Medical Device Industry Challenges Draft Bill's Pharma-like Regulations

India's medical device industry and allied healthcare groups are voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. Industry stakeholders argue that the draft bill, which treats medical devices similarly to pharmaceuticals, could stifle innovation and deter investment in the sector.

Industry Concerns Over Regulatory Approach

The draft bill has sparked concern among manufacturers, patient safety groups, and healthcare providers who have collectively appealed to the Union Health Minister for a reconsideration. The groups stress that equating medical devices with pharmaceuticals fails to recognize the distinct engineering and regulatory requirements of devices, potentially hindering India's ambition to become a global leader in medical device manufacturing.

In a letter dated August 8, industry associations highlighted that the draft continues to use pharmaceutical-centric language and imposes harsh penalties for regulatory lapses. Terms like "adulterated," "spurious," and "misbranded" are used in the bill, which the industry argues are inappropriate for devices, which are typically governed by engineering standards and risk-based assessments.

Comparison with Global Standards

The draft bill suggests penalties including imprisonment of 1-7 years for issues such as labeling errors and documentation lapses, even when no harm occurs. This approach contrasts sharply with international standards, where administrative enforcement is more common. Regulatory frameworks in the EU, US, Japan, UK, and Australia rely on quality management systems, post-market surveillance, and recalls rather than criminal penalties.

The industry fears that such stringent measures could discourage innovation and investment, making India less attractive to global manufacturers. The letter from the associations emphasized that the draft does not provide the necessary regulatory foundation for the sector's growth and global competitiveness.

Call for Policy Reevaluation

As the draft bill undergoes inter-ministerial consultation, the medical device sector is advocating for a regulatory framework that aligns more closely with international norms. They argue that a differentiated approach recognizing the unique nature of medical devices is crucial for fostering growth and innovation in the industry.

With the government aiming to replace an 86-year-old law governing pharmaceutical regulations, the medical device industry hopes for a more nuanced policy that supports its distinct needs and potential for contributing to India's healthcare landscape and economic development.