Drug pull out

Indian firms temporarily leave AIDS war zone

Published: Wednesday 15 December 2004

two Indian pharmaceutical companies, including pharma major Ranbaxy, have voluntarily pulled their anti- aids drugs out of the World Health Organization's (who) " prequalification" list. While Ranbaxy withdrew its seven remaining drugs on the list, Hyderabad-based Hetero Drugs withdrew all its six drugs on it. The reason cited was flaws in laboratory tests proving their effectiveness. Earlier this year, the who had removed three anti- aids drugs of Ranbaxy and two of another Indian firm, cipla, from the list after detecting similar discrepancies during inspections (see 'Victimised?', Down To Earth, September 15, 2004).The un health agency has, however, asked patients to continue taking the de-listed drugs, saying alternatives wouldn't be found quickly.

The who 's prequalification list, which sets minimum quality standards for cheaper medication, is an attempt to supply cheaper anti- aids drugs in poor countries. who members adopted this single international approval for generic and brand name drugs earlier this year, amid fears that it might override stricter national regulatory norms.

The who said Ranbaxy's withdrawal followed "discrepancies" in data compiled by independent Indian laboratories. "We're not satisfied with the way these laboratories have handled the tests," who spokesperson Daniela Bagozzi reportedly said. While admitting that the move would disrupt anti- aids programmes that rely on Indian drugs, Bogozzi did not specify the areas that would be affected.

The who has asked companies to recheck their data and laboratory tests. Indian companies are redoing the tests and documentation and aim to get fresh approval by early next year.

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