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.


s
Sudan Tribune

Promote your Page too

Latest Comments & Analysis


Sudan’s Independence: 19th of December should not go into Oblivion 2018-11-19 09:27:07 By Mahmoud A. Suleiman These important Reflections came to me against the backdrop of what was said about the date of the return of the Head of the Umma National Party (UNP), and the Imam of the (...)

Sudan’s removal from terror list taints U.S. values 2018-11-10 08:34:32 November, 9th, 2018 The Honorable Michael Richard Pompeo Secretary of State U.S. Department of State 2201 C St NW, Washington DC 20520 USA RESPONSE BY SUDAN LIBERATION MOVEMENT (SLM/A-AW) TO (...)

R-ARCISS: A Peace that divides the signatories and non-signatories 2018-11-10 07:58:28 By Tito Awen, Juba-South Sudan I keep wondering if peace can divide or unite the partners. I am not so young nor unmindful not to have known what happened after signing of the Comprehensive (...)


MORE






Latest Press Releases


Progress observed at end of second month of R-ARCSS implementation 2018-10-22 06:44:02 Press Release 21 October 2018 South Sudanese government released 24 detainees in the implementation of the revitalized peace agreement said the International Committee of the Red Cross (ICRC) (...)

4th Annual Tony Elumelu Foundation Entrepreneurship Forum Announced for 25th October 2018 2018-10-15 12:38:14 PRESS RELEASE OCTOBER 14, 2018 Africa’s leading entrepreneurship-focused philanthropic organisation, the Tony Elumelu Foundation (TEF), has announced October 25, 2018, as the date for its (...)

Unity State community in Kenya supports Khartoum peace agreement 2018-08-17 08:33:21 PRESS STATMENT 14th Aug, 2018 Re: We shall Rally behind Khartoum Peace Agreement The Unity State Community Association in Kenya was established in 2010 to organize and mobilize the people of (...)


MORE

Copyright © 2003-2018 SudanTribune - All rights reserved.