Illegal drug trials: NHRC issues notice to Health Ministry

Annoyed at non-submission of reports with regard to unauthorised clinical drug trials in Andhra Pradesh, the National Human Rights Commission (NHRC) on Monday asked the Health Ministry and state officials to respond within six weeks or face action under law.

The Commission had sent notices to the Union Health Secretary, Secretary of the Indian Council of Medical Research, Drug Controller General of India and Andhra Pradesh Chief Secretary last year, asking them to file reports with regard to unauthorised drug trials on six women in the state.

"The Commission has now asked them to submit these within six weeks positively failing which the Commission may invoke the provisions contained in Section 13 of the Protection of Human Rights Act, 1993," an official statement said.

While issuing notices in June last year, the NHRC had also directed its investigation team to ascertain the facts that 25 poor women in Guntur were lured to take part in a cancer drug trial by a Hyderabad-based pharmaceutical company.

After taking the drug, six women had to be hospitalised for complications, media reports had said.

Subsequently, the state and Central authorities concerned were again asked to send reports on September 26 and December 5, 2011, the release said.

The only communication received from the Drug Controller General of India, dated July 7, 2011, stated that all the drug trials were required to be conducted as per Good Clinical Practices guidelines issued by the CDSCO, it said.

"However, there was no specific response to the issues raised by the Commission in its notices to him. Neither a copy of GCT guidelines was submitted," the release said.

The investigation team of the Commission found that there were eight more laboratories in Hyderabad in addition to Axis Clinicals Ltd. which were conducting clinical drug trials.

The team had asked Health Secretary, Andhra Pradesh, to properly assess health condition of the villagers and ensure suitable compensation for the victims.

It also asked the Central Drugs Standard Control Organisation (CDSCO) to conduct proper study in various parts of India to ensure lapse adhere to the guidelines on clinical drug trials.

"The amount paid to the volunteers for drug trials needed to be adequately increased and it should be monitored by CDSCO," the NHRC said.