Clinical Trials on Children at Safdarjung Hospital, Delhi

There is no report regarding the conduct of clinical trials on children particularly on new borns  by foreign pharmaceutical firms at Safdarjung Hospital, New Delhi.

Research in the area of drug discovery leads to newer, safer and more efficacious drugs being made available in the country.  Clinical trials are the only way of establishing the safety and efficacy of any new drug before its introduction in the market for human use.  Clinical trials (with safeguards) are necessary for introduction of new drugs for a country like India, considering its disease burden and emergence of new variants of disease.  The trials in the long run benefit the country and its patients. However, lesser number of clinical trials are taking place in the country as compared to the trials in other countries. As on 20-03-2013, as per the information available in www.clinicaltrials.gov of National Institute of Health, United States of America (USA), a total number of 1,42,239 clinical trials of different countries worldwide were registered.  Out of these, 67,881 are from USA, 38,473 from Europe, 10,702 from Canada, 2,645 from Japan, etc.  Only 2,178 clinical trials were registered from India.

Banning clinical trials, whether local or global, will not be in the interest of drug discovery and research in the country. However, there is a need to effectively monitor these trials so as to avoid irregularities therein. The Government has been continuously making efforts at strengthening the regulatory provisions  and the monitoring mechanism of clinical trials in the country and to avoid irregularities therein. The provisions in the Drugs and Cosmetics Rules, 1945 relating to clinical trials have recently been amended as follows:

(i)         Amendment vide Gazette Notification G.S.R. 53 (E) dated 30-01-2013 specifying procedures  to analyse 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.

(ii)        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.

(iii)       The registration of the Ethics Committees has been made mandatory in the Drugs & Cosmetics Rules vide Gazette Notification G.S.R No. 72(E) Dated 08.02.13 specifying requirements and guidelines for registration of Ethics Committee.

This information was given by the Minister for Health & Family Welfare Shri Ghulam Nabi Azad in written reply to a question in the Rajya Sabha on 30 April 2013