Initiatives by Government of India and Development of the Indian Medical Devices Sector by EEPC

The Indian medical devices sector has been receiving significant attention and support from the Government of India (GoI), with several initiatives aimed at boosting the growth and development of this industry. This includes initiatives to improve the manufacturing ecosystem, promote innovation, and enhance the overall competitiveness of the sector in the global market. The Engineering Export Promotion Council (EEPC), a key body that supports the export of engineering products, including medical devices, plays a crucial role in facilitating these initiatives.

Key Initiatives by the Government of India:

1. National Medical Devices Policy 2023:

The Government of India announced the National Medical Devices Policy 2023 to strengthen the medical devices sector, aimed at making India a global hub for medical device manufacturing. Some key highlights include:

• Focus on Manufacturing and Innovation: The policy emphasizes increasing domestic manufacturing of medical devices and reducing dependence on imports.
• Promotion of Research and Development (R&D): It supports the development of new technologies and encourages collaboration between academia, industry, and research institutions.
• Regulatory Reforms: The policy introduces measures to streamline regulations and approval processes for medical devices, ensuring faster time-to-market.
• Incentives for Investment: The policy aims to attract investments through various incentives, including fiscal and non-fiscal support for the establishment of medical device parks, R&D funding, and more.
• Export Promotion: The policy aims to position India as a competitive exporter of medical devices globally, enhancing the country’s share in global exports.

2. Production-Linked Incentive (PLI) Scheme for Medical Devices:

The Government of India launched the PLI Scheme for Medical Devices in 2020 to incentivize the manufacturing of medical devices domestically and reduce reliance on imports. The key objectives of the scheme are:

• Increasing Domestic Manufacturing Capacity: The scheme provides financial incentives to domestic manufacturers of medical devices, which can help scale up production capabilities.
• Attracting Global Investment: By offering attractive incentives, India hopes to bring in international manufacturers to set up production units in the country, boosting the overall manufacturing ecosystem.
• Promoting Innovation: The scheme aims to encourage innovation and R&D in the medical device sector by providing financial support to companies that develop new technologies and products.
• Import Substitution: It aims to reduce the import of medical devices by making India a self-sufficient hub for the production of high-quality devices.

3. Medical Devices Parks:

As part of the Atma Nirbhar Bharat initiative, the government has also proposed the creation of medical device parks in various states to promote the growth of the sector. The key objectives include:

• Infrastructure Development: Setting up world-class infrastructure for the production of medical devices.
• Ease of Doing Business: Simplifying regulatory processes to create a conducive environment for manufacturers.
• Supporting SMEs: These parks are expected to provide support for small and medium-sized enterprises (SMEs) and startups, helping them scale up their operations and improve their competitiveness.

4. Standardization and Regulatory Reforms:

• National Regulatory Authority for Medical Devices: The GoI has introduced a regulatory body, the Central Drugs Standard Control Organization (CDSCO), to oversee medical devices’ standards, approvals, and market surveillance.
• Harmonization with Global Standards: The Indian government is aligning regulations with international norms (e.g., ISO 13485, IEC 60601) to ensure that Indian-made devices are globally competitive.

5. Skilling Initiatives:

The government has launched several skill development programs to train the workforce in the medical device sector. This includes specialized training for technicians, engineers, and designers, helping to create a robust talent pool to support the growing industry.

Role of EEPC (Engineering Export Promotion Council):

The Engineering Export Promotion Council (EEPC) has been playing a key role in promoting India’s medical device sector internationally by:

1. Export Promotion Activities:

• Trade Fairs and Exhibitions: EEPC India organizes participation in various international trade shows, including the Arab Health and Medica fairs, providing Indian manufacturers with global exposure.
• Trade Missions: EEPC arranges trade missions and B2B meetings with potential buyers from countries with high demand for medical devices, facilitating entry into international markets.
• Market Intelligence: The council provides market intelligence and insights into global trends, regulatory frameworks, and consumer preferences to help Indian medical device manufacturers make informed decisions.

2. Focus on Quality and Certification:

• EEPC has been actively working with Indian manufacturers to help them obtain international certifications (such as ISO 13485) and regulatory approvals (such as CE marking and FDA certification). This ensures that medical devices made in India are of the highest quality and can be sold in international markets.
• Training and Awareness: EEPC conducts training programs to improve the knowledge of medical device manufacturers about global certification processes, quality standards, and regulatory requirements.

3. Capacity Building for SMEs:

EEPC India plays a crucial role in helping small and medium-sized enterprises (SMEs) in the medical device sector enhance their export capabilities. Through various schemes, it offers support for capacity building, financing, and business development.

4. Collaboration with Government Agencies:

• EEPC works closely with the Ministry of Commerce, the Ministry of Health, and the Ministry of Industry to push for policies that support the medical device sector’s growth.
• The council also advocates for industry-specific incentives and has played a role in pushing for the inclusion of medical devices under the PLI Scheme.

5. R&D and Innovation Promotion:

• EEPC is working with Indian medical device companies to encourage investment in R&D and innovation. This is critical as the global demand for advanced medical technologies continues to rise, and Indian manufacturers need to keep pace with global trends.

6. Fostering Industry Partnerships:

• EEPC facilitates collaborations between Indian companies and international medical device manufacturers to enhance technology transfer, knowledge sharing, and joint ventures. These partnerships help in scaling up production and introducing new products to the market.

Future Outlook and Conclusion:

The Indian medical devices sector is poised for significant growth in the coming years, driven by the government’s initiatives and the ongoing support from industry bodies like EEPC. India’s focus on becoming a global hub for medical device manufacturing is supported by:

• Incentives for domestic production
• Enhanced regulatory frameworks
• Skilled workforce development
• Global market access through export promotion initiatives

With increasing demand for healthcare products worldwide, coupled with the GoI’s policies and EEPC’s efforts, India is likely to become one of the major players in the global medical device market. These initiatives not only improve domestic capabilities but also ensure that Indian companies can meet international standards and compete effectively on the global stage.