The Ministry of Health and Family Welfare in its notification dated 11th February 2020 has notified certain medical equipment used on humans or animals as “drugs” under Section 3 of the Drugs and Cosmetics Act, which shall be in effect from April 1, 2020.
Currently, only 23 medical devices are regulated under the Drugs and Cosmetics Act. The move to regulate medical devices under the Drugs and Cosmetics Act has its genesis in the recommendation from the Drugs Technical Advisory Board (DTAB) that came in April 2019. Though notified as drugs, devices will be regulated under the Medical Devices (Amendment) Rules, 2020. The new rules specify the timelines for bringing the said devices under regulation.
Therefore through this notification the following equipment’s are now termed as drugs:
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.
Click here to read the Notification.