The central government on Tuesday notified all medical devices as ‘drugs’, effective from April 1, bringing a range of products from instruments to implants to even software intended for medical use in human beings or animals under the purview of the Drugs and Cosmetics Act, 1940.
Apart from expanding the scope of regulation to ensure safety and efficacy, the move may pave the way for regulation of prices under the Drugs Price Control Order (DPCO). It will also make companies, in case of violations, liable to be penalised in a court of law. At present, only 37 medical devices are notified as drugs.
Companies will now have to seek approval from the drug controller to manufacture, import and sell any medical device in the country.
Besides, they will also have to follow other norms and regulations applicable under the law.
Though welcoming the move, consumer groups remained sceptical about the ability of the Central Drugs Standard Control Organisation 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,” said Malini Aisola of All India Drug Action Network.





Source link