Govt. rolls out Draft Medical Device Policy 2022; aims to put comprehensive measures in place to ensure sustained growth and development of the sector

The Ministry of Chemicals and Fertilizers has issued an approach paper on Draft Medical Device Policy 2022 for stakeholder consultation. The paper is aimed at addressing the core objectives of accessibility, affordability, safety and quality, self-sustainability, innovation and growth in the medical devices sector.

The policy proposes the following interventions:

1. Single Window Clearance System’ for Licensing of Medical Devices
2. Quality Compliance and Standardization:
3. Price Control and Uniform Code for Marketing

Background:

The medical devices sector in India is an essential and integral constituent of the Indian healthcare sector, particularly for the prevention, diagnosis, treatment and management of all medical conditions, diseases, illnesses, and disabilities. It forms an important pillar in the healthcare delivery system along with healthcare providers, pharmaceuticals and health insurance industry, thereby helping achieve the key values enshrined in the National Health Policy (NHP) 2017 in terms of provision of good quality, affordable, and comprehensive healthcare to all citizens. 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.

In order to attract investments in this sector, the Government has allowed 100% foreign direct investments (FDI) in medical devices sector. Recently, the Indian medical devices sector’s contribution has become even more prominent as India supported the global battle against COVID-19 pandemic through the production of medical devices & diagnostic kits, e.g., Ventilators, RT-PCR kits, IR Thermometers, PPE Kits & N-95 masks.

The current policy aims to facilitate an orderly growth of the medical device sector to meet the underlying objectives of accessibility, affordability, safety and quality, while ensuring focus on self-sustainability and innovation. Through this policy, the Department of Pharmaceuticals is driven to help the sector realize its full potential by creating a robust regulatory framework with feedback mechanisms, building an enabling ecosystem for medical device manufacturing within the country, focusing on innovation for high end technology, providing support in training and capacity building programs and promoting higher education to foster fresh talent and skilled resources in line with the industry requirements. Encouraging domestic production of medical devices is in consonance with the Government’s ‘Atmanirbhar Bharat Abhiyan’ and ‘Make in India’ campaign.

Policy Framework:

The Medical Devices sector will be placed on an accelerated growth path to increase access and affordability of products and services of excellent quality to meet the evolving health care needs of patients, by building an innovative and globally competitive industry in India, supported by best of class infrastructure, enabling ecosystem, streamlined regulatory framework and quality manpower. This would enable India to emerge as the global leader in the manufacturing of medical device products, duly ensuring accessibility to patent-centric, innovative and affordable healthcare products for better healthcare outcomes.

It is envisaged that by 2047:

• India will be one amongst Top 5 Global manufacturing hubs in terms of value and technology for Medical Devices
• India will be home to 25 MedTech $Bn companies and home & originator to 25 high-end futuristic technologies in MedTech
• India will emerge as Champion in critical components, cancer diagnostics, medical imaging, ultrasonic scans, molecular imaging, & PCR technologies
• India will achieve 10-12% of Global Market Share of Medical Devices Sector to arrive at a $100-300 Bn industry
• India will have about 50 Medical Devices Clusters across India for faster clinical testing of Medical Devices to boost product development and innovation

For a detailed read of the Draft Policy, please refer to the link provided below.

Source: Ministry of Chemicals and Fertilizers