The Centre in a notification on Friday said that medical devices — all implantable devices, CT Scan, PET and MRI equipment, defibrillators, dialysis machines and bone marrow separators — will be treated as drugs for human beings with effect from April 1, 2020.
The decision was taken in consultation with the Drugs Technical Advisory Board.
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“Majority of medical devices are completely unregulated in India. With this move, all implantable devices and some diagnostic equipment will be brought into the regulatory framework which is important from a patient safety perspective. We welcome this step. However we are disappointed about the delay with which the notification takes effect,” said Malini Aisola of All India Drug Action Network.
She added that it also sends mixed messages because the Government is deliberating a roadmap for brining new and separate regulatory framework for devices.
Meanwhile after the first stakeholders meeting of The Central Drugs Standard Control Organisation(CDSCO) here on Friday on roadmap for regulation of medical devices with stakeholders of the industry Pavan Choudary,chairman,Medical Technology Assocition of India said: ““Since substantial expertise and experience lie with CDSCO in regulating this sector, the medical device sector feels that it would be best that the authorship of the agenda and the road map stays with them. This would also prevent any duplication.”
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He added: “As this is a technology and capital intensive sector, growth in indigenous manufacturing is a function of maturity of technological ecosystem, ability to attract capital particularly from legacy investors, market attractiveness & ease of doing business. We, therefore think, that to judge the quality of regulations by the yardstick of how much import substitution these have delivered is unfair. A time bound regulatory roadmap was discussed,” said