Medical Device Firms Oppose Draft Bill Treating Devices as Pharma

India's medical device industry is rallying against the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, which they argue improperly equates medical devices with pharmaceuticals. Industry and healthcare groups warn that this approach could stifle innovation, investment, and manufacturing within the sector.

Industry Pushback on Regulatory Approach

Associations representing manufacturers, healthcare providers, and patient safety groups have formally expressed their discontent, urging the Union Health Ministry to reconsider the draft legislation. Their primary concern is that the bill fails to distinguish between medical devices and pharmaceuticals, despite their distinct scientific and regulatory differences.

In a letter dated August 8, these groups highlighted that the draft law's language is heavily influenced by drug regulation, using terms such as "adulterated" and "spurious". This terminology, they argue, is inappropriate for engineering products like medical devices, which are typically governed by risk-based assessments and quality management systems globally.

Concerns Over Criminal Penalties

A significant point of contention is the draft bill's provision for criminal penalties, including imprisonment for periods ranging from one to seven years, for regulatory lapses that include labeling errors and documentation issues. The industry contends that such measures are excessive and not in line with international practices. For instance, regulatory bodies in the European Union, United States, Japan, and Australia favor administrative enforcement over criminalization.

According to industry insiders, the imposition of such stringent penalties could deter potential investors and manufacturers, undermining India's goal of becoming a global hub for medical devices. The sector advocates for a regulatory framework that supports growth and innovation while ensuring patient safety through appropriate oversight mechanisms.

Global Standards and Local Challenges

The draft bill's approach contrasts with the global trend where medical devices are regulated through conformity assessments and post-market surveillance rather than punitive measures. Industry representatives argue that India's regulatory framework should align with these international standards to remain competitive.

The draft legislation is currently under inter-ministerial review, and its outcome could significantly impact the trajectory of India's medical device industry. Stakeholders are hopeful that their feedback will prompt a revision of the bill to better reflect the unique nature of medical devices compared to pharmaceuticals.