Two Cipla antiretrovirals return to WHO prequalification list

This article is more than 20 years old. Click here for more recent articles on this topic

The World Health Organization (WHO) has reinstated two antiretrovirals manufactured by Cipla Ltd., India, in its list of

prequalified medicines. The two medicines had been delisted by WHO in May this year due to non-compliance with international standards found at the contract research organisations (CROs) hired by Cipla to conduct

bioequivalence tests on the products.

Glossary

compliance

An alternative term for ‘adherence’.

capacity

In discussions of consent for medical treatment, the ability of a person to make a decision for themselves and understand its implications. Young children, people who are unconscious and some people with mental health problems may lack capacity. In the context of health services, the staff and resources that are available for patient care.

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.

fixed-dose combination (FDC)

Two or more drugs contained in a single dosage form, such as a capsule or tablet. By reducing the number of pills a person must take each day, fixed-dose combination drugs may help improve adherence.

As a consequence of WHO's delisting, the manufacturer carried out new bioequivalence studies to confirm that the two medicines are equally as effective as their respective brand-name counterparts. Further WHO scientific assessment and inspections have validated the compliance of these new studies, including the CROs involved, with all international

requirements.

The two medicines - the lamivudine 150mg tablet from Cipla Ltd, blister pack of 10; and lamivudine 150mg plus zidovudine 300mg tablet, Cipla Ltd, blister pack of 10 - are widely used by patients in developing countries.

"This shows that generic manufacturers are reacting responsibly to recent de-listings," said Vladimir Lepakhin, Assistant Director-General for Health Technology and Pharmaceuticals. "The prequalification process does work. As well as a list of validated products, it is also a much needed capacity building effort to promote quality and safety of medicines in developing countries. "

Two other companies - Hetero and Ranbaxy - have withdrawn products from the prequalification list as a result of contract research organisation inspections and are currently carrying out new bioequivalence studies.

A number of new antiretrovirals - including fixed-dose combinations – are currently in the pipeline for WHO assessment.