All imported and locally-made medical devices will have to meet certain standards of quality and efficacy to enter the Indian market. The government has begun framing the rules and a draft notification to this effect is likely to be put out soon, people aware of the matter told ET.
Currently, only 23 categories of medical devices are regulated in India under the Drugs and Cosmetics (D&C) Act. The change to bring all medical devices under regulation will be implemented in a phased manner.
According to the persons cited earlier, certification of devices by the Central Drugs Standard Control Organisation (CDSCO), regulatory authority in this case, will be on voluntary basis up to 18 months from date of notification, and thereafter it will be made mandatory.
Once the rules get notified, all import, manufacture and sale of medical devices will need to be certified by the CDSCO. “The new rules will be incorporated in the existing Act,” said a senior official, requesting not to be named.
“We cannot be lax about standardisation and quality of medical devices. There is a consensus now among all departments and we will soon put up a draft notification. All medical devices will have to be registered with the regulatory authority before they enter the market,” the official said.
The decision is part of a move to increase safety of end users of such devices. Last year, problems due to hip implants manufactured by a subsidiary of Johnson & Johnson (J&J) required some patients to undergo revision surgery.
The rules for regulation are being worked out as per a roadmap that the health ministry has chalked out in consultation with the department of pharmaceuticals, government think tank Niti Aayog, the department of biotechnology, the Indian Council of Medical Research, the Bureau of Indian standards and industry experts and associations. The roadmap mandates every manufacturer and importer of medical devices to report serious adverse events to the drug regulatory authority and the materio-vigilance programme.
The document on roadmap of medical devices, a copy of which is with ET, says that “reports can be analysed to assess the safety and performance of the devices and appropriate regulatory interventions can be taken to ensure patients’ safety”.
The CDSCO will be the nodal authority to investigate quality, safety-related issues and complaints and can suspend the registration based on the outcome of its investigation. At present there is no mechanism for reporting malfunctioning of non-notified medical devices.
Also, the government does not have an exact figure for how many non-notified medical devices are available in the country. There have also been complaints of refurbished imported equipment making their way into the country. “They are being imported and sold in the country. The new rules will take care of all such problems pertaining to medical devices,” said another official.
