New Delhi, : In a significant step towards improving the regulatory environment for India’s medical devices sector, NITI Aayog and the Department for Promotion of Industry and Internal Trade (DPIIT) have initiated measures to decriminalise minor offences and rationalise penalties under existing regulatory frameworks. The move is aimed at enhancing the ease of doing business, encouraging innovation, and reducing compliance burdens for industry stakeholders.

The proposed reforms focus on replacing criminal penalties with civil or administrative actions for minor, technical, and procedural violations in the medical devices sector. This shift is expected to reduce litigation risks, improve operational efficiency, and foster a more trust-based regulatory ecosystem for manufacturers, importers, and healthcare technology companies.

Officials noted that the current regulatory framework often imposes criminal liabilities for non-serious offences, creating compliance challenges and deterring investment, particularly for small and medium enterprises. By adopting a proportionate and risk-based approach, the government aims to balance regulatory oversight with business facilitation, ensuring accountability without hindering sectoral growth.

The initiative aligns with India’s broader policy direction under the ease of doing business reforms and complements ongoing efforts to strengthen the medical devices manufacturing ecosystem, including the implementation of the National Medical Devices Policy and the development of dedicated medical device parks.

Industry stakeholders have welcomed the move, highlighting that decriminalisation will help create a more predictable and business-friendly environment, enabling companies to focus on innovation, quality improvement, and global competitiveness. The reforms are also expected to support India’s ambition to emerge as a global hub for medical device manufacturing and exports.

Experts believe that such regulatory rationalisation is critical at a time when the MedTech sector is witnessing rapid growth, driven by increasing healthcare demand, technological advancements, and global supply chain realignments.

The proposed changes are expected to be implemented through amendments to existing laws and regulatory provisions, with further consultations likely to ensure alignment with industry needs and public health priorities.