India weighs options as WHO strikes down cheap HIV drug Stavudine

The Department of AIDS Control is planning to call a meeting of experts to decide on the issue. “The technical resource group on antiretroviral treatment will meet shortly and examine the pros and cons before some decision is taken,” Dr Damodar Bachani,Deputy Director General,Department of AIDS Control,said.

According to WHO,Stavudine is widely used in developing countries as a first-line therapy for HIV because it is easy to use and inexpensive. However,it causes serious side effects (see box). The drug is marketed as Zerit by Bristol-Myers Squibb,but is also available in generic versions through companies in India — Cipla,Aurobindo Pharma and Strides Arcolab.

Scientists at National AIDS Research Institute (NARI) are surprised at the new guidelines,noting that Tenofovir costs twice as much as Stavudine,while an AZT regimen is also costlier. The regimen that uses Stavudine,Lamivudine and Nevirapine is also preferred as the AZT regimen causes anaemia. “In a country where anaemia is already a problem,this cannot be administered,” Dr Bachani says. Tenofovir is normally used as an alternative first-line drug for patients who have developed resistance to Stavudine and AZT.

Saying that there is no immediate threat to those using Stavudine,Dr Bachani told The Indian Express that 2.8 lakh people in the country are on antiretroviral treatment.

Dr Yusuf Hamied,Chairman and Managing Director of Cipla pharmaceuticals who fought multinational companies to provide generic AIDS drugs at a low cost in India and Africa,is outraged at the new guideline,and hints at big companies trying to kill a drug because of the expiry of patent. “Let the doctors decide instead of multinational companies,” he fumes.

Cipla produces a triple-drug cocktail that includes Stavudine and sells between US $60 and $90 per patient per year in Africa. This same cocktail,which was under a monopoly,was being sold at US $12,000 per patient per year in 2001. Cipla eventually brought it down to US $100 in Africa. Hamied points out that today four million patients are on generic drugs in Africa due to the low cost.

“Cipla is selling a family of AIDS drugs,” Hamied says. “We manufacture according to requirements. When the product patent of a drug expires,companies try to kill it in a bid to retain monopoly over their drugs. Let the doctors decide whether the drug has to be phased out or not,he says.

Cipla CEO Amar Lulla,said that if there was medical evidence showing that Stavudine had adverse effects,he would support its phasing out. However,he added: “There will have to be more budget allocations if the government plans to shift (to another drug).”