United Press International - November 10, 2004
Harbaksh Singh Nanda

India's Ranbaxy Laboratories has informed the World Health Organization that it was voluntarily withdrawing seven of its antiretrovirals, or the product dossiers under assessment, and all pre-qualified products from the WHO pre-qualification.

The WHO said in a statement from Geneva that Ranbaxy had found some discrepancies relating to the proof of the products' bioequivalence with originator medicines.

Ranbaxy could not guarantee that its drugs were as potent as more expensive brand-name versions. The Indian Company's drugs have not been found to be substandard but are not proven to be as effective as drugs of rival expensive brand names.

Ranbaxy is one of the premier pharmaceutical firms trying to offer a very inexpensive AIDS medicine to the WHO to fight AIDS, especially in the African continent.

Health workers across Africa were scrambling to put together the number of patients who were dependent on Ranbaxy manufactured drugs. It will be weeks and months before the patients are able to switch over to the alternative drugs.

Ranbaxy plans to resubmit its plan to the WHO with new drugs by the end of next month. The company refused to make a comment.

Ranbaxy withdrew its products after the WHO had earlier this year removed three other antiretroviral medicines manufactured by Ranbaxy and two antiretroviral medicines manufactured by Cipla, from the list of pre-qualified products.

After the WHO inspections revealed serious discrepancies and non-compliance with good clinical practices and good laboratory practices in some of the Ranbaxy and Cipla drugs, the WHO sent a warning letter to all manufacturers of HIV/AIDS medicines participating in the pre-qualification project.

The WHO urged companies to verify the data they had submitted, as well as compliance with good clinical practices and good laboratory practices at the sites where bioequivalence studies had been conducted, the WHO statement said.

Although the patients using Ranbaxy drugs should suspend the use, the Who has asked patients to continue using de-listed medicines due to the lack of finding an alternative pre-qualified product immediately.

"The risk of withholding treatment is higher than that of providing medicines whose bioequivalence is not proven but which have otherwise been pre-qualified," the WHO statement said, adding: "A switch to non-prequalified products is not recommended as their quality has not been documented by WHO."

Last week Ranbaxy had recalled its entire portfolio of AIDS drugs marketed in South Africa, citing problems with the research behind the product.

The pharmaceutical major's decision to withdraw the drugs from the market is expected to affect tens of thousands of patients using the drugs in poor countries.

There are at least 3 million people infected with human immune deficiency virus (HIV) in poor countries on antiretroviral therapy. The WHO's "3 by 5" target - treating 3 million infected people by 2005 -- is already well behind in its timetable, The Washington Post reported.

"It's likely to cause a lot of confusion in countries and ministries of health," said Paul Lalvani of the Global Fund to Fight AIDS, Tuberculosis and Malaria, which is providing money for AIDS programs in 95 countries, at least 10 using Ranbaxy drugs.

The de-listed medicines include Indinavir, Lamivudine, Nevirapine, Stavudine and Zidovudine tablets, as well as two different combinations of Lamivudine and Stavudine.

Ranbaxy is one of few major pharmaceutical firms that have committed to develop inexpensive HIV drugs to fight the menace which engulfs nearly five million patients each year to the already toll of nearly 35 million HIV patients.

India is home at least 5 million HIV cases, most of them unreported.
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