Industry Pushback: Medical Devices Shouldn't Be Regulated as Pharma Products

India's medical device industry has voiced strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, which seeks to regulate medical devices under the same framework as pharmaceuticals. Industry leaders argue that such an approach could hinder manufacturing, investment, and innovation in the sector.

Concerns Over Regulatory Approach

Several associations representing manufacturers, traders, and healthcare providers have raised concerns with the Union Health Ministry. They argue that the bill, which is under inter-ministerial consultation, fails to acknowledge the fundamental differences between medical devices and pharmaceuticals. The draft continues to use language and impose penalties typical of pharmaceutical regulation, such as terms like "adulterated" and "misbranded," and proposes criminal penalties for regulatory lapses.

The industry argues that medical devices are engineering products and should be regulated through a different framework that reflects their specific nature. They point out that globally, medical devices are subject to risk-based conformity assessments, quality management systems, post-market surveillance, and recalls, rather than criminal penalties.

Potential Impact on the Medical Device Sector

The associations have warned that the draft bill could discourage investment and manufacturing in India, potentially derailing the country's ambitions to become a global hub for medical devices. The proposed legislation includes imprisonment terms ranging from one to seven years for issues such as labelling errors, documentation lapses, and engineering defects, even in cases where no harm is caused. This, industry representatives argue, is not in line with international practices seen in regions like the EU, US, Japan, and Australia, where administrative enforcement is the norm.

In a letter to the Union Health Ministry dated August 8, industry stakeholders emphasized that the draft bill does not provide the necessary regulatory foundation for the medical devices sector to thrive and compete on a global scale. They urge the government to reconsider the draft and develop a regulatory framework that recognizes the distinct nature of medical devices.

Call for a Separate Regulatory Framework

The medical device industry is calling for a regulatory system that differentiates between pharmaceuticals and engineering-based medical devices. They advocate for a framework that supports growth and innovation while ensuring patient safety through appropriate regulatory measures.

As the draft bill undergoes further consultation, the industry hopes for a more tailored approach that aligns with international standards and practices, fostering a conducive environment for the medical device sector to flourish in India.