The Hindu Business Line : Anti-AIDS drug: Cipla re-submits data to WHO

DRUG company Cipla has submitted the bio-equivalence data for its anti-AIDS drug Lamivudine to the World Health Organisation (WHO), Geneva. Lamivudine is one of the two drugs from Cipla that was dropped from the WHO pre-qualification list in June this year.

In submitting the data, Cipla may help dull some of the intense international glare that Indian anti-AIDS drugs have been facing in recent times, according to industry-watchers. Only last week, three of Ranbaxy's anti-AIDS drugs were dropped from the WHO pre-qualification list.

"We have submitted the bio-equivalence data for one of our drugs (Lamivudine) to the WHO, Geneva. Similar data for the other drug dropped from the WHO list, (Lamivudine 150 mg plus Zidovudine 300 mg tablet) is likely to be submitted by mid-September," Mr Amar Lulla, Joint Managing Director of Cipla, told Business Line.

Whether the drug gets re-listed or not by the WHO would depend on the outcome of the processing of the bio-equivalence data supplied by Cipla. However, Mr Lulla added that the whole episode was unlikely to dent its sales.

A WHO pre-qualification list acts as a safety endorsement of sorts, guiding the procurement policy for UN agencies and governments that look to buy medicines for its people. Bio-equivalence tests help establish that the generic drug is chemically equivalent to the original branded products, which in this case belong to GlaxoSmithKline.

Cipla's anti-retroviral (ARV) or anti-AIDS drugs — Lamivudine 150mg tablet and Lamivudine 150mg plus Zidovudine 300mg tablet — had been dropped from the WHO pre-qualification list on grounds of "inadequate bio-equivalence data."

The WHO communiqué had, however, pointed out that the contract research organisation (CRO), engaged by Cipla to do the bio-equivalence studies, had not complied with good laboratory practices (GLP). Cipla's medicines were "still compliant with quality standards," the note had said.

Meanwhile, the whole episode has generated a heated debate internationally on the quality of Indian anti-AIDS drugs. Organisations that claim to be working in the health sector have been demanding a reassurance from Cipla and Ranbaxy on the fate of patients who have consumed the drugs that have now been dropped from WHO's list.

This week saw a joint representation from The Treatment Action Campaign (TAC) and Medecins Sans Frontieres (MSF) urging Cipla to address their concerns on its drugs.

Another interesting communication, received here on Friday, was from the Sweden-based "think-tank" Eudoxa that called for the "WHO director and senior leadership to step down after recent AIDS drug scandals."

"Last week's decision by the World Health Organisation to remove three Indian-made generic AIDS drugs from the list of approved medicines underscores the need for new and responsible leadership at the helm of what should be the world's preeminent health agency," the Eudoxa communication said.

Responding to some of these concerns, Cipla's Mr Lulla said that the safety and efficacy of Cipla's drugs had never been in question, it was only a documentation-related issue.

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