Wednesday, November 27, 2013

Video recording compulsory for all clinical trials in India now

Video recording compulsory for all clinical trials in India now
The Ministry of health and family welfare office of drug controller general India in its order dated 19th November 2013 make video recording compulsory for all clinical trials including Global clinical trials in India. This order was based on the order of  Hon'ble supreme court dated 21st October 2013 in the case writ petition (C) 33 of  Swasthya Adhikar Manch & Anr vs Ministry of health and family welfare & ors.
The Hon’ble Supreme Court ordered MoHFW to conduct  clinical trials  only after ensuring proper mechanism & procedure to ensure safety of the patients along with audio-visual recording of participants maintaining principle of confidentially and preservation of documentation.
Swasthya Adhikar Manch has welcome this move in order to ensure transparency in conducting clinical trials of discovered drugs  in India. SAM  has regularly brought to notice the fact that Indian citizens are being exploited by Multinational drug companies using the loopholes and lacunae in law and regulatory framework.