Last Updated on October 10, 2024 by The Health Master
Medical Device Officers
Medical Device Officers: In a recent development, the Department-related Parliamentary Standing Committee on Chemicals and Fertilisers has raised concerns about the prolonged recruitment process for manpower in regulating the medical devices sector.
The committee has specifically urged the Department of Pharmaceuticals (DoP) to ensure that the recruitment process adheres to the prescribed timeline without any further delay.
Current State of Medical Device Officers (MDO)
The committee’s report highlighted that in 2022, the Department informed about the notification of 236 Medical Device Officers (MDO) within the Central Drugs Standard Control Organisation (CDSCO).
Additionally, states have also notified MDOs in accordance with the Medical Device Rules, 2017.
However, the committee expressed apprehension about the pending recruitment process for the 236 notified posts and an additional 219 newly created positions.
Implications on Regulation and Licensing
The committee emphasized that the prolonged delay in recruiting for these crucial positions could have severe implications on the regulation and issuance of licenses to manufacturers.
It stressed the need for expediting the recruitment process and ensuring that specialized medical device officers are appointed within the stipulated timeline.
Committee’s Recommendations
The committee, led by Lok Sabha member Dr Shashi Tharoor, recommended that the DoP should press upon the Ministry of Health and Family Welfare (MoHF&W)/CDSCO to expedite the recruitment and appointment process.
Furthermore, they called for regular updates to keep the committee informed of the progress.
Training Initiatives for Medical Device Industry
Recognizing the challenges faced by the medical device industry, the committee proposed an increase in training programs, workshops, and interactive sessions.
They suggested that these programs should target both state licensing authorities and representatives from the medical devices industry, focusing on the effective implementation of the Medical Device Rules, 2017.
Licensing Regime and Application Approval
With the implementation of a licensing regime for all medical devices, the health ministry has been inundated with license applications from the industry.
The committee acknowledged that out of 3,413 manufacturing license applications, 2,262 were approved. Notably, pending applications will still be permitted to sell their products for the next six months without penalties.
National Institute for Medical Device Education and Research (NIMERs)
The committee lauded the government’s initiative to establish the National Institute for Medical Device Education and Research (NIMERs) along the lines of National Institutes of Pharmaceutical Education & Research (NIPERs).
They expressed trust that these initiatives would be implemented effectively, ensuring no resource crunch.
Addressing the Skill Gap
A major concern highlighted by the committee is the lack of skilled manpower in the medical device industry.
It noted the initiation of M Tech (Medical Devices) courses at NIPERs, along with the DoP’s announcement of a new Scheme on ‘Human Resource Development in Medical Devices Sector’ with an outlay of Rs. 480 crore for a three-year period.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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