Industry Pushback: Medical Devices Not Pharma, Say Companies

India's medical device industry is rallying against the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which proposes treating medical devices akin to pharmaceutical products. Industry experts and healthcare groups argue that such a classification could stifle innovation and deter investment in the sector.

Industry Concerns Over Regulatory Framework

Associations representing manufacturers, healthcare providers, and patient safety groups have expressed their concerns in a letter to the Union Health Minister. They argue that the draft bill fails to establish a regulatory foundation conducive to the growth and global competitiveness of India's medical devices sector. The letter highlights that medical devices, fundamentally engineering products, should not be subjected to pharmaceutical-style regulation.

The draft bill, currently under inter-ministerial consultation, proposes criminal penalties for regulatory lapses, including labelling errors and documentation mistakes. Industry representatives warn that this approach could discourage manufacturing and innovation, making India less attractive as a global hub for medical devices.

Comparisons with Global Standards

Critics of the draft bill point out that the proposed regulations do not align with international practices. In regions like the European Union, the United States, Japan, the United Kingdom, and Australia, medical devices are governed by risk-based assessments and quality management systems, rather than punitive measures. The industry's letter emphasizes that administrative enforcement, not criminalization, is the norm globally.

The draft's use of drug-centric language, employing terms such as "adulterated" and "spurious," further underscores the disconnect between the proposed regulations and the actual nature of medical devices. Industry leaders argue that these terms are inappropriate for engineering products and could lead to unnecessary penalization.

Call for Policy Re-Evaluation

As the draft bill moves through the consultation phase, the medical device industry is urging policymakers to reconsider its provisions. They advocate for a regulatory framework that recognizes the distinct nature of medical devices, fostering an environment that supports innovation while ensuring patient safety.

The opposition to the draft bill highlights a broader concern within the industry about India's regulatory landscape. As the country aims to establish itself as a leader in the global medical device market, stakeholders stress the importance of adopting regulations that align with international standards and support industry growth.