Medical device regulation set for overhaul

Autonomous body on lines of FSSAI in the works

The regulation of medical devices in the country is set for an overhaul. The government plans to bring all medical devices under the jurisdiction of the Central Drugs Standard Control Organisation (CDSCO) with an aim to improve their quality as well as safety.

Sources said this would require a complete revamp of the CDSCO, with a new vertical to monitor devices and conduct fresh recruitment. Besides, plans are afoot to have a separate statutory body on the lines of the Food Safety and Standards Authority of India (FSSAI) for the regulation of medical devices. In that case, devices will be out of the purview of the Drugs Controller General of India (DCGI).

A senior government official said the DCGI had requested the health ministry to sanction the creation of 700 permanent posts for the separate vertical. “A separate vertical needs to be carved out if this is to be implemented. Drug inspectors of the state Food and Drug Administrations (FDAS) cannot be deployed to inspect medical devices. This needs a separate set of expertise and we need engineers and scientists who will be equipped to do the same,” the official said.

Another source said the proposal to have 700 new posts for the medical devices wing of the CDSCO received in-principle approval of the Drug Technical Advisory Board (DTAB), the country ’s apex drug advisory body, around June. This, however, will need Cabinet approval.

Earlier this month, the Ministry of Health and Family Welfare issued a draft notification where it said it planned to define all medical devices (including software, equipment, accessories and contraceptives) in accordance with the Drugs and Cosmetics Act and the apex drug controller, effective December 1.

This would also include medical devices which were earlier not under the purview of the DCGI. The government has sought comments from stakeholders before the draft notification is finalised. Once finalised, the import, manufacture and sale of all medical devices will be certified by the CDSCO.

Industry sources claimed that plans were afoot to create a separate statutory body for the regulation of medical devices on the lines of the FSSAI, an autonomous body under the health ministry.

“Food is different from drugs. And thus the FSSAI was created to monitor it. Similarly, the NITI Aayog is of the opinion that a separate body is to be created for medical devices too,” said an industry source, who did not wish to be named. He added that already a draft Medical Devices Bill had been formulated and it would be sent to all stakeholders within a quarter. Industry, he said, was in favour of having a separate statutory body as devices were different from drugs.

The creation of a new body will take time, and the Medical

Devices Act also needs to be notified. This may take at least two to three years before the infrastructure and the ecosystem is in place.

As long as it takes shape, the industry can continue to be regulated by the CDSCO, albeit through a separate wing.

The government move to overhaul the way medical devices are regulated follows concerns it received from various stakeholders for regulating non-notified medical devices around safety, quality and performance. In February, the government had put medical devices like CT scan equipment, MRI equipment, dialysis machines, X-ray machines, etc, under the purview of the Drugs and Cosmetics Act.