Ranbaxy says seven ARV products are back on WHO list

This article is more than 19 years old. Click here for more recent articles on this topic

India’s Ranbaxy Laboratories has announced that seven of its antiretroviral products have been reinstated to the World Health Organization’s list of prequalified antiretrovirals (ARVs) after new bioequivalence tests carried out by `globally recognised` contract research laboratories.

Three Ranbaxy products were taken off the list last year after discrepancies in record-keeping came to light that were traced to contract research organisations that had carried out the original tests proving the company’s generic antiretrovirals were equivalent to the originator, or branded, products.

Ranbaxy voluntarily removed a further eight products in order to check the bioequivalence in November 2004.

Glossary

equivalence trial

A clinical trial which aims to demonstrate that a new treatment is no better or worse than an existing treatment. While the two drugs may have similar results in terms of virological response, the new drug may have fewer side-effects, be cheaper or have other advantages. 

generic

In relation to medicines, a drug manufactured and sold without a brand name, in situations where the original manufacturer’s patent has expired or is not enforced. Generic drugs contain the same active ingredients as branded drugs, and have comparable strength, safety, efficacy and quality.

combination therapy

A therapy composed of several drugs available either as separate tablets, or as fixed-dose combination (FDC).

Food and Drug Administration (FDA)

Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.

Last week Ranbaxy said that the following products have been added to the WHO prequalification list:

  • Lamivudine 150mg+Nevirapine 200mg+Stavudine 40mg tablets
  • Lamivudine 150mg+Nevirapine 200mg+Stavudine 30mg tablets
  • Lamivudine 150mg+Stavudine 40mg tablets
  • Lamivudine 150mg+Stavudine 30mg tablets
  • Lamivudine 150mg+Zidovudine 300mg tablets
  • Lamivudine 150mg tablets
  • Zidovudine 300mg tablets

Three of these products have already received `tentative approval` from the US Food and Drug Administration, which means that they can be purchased with funds made available through the President’s Emergency Plan for AIDS Relief (PEPFAR) in fifteen countries where the United States is funding a major expansion of ARV treatment.

The return of Ranbaxy’s fixed dose products to the WHO prequalification list is likely to widen the choice available to treatment programmes wishing to follow the WHO recommendation that fixed dose ARV products combining two or three of the drugs used in triple combination therapy should be used wherever possible in resource-limited settings.