India’s Medical Device Rules Undergoing Major Reforms to Improve Safety
India is undertaking significant reforms to its medical device regulations to enhance safety, quality, and self-reliance in the healthcare sector.
Expansion of Regulatory Oversight:
The Central Drugs Standard Control Organization (CDSCO) has mandated that all Class C and D non-notified medical devices secure comprehensive licenses by October 2023. This move extends regulatory oversight beyond the initial 35 device categories, ensuring that higher-risk devices meet stringent safety and efficacy standards before entering the Indian market.
National Medical Devices Policy, 2023:
The Indian government approved the National Medical Devices Policy in 2023, aiming to accelerate growth with a patient-centric approach. The policy envisions India emerging as a global leader in manufacturing and innovation of medical devices, targeting a 10-12% share in the expanding global market over the next 25 years.
Implementation of the SMDI Scheme:
The Department of Pharmaceuticals introduced the “Strengthening of Medical Device Industry” (SMDI) scheme to support the sector’s growth. The scheme focuses on:
- Reducing Import Dependence: Providing grants to manufacturers for producing essential components, raw materials, and accessories domestically.
- Establishing Common Facilities: Funding the creation of common facilities and testing laboratories to enhance manufacturing quality.
- Skill Development: Implementing training programs to develop a skilled workforce for the medical device industry.
Revised Schedule M and Quality Standards:
The government has updated Schedule M of the Drugs and Cosmetics Rules, 1945, to incorporate:
- Pharmaceutical Quality Systems (PQS): Ensuring consistent quality in manufacturing processes.
- Quality Risk Management (QRM): Identifying and mitigating potential risks in production.
- Product Quality Review (PQR): Regular assessment of product quality to maintain high standards.
Large manufacturers are required to comply within six months, while small and medium manufacturers have twelve months to implement these changes.
Adoption of the National Single Window System (NSWS):
To streamline regulatory processes, CDSCO has transitioned to the NSWS portal for medical device applications, replacing the previous CDSCO MD Online system. This digital platform centralizes approvals and clearances, simplifying the application process for businesses.
Implications for Stakeholders:
These reforms aim to:
- Enhance Patient Safety: By ensuring that all medical devices meet rigorous safety standards.
- Promote Domestic Manufacturing: Reducing reliance on imports and fostering self-reliance.
- Facilitate Market Access: Streamlining regulatory procedures to ease the entry of new products into the market.
Manufacturers and stakeholders must stay informed and compliant with these evolving regulations to ensure seamless operations and contribute to the advancement of India’s healthcare industry.
