Medical Devices now to be regulated under Drugs and Cosmetics Act
On February 11, 2020, Ministry of Health and Family Welfare announced that medical devices are to be brought under Drugs and Cosmetics act (DCA). This is to come into effect from April 1, 2020
According to the regulation, every product that is used to treat a patient will now be under the ambit of DCA. It includes MRI, CT scan, thermometer, dialysis machines, etc. A list of 37 devices has been included. This includes medical devices used on animals as well.
Drugs and Cosmetics Act
The DCA regulates manufacture, distribution and import of drugs in India. It was passed in 1940. The act was prepared based on the recommendations of Chopra Committee that was constituted in 1930.
The term Drug in the act includes substances and diagnostic devices as well. The act provides guidelines for sale, display, prescription and storage of drugs. The act has so far been amended in 7 times.