New Guidelines for Medical Device Manufacturers in India: What You Need to Know
India has recently introduced comprehensive guidelines to bolster its medical device industry, focusing on enhancing domestic manufacturing, ensuring product quality, and reducing import dependency.
Strengthening of Medical Device Industry (SMDI) Scheme:
The Department of Pharmaceuticals (DoP) has launched the SMDI scheme, effective from FY 2024-25 to 2026-27, with a financial outlay of ₹500 crore. This initiative aims to support the medical device sector through several key components:
- Marginal Investment Support for Reducing Import Dependence: This sub-scheme offers grants to manufacturers for producing essential components, raw materials, and accessories, thereby decreasing reliance on imports. Eligible manufacturers can receive a one-time capital subsidy, with amounts varying based on company turnover.
- Establishment of Common Facilities and Testing Laboratories: The scheme allocates funds to set up common facilities and testing labs to enhance manufacturing quality. Government-backed institutions may receive up to 70% funding, capped at ₹20 crore for equipment, while private entities can obtain up to 50% support.
- Skill Development and Clinical Evidence Support: The SMDI scheme emphasizes capacity-building by supporting educational and training programs to bridge skill gaps in the medical device sector. It also provides financial assistance for clinical studies to improve the safety, efficacy, and marketability of medical devices.
National Medical Devices Policy, 2023:
In a strategic move to boost domestic manufacturing and reduce import dependency, the Indian government approved the National Medical Devices Policy in 2023. The policy envisions accelerated growth with a patient-centric approach, aiming for India to emerge as a global leader in medical device manufacturing and innovation, targeting a 10-12% share in the global market over the next 25 years.
Production Linked Incentive (PLI) Scheme:
To further promote domestic manufacturing, the government has implemented the PLI Scheme for medical devices. This scheme offers financial incentives to boost domestic production and attract large investments in medical device segments such as cancer care, radiology, imaging, and anesthetics. The scheme is set to create global champions out of India and boost the “Make in India, Make for the World” mandate.
Regulatory Enhancements:
The Central Drugs Standard Control Organisation (CDSCO) has expanded its regulatory oversight to include all medical devices, ensuring comprehensive quality and safety standards. This move aligns with international practices and aims to enhance the global competitiveness of Indian medical devices.
Implications for Manufacturers:
Manufacturers are encouraged to align their operations with these new guidelines to leverage government incentives and support. This alignment is crucial for enhancing product quality, ensuring regulatory compliance, and capitalizing on emerging opportunities in the domestic and global markets.
These initiatives reflect India’s commitment to strengthening its medical device industry, fostering innovation, and ensuring the availability of high-quality medical devices to meet both domestic and international healthcare needs.
