Industry Pushback: Medical Devices Not Pharmaceuticals, Firms Say

India's medical device sector is voicing strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which proposes to regulate medical devices in the same manner as pharmaceutical products. Industry representatives and healthcare groups argue that this approach threatens to stifle innovation, deter investment, and hinder the country's aspirations to become a global leader in medical device manufacturing.

Industry Concerns Over Draft Bill

Key stakeholders, including manufacturers, healthcare providers, and patient safety groups, have formally expressed their concerns to the Union Health Minister. They argue that the bill's provisions do not reflect the distinct nature of medical devices compared to pharmaceuticals. The draft bill, currently undergoing inter-ministerial consultation, has been criticized for using language and penalties typical of pharmaceutical regulation, such as terms like "adulterated," "spurious," and "misbranded." This, they claim, fails to acknowledge the engineering and scientific differences between the two industries.

The industry letter, submitted on August 8, highlights that the proposed regulations could impose criminal penalties for regulatory lapses, such as labelling errors and documentation mistakes, with imprisonment terms ranging from one to seven years. This level of criminalization, they argue, is not in line with international practices, where administrative measures are preferred.

Calls for Regulatory Reform

Associations representing the medical device industry emphasize the need for a regulatory framework that supports growth, innovation, and global competition. They point out that medical devices require risk-based assessments, quality management systems, and post-market surveillance, rather than the stringent pharmaceutical-style regulations suggested in the draft bill.

Leaders within the sector fear that the proposed regulations could discourage investment and manufacturing in India, undermining efforts to establish the country as a global hub for medical devices. The draft bill's approach is seen as a regression from the country's ambitions to foster a thriving medical device industry, which has different operational and safety standards compared to pharmaceuticals.

Global Standards and Practices

Industry experts note that major international regulatory bodies, such as the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA, employ administrative enforcement mechanisms rather than criminal penalties for regulatory compliance in the medical device sector. These global standards focus on ensuring safety and efficacy through rigorous conformity assessments and quality controls without resorting to punitive measures for non-harmful deviations.

The medical device industry is urging the government to reconsider the draft bill and develop separate, appropriate regulations that recognize the unique challenges and requirements of medical devices. By aligning with global best practices, India could enhance its competitiveness and innovation in the medical device sector, attracting international investment and fostering domestic growth.