Medical Device Industry Pushes Back on India's Draft Bill

India's medical device industry and healthcare groups have voiced strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026. They argue that the bill, which proposes treating medical devices as pharmaceutical products, could severely impact manufacturing, innovation, and investment in the sector.

Concerns Over Regulatory Approach

Industry associations, including manufacturers, healthcare providers, and patient safety groups, have expressed their concerns in a letter to the Union Health Minister. They warn that the draft bill's approach could undermine India's ambitions to become a global hub for medical devices. The letter emphasizes the fundamental differences between medical devices and pharmaceuticals, noting that the bill fails to establish a suitable regulatory framework for the former.

Critics of the draft bill highlight its use of drug-centric language, which includes terms like "adulterated," "spurious," and "misbranded." They argue that applying pharmaceutical-style criminal penalties for regulatory lapses in the medical device sector is inappropriate. The draft proposes imprisonment of 1-7 years for labeling errors, documentation lapses, and other issues, even when no harm occurs.

Calls for a Risk-Based Regulatory Model

The medical device industry points out that globally, regulatory frameworks for medical devices focus on risk-based conformity assessments, quality management systems, and post-market surveillance rather than criminal penalties. Countries such as those governed by the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA typically use administrative enforcement measures.

Associations argue that the draft bill's approach could discourage investment and innovation, as potential criminalization of engineering deviations may deter manufacturers. The industry advocates for a regulatory model that aligns with international standards, focusing on risk management and quality assurance rather than punitive measures.

Inter-Ministerial Consultations Underway

The draft bill is currently under inter-ministerial consultation, with stakeholders hoping for revisions that better reflect the unique nature of medical devices. As the government seeks to update the 86-year-old law governing pharmaceuticals, the medical device industry is pushing for a framework that supports growth and competitiveness on a global scale.

India's medical device sector is a critical component of its healthcare system, and stakeholders are keen to ensure that regulatory changes do not stifle its potential. The ongoing discussions are expected to shape the future of medical device regulation in the country, with industry leaders advocating for a balanced approach that fosters innovation while ensuring patient safety.