Salient features of “Drugs and Cosmetic Act 1940” as amended and Regulations made therein are appended below;-
Any injury or death of the subject occurring in clinical trial due to following reasons shall be considered as clinical trial related injury or death as follows:
- Adverse effect of investigational products
- Failure of investigational product to provide intended therapeutic effect
- Use of placebo in a placebo-controlled trial
- Adverse effect due to concomitant medication excluding standard care, necessitated as part of approved protocol
- For injury to a child in-utero because of the participation of parent in clinical trial
- Any clinical trial procedures involved in the study
- Medical expenses in addition to the financial compensation for bodily injury .
These terms and conditions are to be incorporated in the policy otherwise Insurer is having its own wordings which are not as per Drugs and Cosmetic Act 1940 and Insured may not be able to meet the requirements as required under the Act. The Hospitals/Participating Institutions/Principal Investigator//All persons involved in the trial including the Ethics Committee and its individual members should also be made part of the policies. The minimum compensation is Rs 72 lakhs per person and AOA( Any of Act): AOY should be 1:3 i.e. Rs 72 lakhs: Rs 216 lakhs.