In order to strengthen the regulatory provisions and the monitoring mechanism of clinical trials in the country, Drugs and Cosmetics Rules, 1945 have been amended as follows:-
A. Amendment vide Gazette Notification G.S.R. 53 (E) dated 30-01-2013 specifying procedures to analyze the reports of Serious Adverse Events occurring during clinical trials and procedures for payment of compensation in case of trial related injury or death as per prescribed timelines.
B. Amendment vide Gazette Notification G.S.R. 63(E) dated 01-02-2013 specifying various conditions for conduct of clinical trials, authority for conducting clinical trial inspections and actions in case of non-compliance.
C. Amendment vide Gazette Notification G.S.R No. 72(E) dated 08.02.13 specifying requirements and guidelines for mandatory registration of Ethics Committee.
The National Institutes of Health (NIH), have raised concerns about how these new requirements will be implemented, particularly the specific provision related to compensation.NIH have suspended enrolment of participants in 35 interventional trials in India. This will, however, not affect this country™s health programme and domestic pharma industry.
The drug trial policy has been evolving in course of time. Government has been trying to strengthen the regulatory mechanism to ensure proper drug trials.
This information was given by the Union Minister of Health & Family Welfare Shri Ghulam Nabi Azad in written reply to a question in the Rajya Sabha yesterday.
