In a bid to prevent incidents similar to the Johnson & Johnson faulty implant case in future, the government may introduce a legal provision under which a company manufacturing medical devices will have to offer compensation to patients in case of an adverse event, The Times of India reported.
The provision will help the government bridge gaps in the existing rules. The absence of such a law rendered the government "helpless" in directing the MNC to compensate patients who had undergone faulty hip implant surgeries.
The government will soon notify such a provision under the Medical Device Rules, 2017, officials told the paper.
If implemented, this would be the first law that would provide teeth to the government to catch hold of such companies in case of an adverse event or death.
Under the proposal, medical device manufacturing companies will have to compensate patients in case malfunctioning of the medical devices or non-compliance with the manufacturing licence, or injury caused to patients, the official added.
Depending on the severity of the case, the government may also direct the company to pay compensation or take care of the patient’s medical needs (covering medical tests or corrective surgery) or both.
The central expert committee, headed by Dr Arun Agarwal, had also recommended including the provision relating to compensation. The 11-member expert committee constituted in February 2017 examined issues related to Johnson & Johnson’s faulty ASR hip implants.
The central government has constituted a five-member central expert committee to recommend the quantum of compensation for patients who suffered from the faulty hip implants.
Such provision is being finalised and will be put up for public comments soon, Drug Controller General of India S Eswara Reddy told the paper.
According to the report, the compensation would be provided only in case of an adverse event/death reported for already approved devices, and not those which are under clinical trials.
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