Misuse of human clinical trials: Jail term up to 10 years, fine up to Rs 10 lakh

Syed Akbar
Hyderabad: The Biomedical Research Human Subjects Promotion and Regulation Bill, which calls for stringent punishment with up to Rs 10 lakh fine and up to 10 years imprisonment for those involved in errant clinical trials, will be introduced in the ensuing winter session of Parliament.
Dr VM Katoch, director-general of the Indian Council of Medical Research, told reporters here on Monday that the old draft of the Bill prepared six years ago had been updated increasing penalty for violation of ethical guidelines on human trials for vaccines, drugs and diagnostics. With clinical trials on human beings going on unchecked in the country, the Central government is hastening through the Bill to curb exploitation of marginalised and economically poorer sections for testing of new drugs and vaccines.
He said the legislation, when enacted, will protect the human subjects used in any form of scientific research carried out by academic institutions or pharmaceutical companies. He said a Biomedical Research Authority will be set up in the country which will supervise the functioning of ethical committees and clinical trials. Dr Katoch said the ICMR would consider whether registration of volunteers for clinical trials with the Authority should be made compulsory. There may be government representatives in ethical
committees to make them more responsible.
Dr Katoch said all government medical colleges in the country will soon have ICMR research centres to deal with infections and diseases at the local level. The ICMR will develop a chain of 256 research laboratories across the country to identify emerging diseases and pathogens. "Our focus is to make
medical colleges hub of research activity," he said.