Poorer countries to benefit from reinstatement of 7 generic AIDS drugs to WHO's list

Aug 21 2005

India's Ranbaxy Laboratories, seven anti- AIDS drugs, have been added to World Health Organisation's (WHO) prequalification list for use in poor countries.

The United Nations agency has said that three anti-AIDS drugs by Aurobindo Pharma, of India, were also being added to the list.

Three of Ranbaxy's generic drugs were dropped by WHO last year when the organization said the drugs had not been proved to be equivalent to patented counterparts. This more or less forced India's top drug maker to withdraw its remaining antiretrovirals from the WHO list in November.

But now, according to the WHO, after a full range of quality, safety and efficacy checks on the medicines, as well as thorough laboratory inspections, the products and laboratories have all been found to be satisfactory.

The purpose of the WHO's prequalification list is to make it easier for countries to determine which medicines to buy, when they are planning anti-AIDS campaigns.

WHO says that the addition of 10 medicines will be of benefit to existing and proposed AIDS programmes.

WHO believes that better access to life-prolonging drugs and more choice of quality products is important for countries hard-hit by the AIDS epidemic, who are very often unable to fully control and monitor medicines.

WHO spokeswoman Daniela Bagozzi says the addition of the 10 drugs brings the number of drugs now on the prequalification list to 63, which includes 29 generics.

Apparently the reinstated Ranbaxy drugs are two combinations of lamivudine, nevirapine and stavudine, two combinations of lamivudine and stavudine, a combination of lamivudine and zidovudine and tablets of each of these two.

The Aurobindo products are lamivudine, in the form of 150 mg and 300 mg tablets, and zidovudine tablets in 300 mg form.

The FDA has also given drug company Ranxbaxy tentative approval for three drugs they want to qualify for inclusion in U.S. programmes for AIDS drugs relief.

The WHO estimates that as many as 6.5 million adults and children in poorer countries need ARV drugs.

In June the agency admitted that even though one million people were receiving the AIDS drugs in poor countries, it was unlikely to reach its goal of getting three million on treatment by the end of the year.