The Hindu Business Line : Global draft on generic anti-AIDS drugs soon

IT will be at least another fortnight before companies such as Cipla or Ranbaxy fully understand whether their generic anti-AIDS drugs have received a thumbs-up or not from the recently concluded meeting at Botswana, organised by the US Health Department and a clutch of UN agencies.

A draft defining the safety benchmarks for Fixed Dose Combination (FDC) anti-retrovirals or anti-AIDS drugs will be published by mid-April, to help all participants in AIDS-related programmes understand the requirements of these drugs, Mr Ashwini Kumar, Drug Controller General of India (DCGI), told Business Line.

Mr Kumar had participated in the two-day Botswana meeting, where India provided "technical inputs" since it both produces and uses FDCs.

FDCs essentially decrease the pill burden on patients, requiring that they take only one pill two times in a day as opposed to three pills twice a day.

Besides being effective price-wise, FDCs also help patients stick to the regimen given by the doctors. And this helps nip the emergence of drug resistance, a fallout of bad adherence to the drug regime.

"Concerns were raised on the safety and efficacy of FDCs used to treat tuberculosis, malaria and HIV/AIDS. Apprehensions were also voiced on the quality consistency of these drugs. It was a technical meeting and all concerns have been addressed. A draft outlining the benchmarks regarding quality and other risk-benefit related issues would be published around April 19. This would give clarity to all stakeholders using the present set of FDCs and future drugs that would be rolled out in these segments," the DCGI said.

The implications of the draft would be clear to domestic drug manufacturers only when the document is put out in the public domain to invite comments, said pharma industry representatives.

However, they pointed out that the effort was merely to question the efficacy of FDCs despite the fact that the World Health Organisation (WHO) had endorsed FDC anti-retrovirals.

For Indian companies marketing to Africa, supplying to these markets is a boost for their image, besides adding revenue to the kitty.

The Botswana meeting was co-organised by the WHO, besides the UN Programme on HIV/AIDS, the Southern African Development Community and the US Department of Health and Human Services.

Meanwhile, generic drugs have got overwhelming support from over 380 global non-government organisations, which have written to the US Global AIDS co-ordinator decrying the US governments efforts to "undermine" FDCs and link it to the financial aid that the US gives to developing countries.

More Stories on : Pharmaceuticals | Health

Article E-Mail :: Comment :: Syndication :: Printer Friendly Page