation or the governments, rather than middlemen, and be paid immediately.
But no such agreement is planned in India, where the drug companies say past efforts to work with the government have been frustrating. Ranbaxy has quietly undertaken to provide antiretroviral therapy directly to Indian patients at less than 90 cents a day in AIDS-endemic states. Cipla donates the drug used to prevent mother-to-child transmission in the government program. But at this point, "we are probably doing more outside the country than in the country," Cipla's chairman and managing director, Yusuf K. Hamied, said in a recent interview.
Mr. Hamied said the companies needed to be able to sustain the manufacture of the drugs indefinitely, and to predict how much would be required. "If the government wants to buy, they must let us know for how many, when, and do they have the money," he said.
For two weeks, the companies and government have been in what one participant called "backbreaking" negotiations over those issues. Ms. Swaraj has made clear that she would like the companies to provide lower prices in India than those agreed to with the Clinton Foundation. "That's only natural because these are companies based in India," she said.
Industry representatives say the government needs to understand the business imperatives of companies that have become Indian success stories and wealth creators.
The Clinton Foundation agreement, they say, has left them a small margin of profit that will allow their businesses to keep growing and appease shareholders .. To go any lower, they say, will require concessions from the government, like exemptions on sales and excise taxes.
Ms. Swaraj announced at a news conference Sunday the day before elections in four important states that an agreement with the companies had been reached, but privately industry and government officials said negotiations were continuing.
Still, the commitment to offer the therapy in itself is significant in a country struggling, like many, to balance prevention and treatment. It has been brought about, analysts say, largely by Ms. Swaraj's personal commitment to tackling the crisis. In the interview, she said the government's approach to AIDS had undergone a "sea change" in the past six months.
She has increased the supply of condoms to high-risk populations to 171 million this year from 114 million two years ago and sought to destigmatize the disease through a campaign explaining how it is spread and how it is not spread. Last summer, India also convened its first parliamentary forum on H.I.V./AIDS.
Advocates for AIDS patients, epidemiologists and donors had criticized India, home to more than one billion people, as being too slow and cautious in reacting to a steadily spreading epidemic.
Some still worry, however, that another shift brought about by Ms. Swaraj the move away from what she called a "condom-centric" public education campaign to a more "holistic" one could hurt efforts to prevent the disease.
As is the case with officials in many conservative societies, Indian officials have been reluctant to engage in sexually explicit campaigns, and Ms. Swaraj has made clear her distaste for prime-time discussions of condoms on television. Although 80 percent of new infections in India are sexually transmitted, she said it was important to focus on "all the routes of transmission," not just sex.
Dr. Meenakshi Datta Ghosh, the project director of the National AIDS Control O rganization, said an undue focus on sex could lead to an unfair presumption that those who contracted H.I.V. had engaged in "immoral" or "wicked" behavior.
She cited a poster saying, "If there is loyalty and fidelity between husband and wife, there is no space for H.I.V./AIDS," as an example of the government's preferred approach.
The campaign now, she said, explains that AIDS is transmitted through unprotected sex, and encourages people to have protected sex, but does not explain how they should protect themselves.
"That will come," she added.
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