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

The Indian medical device industry is raising strong objections to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, which seeks to regulate medical devices similarly to pharmaceutical products. Industry leaders and healthcare groups are voicing concerns that the bill's approach could stifle innovation and deter investment in the sector.

Industry Concerns Over Regulatory Approach

Associations representing manufacturers, healthcare providers, and patient safety groups have communicated their opposition to the draft bill in a letter to the Union Health Minister. They argue that the legislation fails to acknowledge the fundamental differences between medical devices and pharmaceutical products. Unlike drugs, medical devices are primarily engineering products and require a distinct regulatory framework, they assert.

The draft bill proposes criminal penalties for regulatory lapses, such as labeling errors or documentation issues, which the industry argues could negatively impact manufacturing operations and India's potential as a global medical device hub. The letter emphasizes that the bill's drug-centric terminology and punitive measures are inappropriate for the medical device industry.

Comparison with Global Standards

Industry representatives have highlighted that global standards, such as those set by the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA, focus on risk-based conformity assessments and quality management systems rather than criminal penalties. The draft bill, however, includes provisions for imprisonment ranging from one to seven years for various regulatory infractions, even when no harm is caused.

According to the industry letter, the draft bill's approach contrasts sharply with international practices, where administrative enforcement is the norm. The industry fears that these stringent measures could hinder India's competitiveness in the global market and discourage future investment.

Call for a Reconsideration

The medical device industry is urging the government to reconsider the draft bill's provisions and develop a regulatory framework that aligns with international standards and supports the sector's growth. The letter stresses the importance of creating a conducive environment for innovation and manufacturing, which is seen as essential for achieving India's goal of becoming a leading global hub for medical devices.

The draft bill is currently undergoing inter-ministerial consultation, and the industry awaits further developments. As the debate continues, stakeholders are keen to ensure that any new regulations foster rather than hinder the growth and development of India's medical device sector.