Industry

Inter-Ministry Coordination For Medical Device Industry: A Critical Examination

The committee's 146th report highlights the necessity of the Ministry of Health and Family Welfare (MoHFW) taking charge of this crucial aspect.

The Health Master

August 15, 2023

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Last Updated on December 31, 2023 by The Health Master

Inter-Ministry Coordination

In a recent development, the Department Related Parliamentary Standing Committee on Health and Family Welfare has reaffirmed its stance on inter-ministry coordination for the promotion of the medical device industry.

The committee’s 146th report highlights the necessity of the Ministry of Health and Family Welfare (MoHFW) taking charge of this crucial aspect.

This recommendation was made in response to the concerns raised in the committee’s earlier 138th report regarding the promotion, regulation, and control of medical devices.

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138th Report: A Concerning Discrepancy

In the committee’s 138th report, a concern was raised regarding the promotion of the highly technical medical device industry.

It was observed that instead of being overseen by the Ministry of Health and Family Welfare, which has a natural synergy due to its core responsibilities, the promotion of the industry was being handled by the Ministry of Chemicals & Fertilizers.

This discrepancy was deemed detrimental to the industry’s growth and effective regulation.

Bp Apparatus, Medical Devices — Picture: Pixabay

Need for Inter-Ministry Coordination

The committee’s recommendation stems from the recognition that the MoHFW holds a pivotal role as the key stakeholder in the medical devices sector.

Given the diverse range of medical devices in terms of technology and material sciences, effective inter-ministry coordination becomes imperative.

This coordination should be facilitated by the ministry that possesses the necessary expertise and understanding of the industry’s nuances, the Ministry of Health and Family Welfare.

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Ministry’s Response and Strengthening of CDSCO

In response to the committee’s concerns, the Ministry of Health and Family Welfare informed the panel about the steps taken to strengthen the Central Drug Standard Control Organization (CDSCO).

The regulatory body now has a dedicated vertical on Medical Devices, with a team of 23 Drugs Inspectors (Medical Devices), 236 Medical Device Officers (MDO), and 03 Assistant Drugs Controllers (Medical Devices) working to ensure regulatory compliance.

Furthermore, the government has recently created 219 additional posts at various levels within CDSCO to enhance its capacity for effectively regulating medical devices.

This move indicates a commitment to addressing the growing demands and complexities of the sector.

Role of Department of Pharmaceuticals (DoP)

The Department of Pharmaceuticals (DoP), which operates under the Ministry of Chemicals and Fertilisers, also provided its perspective.

The DoP suggested that while there might not be a need for the creation of a separate department for medical devices, the existing medical device division could be bolstered with increased manpower.

This approach aims to cater to the sector’s evolving needs.

The DoP emphasized its ongoing efforts in the medical devices sector over the past seven years, demonstrating its dedication to supporting the growth and advancement of the industry.

Latest Developments in the 146th Report

In its most recent 146th report, the committee reiterated its stance on the matter.

It acknowledged and appreciated the steps taken by the government to strengthen CDSCO, recognizing the efforts made in enhancing regulatory mechanisms.

However, the committee firmly asserted that the Ministry of Health and Family Welfare, as the primary stakeholder, should take the lead in coordinating the promotion of the medical device industry.

Recommendations for Legislative Enhancements

The committee’s report also emphasizes the need for legislative improvements.

It suggests incorporating suitable provisions in the new Drugs, Medical Devices, and Cosmetics Bill to address the shortcomings identified in the existing Medical Devices Rules (MDR), 2017.

His forward-looking approach aims to ensure that the regulatory framework keeps pace with the evolving dynamics of the medical device sector.

Response to Specific Recommendations

Regarding the committee’s earlier recommendation for the establishment of bone banks to facilitate the availability of bones for grafting, the Ministry responded by suggesting that appropriate institutions or entities could consider this after consultations with stakeholders.

It was noted that such activities are not typically regulated, indicating a collaborative approach to addressing the recommendation.

Furthermore, in response to the committee’s suggestion to make biocompatibility studies mandatory to prevent subpar products from entering the market, the Ministry pointed out that such studies are already mandatory for implantable devices under the existing MDR, 2017.

This highlights the government’s commitment to ensuring the safety and quality of medical devices reaching consumers.

Conclusion

In conclusion, the Department Related Parliamentary Standing Committee on Health and Family Welfare has reaffirmed the importance of inter-ministry coordination for the promotion of the medical device industry.

The committee’s reports have consistently highlighted the need for the Ministry of Health and Family Welfare to lead this coordination effort due to its inherent stake in the sector.

With the strengthening of CDSCO and ongoing efforts to address legislative shortcomings, the government’s commitment to the growth and regulation of the medical device industry is evident.

FAQs (Frequently Asked Questions)

1. Why is inter-ministry coordination important for the medical devices industry?
Inter-ministry coordination ensures that the industry’s promotion and regulation align with the sector’s technical and material complexities, ultimately fostering its growth.

2. What steps has the Ministry of Health and Family Welfare taken to strengthen CDSCO?
The Ministry has established a dedicated vertical on Medical Devices within CDSCO and created additional positions to enhance regulatory capacity.

3. What is the role of the Department of Pharmaceuticals in the medical device sector?
The DoP, under the Ministry of Chemicals and Fertilizers, suggests bolstering the existing medical device division with increased manpower to cater to sector needs.

4. How is the government addressing legislative gaps in medical device regulation?
The committee recommends incorporating provisions in the new Drugs, Medical Devices, and Cosmetics Bill to overcome shortcomings in the current regulatory framework.

5. Are biocompatibility studies mandatory for medical devices entering the market?
For implantable devices, biocompatibility studies are already mandatory under the existing Medical Devices Rules (MDR), 2017, showcasing the government’s commitment to quality and safety.

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