NEW DELHI: Indian patients suffering due to faulty medical devices may soon be empowered to demand compensation for health problems caused by such products from the company making or importing them.
Drugs Technical Advisory Board (DTAB), the country’s apex drugs advisory body, on Thursday approved a proposal to amend the country’s rules for medical devices to include provisions for compensation, people close to the development told ET.
“But, before that, they want a detailed study from a sub-committee on how this compensation can be implemented,” one of them said on condition of anonymity. The sub-committee, expected to be headed by DTAB member Nilima Kshirsagar, will submit its report to the body for further approval, the person said. It has not been given a specific deadline to submit its report.
The move comes on the heels of a controversy surrounding hip implants marketed by US medical device giant Johnson & Johnson, which a government expert committee earlier this year concluded were faulty and toxic to patients using them. Currently, India does not have any legal provisions to compensate patients facing health problems due to faulty medical devices.
As per the proposed change in rules, in case someone has died or has been injured due to a malfunctioning or unsafe medical device, the company making or importing the product will be liable to pay damages to the patient or their family. This applies to medical devices found violating any conditions of licences granted to manufacture, import and sell their products in India, according to the agenda of the DTAB meeting. ET has viewed a copy of the agenda.
“The issue of having regulatory provision for payment of compensation by the manufacturer/ importer in case of injury or death of patient for use of notified medical device found malfunctioning/ found unsafe/ not in compliance with the conditions of the licence has been under consideration for quite some time now,” it said. According to the proposed amendments in the earlier agenda, the manufacturer or importer shall provide medical management and compensation in accordance with a formula prescr ..