The Hindu Business Line : Cipla stands by quality of AIDS drugs; to repeat test for WHO listing

THE recent decision by the World Health Organisation (WHO) to drop two of Cipla's anti-AIDS drugs from the WHO pre-qualification list is likely to be no more than a hiccup for the company, say pharma industry analysts.

The WHO has recently dropped anti-retroviral (ARV) or anti-AIDS drugs - Lamivudine 150mg tablet and Lamivudine 150mg plus Zidovudine 300mg tablet, from its pre-qualification list for inadequate bioequivalence data.

However, Cipla sources told Business Line that the company stood by the quality of its products and the recent development was a consequence of ``inadequate record keeping and documentation'' by the contract research organisation (CRO) used by Cipla.

The WHO statement in fact indicates that the ``CRO was found not to be compliant with good clinical practices (GCP) and good laboratory practices (GLP) and the raw data failed to prove bioequivalence.'' The source said that Cipla has since shifted its bioequivalence studies for these products to a different CRO. A bioequivalence study establishes that the generic drug is chemically equivalent to the originally branded products, which in this case belong to GlaxoSmithKline.

A WHO pre-qualification acts as a safety endorsement of the generic drug. Further, it facilitates the easy procurement of these drugs by United Nations agencies or governments of different nations, since they can rest assured on the safety aspect.

Meanwhile, Cipla's management has issued statements on the company's Web site stating that they are committed to repeat the bioequivalence test and hope to receive the results by July-end this year. However, Cipla topbrass could not be reached as they were abroad.

Industry analysts said that the development would not affect company's financials in the short or long term, as the sale of the two indicated drugs account for less than one percent of Cipla's Rs 800-crore exports.

Further, the analyst observed that the global image of the company is unlikely to get dented, as the quality of the drug was not being questioned.

In fact the WHO statement has said that products ``are still compliant with quality standards (specifications for Active Pharmaceutical Ingredients, impurity profile, formulation, manufacturing in compliance with Good Manufacturing Practices). What is missing is proof of bioequivalence.''

Once bioequivalence is demonstrated by Cipla (i.e once Cipla submits the data) and, if it is found reliable by WHO assessors, WHO will consider the products for listing again.

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