Archive \ Volume.5 2014 Issue 6

IMPACT ON CLINICAL TRIAL STUDIES DUE TO REGULATORY AMENDMENTS IN INDIA: A LATEST REVIEW

Abhimanyu Thakur , Aishwarya Roy and Sriram Mullapudi
Abstract

Schedule Y of Drug and Cosmetic Rule, 1945 plays an important role in regulation of clinical trials in India. There have been various rules there under to regulate the conduct of clinical trials. In spite of these, several incidences of non compensation to the volunteers, non compliance of regulatory requirements, the implementation of unethical procedures, and health related issues, improper documentation procedure being employed by multinational companies and malpractices by the government and private doctors during the clinical trial have been reported. A good number of unethical clinical trials have also been reported in the recent past. From time to time, many regulatory amendments have been done to enforce better laws to safeguard the rights, safety and well being of the trial subjects. This paper reviews the latest regulatory amendments in India and its impact on clinical trials.