Centre sets the ball rolling on a patient registry for medical devices

In an initiative that would benefit patients in the long run, the Centre has begun discussions for a registry on medical devices to help trace products and follow- up on its outcomes in patients.

Internal discussions have started and a committee has been set up to get industry and stakeholder feedback on how to proceed, a Health Ministry source told BusinessLine .

Experts, however, caution that in the absence of a dedicated regulatory framework that views medical devices as different from drugs, the registry effort could end up putting the cart before the horse.

Product(s) recall

The absence of a patient registry is felt when medical products are recalled but patients remain in the dark as the responsibility to follow up with them falls between the regulatory cracks.

Companies claim they cannot contact patients directly and hospitals do not keep the records for too long. And this existing loop-hole came into sharp focus during the exercise to contact all patients who had undergone surgery using hip implants that were recalled by Johnson and Johnson’s DePuy Orthopaedics in 2010 for being faulty.

Regulatory teeth

For a patient registry to be effective “it has to have regulatory teeth” and a key part of the problem is the absence of a regulatory framework within which medical device companies should operate in India, says Dr Bhuvaneshwar, who had worked on the initial draft to regulate medical devices in the early 2000s.

The government did bring in the Medical Device Rules, effective January 2018, but these cover only a revised 27 product categories in a market that, according to industry estimates, has more than 5,000.

A registry has many parts, including manufacturer or importer details on when it was produced, materials used, etc; details on the sale through hospitals, etc for traceability in patients, followed by post-marketing surveillance to track “adverse events” that may be seen in a patient as a result of the product.

Data handling

There needs to be a key driver behind the registry, expertise to handle the data coming in and laws to protect all of these and outline who owns the data and how much of it can be publicly accessible, he points out.

Handling the data requires people with domain knowledge and multi-level validation to be able to red-flag an event if something is amiss, says Bhuvaneshwar.

Pointing to patient registries abroad, experts suggest that similar systems be studied and modified to meet Indian requirements.

But Rajiv Nath, who is with the Association for Indian Medical Device Industry, points out that with medical devices still under the Drugs and Cosmetics Act, 1940, the task of understanding and regulating these products only gets that much more difficult.

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