Home | Press Releases    Thursday 5 August 2004

Three aids medicines will be removed from prequalification list this week

separation
increase
decrease
separation
separation

World Health Organisation (WHO)

Press Release WHO/53
4 August 2004

GENEVA - As part of the continuous effort to rigorously monitor the quality of medicines, the World Health Organization (WHO) is carrying out systematic inspections of contract research organizations which have done bioequivalence studies for prequalified medicines, starting with products for priority diseases.

During the most recent inspection a contracted laboratory which had done bioequivalence studies for three AIDS medicines has been found non-compliant with international standards of good clinical and laboratory practices. As a result, the three antiretrovirals, which are manufactured by Ranbaxy, will be removed from the list until such a time as Ranbaxy can submit data of new studies providing unequivocal evidence of the products’ bioequivalence with the originator medicines.

Although it is not standard procedure for prequalification assessments to include the inspection of laboratories where bioequivalence studies are done (in Europe, Directive 2001/10/EC, asking that countries carry out such inspections, came into force only on 1 May 2004 ), WHO is committed to ensuring that the medicines it prequalifies for procurement in developing countries are of the highest standard.

The antiretrovirals in question are the triple fixed-dose combination pill containing lamivudine, stavudine and nevirapine in two different strengths and a lamivudine plus zidovudine tablet.

The recent inspections follow another inspection which took place in late May when similar non-compliance was found at a laboratory contracted by CIPLA to do bioequivalence studies of two AIDS medicines. However, another WHO inspection of a contract research organization has found that the bioequivalence tests for the triple fixed-dose combination lamivudine, stavudine and nevirapine tablet manufactured by CIPLA were carried out properly in compliance with requested standards. This product will therefore continue to be included in the list of WHO prequalified products.

While the three Ranbaxy products to be removed from the list meet quality specifications, proof of bioequivalence is missing in view of non-compliance with good clinical and laboratory practices as well as data handling requirements found in the contracted laboratory. This effectively means that the medicines may or may not offer the same therapeutic benefits as the originals on which they are based. (Bioequivalence tests are conducted in volunteers whose blood is tested after receiving the test medicines, to determine whether the concentration of the test medicine (generic medicine) is similar to that of the innovator or patented medicine).

Ranbaxy has undertaken to resubmit the products in question to a different laboratory for proof of bioequivalence. If and when those products and the laboratories are found to meet the specified requirements, WHO will reinstate them in its list of prequalified products.

WHO will provide advice to countries, UN partners and the NGO community involved in the procurement of medicines as to the best ways to proceed.

In addition to good clinical and laboratory practices inspections, WHO assesses the quality of antiretrovirals through: evaluation of data in the product dossiers for quality as well as bioequivalence; inspection of manufacturing sites for compliance with good manufacturing practices; and testing of product samples at independent laboratories for compliance with product specifications.

The following products have been removed from the list of prequalified products to date:

- Lamivudine 150mg plus Zidovudine 300mg tablet by Ranbaxy Laboratories Ltd Dewas, India. 60’s and 100’s

- Lamivudine 150mg plus Stavudine 30mg plus Nevirapine 200mg tablet by Ranbaxy Laboratories Ltd Dewas India. Al strip of 10, 60 per box

- Lamivudine 150mg plus Stavudine 40mg plus Nevirapine 200mg tablet by Ranbaxy Laboratories Ltd Dewas, India. Al strip of 10, 60 per box

- Lamivudine 150mg tablet by Cipla Ltd, Kurkumbh, India. Blister 10.

- Lamivudine 150mg plus Zidovudine 300mg tablet by Cipla Ltd, Vikhroli, India. Blister 10.

For more information on the current list of prequalified products, go to the web page at http://mednet3.who.int/prequal/

For more information please contact Daniela Bagozzi, Communications Officer, Health Technology and Pharmaceuticals, World Health Organization, Tel. +41 22 791 45 44, mobile: +41 79 475 54 90, email: bagozzid@who.int or André van Zyl, Scientist, Health Technology and Pharmaceuticals, World Health Organization, Tel: +41 22 791 35 98, Mobile: +41 79 475 55 27; email: vanzyla@who.int.

All WHO Press Releases, Fact Sheets and Features as well as other information on this subject can be obtained on the Internet on the WHO home page www.who.int.

Comments on the Sudan Tribune website must abide by the following rules. Contravention of these rules will lead to the user losing their Sudan Tribune account with immediate effect.

- No inciting violence
- No inappropriate or offensive language
- No racism, tribalism or sectarianism
- No inappropriate or derogatory remarks
- No deviation from the topic of the article
- No advertising, spamming or links
- No incomprehensible comments

Due to the unprecedented amount of racist and offensive language on the site, Sudan Tribune tries to vet all comments on the site.

There is now also a limit of 400 words per comment. If you want to express yourself in more detail than this allows, please e-mail your comment as an article to comment@sudantribune.com

Kind regards,

The Sudan Tribune editorial team.

Comment on this article



The following ads are provided by Google. SudanTribune has no authority on it.



Sudan Tribune

Promote your Page too

Latest Comments & Analysis


South Sudan’s universities should explore other revenues 2019-03-17 20:33:06 By Ukongo Benson Athia Of recent, it transpired that the five public universities dons have advanced their cause to increase the tuition fees for the students. I have seen such complaints of (...)

Pressure from the people in Sudan 2019-03-17 10:55:35 The longer genuine political and economic reform is delayed in Sudan, the greater the risk of wider instability and deepening economic crisis. By Rosalind Marsden President Omar al-Bashir, who (...)

Sudan’s al-Bashir burnt the boats before crossing 2019-03-11 06:19:03 By Mahmoud a. Suleiman Second Military Coup D’état of Omer Bashir will Not Protect him from his inevitable fate at the hands of the uprising Sudanese people The angry uprising men, women and (...)


MORE






Latest Press Releases


Sudan Protests: Investigate the custodial death of three University students 2019-03-13 12:53:14 The African Centre for Justice and Peace Studies (ACJPS) Sudan Protests: Urgent call for investigations into the custodial death of three University students and alleged torture of detainees by (...)

The Alliance for Restoration of Sudanese Workers Trade Unions Joins the Declaration of Freedom and Change 2019-03-10 21:16:50 PRESS RELEASE For immediate release 10 th March 2019 The Alliance for Restoration of Sudanese Workers Trade Unions announced on Sunday 10th March that it was joining the revolutionary forces (...)

Ethnic Murle politicians say enough to cattle raiding 2018-12-28 09:32:00 December 27, 2018 (JUBA) - Murle political leaders in Buma state have vowed to end the practice of cattle raiding and child abduction by individuals in the community. Jodi Jonglei, who is also (...)


MORE

Copyright © 2003-2019 SudanTribune - All rights reserved.