In good news for patients, the government has set up an expert panel to frame rules for compensation in case of an adverse event due to a faulty or unsafe medical device.
Health ministry’s apex panel has cleared formation of the sub-committee to amend Medical Devices Rules, 2017, to include provisions for compensation on the grounds of a malfunction in the device, or it being unsafe or non-compliant.
This would help plug a loophole in the rules, as under the existing dispensation, the government initially found itself “helpless” in handling the Johnson & Johnson hip implant case.
The decision to bring in separate rules has been taken to simplify the legal process, cut down time and multiple stages. A case of an adverse event due to a medical implant is difficult to prove in the existing system and lacks clarity in law, experts said earlier.
The need for a legal provision for compensation is especially important for India with its socio-economic demographics, which may not have the strength to fight against powerful corporates in courts, sources said. The compensation will have to be given in the case where an adverse event or death is reported only for already approved devices, and not those which are under clinical trials.
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