With the inclusion of four new devices, there will be 27 medical devices under the definition of drugs under the Drugs and Cosmetics Act, 1940.
Medical devices such as blood pressure monitors, nebulizers, digital thermometers and glucometers may cost less as the government has decided to bring them under the purview of the Drugs and Cosmetics Act, in a move to ensure performance and enable price and control checks. Once the proposal gets the green signal, all the companies engaged in manufacture and import of these devices will need to get approval or license from the Drug Controller General of India (DGCA) from January 2020 onwards.
The Minister of Healthcare and Family Welfare has notified that “…specified devices intended for use in humans for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, to be included in the definition of drug under the Drugs and Cosmetics Act, 1940; effective from January 1,”.
India’s highest drug advisory body – The Drug Technical Advisory Body (DTAB) – had cleared the proposal to include blood pressure monitoring devices, nebulizers, digital thermometers and glucometers under the purview of the Drug law. Therefore, all such devices will have to be registered under the quality parameters prescribed under Medical Devices Rules, 2017 and other standards set by the Bureau of Indian Standard (BIS) certification.
As of now, just 23 medical devices are monitored for quality by DGCA. With the inclusion of four new devices, there will be 27 medical devices under the definition of drugs under the Act. Other medical equipment are currently sold without any clinical trials or quality checks.
The ministry has also proposed to expand the list of devices in eight new categories, including MRI equipment, CT scan equipment, defibrillators, dialysis machines, PET equipment, X-ray machines and bone marrow cell separator, under the purview of the drug law. The proposal is being deliberated.