Medical Device Sector Fights Draft Bill Equating Devices with Drugs

India's medical device industry is pushing back against the draft Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that it inaccurately categorizes medical devices as pharmaceuticals, potentially stifling innovation and investment. The draft bill, which is under inter-ministerial review, proposes stringent measures that industry leaders claim could hinder the sector's growth.

Concerns Over Regulatory Approach

Manufacturers, healthcare providers, and patient safety groups have expressed serious concerns about the draft legislation. These stakeholders argue that the bill's approach fails to recognize the distinct nature of medical devices, which are primarily engineering products rather than pharmaceutical goods. By applying pharmaceutical-style regulation, the bill could impose unnecessary burdens on the device manufacturing sector.

In a letter dated August 8, industry associations urged the Union health minister to reconsider the draft's implications. The letter highlights that the draft continues to use drug-centric terminology such as "adulterated," "spurious," and "misbranded," which could lead to criminal penalties for issues typically addressed through administrative means in other countries.

Potential Impact on Innovation and Investment

The draft bill's stringent penalties, including imprisonment for documentation and labeling errors, have raised alarms. Industry representatives argue that such measures could deter investment and discourage local manufacturing, undermining India's goal to become a global hub for medical devices.

Globally, medical devices are regulated through frameworks that focus on risk-based assessments, quality management systems, and post-market surveillance rather than punitive measures. The industry points to international standards set by regulatory bodies like the EU MDR, US FDA, and Japan PMDA, which favor administrative enforcement over criminal penalties.

Call for a Tailored Regulatory Framework

The medical device sector is advocating for a regulatory framework that acknowledges the unique characteristics of medical devices. Stakeholders emphasize the importance of a system that fosters growth and innovation while ensuring patient safety. The current draft, they argue, does not provide a conducive environment for the sector to thrive.

As the draft bill undergoes further review, industry leaders hope for revisions that will align India's regulations with international best practices, thereby supporting the sector's development and maintaining its competitive edge globally.