Last Updated on January 2, 2024 by The Health Master
Separate Legislation and Department for Medical Devices
The Parliamentary Panel, entrusted with overseeing matters pertaining to the Ministry of Health and Family Welfare, has underscored its vital recommendations to the Central Government.
These recommendations emphasize the necessity to establish distinct legislation, create a new department within the Ministry, and establish a separate regulatory framework for the burgeoning medical devices sector.
Background and Industry Demand:
The healthcare industry, especially the medical devices sector, has been fervently advocating for this shift.
This demand has gained momentum, particularly in recent times, coinciding with the imminent introduction of the New Drugs, Medical Devices, and Cosmetics Bill, 2023, during the ongoing session of Parliament.
Committee’s Insights:
The Department Related Parliamentary Standing Committee on Health and Family Welfare released its 146th report on August 4, 2023, presenting its insightful recommendations.
The Committee discerns a distinct difference between medical devices and pharmaceuticals, warranting tailored regulations for each.
To bolster the medical device industry, encourage domestic production, and reduce import dependency, the Committee recommends the establishment of a dedicated Department for Medical Devices and separate legislation catering exclusively to this sector.
Committee’s Key Points:
The report emphasizes the following key aspects:
Separate Legislation and Department:
The Committee strongly advises against merging regulations for Drugs, Medical Devices, and Cosmetics.
Instead, they propose formulating independent legislation solely for Medical Devices.
Additionally, they advocate creating a Department of Medical Devices within the Ministry of Health and Family Welfare.
Technical Advisory Board:
The Government’s proposal to institute a distinct Medical Devices Technical Advisory Board is warmly welcomed.
This board will offer specialized technical guidance related to medical devices.
Regulatory Infrastructure:
The Committee stresses the urgency of establishing a separate regulatory structure for the medical device industry.
Rather than integrating with the Central Drugs Standards Control Organisation (CDSCO), this infrastructure should possess its own dedicated workforce to effectively cater to the industry’s needs.
Quality Control and Standards:
To align with global benchmarks, the Committee insists on stringent quality control and certification processes.
Special attention should be paid to Class C and D medical device products.
Must read: Classifications of Medical Devices under the provisions of MDR 2017
Ministry’s Response and Progress:
The Ministry responded by pointing out that the proposed “Drugs, Medical Devices & Cosmetics Bill, 2022” integrates regulations for drugs, cosmetics, and medical devices.
However, the Bill does dedicate a separate chapter to medical devices, encompassing aspects such as import, manufacturing, sale, distribution, and clinical investigations.
The Ministry highlights ongoing efforts to strengthen the Central Drugs Standards Control Organisation (CDSCO) by bolstering manpower and infrastructure.
Recruitment from diverse engineering fields has been undertaken to better regulate the medical device sector.
The CDSCO currently employs:
- 23 Drug Inspectors (Medical Devices),
- 236 Medical Device Officers (MDO),
- 3 ADCs (Medical Devices).
Moreover, an additional 219 positions have been created to enhance CDSCO’s capacity in medical device regulations.
Committee’s Firm Stand:
After considering the Ministry’s response, the Committee reiterates its call for a separate regulatory framework, an exclusive department, and dedicated regulatory infrastructure for the medical devices sector.
The Committee’s recommendations, outlined in its 138th report, prioritize the industry’s growth and quality assurance.
Conclusion:
In conclusion, the Parliamentary Panel’s recommendations highlight the pressing need to establish a separate legislative framework, a dedicated department, and a distinct regulatory infrastructure for the medical device industry.
These measures are essential to foster domestic growth, ensure quality control, and minimize reliance on imports.
The Committee’s insights reflect a concerted effort to propel the medical device sector towards international standards of excellence.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model, to rewrite and present the news / article in a unique format.
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