10 years in jail for CT rule violations in India

The Drug Controller General of India has approved new guidelines to raise the maximum penalty for violating clinical trial rules to 10  years in jail and the cancellation of the testing firm's license.  Vishwa Mohan Katoch, secretary of the department of human research at  the Indian Council of Medical Research, told the Economic Times of  India: "the new set of guidelines would ensure that those who do not  follow the norms approved by the [DCGI] for conducting clinical trials  on humans are brought to book and punished." The proposal would involve  changes to the Drugs and Cosmetics Act, Dr Katoch said. The ICMR drew  up the new guidelines which have been endorsed by both the Ministries of  Health and Law.

The government is keen to act in order to maintain the reputation of  India as a high-quality location for drugmakers to conduct trials. At  the same time, it faces local opposition to Indians being "exploited"  as "human guinea pigs," after 49 deaths in pediatric trials at the  All-India Institute of Medical Sciences in Delhi (Marketletters passim)  and other alleged failures by the DGCI to act over clinical trial  incidents.