Inquiry finds flaws in getting informed consent of parents

Government today admitted certain 'flaws' in getting the informed consent of parents or guardians before conducting clinical trials on children in Safdarjung Hospital.
In reply to a question in the Rajya Sabha on National Human Rights Commisssion notice on illegal drug trials in three government hospitals in Delhi, Minister of Health and Family Welfare Ghulam Nabi Azad said his Ministry has sent its reply on March 11 after the matter was examined by three expert committees.
The NHRC had sent the notice on February 7 this year over alleged illegal clinical trials on 3,479 children during the last five years in Delhi's three government hospitals - Safdarjung Hospital, Lok Nayak Jaya Prakash Narayan Hospital and Kalawati Saran Hospital.

Azad said the matter was immediately examined by the Drugs Controller General (India) through three expert committees, each having an expert in the relevant area, an officer from CDSCO and one officer from state drug control department, Delhi.
"On the basis of the report of these committees, the DCG (I), in its report to the Ministry, concluded that the studies at these hospitals were conducted on the children after taking the consent of their guardians/parents. However, in case of Safdarjung Hospital, a few flaws were noted in getting their informed consent," Azad said.
The Health Ministry will ensure that all required measures are taken by DCG(I) "so that only those clinical trials are allowed in future which are strictly as per prescribed norms", the Minister assured the House.