Centre working on roadmap for medical device regulation

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To better regulate the medical device industry and ensure patient “safety” and “well-being”, the Centre has developed a roadmap for the medical device industry.

According to the health ministry, currently, several medical devices used in healthcare facilities for diagnosis, treatment, and mitigation are out of the scope of regulation under the Drugs and Cosmetics Act, 1940. “Concerns have been raised from time to time in different fora regarding safety, quality and performance of non-notified medical devices,” said an official from the ministry.

On February 8, the health ministry notified eight categories of medical devices such as all implantable devices, MRI equipment, CT scan equipment, dialysis machine, PET equipment, and X-ray machines, among others, taking the total of notified medical devices to 36.

The official said on February 4, the health ministry set up a committee to work out a roadmap for regulation of all medical devices. The terms of reference of this committee included working out on a roadmap for notification of all medical devices under the Drugs and Cosmetics Act, 1940, and developing a medical devices vertical in Central Drug Standards Control Organisation (CDSCO).

Key features of this roadmap include an expanded definition of medical devices to encompass “an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination including a software or an accessory...”.

As per the roadmap, the government will issue a notification to include all medical devices by their technical definition, make provisions for exemptions to obtain import/manufacturing license, and initiate registration of all non-regulated medical devices.

Based on their risk category, the devices would fall under voluntary registration for a certain period of time, after which it would be mandatory to obtain a license. A separate vertical for medical devices within the drug regulator's office is also being worked on to include 754 posts of regulatory, laboratory and medical specialists. “Officials in various disciplines of medical devices have been proposed for recruitment and are under active consideration as per procedures,” the official said.

Besides, the government is also working on drafting guidelines for recall of medical devices.

Patient rights groups have demanded that they should also be made a part of the consultations for regulations on medical devices, especially on the safety aspect of medical devices. They have contended that in the wake of cases such as that of the Johnson and Johnson's faulty ASR metal-on-metal hip implants, and global withdrawals of pacemakers, bioresorbable stents, pevlic mesh and breast implants, there is a need for having a strong regulatory framework, and not over-relying on foreign regulatory authorities before granting licenses in India.

“We are dismayed at the decision of the CDSCO’s Drug Technical Advisory Board to further relax the provisions in the Medical Devices Rules, 2017, for granting approvals to imported devices based on marketing approvals by foreign regulatory bodies and extend the waiving of clinical investigations for products approved in the EU through CE certification, in addition to regulatory approvals in US, UK, Australia, Canada or Japan,” the Hip Implant Patients Support Group (HIPS) and All India Drug Action Network (AIDAN) said in a statement. CE approval for medical devices, particularly high-risk devices and implants, is a "deeply flawed system" and must not be used as the basis for allowing inadequately tested devices into the Indian market, they said, citing failed devices such as Abbott’s bioresorbable scaffold ABSORB and Johnson & Johnson’s ASR hip implants. These were approved in India through CE approvals.

The International Consortium of Investigative Journalists (ICIJ) has extensively highlighted the flawed system for CE marking approvals of high-risk devices, including weak clinical data requirements in its recent investigation, they said.

Patient rights groups have also stated that key reforms in the medical device industry should include statutory provisions to check unethical business practices in marketing and promotion of these devices, developing standard treatment protocols and medical audits for common procedures, involving medical devices, consistent post-marketing monitoring of devices' performance, and revamping rules pertaining to reporting and collection of adverse events, among others.