Regulatory checks on medical devices essential, says govt.

Minister of state for health and family welfare, India, Dinesh Trivedi said on Friday that an extensive amendment to the current drug law is under progress to bring the regulation of all medical devices directly under health ministry.

Business Standard quoted the minister as saying, “We will give the states a deadline to respond and take the bill forward.”

Regulating quality of medical devices
With the implementation of the amendment, all medical device manufacturers and importers will be required to register with Drugs Controller General of India (DCGI), the nation’s drug regulatory authority.

But the stringency in such requirements will vary according to the nature of the devices, stated Trivedi. For instance, high-risk implantable devices like stents will be directly regulated and licensed by DCGI.

On the contrary, low-end and inexpensive devices like thermometers and X-Rays could be self-regulated by the industry.

The minister stated that the Central Drug Authority Bill had been sent to states for observation and will be approved shortly.

Only 14 medical devices are presently being classified as drugs and are being regulated under the existing drug laws.

Medical device, diagnostics and equipment industry
According to the minister, the current size of the domestic medical device, diagnostics and equipment industry is mere six percent of $35-billion healthcare sector ($2.1 billion or Rs 9,450 crore).

With the intention of ascertaining patients’ safety, government will be controlling the $2.1 billion medical devices industry.

It will also digitize medical records of all Indian citizens after the implementation of the proposed national unique ID project, added Trivedi. These records will be used for immediate reference for diagnosis in future.

Orissadiary quoted Trivedi as saying, “The increasing population with greater awareness and transforming disease profile of the country has resulted in an increased demand for healthcare services.”

“Medical devices provide the means for complex diagnosis and life support systems. In view of their extensive use, it is necessary to have a proper regulatory control over medical devices so that the patients are provided with safe, affordable and effective tools of healthcare,” added Trivedi.

The minister presented the proposal details while addressing a national workshop on medical devices organised by Federation of Indian Chambers of Commerce and Industry and Central Drugs Standard Control Organisation.