The Drugs Technical Advisory Board (‘DTAB’), the highest technical advisory body under the Drugs and Cosmetics Act, 1940 (‘DCA’), has accepted the suggestion of the Drugs Controller General of India (‘DCGI’) to make audio- video recording of procedure to obtain informed consent of subjects of clinical trial in India and maintain it.11 According to DCGI, such a step will authenticate that at the time of enrollment proper care was taken to inform the subject about the pros and cons of the clinical trial and his participation was voluntary.12 The DTAB has also accepted DCGI’s proposal to make it mandatory for the investigator of a clinical trial to inform the trial subject about the possibility of failure of investigational product to provide intended therapeutic effect and in the case of placebo- controlled trial, to inform that the placebo administered would not have therapeutic effect.13 The reason behind this proposal is obvious and does not require mention.

The proposed changes will be reflected in law as an amendment to the Schedule Y of Drugs and Cosmetics Rules, 1945 (‘DCR’) and Appendix V thereunder.

The Clinical Trial Industry, which is already encumbered with approval delays and continuing regulatory uncertainty surrounding compensation in case of trial related injury or death, may find this amendment to be burdensome as recording of informed consent procedure and maintenance of such recording will require a lot of resources and specialty with the investigator who is engaging the trial subjects.