A letter to CIPLA on the situation of ARV bioequivalence study participants

[Guest guest]

Mr. Amar Lulla

Managing Director

CIPLA

Mumbai

e-MAIL: mdoffice@...,alulla@...

Sub: Concerns about two CIPLA ARV products being withdrawn from the WHO

qualification list and the the situation of ARV bioequivalence study

participants

Dear Mr. Amar Lulla

This is to enquire about the current statues and related issues of the

revalidation of two ARV singles, Lamivudine (3TC) and zidovudine (AZT) produced

by CIPLA in India.

Many members of AIDS INDIA e FORUM,

(AIDS Treatment/ an electronic forum for

information and communication on AIDS related issues in India, with a daily

transmission to about 2,000 subscribers) are interested in the latest

developments regarding the withdrawal of two CIPLA products from the WHO

qualification list and related aspects.

We would like to record our great appreciation of the fact that CIPLA has

strategically contributed to reduce the cost of ARV mediation globally from

about US$ 10,000 per anum per patient to about US$ 140. Several million people

living with HIV/AIDS has been benefited by this effort.

Based on the media reports, our understanding is that, three years ago, in

accordance with the WHO pre-qualification regulatory requirements, CIPLA

submitted the two above mentioned products to a Contract Research Organization

(CRO) for bioequivalence studies.

However, due to the failure of this CRO to keep the necessary back-up

documentation in an accepted standards, WHO withdraw of two CIPLA products

Lamivudine (3TC) and zidovudine (AZT)from their qualification list. CIPLA

withdrew the products and resubmitted them to another CRO for investigation.

As a matter of public interest we would like to know;

a) Please provide us with the name and contact details of the Contract Research

Organization and the principal researchers carrying out ARV bioequivalence

studies for CIPLA in India.

Please let us know what safety mechanisms are in place to protect the best

interest of the bioequivalence study participants of CIPLA by this CRO in India?

c) What is the fate of the treatment of the patients who were participating in

the ARV bioequivalence study by this CRO?

d) We would also like to know the details of the Ethics Review Committees

monitoring and supervising ARV bioequivalence studies for CIPLA in India if

there are any?

It will be deeply appreciated, if you could inform us these details at your

earliest convenience.

Keep up the good work of enhancing access to life saving ARV medications to

millions.

Thank you for your attention

Joe

Moderator

e FORUM

AIDS Treatment/