Come April 1, all medical devices sold in the country would be treated as drugs and would be regulated under the Drugs and Cosmetics Act of 1940, the ministry of health and family welfare said in a notification on Tuesday.
At present, only 23 medical devices have been classified as drugs. Of these, only a few including cardiac stents, drug eluting cardiac stents, condoms, intrauterine devices, have been brought under price control.
To be regulated under the Drugs and Cosmetics Act, says a notification by govt.
The health ministry said the decision was taken after consultation with the Drugs Technical Advisory Board (DTAB), the apex decision making body on technical matters related to drugs.
According to the industry there is no formal assurance that the health ministry would work with the NITI Aayog on the draft Medical Devices Bill. “Medical devices cannot be treated as drugs. It needs a separate regulatory framework. This can only be a temporary set up,” a senior member of a medical devices lobby group said.
Around December, the NITI Aayog had proposed to bring all medical devices under one regulatory regime in a phased manner and have a separate Medical Devices Administration (MDA) with four divisions.
The new regime aims to bring in ease of doing business, as the NITI Aayog has proposed to do away with the need to have manufacturing licences to register medical devices or to get a certificate of compliance. Moreover, the government also mooted to have a national register of medical devices, which will be a database of all devices with unique identification, manufacturers, importers, distributors, as well as foreign manufacturers.
Industry experts expect the proposed Medical Devices Bill to be notified within the next six months.
The MDA would be a parallel vertical to the Central Drugs Standard Control Organisation (CDSCO) and would be under the Directorate General of Health Services, the NITI Aayog had proposed. The CDSCO, it is learnt, has already requested the health ministry to sanction the creation of 700 permanent posts for the separate vertical.
There can also be a separate statutory body on the lines of the Food Safety and Standards Authority of India for the regulation of medical devices, government sources had indicated. – Business Standard