With the new drugs and medical devices bill recognising medical devices as the separate domain, the government has decided to create 219 jobs for senior officials and inspectors to regulate the sector, News18 has learnt.
Until now, regulations for medical devices and drugs were kept under one umbrella — the Drugs & Cosmetics Act, 1940. But, the new upcoming Drugs, Medical Devices & Cosmetics Bill, 2022, which replaces the previous act, recognises medical devices as a separate entity.
“The proposal sent by the ministry of health and family welfare for the creation of 449 posts on a regular basis for the medical devices has been cleared by the ministry of finance. However, the ministry has agreed to create 219 posts,” a top official at the health ministry told News18.
“The medical devices vertical will bring all the central devices under regulation from the perspective of quality and patient safety which will be handled by the drug and medical devices regulator, the Central Drugs Standard Control Organisation (CDSCO),” the official further said.
Who will come on board?
The finance ministry has cleared the creation of 85 posts of assistant drug inspector (for medical devices) against 192 proposed positions whereas 77 jobs have been cleared by drug inspectors (for medical devices) against 192 proposed posts.
Nearly 43 posts will be created for the assistant drugs controller against the proposed 48 positions whereas 13 jobs will be created for the deputy drugs controller (9), joint drugs controller (4) and additional drugs controller (1) against the requested 17 posts.
No posts for technically competent officers: Industry
While the medical device manufacturers “welcome” government’s move to recognise the industry, it noted that the appointment of “drug inspectors” instead of experienced medical device inspectors will again create confusion.
“While we welcome the move to add 85 personnel to regulate medical devices in CDSCO. However, we regret to note that instead of appointment of technically competent auditors as medical devices regulatory officers, the government proposed to appoint assistant drug inspectors,” Rajiv Nath, forum coordinator at the Association of Indian Medical Device Industry (AIMED).
“This is a major discrepancy which will continue to add to the problem of manufacturers being viewed with the eye of drugs rather than as engineering products that need assured quality for assured patients’ safety,” Nath added.
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