On February 08, 2019, the Central Government announced1 that all Implantable Medical Devices along with CT scan Equipment, MRI Equipment, Defibrillators, Dialysis Machine, PET Equipment, X-Ray Machine, and Bone Marrow Cell Separator are defined as drug under the Drugs and Cosmetics Act, 1940 (the 'Act'). This inclusion will be effective from 1st April 2020. Once effective, the national regulatory body Central Drug Control Standard Organization (CDSCO) will become the approving authority for sale, manufacture and import licenses of these medical devices.
The Central Government in pursuance of sub-clause (iv) of clause (b) of section 3 of the Act and after consultation with the Drugs Technical Advisory Board (DTAB) has categorized these medical devices as drugs.
[Section 3 Definition.—In this Act, unless there is anything repugnant in the subject or context, ........(b) ―drug includes....(iv) such devices* intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board;]
Medical device regulation in India
Medical device sector is still emerging in India and is dominated by imports. According to a report Medical Device Sector Survey: Make In India, the Medical Devices industry in India is presently valued at USD 5.2 billion and contributes 4-5% to the USD 96.7 billion Indian health care industry. Currently, India is counted among the top 20 global medical devices market and is the 4th largest medical devices market in Asia after Japan, China and South Korea.
At present majority of medical devices are unregulated, only notified medical devices are regulated as Drugs under the Act and Rules made thereunder. There are 27 categories of devices which were notified as drugs till 2018 including blood pressure monitoring devices, digital thermometers and glucometers that were last notified in December 2018. With this announcement government has brought all implantable devices and some diagnostic equipment into the regulatory framework which is an important step from patient safety perspective. Moreover, the government has also notified the Medical Device Rules, 2017. The Rules provide risk-based classification of medical devices for the medical devices industry.
The impact of this notification
- The notified Medical Devices come under regulatory framework. It will ensure that medical devices and implants used in India are safe and tested.
- These notified Medical Devices may also come under the purview of Drug Price Control Order (DPCO), 2013 as it qualify the definition of drug required for price regulation.
A large segment of devices still fall under unregulated category; the government needs to regulate medical devices as a product group on the basis of safety and performance rather than regulating device by device. Moreover, forming a separate medical device policy is recommended which could regulate the medical devices sector in the country.
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