WHO removes Ranbaxy's HIV drugs from crucial list

Published: Wednesday 15 September 2004

Is the World Health Organization (WHO) targeting Indian generic drug manufacturers?

The UN agency recently removed three anti-HIV drugs produced by India's Ranbaxy Laboratories Limited from its prequalification list. This list is used by procurement agencies to select good quality medicines. Exclusion from the list could affect the availability of these drugs for patients. Earlier, the WHO had also removed two anti-HIV drugs of CIPLA, another Indian pharmaceutical company, from the list. They have now been reinstated, though.

The cited reason for the move, as was also in CIPLA's case, is inadequate bioequivalence data. This data is essential to prove that a generic drug is equally effective as the original patented drug.

The WHO has said it would reinstate Ranbaxy's drugs after the company submits the required data from new studies. This would take at least four to five months, according to Ranbaxy officials. Meanwhile, a senior official of India's Union ministry of health and family welfare (MoHFW) has said the MoHFW has never received any complaints about these drugs.

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