The Ministry of Health and Family Welfare (MoHFW) through notification dated 18th October, 2019 has issued Draft Notification to notify that the specified devices intended for use in human beings or animals qualify as “DRUGS “under section 3(b) of the Drugs and Cosmetics Act, 1940(Sec 3b-Defines Drugs) with effect from December 01, 2019. The devices will thereby comes to be regulated by the Act and the Medical Devices Rules, 2017. At present, only 23 medical devices are regulated under the Drugs and Cosmetics (D&C) Act.
Following are the Medical Devices which are to be 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 –
(i) Diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
(ii) Diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
(iii) Investigation, replacement or modification or support of the anatomy or of a physiological process;
(iv) Supporting or sustaining life;
(v) Disinfection of medical devices; and
(vi) Control of conception.
The Stakeholders/Public have been given 30 days time to respond to the draft notification by email at drugsdiv-mohfw@gov.in or by post
Click here to read the notification
