Medical Devices Still Has Some Regulatory Stumbling Blocks

Against the backdrop of recalled products and patient compensation issues, a slew of meetings are underway between government and industry representatives to hammer out a roadmap for the medical device industry.

Even as one such meeting is scheduled for Tuesday at the NITI Aayog, an industry consensus seems elusive just yet, even on key regulatory issues.

For long now, the industry has called for a separate dispensation for medical products, as compared to drugs. But when it comes to execution, not everyone seems to want a clean break from the present system.

Calling for medical devices to “emerge” from the shadow of drugs, is Rajiv Nath with the Association of Indian Medical Device Industry (AiMeD). “Medical devices should walk alongside big brother (pharma), but separately,” he says, adding that the industry would remain under the Health Ministry. The new framework would balance being industry-friendly with being patient-oriented as well. There are provisions to make products track and traceable, besides rules that outline “risk-proportionate controls and penalties”, he explained.

‘Make in India’ move

Referring to recent consultations, he said, the direction was to support “Make in India” and help local producers export. Over the last two-odd months there have been many developments involving medical devices, he said, including a one-year extension on four products that were to be notified from January 2020. Currently, only 23 medical products are regulated as “drugs” under the Drugs and Cosmetics Act (D&C, 1940).

While some local medical device-makers are keen on a fresh start in terms of a separate regulatory authority alongside the CDSCO (Central Drugs Standard Control Organisation), a different set of officials to handle approvals etc, there are voices who want to stay within this framework and not have to make fresh inroads.

A seasoned industry-hand who did not want to be identified told BusinessLine that the framework articulated by the NITI Aayog in recent discussions seemed depart from international regulatory practices for medical devices.

India already has the Medical Device Rules (2017), it just needed to be fine-tuned, the representative said. There was no need to have an authority separate from the present system operational under the D&C Act, he said.

The system of approvals being proposed is circuitous and involves too many departments, the industry-hand said, and the process could take years to just get an approval to sell a product in the country. This would not just inhibit foreign companies but hurt local manufacturers too, he added.

Penalties & compensation

Another point of dissonance involved penalties and compensation for faulty devices. Like drugs, devices too have a risk-benefit profile and no amount of prior testing can ensure completely safety, the representative said, urging that penalties and punishment be left to the Courts. Including it in the law will make it difficult for innovators and new-comers in the industry, the representative said.

Speaking for multinational companies, AdvaMed Vice-President Abby Pratt urged the government to look at the WHO model regulatory framework for medical devices and diagnostics that recommended a phased-in approach utilising global standards. “A singular focus on testing to vertical standards runs the risk of creating roadblocks for local innovative medical device companies by duplicating regulatory requirements as they look to expand their business globally,” she said.

But having lived with a faulty hip-replacement for over 10 years, Vijay Vojhala reserved comment. Patients would wait for the government to make its proposal public before giving their views, he said.-The Hindu Businessline