Department of Pharmaceuticals releases Approach paper on ‘Draft National Medical Devices Policy 2022’ for consultation

What is the News?

The Department of Pharmaceuticals has released “Draft National Policy for the Medical Devices, 2022”.

What is the Medical Devices Sector?

The medical device is a multi-product sector, with the following broad classifications: (a) Electronics Equipment; (b) Implants; (c) Consumables and Disposables; (d) IVD reagents; and (e) Surgical Instruments. 

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

The Indian medical device market has a significant presence of multinational companies with about 80% of the sales by value generated from imported medical devices.

This Sector is expected to grow in market size from the present $11 Bn to $50 Bn by 2025.

Moreover, to encourage the domestic manufacturing of Medical Devices, Government has launched PLI scheme for promoting domestic manufacturing of Medical Devices, Promotion of Medical Devices Parks.

What is the Draft National Policy for the Medical Devices, 2022?

Released by: Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers.

Aim: To address core objectives of accessibility, affordability, safety and quality, focus on self-sustainability, innovation and growth in the Medical devices sector.

Objectives: The policy envisions that by 2047, India

– Will be having few National Institutes of Medical Devices Education and Research (NIMERs) on the lines of NIPERs;

– Will be home & originator to 25 high-end futuristic technologies in MedTech

– Will have a MedTech Industry of $100-300 Bn size with 10-12% of Global Market Share.

Features of the Policy

– Regulatory streamlining in order to optimise regulatory processes and multiplicity of agencies for enhanced ease of doing business.

– Quality Standards and Safety of the Devices in order to provide safe devices to the consumers.

– Building Competitiveness through fiscal and financial support.

– Infrastructure Development to provide a best-in-class physical foundation, including medical devices parks.

– Facilitating R&D and Innovation with a focus on enhanced collaboration in innovation and R&D projects.

– Awareness Creation and Brand Positioning in creating awareness and positioning India as a hub for manufacturing of medical devices as part of the “Make in India, Make for the World” initiative.

Read more: Drug Regulations in India – Explained, pointwise

Source: This post is based on the article Department of Pharmaceuticals releases Approach paper on ‘Draft National Medical Devices Policy 2022’ for consultationpublished in PIB on 14th Mar 2022.

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