National Human Rights Commission (NHRC) on Friday decided to intervene in the case related to the clinical trials of drugs pending before the Supreme Court. The case has been filed as public interest litigation by two Indore-based NGOs.
In addition to this, the Clinical Trial Welfare Society has also decided to intervene in the case on the grounds that people who had been affected by the clinical trials should be given a chance to express their views before the court. "Most of the people of our organization are those whose names have figured in the list of 81 people, who were affected by clinical trials, submitted by EOW to the government. We are the victims and we should be given a chance to express our views before court," said vice-president of the Society, Ashish Jatav.
Dr Anand Rai, who has been raising the issues of clinical trials of drugs for years, said that a series of unethical and illegal clinical trials were conducted on psychiatric patients by several government and private doctors in Indore. Psychiatric patients have been made clinical guinea pigs for drug trials sponsored by multinational and Indian pharmaceutical companies. Now matter is pending before the Supreme Court and victims have decided to put forth their views before it.
In his complaints to NHRC, Rai had stressed that clinical trials had been conducted in flagrant violation of article 21 of the Constitution; whereby human rights of psychiatric patients have been overlooked. "Psychiatric patients are often not in a position to give their informed consent for participating in such clinical trials and the trials have also violated the Indian Council of Medical Research guidelines and provision of the Drug and Cosmetic Act 1940," he said.
Taking cognizance of the complaints over clinical drug trials NHRC on Friday has constituted an expert committee for framing guidelines of drug trials in the country; it was said in an official communique of NHRC.
The committee will comprise Dr D C Doval, director of research and Director, medical oncology, Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, Prof Vivekananda Jha from department of Nephrology, PGIMER, Chandigarh, Prof B N Dhawan, former director of Central Drug Research Institute, Lucknow, Dr Subhash Yadav, additional professor, department of Endocrinology and member secretary, IEC, SGPGI, Lucknow, Dr Nilima Kshirsagar from national chair in clinical pharmacology, Indian Council of Medical Research and dean ESI-PGIMER, MGM Hospital, Mumbai Law Division. The meetings of the committee will be coordinated by NHRC.
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