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


Peacekeeping faces challenges: here’s how we can meet them 2018-09-23 11:47:05 By Jean-Pierre Lacroix* United Nations peacekeeping remains one of the most effective tools to respond to today’s challenges of global peace and security. Every day, women and men who serve under (...)

Pragmatic patriarchy of Sudan over South Sudan 2018-09-22 09:28:17 James Okuk, PhD “We honour the human capacity to manage our collective lives with peace and even, at times, dignity” – Barbour & Wright The political process of Sudan and South Sudan has (...)

Salient features of South Sudan latest peace deal 2018-09-21 05:36:06 By Roger Alfred Yoron Modi Last week, the government of South Sudan under President Salva Kiir, various armed and unarmed opposition groups and other parties, including the SPLM/A-IO led by Dr (...)


MORE






Latest Press Releases


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 (...)

The Suspension of Hurriyat Online Newspaper 2018-04-29 07:04:37 Sudan Democracy First Group 28 April 2018 The Sudanese civil and political circles and those concerned with Sudan were shocked by the news that the management of Hurriyat online newspaper has (...)

Petition on the Deteriorating Human Rights and Humanitarian Situation in Sudan 2018-04-22 10:01:20 UN Secretary-General, New York African Union Commission, Addis Ababa UN High Commissioner for Human Rights, Geneva Petition on the Deteriorating Human Rights and Humanitarian Situation in Sudan (...)


MORE

Copyright © 2003-2018 SudanTribune - All rights reserved.