Medical Device Firms Challenge Draft Bill on Regulatory Grounds

India's medical device industry is rallying against 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 this approach could stifle innovation and investment in a sector poised for growth.

Industry Voices Raise Concerns

Several associations, including those representing manufacturers, traders, and healthcare providers, have formally appealed to the Union health minister to reconsider the draft bill. They claim that the bill's current provisions could undermine India's ambitions to become a global hub for medical devices by treating engineering products like pharmaceuticals.

The August 8 letter from these groups highlights the scientific and regulatory differences between pharmaceuticals and medical devices, urging the government to adopt a distinct regulatory framework. The letter criticizes the draft for using drug-centric terminology such as "adulterated," "spurious," and "misbranded," which are not typically applied to engineering products.

Potential Impact on Innovation and Investment

Industry representatives warn that the draft bill's punitive measures, including potential imprisonment for labeling errors or documentation lapses, could deter investment and innovation. "Globally, medical devices are regulated through risk-based assessments and quality management systems, not imprisonment," the letter states, pointing to regulatory practices in the EU, US, Japan, UK, and Australia, where administrative enforcement is preferred.

The bill proposes imprisonment of one to seven years for various regulatory infractions, even in cases where no harm occurs. This contrasts sharply with international norms, where administrative actions are typically taken for such violations.

Call for a Revised Regulatory Approach

The medical device sector is advocating for regulations that reflect the unique nature of engineering products. They argue that the draft bill, as it stands, lacks the regulatory foundation needed for the sector to thrive and compete internationally.

The draft bill is currently under inter-ministerial consultation, and industry stakeholders are hopeful that their feedback will lead to a more nuanced regulatory approach that supports growth and innovation in India's medical device industry.