India Strengthens Medical Device Licensing to Ensure Global Competitiveness
India is actively enhancing its medical device licensing framework to bolster global competitiveness and ensure the safety and efficacy of its medical devices. Key initiatives include:
1. National Medical Devices Policy 2023: The Indian government introduced this policy to streamline regulatory processes and promote the medical device sector’s growth. It aims to expand the industry from USD 11 billion to USD 50 billion by 2030. The policy includes:
- Single Window Clearance System: Simplifies licensing by reducing complexity and compliance burdens.
- Standardization Efforts: Collaborates with bodies like the Bureau of Indian Standards to enhance product quality and standardization.
- Pricing Regulation: Develops mechanisms to ensure affordable access to quality medical devices.
2. International Collaboration: India’s affiliate membership in the International Medical Device Regulators Forum (IMDRF) facilitates:
- Regulatory Harmonization: Aligns domestic regulations with global standards.
- Global Competitiveness: Enhances the international standing of India’s medical device industry.
3. Production-Linked Incentive (PLI) Scheme: This initiative encourages domestic manufacturing of medical devices by:
- Financial Incentives: Provides benefits to manufacturers to boost production.
- Import Reduction: Aims to decrease reliance on imported medical devices.
4. Infrastructure Development: The policy plans to establish:
- Medical Device Parks: Equipped with world-class infrastructure to support manufacturing and innovation.
- Clusters: Medium-sized clusters to enhance standardization and quality.
5. Export Promotion: Efforts are underway to:
- Increase Exports: Aim to reach USD 20 billion in medical device exports by 2030.
- Government Support: Seek extended incentives and improved ease of doing business to accelerate growth.
Through these comprehensive measures, India is strengthening its medical device licensing framework, fostering innovation, and enhancing its position in the global medical device market.
