The Hindu Business Line : WHO relists Ranbaxy's anti-retroviral Nevirapine

THE World Health Organisation (WHO) has relisted Ranbaxy Laboratories Ltd's anti-retroviral (ARV) drug, Nevirapine tablets 200 mg, on its pre-qualification list.

This drug is widely used as part of first line ARV treatment around the world to reduce mother to child transmission. It is also recommended for HIV-infected women in labour who have had no prior ARV therapy.

In a statement, Dr Brian Tempest, CEO and Managing Director, Ranbaxy, said: "We are glad that our Nevirapine is now on the WHO list and more patients can access this vital ARV at cost-effective prices."

Ranbaxy's Nevirapine tablets are already approved by US Food and Drug Administration (FDA) and are eligible for use in programmes funded by the US President's Emergency Plan for AIDS relief. Ranbaxy's ARVs including Nevirapine, are manufactured at the company's manufacturing facilities, that have been inspected and approved by some of the most stringent agencies in the world, including FDA and WHO.

Earlier, Ranbaxy's anti-AIDS drugs were dropped from the WHO pre-qualification list due to inadequate documentation. The company claimed that the Contract Research Organisations (CROs) used by it to carry out bio-equivalence studies for its ARVs are globally reputed and conduct and file their studies routinely with some of the most stringent regulatory authorities around the world. The CROs also regularly undergo routine audits by these regulatory authorities, it said.

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