Hudson Institute Statement on World Health Organization's Delisting of Indian-Made AIDS Drugs

6/15/2004

From: Jean Weicher of Hudson Institute, 202-974-2425

WASHINGTON, June 15 -- The following is a statement on World Health Organization's (WHO) delisting of Indian-made AIDS drugs from its prequalification list:

By Hudson Institute Scholars Carol Adelman, Jeremiah Norris and Jean Weicher

On May 12, Hudson Institute released a White Paper entitled, "Myths and Realities on AIDS Prices." This Paper (found at http://www.hudson.org) compared the prices of 13 different single-dose patented antiretroviral drugs and three fixed-dose combination drugs with copy drugs made by Indian companies.

On May 27, the WHO de-listed two of the drugs: lamivudine 150 mg tablets, and lamivudine 150 mg+zidovudine 300 mg tablets (http://mednet3.who.int/prequal/). These products are manufactured at two different production sites in India.

According to the WHO, these drugs were "removed from the list as a result of the outcome of an inspection performed by the (WHO) in which compliance with Good Clinical Practices and Good Laboratory Practices was assessed, as well as data verification of the bioequivalence study at the Contract Research Organization used by the sponsor. Products are subject to re-assessment when completely new data set is presented about the bioequivalence studies."

WHO is to be applauded for taking these responsible steps on behalf of AIDS patients, as these drugs are widely used in Africa and purchased by non-governmental organizations around the world. Deficient products can catalyze a serious public health concern specifically by promoting HIV resistance.

At the same time, WHO must use this de-listing experience to develop recall procedures for the products it had Pre-qualified whenever that becomes necessary. In addition, determining possible adverse reactions among patients can be reached only through post-marketing surveys in the field. While WHO can mandate these procedures as a condition of Prequalification, the responsibility to conduct and finance them should rest with the companies that manufactured the products.

Given the reasons for de-listing, and the fact that many of these products are currently in use and in the procurement pipeline, WHO should re-evaluate its entire Prequalification program. Since stringent regulatory authorities in developed countries have substantial experience with recall procedures, post-marketing studies, and enforcement mechanisms, WHO needs to convene an expert committee from these members and seek their guidance before it continues with business as usual.

Dr. Adelman was former assistant administrator at the U.S. agency for international development (USAID) and Norris was former director of international affairs at the non-governmental organization, Project Hope. Jean Weicher is a research assistant at the Hudson Institute.

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