Draft Bill Sparks Opposition from India's Medical Device Industry
Industry leaders argue the Draft Bill treats medical devices like drugs, threatening growth.
India's medical device industry has voiced strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. Industry representatives argue that the bill wrongly categorizes medical devices alongside pharmaceuticals, potentially stifling innovation and investment.
Concerns Over Regulatory Approach
Various associations, including those representing manufacturers, healthcare providers, and patient safety groups, have expressed concerns in a letter to the Union Health Minister. They argue that the draft bill threatens to undermine India's ambitions of becoming a global hub for medical device manufacturing by imposing pharmaceutical-style regulations on devices that are fundamentally different.
The industry's primary contention is that medical devices, which are engineering products, should not be treated under the same regulatory framework as drugs. The draft bill's current form includes provisions for criminal penalties for regulatory lapses, such as labeling errors and documentation issues, which the industry believes could deter investment and manufacturing growth.
Industry's Response and Global Standards
The letter from industry associations, dated August 8, criticizes the draft bill's use of drug-centric language. Terms such as "adulterated," "spurious," and "misbranded," along with the application of criminal penalties, are seen as inappropriate for the engineering-centric nature of medical devices.
Internationally, medical devices are regulated based on risk-based conformity assessments and quality management systems. For instance, regulatory bodies like the EU MDR, US FDA, Japan's PMDA, UK MHRA, and Australia's TGA typically employ administrative enforcement rather than criminal penalties for compliance failures. The Indian draft bill, however, suggests imprisonment of one to seven years for various regulatory infractions, even when no harm has occurred.
Call for Reconsideration
The opposition to the draft bill highlights the industry's call for a regulatory framework that recognizes the distinct nature of medical devices. Industry leaders urge the government to reconsider the draft bill, advocating for regulations that support innovation and align with global standards.
As the draft bill undergoes inter-ministerial consultation, stakeholders hope for revisions that would establish a robust regulatory foundation conducive to growth and global competitiveness in India's medical device sector.