New Delhi: The government is contemplating changes in the Drugs and Cosmetics Act, 1940, to make pharma firms liable to pay compensation for injuries and damage caused to consumers by their products, including drugs and medical devices.

Under the existing law, companies pay compensation only in case something goes wrong during a clinical trial.

The Central Drug Standards Control Organization (CDSCO), the national regulatory body for Indian pharmaceutical and medical device makers, has proposed changes in the existing law to introduce a compensation provision for approved drugs and medical devices that have an adverse impact on a patient.

“As of now there is no provision to give compensation in case of any malfunction or untoward incident that happens due to an approved product (drug or a device)," said a government official on condition of anonymity. “In India, monetary benefits are provided only in case of clinical trial-related injury. This is the first time that compensation for an approved product or device has been proposed."

The proposal is the result of recent investigations by an expert committee of hip implants manufactured by a Johnson and Johnson subsidiary that required some patients to undergo revision surgeries because of the allegedly defective design of the product.

The panel, which is preparing to submit its report to the health ministry, wants the company to pay as much as Rs20 lakh in compensation to each of the 22 patients, Mint reported on Monday.

“This (amendment)...will help affected consumers get their due," said a second official, also on the condition of anonymity.

India needs a law that offers automatic compensation to patients for harm done by any defect in a product or because a manufacturer compromised on quality and safety, said consumer activist Bejon Misra, founder of Patient Safety and Access Initiative of India.

“India needs to be aligned with the global best practices. Even the prime minister has said that consumer protection is his top priority. If the patient has to undergo harassment for the device or drug which was supposed to give him remedy, then naturally a process is needed to be adopted for giving compensation to the consumer so that they are protected from any kind of failure, like it’s done overseas," Misra said.

“The moment any product is found to be defective or substandard, it has to be withdrawn from the market promptly. Any damage caused has to be compensated to the consumer and the government should file a compensation claim," he added.

The proposed compensation regime, senior officials say, promises greater transparency and better checks for patient safety.

Implementation of the proposed new amendment will not be easy, said Narayanan Suresh, chief operating officer of the Association of Biotechnology Led Enterprise (ABLE). “It will be difficult to determine whether the product or device was the only cause of fatality. Industry would like clear guidelines on determining the adverse effects," Suresh said.

According to Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry (AiMed), the proposal is complex as far as medical devices are concerned. “In medical devices, unlike drugs, it is a more complex issue and the responsibility can be for either or jointly between the medical user of device (skills/training), manufacturer, consumer and the regulator," Nath said. “It’s understandable for regulations to consider (fixing) accountability and responsibility but intent should be preventing an adverse incident and not witch hunting," he added.

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