Govt releases draft on National Medical Devices Policy

New Delhi: The Department of Pharmaceuticals under the Chemicals and Fertilizers ministry has released an Approach Paper for the Draft National Policy for the Medical Devices, 2022, inviting feedback and remarks of the Industry and stakeholders.

Realising the need to have a holistic policy to accelerate growth and explore the potential of the Medical Devices Sector, the Department of Pharmaceuticals has published this approach paper after extensive stakeholder consultations for the Sunrise Sector of Medical Devices, popularly called as MedTech Sector. The sector is expected to grow in market size from the present $11 bn to $50 bn by 2025, said the department in a statement.

The medical devices sector in India is an essential and integral constituent of the Indian healthcare sector for the prevention, diagnosis, treatment and management of all medical conditions, diseases, illnesses, and disabilities.

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The Medical Device Sector has remained largely unregulated till 2017 when Medical Device Rules, 2017 were framed by CDSCO for comprehensive regulation of MDs in a phased manner, especially on the quality, safety, and efficacy aspects, under the Drugs and Cosmetic Act, 1940.

The Department through various programmatic and schematic interventions intends to encourage the domestic manufacturing of Medical Devices. The proposed policy strives to put in place a comprehensive set of measures for ensuring sustained growth and development of the sector and addressing the further challenges of the sector such as regulatory streamlining, skilling of human resources and lack of technology for high end equipment and lack of appropriate infrastructure, through a coherent policy framework.

The Draft National Policy aims to facilitate an orderly growth of the sector for the coming years. While addressing the core objectives of accessibility, affordability, safety and quality, the policy focuses on self-sustainability and innovation.

This policy envisions that India will have few National Institutes of Medical Devices Education and Research (NIMERs) on the lines of NIPERs by 2047. India will be home to 25 high-end futuristic technologies in MedTech, the policy intends.

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