STATUTORY REGULATIONS SURROUNDING SALE AND MANUFACTURE OF PERSONAL PROTECTIVE EQUIPMENT AND MASKS AS A MEDICAL DEVICE UNDER THE DRUGS AND COSMETICS ACT 1940 – Eshwars
Call Us +91 44 42048335

STATUTORY REGULATIONS SURROUNDING SALE AND MANUFACTURE OF PERSONAL PROTECTIVE EQUIPMENT AND MASKS AS A MEDICAL DEVICE UNDER THE DRUGS AND COSMETICS ACT 1940

The definition of “Drugs” under Section 3(b)(iv) of the Drugs and Cosmetics Act 1940 (“DCA”) also includes medical 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 the notification of Official Gazette. The definition of medical devices given under Medical Devices Rules 2017 (“MDR”), which is consistent with the definition of drugs under DCA, also includes such devices notified by Central Government from time to time as “Drugs”. Further, the Ministry of Health and Family (“MOHFW”) based on the recommendation of the Drugs Technical Advisory Board, which recommended proposal to notify surgical gowns, surgical drapes and incision drapes as “drugs” under the provisions of Section 3(b)(iv) of DCA issued a notification under the provisions of Section 3 (b) (iv) of the DCA, on 11th February 2020, stating that-

“All  devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of: 

    • diagnosis, prevention, monitoring, treatment, or alleviation of any disease or disorder;
    • diagnosis, monitoring, treatment, alleviation, or assistance for, any injury or disability;
    • investigation, replacement or modification or support of the anatomy or of a physiological process.
    • supporting or sustaining life;
    • disinfection of medical devices; and
    • control of conception

     will be construed as “drugs” within the meaning of the provisions of the DCA.”

    This notification has been made effective from 1st April 2020. This notification would imply that, effective from 1st April, 2020 each medical device need not be specifically notified by Central Government pursuant to the definition of “drugs” under the DCA in order to be regulated under DCA and MDR. The implication of this notification is that all medical devices with the intended function as listed above will fall under the purview of DCA and MDR.

    Simultaneous to this notification which regulated all medical devices under DCA, the Central Government introduced Medical Devices Amendment Rules 2020. This Amendment requires the manufacturers and importers to register all medical devices (except the medical devices already notified and regulated) on the Online System for Medical Devices, the online portal established by Central Drugs Standard Control Organisation (CDSCO). This registration is voluntary for a period of eighteen months from the date of commencement of the amendment i.e. till 30th September 2021, after which the registration becomes mandatory.

    Further, the Drugs Controller General of India, CDSCO, Directorate General of Health Services under the MOHFW has issued an advisory notice dated 22nd May 2020 advising the manufacturers of Personal Protection Equipment (PPE) Coveralls to voluntarily consider getting themselves registered with the CDSCO, as a benchmark for their quality management system. This note also states that the PPE is an important medical device for healthcare professionals and in handling of COVID-19 patients.

    On a conjoint reading of the above definition of “drugs” under the DCA, the definition of “medical devices” under the MDR, the notification dated issued by the MOHFW and the advisory note issued by the CDSCO, the inclusive nature of the notification and the broad terminology employed therein stating that a “device” includes any “instrument, apparatus, appliance, implant, material or other article” used “for the prevention of a disease”, gives sufficient grounds to interpret that any article or material such as a  PPE or N95 masks will also be construed to be a “medical device” under the MDR and thus fall within the purview of the provisions of the DCA and the MDR. The amendments to DCA and MDR to construe medical devices as drugs and its regulation has come into effect amidst the spread of the pandemic COVID -19 in India, the subsequent increase in the demand of PPEs and the increase in the number of domestic manufacturers of medical devices especially PPEs. The government has filled the gap in the regulatory framework with respect to the regulation of all medical devices, begetting the manufacture and sale of quality medical devices and effective healthcare.

Leave a comment

Your email address will not be published. Required fields are marked *

Eshwars | House Of Corporate & IPR Laws,
Chennai | Delhi | Bengaluru | Mumbai | New Jersey

Board: +91 - 44 - 42048335
+91 - 44 - 42048235