The Ministry of Health and Family Welfare notified the Drugs and Cosmetics (First Amendment) Rules, 2013, on 30 January. The amendment introduces both substantive and procedural changes to the existing regime.
The salient features of the amendment are outlined below:
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Clinical trial subjects are entitled to free medical management for any injury which occurred in the course of clinical trial as long as required and are also entitled to financial compensation for clinical trial-related injury or death. If the subject dies, compensation is payable to the subject’s nominees.- The rules lay out what constitutes “clinical trial-related injury or death”.
- The sponsor or the sponsor’s representative, whichever has obtained permission to conduct the clinical trial in India, must bear the expenses of the subject’s medical management and provide financial compensation. With respect to compensation, the sponsor, whether a pharmaceutical company or an institution, is also required to give an undertaking to the Drugs Controller General of India (DCGI) stating that it will provide compensation in case of clinical trial-related injury or death.
- “Serious adverse event” has now been defined for the purpose of Schedule Y (brought in from the definitions of “adverse event” and “serious adverse event” set out in the Good Clinical Practice Guidelines).
- A set procedure for reporting serious adverse events and processing incidental claims of financial compensation has been put in place. In the event of death, the investigator, sponsor and ethics committee must submit a report containing due analysis of the cause of death to a statutorily constituted independent expert committee within a stipulated time. The ethics committee, in addition to the report, may give its opinion on the quantum of compensation to the expert committee. In the case of a serious adverse event other than death, the DCGI may set up an expert committee to investigate the cause of the adverse event and recommend financial compensation, if appropriate, to the DCGI. The sponsor, investigator and ethics committee have to then submit their report with an analysis of the cause of the adverse event to the experts committee, if the DCGI appoints such a committee, and to the DCGI within a stipulated time. The expert committee considers various reports submitted to it and conducts its own examination of the adverse event. After this examination, the expert committee recommends the cause of the serious adverse event and quantum of compensation to the DCGI within a stipulated time. The DCGI has been authorized to decide the cause of the serious adverse event as well as to pass an order on payment of compensation, if appropriate, taking into account the expert committee’s recommendations.
- The DCGI must determine the cause of a serious adverse event and order financial compensation within three months from the date on which the serious adverse event was reported.
- The sponsor or sponsor representative has been given a time frame of 30 days from receipt of the order of the DCGI to provide compensation to the subject.
- Failure of the sponsor or sponsor representative to provide free medical management and/or financial compensation, as ordered, may lead to suspension or cancellation of existing and future clinical trials in India.
- The informed consent form has been modified to include details relevant to determining compensation such as the subject’s qualifications, occupation and annual income. It is now obligatory to submit a copy of the informed consent sheet and form to the subject or the subject’s attendant.
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The legislative and regulatory update is compiled by Nishith Desai Associates, a Mumbai-based law firm. The authors can be contacted at nishith@nishithdesai.com. Readers should not act on the basis of this information without seeking professional legal advice.
