The Hindu Business Line : Perception deficiency

HAVING ONCE BEEN the preferred suppliers of AIDS drugs especially to the less-developed countries, Indian pharmaceutical companies now seem to be caught in a perception warp with many of their anti-retroviral (ARVs) drugs being put under the microscope this year. Over the last three years, multilateral agencies and non-governmental organisations had started sourcing anti-AIDS drugs from Indian generic companies, and this was seen as an endorsement of the quality and safety of the ARVs. But things changed in 2004, after a US agency-initiated meeting in Botswana in March at which the US government cast doubts on the safety of generic drugs used in the treatment of AIDS.

These fixed-dose combination, or three-in-one, drugs were preferred as they reduced the pill-burden on patients, who needed to take one pill twice a day as opposed to three pills twice a day. The medicines also improved adherence to the regimen, reducing drug resistance. Yet in June, the generic AIDS drugs segment suffered a setback when a couple of drugs made by Cipla were dropped from the World Health Organisation's pre-qualification list. The action was not on safety or quality considerations but due to a problem of documentation by the third-party contract research organisation (CRO) which did the bio-equivalence test that establishes the chemical similarity of the drugs to the original. Then, in August, three of Ranbaxy's AIDS drugs were dropped from the pre-qualification list. Pre-qualification by the WHO makes it easy for governments to decide on the medicines to buy as the listing is seen as an endorsement of the safety and quality of the drugs. Earlier this month Ranbaxy went one step further and unilaterally withdrew more ARVs from the African market and the WHO's list. Its rationale was that if the bio-equivalence data on three drugs could be erroneous, more could be suspect. Then, last week another Indian company, Hetero, withdrew six of its drugs from the WHO pre-qualification list. Is the quality of these drugs an issue or is it a mere technicality with the CROs? Conspiracy theories speak of pressures from Big Pharma and question even the WHO's pre-qualification process.

Surely an unhappy situation for Indian generic companies that had taken the AIDS drugs battle to the Big Pharma, by offering medicines for patients in Africa at one-thirtieth the US price. Gradually, international agencies and NGOs had begun looking to Indian companies for chemically-similar anti-AIDS medicines at competitive prices. This culminated in the Clinton Foundation striking a deal in 2003 with Ranbaxy, Cipla, Hetero and Matrix for the supply of drugs to African and Carribean markets at one-third the market cost. Though multilateral agencies have advised patients to stick to the de-listed drugs, if alternatives are not available, the adverse developments around the AIDS businesses of Indian companies could fuel perception problems on medicines from the developing world. Surely, companies such as Ranbaxy, Cipla and Hetero will recover as they redo their bio-equivalence studies and file again with the WHO. But it will be more difficult for smaller Indian companies that are just beginning to strike out into the global market.

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