There's good news for the Indian pharma industry, and in particular Ranbaxy Laboratories. The World Health Organisation today said it has reinstated seven antiretroviral (ARV) medicines of Ranbaxy Laboratories to its list of approved HIV/AIDS medicines for use in developing countries after the manufacturer was able to prove they were the same as the patented versions.

The WHO had removed three of the drugs from its list of generic AIDS medicines recommended for use in developing countries in August 2004. A random check had found that tests failed to prove the medicines were same as the patented drugs.

Ranbaxy later withdrew the other four drugs in November 2004, saying it was uncertain they were biologically the same as the patented drugs. But the company has now submitted data from new tests that proves that the drugs are equivalent to their patented counterparts, WHO said. "Subsequently, WHO ran the full range of quality, safety and efficacy checks on the medicines as well as thorough inspections of the new laboratories. The products and laboratories were all found to be satisfactory," the health agency said in a statement.

Two of the drugs contain combination of lamivudine and stavudine in different strengths; another two are combinations of lamivudine, stavudine and nevirapine; one is lamivudine; one is zidovudine; and the seventh is a combination of lamiudine and zidovudine.

The incident rattled the Indian pharma industry when the WHO announced that inspections of independent laboratories used by the manufacturer to run bioequivalence studies had revealed practices which did not conform with the international standards required by the world health body.
WHO also said it has added tree new antiretroviral medicines, made by India's Aurobindo Pharma Ltd,to its approved list. Two of these are lamivudine tablets in different strengths and the third is zidovudine.

The WHO's prequalification list aims to make it easier for countries to decide which medicines to buy when they are planning anti-AIDS campaigns.
Better access to life-prolonging drugs and more choice of quality products is important for countries hard-hit by the AIDS epidemic, often unable to fully control and monitor medicines, it added.

Ranbaxy has also been seeking approval from the US Food and Drug Administration (FDA) to qualify for inclusion in US programmes for AIDS drugs relief. The FDA has so far given it tentative approvals for three drugs.