The Ministry of Health and Family Welfare (“MoHFW”) has issued the Draft “Drugs, Medical Devices and Cosmetics Bill, 2022” (“ DMDC Bill”) which specifically regulates medical devices apart from Drugs and Cosmetics. While issuing the draft DMDC Bill, the MoHFW noted that the “Drugs and Cosmetics Act, 1940 is a pre-independence legislation enacted by the Central Legislative Assembly. Review of obsolete laws and updating of the existing laws is a continuing process to accommodate changed requirements and adaptation of new technology.” The MoHFW has initiated a public consultation process seeking suggestions regarding the DMDC Bill till 21st August 2022.
Currently, medical devices in India are regulated as under the broad category of ‘Drugs’ under the Medical Devices Rules, 2017 (“MDR”), which in turn comes within the Drugs & Cosmetics Act, 1940 (“DCA”). However, the DMDC Bill appears to have brought medical devices outside the purview of drugs to be regulated and recognised as a separate category altogether.
- Definition of a Medical Device: The definition of a medical device has been adopted verbatim from the erstwhile Medical Device Rules 2017 and the notification dated 11th February 2020 which expanded the definition of medical devices.
- Medical Devices Technical Advisory Board: An expert body has been proposed to advise the Central and State Government on technical matters pertaining to medical devices. The Board will be headed by DG Health Services, MoHFW with representatives from various ministries and experts from relevant sectors.
- Central and State Medical Devices Testing Centre: For testing and evaluation of medical devices and carrying out other assigned functions testing centres have been proposed.
- Appointment of a Medical Device Officer: A designated Medical Device Officer has been proposed who will be authorised to inspect any premises where medical devices are stored, offered for sale, etc. and has powers relating to search and seizure.
- Regulation of Medical Devices: The medical devices shall have risk- based classification for conformity assessment and regulation in such manner as may be prescribed. An importer/ manufacturer has to submit the adverse event reports and periodic safety update reports in respect of its medical devices.
- Prohibition of import or manufacture and sale of medical devices: The following conditions have been proposed for prohibition of import/manufacture/sale of medical devices -
- non-conformity with prescribed standards of quality, safety and performance
- misbranded, adulterated or spurious
- does not display such details as may be prescribed in respect of accompanying software, part, component or instrument;
- false statement, design or accessory accompanying it or by any other means, purports or claims to cure any disease or ailment,
- unlicensed import or manufacture for sale, stock, distribution of medical devices
- Misbranded medical device: As per the DMDC Bill a medical device will be deemed to be misbranded if -
- it is configured so as to conceal any damage/ or made to appear of greater functional value or made to appear of lesser risk than it really is; or
- it is not labelled or packed in the prescribed manner; or
- it bears label, container, statement, design or device which makes any false claim; or
- it contains colours not expressly permitted in the license or permission issued by the authorities
- Adulterated medical device: As per the DMDC Bill a medical device will be deemed to be adulterated if -
- consists of rusted or corroded or filthy or putrid or decomposed substance; or
- is prepared, packed or stored under insanitary conditions whereby it may have been rendered injurious to health; or
- contains any harmful or toxic substance or component or software or parts thereof which may render it dangerous to use or injurious to health; or
- is having any substance/component/software or part thereof mixed/added/substituted/removed there from so as to reduce its quality or performance or safety which may render it dangerous to use or injurious to health; or
- is having a pack or container composed of any deleterious substance which may render it dangerous to use or injurious to health
- Spurious medical device: As per the DMDC Bill a medical device will be deemed to be ‘spurious’ if it -
- is having the label/pack/container bearing the name of a fictitious/incorrect individual or firm or company purporting to be the manufacturer of the device or
- purports to be the product of a manufacturer who is actually not the manufacturer of the product.
- Initiation of Prosecution: As per the proposed regulations prosecution for violations can be initiated only on complaints by -
- Medical Devices officer
- Authorised gazetted officer of the Central/State Government
- Aggrieved Person
- Recognised consumer association
The MoHFW has taken a welcome step in recognising and regulating medical devices separately rather than considering it as ‘Drug’ under the DCA in order to regulate it. However, it remains to be seen if the comprehensive and sweeping risk-based classification of medical devices for conformity assessment and regulation as per the current notifications issued by the Drugs Controller General (India) under the MDR will continue to apply mutatis mutandis to the DMDC Bill. Additionally, in the interest of transparency the MoHFW should also consider mandating the Medical Devices Technical Advisory Boards to compulsorily engage in a public consultation while issuing any order/guideline/notification under the DMDC Bill.
Draft of the New Drugs, Cosmetics and Medical Devices Bill, 2022: https://main.mohfw.gov.in/sites/default/files/Drugs%2C%20Medical%20Devices%20and%20Cosmetics%20Bill.pdf
Notification dated 11th February 2020: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTU0OA==
Drugs and Cosmetics Act, 1940: https://legislative.gov.in/sites/default/files/A1940-23.pdf