Article of interest_Issues & Concerns in Conducting Clinical Trials in India

Gowree Gokhale and Milind Antani of Nishith Desai Associates India discuss the issues & concerns in conducting clinical trials in India from a legal viewpoint.

 

http://www.pharmafocusasia.com/clinical-trails/issues-concerns-conducting-clinical-trials

 

Issues like approval delays, deficiencies of functioning of CROs and other stake holders, liabilities and compensation to injured subjects, insurance issues etc still remain in India, which has made multinational companies to rethink on opting for India to conduct clinical trials in India recently. There is a need for a law to ensure that the people who undergo clinical trials are not exploited and should be well informed about risk as well to provide clarity on regulations.

 

Summary:

 

1. Regulatory concerns:

Although  regulations relating to clinical trials have evolved considerably to match global standards, many issues still remain. There are several grey areas in the regulations that need to be clarified. Hence, often for several issues, authorities need to be consulted or the industry practices need to be ascertained.

 

2. Clinical trial liabilities:

Liabilities are likely to arise due to breach in “informed consent” rules or adverse reactions due to drugs, negligence of institution or investigator. Typically, the clinical trial agreement allocates the liability among sponsor, CRO, investigator / institution.

 

3. Access to drugs:

Another issue that arises is the liability of the sponsor to provide access to drugs and treatment post termination of the trial. Depending upon the study protocol, availability of the drug and stage of the trial, this issue needs to be addressed.

 

The article concludes with a need for law in this domain.


Also read our earlier post related to clinical trials update at:
http://pharmaliterati.blogspot.in/2015/03/new-drugs-likely-to-escape-local.html