The National Human Rights Commission has asked the union health ministry and the Andhra Pradesh government to respond within six weeks on its demand for reports into unauthorized clinical drug trials on people and warned of action if it failed to do so.
According to NHRC official, the commission can summon the authorities – as well as the Indian Council of Medical Research and Drug Controller General of India – if they fail to respond within the stipulated time.
In the wake of new reports of unauthorised drug trials conducted on six women in Andhra Pradesh June 2011, the human rights watchdog had issued notice on June 20, 2011 to concerned authorities in the state and the centre and had also directed its investigation team to ascertain the facts.
Twenty-five poor women in Guntur (Andhra Pradesh) were allegedly coaxed to go in for testing a cancer drug by a Hyderabad based pharmaceutical company. After taking the drug six women had to be hospitalised for complications.
The concerned state and central authorities were again asked to send reports on the incident on Sep 26, 2011 and Dec 5, 2011.
“The only communication received from the Drug Controller General of India dated 07.07.2011 stated that all the drug trials were required to be conducted as per Good Clinical Practices guidelines issued by the CDSCO,” said a statement for NHRC.
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 investigation team of the Commission found that there were eight more laboratories in Hyderabad in addition to Axes Clinicals Ltd. which were conducting clinical drug trials.