The Hindu : Business : WHO pulls out Cipla's 2 anti-AIDS drugs

Online edition of India's National Newspaper
Saturday, Jun 19, 2004

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Business

WHO pulls out Cipla's 2 anti-AIDS drugs

By Ramnath Subbu

MUMBAI. JUNE 18. The World Health Organization (WHO) has pulled two generic anti-retroviral (ARVs) drugs supplied by the Mumbai-based Cipla from its list of approved HIV drugs that are supplied to poorer countries. This could have been a blow to India being a sourcing base for supply of cheaper anti-retroviral drugs. Cipla had created a stir in the global pharmaceutical industry two years ago by announcing its ability to supply combinations of ARVs at a fraction of the cost at which multinationals were selling the same drugs globally.

Fortunately, the ARVs were pulled out of the list for lack of proper documentation and not for lack of bio-equivalence, which determines whether the concentration of the generic drug in the blood of the patient is the same as in the patented drug.

Speaking to The Hindu, Amar Lulla, Joint Managing Director, Cipla, said, "One of the contract research organisations (CROs) for the WHO found the documentation of our products to be inadequate. However, it is not an issue of quality but that of proper documentation which was lacking and this sort of occurrence is not uncommon.''

The routine tests have been carried out by an independent CRO for the WHO on lamivudine also known as 3TC and zidovudine also known as AZT and supplied by Cipla. Cipla's lamivudine has been tested for bio equivalency in a U.S. laboratory and has been approved by the Food and Drug Administration. This test was carried out because Cipla hopes to sell generic lamivudine when the American patent expires in 2006. GlaxosmithKline of the U.K. holds the American patents on lamivudine and zidovudine.

"We will be filing our products again with WHO by end-July and will be back on the list,'' said Mr. Lulla.

Without revealing any details, Mr. Lulla said the company supplied significant volumes of its ARVs to the WHO and Medicines sans frontiers (MSF) who distribute the drugs in AIDS-ravaged regions of sub-Saharan Africa and in Far East Asia. Domestically, although the National AIDS Control Organization (NACO) had commenced its programme of supplying free ARV drugs in several hospitals all over the country, Cipla did not supply any of its drugs to them, said Mr. Lulla.

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