Ghulam Nabi Azad, Minister for Health & Family Welfare, in written reply to a question in the Rajya Sabha today, said that there are no reports regarding the conduct of clinical trials on children, particularly on new borns, by foreign pharmaceutical firms at Safdarjung Hospital, New Delhi.
In his reply, Azad said that 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.
Quoting data on www.clinicaltrials.gov, of the US National Institute of Health, the Minister sought to make the point that compared to other nations, India had fewer clinical trials. As of 20-03-2013, 1,42,239 clinical trials of different countries were registered on this site, of which 67,881 are from the US, 38,473 from Europe, 10,702 from Canada, 2,645 from Japan, etc. Only 2,178 clinical trials were registered from India.
Azad’s reply went to to state that banning clinical trials, whether local or global, will not be in the interest of drug discovery and research in the country.
He did stress that 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 reply went on to list the following provisions in the Drugs and Cosmetics Rules, 1945 relating to clinical trials which had been recently amended:
- 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.
- 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.
- 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.
EP News Bureau – Mumbai