Medical Device Companies will have to give compensation in case of adverse event: Govt proposes provision in law

The move comes after complaints that patients had suffered due to faulty hip implants by a subsidiary of pharma giant Johnson and Johnson.

New Delhi: The government is planning to bring a provision under which a medical device manufacturing company will have to offer monetary relief to patients in case of an adverse event. The move comes after complaints that patients had suffered due to faulty hip implants by a subsidiary of pharma giant Johnson and Johnson.

The government has formed a high powered expert committee to evaluate the cases and determine the quantum of compensation to be given to the victims.

Under the provision, to be introduced as part of the Medical Device Rules, 2017, companies will have to provide compensation to patients if the device causes injury, turns out to be unsafe, malfunctions or there is non-compliance with the licence rules, a Health Ministry official said.

The value of the compensation to be given to patients will be decided on the severity of the case.

"Once finalised the new rules will be notified," the official said.

The Centre has constituted a five-member expert committee to determine the quantum of compensation to be given to patients who have "faulty" hip implants, manufactured by DePuy International, a subsidiary of Johnson and Johnson.

The committee, which was formed on the recommendations of an earlier expert panel probing the case, is being chaired by Director, Sports Injury Centre, Safdarjung Hospital, R K Arya.

The earlier expert panel, constituted by the ministry to investigate complaints about faulty articular surface replacement (ASR) hip implant devices, said in its report that the pharma giant "suppressed" facts on the harm of surgeries afterwards which was conducted on patients in India using the "faulty" systems.

The committee in its report stated that "the ASR hip implants manufactured by DePuy International Ltd were found to be faulty which resulted in higher instances of revision surgeries globally including India".

The report recommended that DePuy International Ltd be made liable to pay at least Rs 20 lakh to each affected patient, and the reimbursement for revision surgeries should continue till August 2025.

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