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

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A letter to CIPLA on the situation of ARV bioequivalence study

participants

Mr. Amar Lulla

Managing Director

CIPLA

Mumbai

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

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?

We would appreciate a response at your earliest convenience.

Thanks

Sheela

E-mail: <sSitaraman@...>