India proposes sponsor and CRO fines in the event of trial participant injury

Patients injured during clinical trials will receive compensation under new rules proposed by the Indian Government.

The new proposal – available here in draft form – will make drug companies and contractors liable to pay compensation for injuries and damage caused to participants during a clinical trial.

Any company, sponsor or clinical research organization that fails to provide required medical management or compensation shall be punishable with imprisonment or with a fine.

The proposed bill – which is open for comment for the next 45 days - also specifies that, if a patient involved in a trial is to die, the sponsor and or CRO should pay compensation to the legal heir of the person taking part.

The bill also touches on issues related to drug product quality. For example, any person involved with the supply of a product deemed not to be of standard quality or spurious shall be punishable with imprisonment for a term not less than 10 years. They will also be liable to a large fine.

The Government also wants to set up medical device testing centers on the lines of drug laboratories in states and at the central level.

Medical device trials

In addition, the bill proposes the establishment of a separate Drugs Technical Advisory Board (DTAB) and Medical Devices Technical Advisory Board (MDTAB) that will advise central and state governments on technical matters related to devises and medicines.

Rajiv Nath, forum coordinator, at the Association of Indian Medical Device Industry, expressed concerns about the lack of a separate legislative plan for medical devices.

He told Livemint “We are studying the draft and seeking comments from our members.

“We are disappointed that the aspirations of a separate act for medical devices have not been addressed and budding entrepreneurs and start-ups, developers and engineers will still need to grapple with a complex joint law.”

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