Earlier this month, the Drugs Technical Advisory Board took up a long pending issue — the proposal for a roadmap to regulate medical devices and to outline the human resources required to support it.

For a segment so integral to healthcare, medical devices have remained largely on the fringes of the regulatory attention that pharma gets, for instance. Presently 23 (of 5,000) devices are regulated under the Drugs and Cosmetics Act and another 12 are to come under it by 2020. These include equipment such as MRIs and CT scans. The DTAB has further recommended the inclusion of surgical gowns, drapes and incision drapes as drugs.

“DTAB deliberated the matter and agreed to notify all medical devices as drug under the Section 3(b)(iv) of the Drugs and Cosmetics Act, 1940 and also to provide exemptions in the Rule 90 of the Medical Device Rules, 2017 during the transition period. The Board further agreed that CDSCO (Central Drugs Standard Control Organisation) should be strengthened with respect to manpower and infrastructure to regulate all medical devices,” according to minutes of the DTAB meeting.

A roadmap is critical to deal with all aspects of a medical device’s lifecycle, including recalls and the action taken thereafter. And the present discussion comes even as the United States Food and Drug Administration orders surgical mesh products (indicated for the transvaginal repair of pelvic organ prolapse) off market shelves following safety concerns. “Boston Scientific and Coloplast have not demonstrated a reasonable assurance of safety and effectiveness for these devices”, the FDA said. And as litigation mounts, foreign media reports that seven medical device makers were paying about $8 billion to settle claims of about 10,000 women. Closer home, India deals with the aftermath and compensation issues from the global recall of Johnson and Johnson’s hip-implants.

Different from drugs

The DTAB’s recommendation for a policy roadmap falters in failing to see medical devices as different from drugs. Both involve patients and so safety is critical and non-negotiable. But medical devices are different, for instance, in the manner in which they are developed, deployed in a patient by a doctor, or marketed.

The different approaches become clear in the manner inventory is maintained. A drugmaker needs to keep a certain number of medicine stocks at a hospital. But a medical device maker, of a stent, for example, will have to keep multiple dimensions of a stent for use in a single patient, as it would have to be fitted according to the precise requirements of that patient. Industry veterans further explain that medical devices involve engineering, unlike medicines that have to do with chemical analysis and synthesis.

The refusal of sorts to officially acknowledge the uniqueness of this industry has ruffled representatives who have been campaigning for a dedicated dispensation for medical devices.

Rajiv Nath, with the Association for Indian Medical Device Industry (AiMED). asks, “If food can have the FSSAI (Food Safety and Standards Authority of India) run by a Chairperson and CEO under the Health Ministry, why can’t we have a similar structure for medical devices?” The Medical Technology Association of India (MtaI) also calls for a separate law for medical devices. “Medical devices are generically different from drugs and cannot be treated as drugs in the long run. The government should expedite the deliberations on institutionalising an exclusive legal framework for medical devices so that areas of quality, adverse events, compensation, prices, healthcare training and health technology assessment are comprehensively addressed,” says Pavan Choudary, MtaI Chairman.

Roadmap recommendations

The DTAB recommendations outline registrations and licences, classification of products depending on their risk, mapping of adverse events and recalls and strengthening of the CDSCO.

Choudary calls for an exhaustive analysis of the un-notified part of the device universe. “Some of these products could be critical and life-saving, but sold in tiny quantities. CDSCO could look at revising downwards the registration fees so the market stays attractive to these small but vital operators. Also, a game plan should be ready to make up for their likely departure for reasons of viability.”

Promises to keep

Many promises have been made to the medical devices sector to bolster local manufacturing that could bring down prices for patients, without altering quality. But the promise of med-tech parks, procurement and preferential pricing policies and the National Medical Devices Promotion Council have little to write home about. As the Health Ministry prepares to act on the DTAB’s recommendations, medical device makers will be watching if the final roadmap will change course on the core aspect of recognising devices as different from drugs.