State health department promotes outdated AIDS drug

Doctors, though, don’t agree with him. They said there were many other drugs like AZT, 3TC, 4T, DDI, Indinavir, Ritonavir and Nelfinaur which were much more effective. Dr Maniar, head of department, G T Hospital, revealed that the state health department had very little technical data on Saquinavir.

Yet, there are plans to distribute and monitor the drug state-wide to manage the 38,000-odd reported cases of AIDS in Maharashtra.

A hard-gel formation drug, Saquninavir was initially considered the most potent in its class of drugs, and was used as part of a cocktail drug therapy to treat HIV patients. Soon, however, it was found that it lowered patients’ resistance to the disease. Said Dr Maniar, “We stopped using it because its effect was minimal. Also, it was found that patients’ resistance went down after its use. It is surprising that the drug is being marketed in the state.” Another AIDS specialist at GT Hospital said Saquninavir is a low priority drug which is usually given to patients who cannot tolerate other drugs.

Dr I S Gilada, who works in close tandem with AIDS patients, also questioned the need for marketing Saquniavar, pointing out that Roche had sought FDA’s approval to market a new drug with a soft-gel formulation, which gives 10 times the exposure that the current hard-gel formulation gives. The triple combination therapy helped lower blood levels of HIV virus to below detectable levels. If they already have better drugs, why then is Saqunianvir being marketed?” asked Gilada. Mathur, however, pleaded ignorance about the company’s plans to market a new soft-gel formulation drug.

Ramanand Tiwari, Secretary, Public Health Department, when contacted said he would look into the matter. He, however, quickly added that new drugs are cleared by the Food and Drug Administration and that the health department was in no way involved. “These drugs are being imported and distributed to HIV-infected patients on humanitarian grounds.” FDA insists it’s not their responsibility either. FDA Commissioner Anil Kumar Lakhina said the administration was not directly involved in clearing AIDS drugs in the state. These decisions, he said, are taken by the Drug Controller General in New Delhi.

Lakhina said there was no need to conduct clinical trials for Saquininavir in India as it was being used worldwide. “No trials are being conducted in India as the drugs have been cleared by FDA in US after extensive research,” he added. The director of public health, Dr Subash Salunke, also maintained that Saquninavir was effective in controlling viral load and improving the quality of life of a patient. “We will ascertain Saquninavir’s potency in the coming weeks, ” he added.