Medical Device Industry Challenges Draft Bill Over Pharma Classification

The medical device industry in India is raising concerns over the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which proposes regulating medical devices in the same way as pharmaceuticals. Industry groups argue that this approach could stifle manufacturing, deter investment, and hinder innovation.

Industry Pushback Against Draft Legislation

Medical device manufacturers, along with patient safety groups and healthcare providers, have voiced their opposition to the draft bill. They argue that the proposed legislation fails to recognize the fundamental differences between medical devices and pharmaceutical products. The draft's approach, which includes imposing criminal penalties for regulatory lapses, is seen as a potential setback for India's ambition to become a global hub for medical device manufacturing.

In a letter to the Union Health Minister dated August 8, industry associations emphasized that medical devices are engineering products, distinct from pharmaceuticals, and require a different regulatory framework. The letter criticized the draft for continuing to use drug-centric language, applying terms such as "adulterated," "spurious," and "misbranded" to medical devices, and for proposing criminal penalties similar to those used in pharmaceutical regulation.

Concerns Over Regulatory Approach

The draft bill proposes imprisonment for offenses such as labelling errors, documentation failures, and licensing issues, even in the absence of harm. Industry representatives argue that such measures are not in line with international practices. For instance, regulatory bodies like the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA typically rely on administrative enforcement rather than criminal penalties.

Associations are urging the government to adopt a regulatory framework that aligns with global standards, focusing on risk-based conformity assessments, quality management systems, post-market surveillance, and recalls. They argue that this approach would better support the growth and innovation of India's medical devices sector.

Call for a Revised Regulatory Framework

The pushback against the draft bill highlights the need for a regulatory environment that recognizes the unique characteristics of medical devices. Industry stakeholders believe that a revised framework could facilitate the sector's development and enhance India's competitiveness in the global market.

The draft bill is currently under inter-ministerial consultation, and the industry is hopeful that their concerns will be addressed to prevent potential negative impacts on the sector. As the consultation process continues, stakeholders remain engaged in discussions to ensure that the final legislation supports the growth and innovation of the medical devices industry in India.