Alarmed by the rise in illegal drug trials in the country and the lack of effective laws for their monitoring, the National Human Rights Commission (NHRC) is mulling guidelines for clinical trials. The NHRC has written to the Indian Council of Medical Research (ICMR) and other premier medial institutes in the country to suggest the names of experts to assist the commission in framing the guidelines.
Recently, the unauthorised drug trials had caused great concern in the country after the Drug Controller-General of India (DCGI) revealed that 2061 persons died during drug trials between the period from January 2008 to January 2012. Reports suggested that multinational companies used poor and illiterate patients for drug trials without their consent, which recently prompted the Supreme Court to pull up the Central government saying it should prevent human beings being used as “guinea pigs”.
According to an NHRC official, the commission has received almost a dozen complaints about illegal drug trials during the last one year alone. Apart from the ICMR, the commission has also written to the directors of All-India Institute of Medical Sciences, Delhi, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, PGI, Chandigarh and Rajiv Gandhi Cancer Institute and Research Centre, Delhi, to suggest the names of experts to frame the guidelines.
The commission has also asked them to send the copy of protocol, if any, which is being followed by them while conducting clinical trials on human beings.
Earlier in March, while taking up an illegal drug trial case in Andhra Pradesh, the NHRC had asked the Central Drugs Standard Control Organisation to conduct proper study in various parts of India to ensure lapse adhere to the existing guidelines on clinical drug trials.
The commission had then raised some serious questions to the ICMR and the Drug Controller General of India.