All medical devices to be classified as DRUGS, details
New Delhi: Through a recent gazette notification, the Union Health Ministry has notified medical equipment used on humans or animals as "drugs" with effect from April 1, 2020. This mandates all medical devices to clear specific safety and quality standards before they are introduced in the India market.
At present, only 23 medical devices are regulated under the law. However, with the new notification, all medical devices used on humans or animals have been notified as "drugs" under Section 3 of the Drugs and Cosmetics Act
"In pursuance of sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, specified all medical devices intended for use in human beings or animals as drugs," the notification read.
This includes an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including software or an accessory, intended by its manufacturer to be used especially 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.
Once notified, the manufacture, import and sale of all medical devices will need to be certified by the Central Drugs Standard Control Organisation (CDSCO).
Commenting on the notification, Malini Aisola, CO-convenor, All India Drugs Action Network (AIDAN) said, "While this is positive, Consumer groups remain skeptical about how the CDSCO's current ability to regulate devices under the wider scope. We are particularly wary of the CDSCOs competence, expertise and most importantly its commitment towards patient safety given its dismal track record."
"We urgently need comprehensive reforms to strengthen the regulatory mechanism in relation to patients' safety. These may include guidelines for the approval of devices including clinical investigation requirements, oversight of marketing and promotion, putting in place a robust and functioning system of adverse event reporting accessible to the public, rules for voluntary and statutory recalls, and patient compensation scheme," she added.
Further, the Ministry also released another Gazette that states that for eighteen months from April 1, device manufacturers and importers can voluntarily register with the country's apex drug regulator the Central Drugs Standard Control Organisation.
The medical devices referred shall be registered with the central licensing authority via an online portal established by the CDSCO for the purpose.
The manufacturer of a medical device or any person who imports any medical device will have to upload the information related to that medical device for registration on the "Online System for Medical Devices" established by the CDSCO for this purpose.
Upon the expiry of these time periods, all provisions of the Medical Devices Rules 2017 will apply to the respective devices.
"In exercise of the powers conferred by section 12 and section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, amends the Medical Devices Rules, 2017" in order to insert Chapter IIIA into the medical devices rules. It specifies the timelines for bringing more devices under regulation.
Broadly, in respect of the devices not currently notified it provides 30 months for low and moderate-risk devices (Classes A and B), 40 months for moderately high and high-risk devices (Classes C and D).
Commenting on the same, Malini said," Registration requirements for all devices is positive. Timeline for subjecting devices that will be duly notified as of April 1, ranges from 2.5 years to 3.5 years!!! So India has a long wait before all its higher-risk devices are regulated."
For more details click on the links below: