Govt to broaden qualification criteria to recruit medical device inspectors

In order to broaden the scope for the recruitment of medical device inspectors and government analysts, the Union Health Ministry is planning to amend the Medical Device Rules, 2017, by introducing qualification criteria for the posts.

 

The ministry has issued a draft notification proposing an amendment to add qualifications for inspectors and government analysts under Rule 18 of the Medical Device Rules (MDR), 2017.

 

As part of the amendment, a person who has a bachelor’s degree in engineering or technology in areas such as biomedical, chemical, mechanical, electrical, instrumentation, or biotechnology from a recognised university or institute would be eligible for the posts of inspector and analyst in the medical devices vertical.

 

Similarly, candidates with a bachelor’s degree in pharmacy, pharmaceutical sciences, microbiology, biochemistry, or life sciences would also be eligible for the posts.

 

This comes after similar qualifications were added to the recruitment rules for medical device officers in the Central Drugs Standard Control Organisation (CDSCO) in 2024, as part of efforts to strengthen regulatory activities for medical devices in the country.

 

“The said draft rules shall be taken into consideration on or after the expiry of a period of thirty days from the date on which copies of the draft rules are made available to the public,” the notification dated October 10 said.

 

It added that the draft rules have been published after consultation with the Drugs Technical Advisory Board (DTAB) and would be open to objections and suggestions by stakeholders within the specified period.

 

Welcoming the draft notification, Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry (AIMED), said that it is inclusive of the diversity of qualifications.

 

However, some industry executives raised concerns, saying that it would be important to ensure this diversity is reflected in recruitment, with no faction dominating over another.

 

An executive said the concern arises from the fact that the CDSCO recruited 23 people with engineering backgrounds as drug inspectors, as against over 200 pharmacy-background regulators employed as medical device officers.

 

“The system already has excessively pharmacist-educated regulators. Considering the huge diversity of material sciences and technologies deployed to make medical devices, it is important to have a balanced background of regulators with qualifications from engineering and science disciplines of various types,” Nath added.