Medical device regulations in India are facing some positive changes. Recently CDSCO issued adraft billfor medical devices, which recognizes medical devices as separate departments, so the government has decided to create 219 jobs for seniors post to regulate medical devices. The new upcoming Drugs, medical device and cosmetics bill 2022 is replacing the previous Drugs &cosmetics Act 1940.
The ministry of health and family welfare sent a proposal for the creation of 449 posts on a regular basis and the ministry of finance has cleared the proposal, however, the top officials of health ministry said that the ministry of finance agreed to create 219 posts.
To regulate medical devices in India, the drug and medical device regulators, the CDSCO has the perspective of quality and patient safety first. As per given the proposal, the finance ministry has cleared the creation of posts from the 192 proposed positions 85 posts are for drug inspector,77 jobs have been cleared by drug inspector against 192 proposed posts,43 posts will be created for the assistant drug controller against 48 positions,13 jobs for deputy drugs controller (9), joint drug controller (4) & additional drugs controller (1) against the requested 17 posts.
Medical device manufacturers noted that the appointment of ‘Drug inspector’ instead of ‘experienced medical device inspectors will create confusion, though they are positive towards governments’ move for recognizing the industry.
Rajiv Nath, forum coordinator at the Association of Indian Medical Device Industry (AIMED)said, ‘while we welcome the move to add 85 personnel to regulate medical devices in CDSCO. However, we regret to note that instead of the appointment of technically competent auditors as medical devices regulatory officers, the government proposed to appoint assistant drug inspectors.”
According to him this will create discrepancy and it can be a problem of manufacturers as they being viewed with the eye of drugs rather than as engineering product which need assured quality for assured patients’ safety.
Medical device regulation in India getting updated for the betterment of the industry,It’s always a tough job to keep an eye on changing regulations and understand the guidance for manufacturers, importers or exporters, to keep you updated with this we as amedical device regulatory consultantbriefing all regulatory related news in our newsletter. To read more regulatory news kindly subscribe ourNewsletter.!
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