The government is considering amending the medical devices rules to make it easier for regulators to stop the manufacture and sale or distribution, and order destruction, of medical devices found to be unsafe, defective, substandard or spurious, according to an official document ET has seen.
Current rules allow licensing authorities to suspend or cancel a licence if a licensee contravenes provisions of the Drugs and Cosmetics Act, 1940 or the Medical Devices Rules, 2017. But there are no provisions to take more stringent actions like those now proposed.
The proposal to amend Rule 30(1) of the Medical Devices Rules, 2017 has been placed before the drugs consultative committee comprising experts for deliberation and recommendation. It seeks to explicitly empower state licensing authorities and the Central Drugs Standard Control Organisation to direct a licensee to stop the production and sale or distribution of the concerned medical device. State and central authorities may also be empowered to direct destruction of the devices and stocks wherever considered necessary and following the manner specified by the regulator, a person in the know said.
For patients, the proposed changes could have a direct bearing on safety, said another person aware of the matter. “Medical devices, ranging from implants and surgical instruments to diagnostic equipment and consumables, are routinely used in critical healthcare settings, where defective or substandard products can pose significant risks. An explicit mechanism to stop their manufacture, sale or distribution would allow regulators to act more decisively when such devices are identified.”
According to the proposal, there may be cases where medical devices are found to be in contravention of the statutory requirements and where their continued manufacture, sale or distribution may be prejudicial to “public health”.
“In such cases, effective enforcement requires not only regulatory action against the licence (holder) but also an explicit provision enabling the licensing authority to direct cessation of manufacture, sale or distribution of the concerned medical device(s),” the document says.
The proposal notes that medical devices found to be unsafe, defective, substandard, spurious or otherwise unsuitable for continued use or distribution may need to be destroyed to prevent their continued circulation. “Regulatory supervision of the process would also ensure proper oversight and documentation of disposal,” it said.
The proposed provision for supervised destruction of affected stocks could further reduce the possibility of unsafe products remaining in circulation, the second person cited earlier said. “It would also provide a clear enforcement pathway for regulators to ensure that devices found unsuitable are removed from use in a timely manner”.
According to the proposal, the absence of an explicit provision for these enforcement measures under the existing Rule 30(1) may lead to ambiguity in the exercise of regulatory powers and difficulties in taking uniform action against devices that need to be removed from manufacture, sale or distribution.
