Medical Device Firms Criticize Draft Bill for Pharma-like Regulations

India's medical device industry has voiced strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that it unfairly equates medical devices with pharmaceuticals. Industry leaders, healthcare providers, and patient safety groups have collectively raised concerns that the draft legislation could negatively impact manufacturing, investment, and innovation in the sector.

Industry Concerns Over Draft Bill

In a letter to the Union Health Minister, various associations representing manufacturers, traders, and healthcare providers urged a reconsideration of the draft. They argue that the bill treats medical devices as an extension of pharmaceuticals, despite fundamental differences in their scientific, engineering, and regulatory requirements. The letter, dated August 8, underscores that the draft fails to provide the necessary regulatory framework for the growth and global competitiveness of India's medical device sector.

The draft bill proposes stringent penalties, including imprisonment ranging from one to seven years for infractions such as labeling errors, documentation lapses, and engineering defects. Industry representatives argue that these measures are more aligned with pharmaceutical regulations and do not reflect the global standards for medical device oversight.

Global Regulatory Standards

Globally, medical devices are typically regulated through risk-based conformity assessments, quality management systems, and post-market surveillance, rather than through criminal penalties. The letter highlights that countries like the United States, European Union, Japan, the United Kingdom, and Australia employ administrative enforcement rather than criminalization for similar regulatory issues.

By imposing pharma-style criminalization for what are essentially engineering deviations, the draft bill risks deterring potential investors and manufacturers. Industry stakeholders fear that such measures could derail India's ambition to become a global hub for medical devices.

Call for a Distinct Regulatory Approach

The medical device sector is advocating for a regulatory approach that recognizes the distinct nature of medical devices compared to pharmaceuticals. They emphasize the need for a framework that supports innovation and growth while ensuring patient safety through appropriate regulatory mechanisms.

The draft bill is currently under inter-ministerial consultation, and the industry is hopeful that their concerns will be addressed to foster a more conducive environment for the sector's development. The proposed changes to the 86-year-old law governing India's pharmaceutical regulations are expected to undergo further scrutiny before any final decisions are made.