Four more Ranbaxy drugs on WHO pre-qualification list

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Ranbaxy Laboratories announced on 1st June that four more of its generic anti-HIV products have been included on the World Health Organization’s (WHO’s) list of prequalified medicines.

These four products - 600mg efavirenz tablets, 200mg efavirenz capsules, and 30 and 40mg d4T (stavudine) capsules - will now be available for organisations and countries in the developing world to buy at an affordable price.

Inclusion on the pre-qualification list means that the products are of good quality, safe and effective, and that their manufacturing sites comply with the WHO’s criteria.

Glossary

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.

first-line therapy

The regimen used when starting treatment for the first time.

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.

cost-effective

Cost-effectiveness analyses compare the financial cost of providing health interventions with their health benefit in order to assess whether interventions provide value for money. As well as the cost of providing medical care now, analyses may take into account savings on future health spending (because a person’s health has improved) and the economic contribution a healthy person could make to society.

efficacy

How well something works (in a research study). See also ‘effectiveness’.

Ranbaxy's chief executive officer and managing director, Malvinder Mohan Singh, said, “this is a significant development. We strongly feel that generic antiretrovirals are essential in the struggle against HIV / AIDS and are committed to providing high quality, cost-effective generics.”

Ranbaxy is an Indian company, which specialises in producing low-cost versions of drugs for sale in resource-limited countries. It now has twelve products on the pre-qualification list, as well as three antiretroviral products that have been approved by the United States Food and Drug Administration (FDA), making them eligible for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR).

“Efavirenz is rapidly becoming a preferred drug in HIV treatment programmes in developing countries. The other newly listed drug, stavudine, is also being widely used as a first-line therapy against AIDS,” said Mr Singh. “Both products increase customer choice, enabling patients to access therapy easily, at affordable prices.”

The pre-qualification project was set up in 2001 by the WHO in collaboration with the Joint United Nations Programme on HIV / AIDS (UNAIDS), the United Nations Children's Fund (UNICEF), the United Nations Population Fund (UNFPA) and the World Bank. Its aim is to make the universal access to medicines easier by producing a list of medicines that meet standard levels of quality, safety and efficacy.