Three Ranbaxy drugs out of WHO's HIV list

The World Health Organization (WHO) has removed three antiretroviral drugs manufactured by Ranbaxy Laboratories Ltd from its list of approved HIV medicines.

The drugs will be off the list until Ranbaxy submits evidence that the drugs are biologically equivalent to the patented drugs, WHO said in a statement.

"While the three Ranbaxy products to be removed from the list meet quality specifications, proof of bio-equivalence is missing in view of non-compliance of good clinical and laboratory practices as well as data handling requirements found in the contracted laboratory," the WHO said.

This effectively means that the medicines may or may not offer the same therapeutic benefits as the patented drugs on which they are based, WHO said.

WHO said the contracted laboratory, which had done the bio-equivalence studies for the three Ranbaxy drugs, has been found non-compliant with international standards of good clinical and laboratory practices. Ranbaxy has undertaken to resubmit the products in question to a different laboratory for proof of bio-equivalence.

"If and when those products and the laboratories are found to meet the specified requirements, WHO will reinstate them in the list of pre-qualified products," the statement said.

Meanwhile, Ranbaxy said it has suspended all further outsourcing work to the contracted laboratory. "As a part of its commitment to HIV/AIDS patients and to the WHO, Ranbaxy has initiated work on the new bio-equivalence studies in these three products," the company said in a release.

WHO said a similar non-compliance was found at a laboratory contracted by Cipla Ltd. to conduct a bio-equivalence study on two AIDS drugs.

However, Cipla's drugs have been included in the list of pre-qualified products after another WHO inspection found that Cipla's bio-equivalence tests were in compliance with requested standards, the statement said. On Wednesday, shares of Ranbaxy closed at Rs 934.55 on the National Stock Exchange, down 0.6 per cent from Tuesday.