All medical devices sold in India to be CDSCO certified: What is Means

Once this notification comes into effect, the manufacture and sale of all medical devices would have to be certified by the Central Drugs Standard Control Organisation (CDSCO) for safety.

New Delhi: The highest statutory decision making body on technical issues related drugs and medical devices in India, Drugs Technical Advisory Board (DTAB) has agreed to notify all medical devices as Drugs 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.

Once this notification comes into effect, the manufacture and sale of all medical devices would have to be certified by the Central Drugs Standard Control Organisation (CDSCO) for safety.

A decision to this effect was taken by the DTAB, headed by Director General of Health Services, S Venkatesh in the 82^nd DTAB meeting held earlier this month.

With this, the board has recommended the Ministry of Health and Family Welfare to make necessary amendments that would be introduced in a phased manner, when implemented by the Central Drugs Standard Control Organisation (CDSCO).

In the first phase, all manufacturers and importers of all non-regulated Medical Devices should register the details of the devices manufactured/imported by them in a special SUGAM portal to be developed for this purpose and a notification should be issued under the Act in this regard.

In the second phase, registration of Class A & B devices shall be followed by mandatory licensing within 12 months after 18 months of registration period is over.

In the third phase, registration of Class C & D devices shall be followed by mandatory licensing within 24 months after 18 months of registration period is over. After the 24 months period, no person, company and organization should be allowed to manufacture, import, sell or distribute Class C & Class D Medical Devices without prior license under the Medical Devices Rules, 2017.

The Board also recommended that manpower and infrastructure in all States should also be strengthened and an advisory may be issued to all the States in this regard.

Referring to these recommendations, the DTAB has now said, " 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 Rule 90 of the Medical Device Rules, 2017 during the transition period. The Board further agreed that CDSCO should be strengthened with respect to manpower and infrastructure to regulate all medical devices. The Board further recommended to include dentists and ophthalmologists in the category of experts to be recruited."

Presently, there are 5,000-6,000 medical devices in the Indian market, out of which only 23 notified medical devices are under government control.

"Representations have been received from various stakeholders for regulating all non-notified medical devices since concerns have been raised from time to time regarding safety, quality and performance of various medical devices, including diagnostic kits manufactured or imported in the country. Many of the medical devices like equipment analysers, instruments etc used in various healthcare facilities for diagnosis treatment, mitigation are currently out of t scope of regulation under the Drugs and Cosmetics Act," the DTAB noted.

However, the decision has not appealed many and has sparked controversy. Raising concern over the recommendation, Harpreet Singh, associated with The Surgical Manufacturers And Traders Association and All India Surgical Dealers Association told Medical Dialogues," there was a Notification no 4754 dated 03/12/2018 declaring Blood pressure monitoring devices, digital thermometer, Nebulizer, glucometer as devices under section 3b(iv) of DRUG & COSMETICS ACT 1940 for which we have filed our objections. Now the drug department has proposed to include each and every medical device as drugs in the latest 82nd meeting of the DTAB on 02-04-2019 without much thought or before bringing in a medical device act to regulate these devices."

"This is unwarranted act as it would lead to serious implications in the supply chain for these products especially when even much more critical equipment is still not notified and the department is in the process for calling any objections/suggestions of stakeholders and from the general public," Singh added.

Medical Dialogues had earlier reported that the Government had notified eight medical equipment, including all implantable devices including CT scan, MRI equipment, defibrillators, dialysis machine, PET equipment, X-ray machine and bone marrow cell separator as "drugs" under Section 3 of the Drugs and Cosmetics Act, effective from April 1, 2020.