New Delhi: In a bid to ensure quality, all imported as well as locally manufactured medical devices sold in India will have to be certified by the Central Drugs Standard Control Organization (CDSCO) before they enter the market.

Government’s think tank Niti Aayog has prepared a roadmap on medical devices, suggesting that all medical devices clear specific safety and quality standards.

A meeting was held on 25 July between Niti Aayog, Department of Pharmaceuticals (DoP), Ministry of Commerce, Bureau of Indian Standard (BIS), CDSCO, Department of Industrial Policy and Promotion (DIPP) and it was decided to implement the roadmap without any further delay, two people aware of the matter said.

“An inter-ministerial consultation was held and everybody agreed on the roadmap prepared to regulate the medical devices. The ministry of health and family welfare is likely to come out with the draft notification soon to this effect," said the first person quoted above, requesting anonymity.

Once notified, import, manufacture and sale of all medical devices will need to be certified by the Central Drugs Standard Control Organisation (CDSCO). Manufacturers will also have to seek licences from the Drug Controller General of India (DCGI) before their product enters the Indian market.

As of now, only 23 devices are regulated. “There is no system of assuring the quality of non notified devices. Indigenous manufacturers of non-notified devices are not able to participate in public tenders, which affects the growth of industry," said the second person.

The government has suggested regulating the medical devices in a phased wise manner. Earlier the health ministry committee had formed a committee, which recommended that all manufacturers should register details on a special portal to be developed for this purpose. “Such registration shall initially be voluntary basis upto 18 months from the date of notification and thereafter it shall be made mandatory,"suggests the roadmap on medical devices. Mint has reviewed copy of the presentation.

The manufacturers and importers will also have to report serious adverse events to CDSCO so that these reports could be analysed to assess the safety and performace of the devices and appropriate regulatory interventions can be taken to ensure patients safety.

Medical devices are already classified on the basis of the risks they pose. Low-risk devices are classified as ‘Class A’; devices with low to moderate risk are classified as ‘Class B’; devices with moderate risk are classified as ‘Class C’; and devices having high risk are in ‘Class D’ category.

According to public health experts, the medical device industry is ridden with loopholes; regulation thus is extremely important. “The regulation will help ensure safe and tested medical devices reach the end user," the first person cited above said.

As per the roadmap after receiving such incident, the CDSCO shall investigate quality, safety related failure, complaints and suspend or cancel the registration based on the findings.

Earlier this year in February, the government put implantable medical devices, CT scan equipment, MRI equipment, defibrillators, dialysis machine, PET equipment, X-Ray machines and bone marrow cell separator under purview of The Drugs and Cosmetics Act, 1940. The matter of regulating medical implants was first discussed on 16 May 2018. It has now been decided that these devices will be regulated with effect from April 2020.

In India, most implantable medical devices are unregulated.

Both import and export of medical devices grew at more than 10% between 2011-12 and 2014-15, according to a report by the department of pharmaceuticals under the ministry of chemicals and fertilizers. The medical devices industry has grown from $2.02 billion in 2009 to $3.9 billion in 2015, at a compounded annual growth rate (CAGR) of 15.8%.

Close