Ranbaxy drugs off WTO's anti-AIDS list

[Guest guest]

Ranbaxy drugs off WTO's anti-AIDS list

Our Bureau / Mumbai August 5, 2004

World Health Organisation (WHO) has decided to remove three anti-

retrovirals manufactured by Ranbaxy from the pre-qualification list

of AIDS medicines this week.

" 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, " says a release on the website of WHO.

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 release added.

The anti-retrovirals 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 organisation

has found that the bioequivalence tests for 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 pre-qualified 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, " the release said.

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, " the release said.

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.

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[Guest guest]

Dear FORUM,

What exactly is going on? First Cipla, now Ranbaxy. What are these

`international standards of good clinical and laboratory practices'?

For instance, what is accepted as `universal precautions' in health

settings are different in different countries and contexts.

Is WHO genuinely interested in ensuring that the medicines it

pre-qualifies for procurement are of the highest standard? Or are there

other motives at work? Is Big Pharma subject to the same strict

pre-qualification procedures?

Too many questions ... does anyone have the answers?

Mariette Correa

E-mail: <mariette@...>