Recommendation by panel to be sent to health minister for inclusion in Drugs & Cosmetics Act
Indian manufacturers and importers of medical devices will soon have to compensate patients for serious side effects of their products. On Wednesday, an experts’ panel set up by the government finalised the terms of a legally binding compensation formula which will be recommended to the health ministry for incorporation in the Drugs and Cosmetics (D&C) Act, people aware of the matter told ET.
India so far did not have legal provisions to compensate patients who suffer serious side effects due to use of medical devices. The law mandates compensation only when something goes wrong during a clinical trial.
According to the formula finalised by the nine-member medical devices sub-committee, compensation will be determined on the basis of parameters like the base amount, loss of wages, and the degree of disability, the persons cited earlier said, requesting not to be named. The panel is headed by former director general of health services (DGHS), BD Athani.
“If the disability is higher, permanent and the patient is young, the compensation is higher,” said one of the persons cited earlier.
The experts have suggested a composition of “causality assessment committee” to determine if the adverse event happened due to the manufacturing defect of the medical device or otherwise.
In case of imported devices, the liability to pay compensation will fall on the Indian agent licensed to sell the product. Once the formula is approved and notified by the government, all devices regulated under the Drugs and Cosmetics Act will fall under the ambit of the amended legislation.
The proposal to chalk out a formula for compensation in case of medical devices was part of the government’s 100-day agenda. The sub-committee was formed after investigations were started into problems due to hip implants manufactured by a subsidiary of Johnson & Johnson (J&J) which required some patients to undergo revision surgery. While some of the affected patients received compensation this year after court intervention, the gap in the law prodded the government to put in place a structure for future compensations.
Before finalising their recommendation, the experts’ committee had examined the terms of the Motor Vehicles Act, the compensation formula used for awarding subjects who suffer injury in medical clinical trials, the formula prescribed for patients who suffered in the Johnson & Johnson hip implant case, among others.
The expert committee consists of representatives of Indian and multi-national device makers along with state drug controllers and public health experts. “The manufacturers who are part of the committee have come to the conclusion that the patient should be entitled to a decent compensation in case any untoward incident happens. However, cases of medical negligence by doctors will not be covered under this formula,” the person quoted earlier said.
Among other suggestions, the panel has said that state-level expert committees should be formed to investigate compensation claims
