September 21, 2018

Govt. to put onus of compensating victims of adverse events on manufacturers of med devices


Responding to Johnson & Johnson’s faulty implant case, the government will introduce a legal provision by which medical device manufacturing companies have to compensate victims of any such adverse event.

The provision will plug a loophole in the existing rules due to which the government could not hitherto direct the company to compensate patients who had undergone faulty hip implant surgeries. Sources informed that the provision was soon expected to be notified as part of the Medical Device Rules, 2017.

This will be the first such law empowering the government to prosecute companies in case of adverse events or death. Under it, patients will be compensated if the medical device is unsafe or malfunctions, causes injury, or is non-compliant with the manufacturing license. Depending on the seriousness of the case, the company will be responsible for compensating the patient or taking care of his/her medical needs (corrective surgery or medical tests) or both.

S. Eswara Reddy, Drug Controller General of India, confirmed that the provision was being finalized and would soon be put up for public comment, after which a notification would follow. The amount of compensation will depend on the seriousness of the case.

A notification will be brought in and not an Act of Parliament as the latter takes a lot of time owing to multiple stages and approvals.

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