Union Health Ministry has ruled out any irregularities regarding the clinical trials involving children in the last five years at the Delhi hospitals, for which the National Human Rights Commission (NHRC) had sought an explanation from the authorities.

In its replay to the NHRC, which sought the report from the Ministry in early February, the Health Ministry said the matter was examined by the expert committees set up by the Drug Controller General of India (DCGI) and found that the trials were held as per the norms specified in this regard.

The NHRC had sent the notice to the Ministry on February 7, seeking requisite information/report on the complaint alleging that three big government hospitals in Delhi conducted illegal clinical drug trials on 3479 children during the last five years. These include 2056 children at Safdarjung Hospital, 1023 children in Kalawati Saran Children Hospital and 400 children at Lok Nayak Jai Prakash Hospital. The complaint was filed by R H Bansal, general secretary, Antarrashtriya Manav Adhikar Nigrani Parishad.

“The matter was immediately got examined by the DCGI 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 his report to the Ministry, concluded that the studies at these hospitals were conducted on the children after taking the consent of their guardians/parents,” Health Ministry sources said.

“However, in case of Safdarjung Hospital, a few flaws were noted in getting their informed consent. The Ministry would ensure that all the required measure are taken by the DCG(I) so that only those clinical trials are allowed in the future which are strictly as per the prescribed norms. The reply to the notice of the NHRC has been sent on 11.3.2013,” sources said.

The complainant had claimed that he got the information about the number of children subjected to clinical trials under RTI. He also alleged that parents' approval was not taken for subjecting their children to clinical trials which is an illegal and punishable act. The clinical drug trials also violated the human rights of the innocent children.