WHO drug pullout not to impact Ranbaxy

Ranbaxy Laboratories said the removal of its anti-AIDS drugs from the UN approved list will not have any impact on its top line or bottomline.

The company plans to file all the anti-retrovirals with the USFDA and the World Health Organisation (WHO) between end-December 2004 and end-March 2005. The company had earlier this week removed its anti-AIDS drugs off the UN approved list, after discovering discrepancies in tests done to show the anti-retrovirals were equivalent to brand-name drugs.

A company spokesperson said margins on the anti-retrovirals were thin and removal from the UN approved list will not have any serious impact on Ranbaxy's profitability.

The WHO had said yesterday that Ranbaxy planned to submit new studies of seven drugs which could see the firm re-admitted o the list. The first study is expected to be completed next month.

The removal of Ranbaxy's anti-AIDS drugs is knee-jerk to the WHO's attempts to ensure easy availability of cheaper drugs in developing nations.

The agency however said that the patients must continue with the dosage even if they are not in the approved list. In August, WHO dropped three of Ranbaxy's drugs after finding that the independent laboratory used by the company to verify their equivalence to patented drugs did not meet international standards.

Three month earlier, WHO had also removed two anti-retrovirals from Cipla. The WHO list currently has 89 drugs of which 54 are anti-retrovirals.

Reuters adds: The latest development is more likely to have an impact on the roll-out of cheap generic HIV/AIDS drugs in the developing world than hurt Ranbaxy, but even that will only be temporary as the company plans to submit fresh data soon to prove their drugs' bio-equivalence.

"AIDS drugs are not very significant to Ranbaxy's revenue and profits, so it does not really matter," said Shahina Mukadam, analyst with HDFC Securities.

Ranbaxy's shares ended 1.1 percent higher at Rs 1,092.55 at the Bombay Stock Exchange on Wednesday.

New Delhi-based Ranbaxy has said it makes AIDS drugs more as a social commitment than for making huge profits, given that the company is based in the developing world, which is badly affected by the disease. Ranbaxy was among the generic medicine makers to feature on the WHO prequalification list, which serves to guide agencies such as the United Nations which are looking for bulk drug purchases.

Ranbaxy expects the first of the new bio-equivalence studies for its antiretrovirals to be submitted by next month.