Patients suffering from adverse effects of a faulty medical device will soon be entitled to compensation from the manufacturers and importers of such devices. A nine-member medical devices sub-committee headed by former director general of health services (DGHS), Dr B.D. Athani, is in the final stages of coming up with a legally binding compensation formula, two people aware of the matter said, requesting anonymity.
New provisions will be added to the Drugs and Cosmetics Act to introduce a compensation plan for faulty medical devices having adverse impacts on patients, they said. India does not have any legal provisions to compensate patients facing health problems due to implants or use of faulty medical devices. Under the law, companies are liable to pay compensation only when something goes wrong during a clinical trial.
The medical devices sub committee, which was set up in December 2018, has already examined relevant provisions in legislation, such as the motor vehicles Act, the formula prescribed in the Johnson and Johnson (J&J) hip implant case and the rules for injuries or deaths from clinical trials. Compensation has been determined on the basis of parameters such as the base amount, loss of wages, and the degree of disability, said the first person mentioned above.The formula that’s being worked out, according to the people aware of the details, takes into account the extent of disability, age and risk factor. For example, if the disability is high (50%) and the patient suffered at a young age, the quantum of compensation will be higher.
Another expert committee will be formed to investigate compensation claims, and patients will have to report the serious adverse events at a new registry being proposed along the lines of those in the UK and Australia.
The proposal is part of the government’s 100-day agenda. The compensation sub-committee was the result of recent investigations by an expert panel into hip implants manufactured by a Johnson and Johnson subsidiary that required some patients to undergo revision surgeries because of alleged defects in the design of the product.
India’s drug technical advisory board (DTAB), in a meeting held in November 2018, had deliberated on a proposal for providing compensation in case of injury from faulty medical devices. It was decided to form a sub-committee comprising a consumer activist, representatives from both domestic and international medical device manufacturers, doctors from the prestigious All India Institute of Medical Sciences (AIIMS) and Delhi’s Safdarjung Hospital, and a representative from the drug regulatory authority, Central Drugs Standard Control Organization (CDSCO).
“The sub-committee held its first meeting in January this year and is now on the verge of finalizing the formula. It is likely to be declared soon," said the second person.
Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry (AiMed), said it is important to have regulations for patient safety. “The current medical devices regulations are incomplete and still being built up as our regulators grapple with the complexities they are experiencing and we all stakeholders notice the inadequacies of the Drugs Act."
Reporting of adverse events, which relate to death or serious injuries needing surgical intervention, to the regulator is still in its infancy. Besides, the medical registry programme needs to be used judiciously to safeguard public health, but not for witch hunting to ensure voluntary participation of device manufacturers.
“Compensation for patients suffering due to implants or use of devices with manufacturing defects or a drug is currently not part of the Drugs Act, and so far, this was left to the judiciary to decide on a case-by-case basis," said Nath.