New Delhi: In a significant move to provide safety to patients and regulate the quality of diagnostic and medical devices in India, the health ministry has notified eight medical equipment, including all implantable devices, as “drugs” under Section 3 of the Drugs and Cosmetics Act, effective from April 1, 2020.
Through a Gazette notice, the Central Government, after consultation with the Drugs Technical Advisory Board, specified the following devices intended for use in human beings as drugs with effect from the 1st day of April 2020, namely:—
- All implantable medical devices;
- CT scan Equipment;
- MRI Equipment;
- Dialysis Machine;
- PET Equipment;
- X-Ray Machine; and
- Bone marrow cell separator.
All implantable medical devices, CT scan, MRI equipment, defibrillators, dialysis machine, PET equipment, X-ray machine and bone marrow cell separator will be regulated as “drugs”.
A notification issued on Friday by the health ministry read,
“In pursuant of sub-clause (IV) of clause (b) of section 3 of the Drugs and Cosmetics Act of 1940, the central government after consultation with the drugs technical advisory board hereby specifies the following devices intended for use in human beings as drugs with effect from the first day of April 2020 namely — all implantable medical devices, CT scan equipment, MRI equipment, defibrillators, dialysis machine, PET equipment, X-ray machine and bone marrow cell separator,”
A majority of medical devices are unregulated in India. This move is important for patient’s safety as with this notification, all implantable and diagnostic devices will come under the regulatory framework.
“Majority of medical devices are completely unregulated in India. With this move, all implantable devices and some diagnostic equipment will be brought into the regulatory framework which is important from a patient safety perspective. We welcome this step. However, we are disappointed about the delay with which the notification takes effect,” Malini Aisola of All India Drug Action Network told The Hindu.
Meanwhile after the first stakeholders meeting of The Central Drugs Standard Control Organisation(CDSCO) here on Friday on roadmap for regulation of medical devices with stakeholders of the industry Pavan Choudary,chairman,Medical Technology Association of India told the daily,“Since substantial expertise and experience lie with CDSCO in regulating this sector, the medical device sector feels that it would be best that the authorship of the agenda and the road map stays with them. This would also prevent any duplication.”
He further added, “As this is a technology and capital intensive sector, growth in indigenous manufacturing is a function of maturity other f technological ecosystem, ability to attract capital particularly from legacy investors, market attractiveness & ease of doing business. We, therefore think, that to judge the quality of regulations by the yardstick of how much import substitution these have delivered is unfair. A time-bound regulatory roadmap was discussed.”