Medical Device Industry Challenges India's Draft Regulatory Bill
India's medical device sector opposes a draft bill aligning it with pharma, citing risks to innovation and investment.
The Indian medical device sector is voicing strong opposition against the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. Industry leaders argue that the draft treats medical devices akin to pharmaceuticals, which could stifle innovation and deter investment.
Industry Pushback Against Regulatory Changes
Key stakeholders, including manufacturers, healthcare providers, and patient safety groups, have formally addressed their concerns to the Union Health Minister. They argue that the bill's approach could undermine India's aspirations to become a global hub for medical devices. The draft legislation is currently under inter-ministerial review.
The central grievance is that the legislation fails to recognize the scientific and regulatory distinctions between pharmaceuticals and medical devices. The draft bill continues to describe medical devices using drug-centric terminology such as "adulterated" and "misbranded," and proposes criminal penalties for regulatory non-compliance.
Concerns Over Criminal Penalties
Industry representatives highlight that the bill proposes imprisonment ranging from one to seven years for issues such as labeling errors or documentation lapses, even in cases where no actual harm occurs. This approach contrasts with international standards, where administrative enforcement is more common. Regulatory bodies in the EU, US, Japan, UK, and Australia typically handle such issues through administrative measures rather than criminal penalties.
In a letter dated August 8, industry associations stressed that the draft does not provide a suitable regulatory framework for the medical devices sector to flourish. They argue for a system based on risk-based assessments, quality management systems, and post-market surveillance, aligning more closely with global practices.
Impact on India's Medical Device Sector
Critics of the draft bill fear that the proposed regulations could deter manufacturing and innovation within the sector. The bill's approach may discourage investment and hinder India's potential to enhance its position in the global market for medical devices. The current regulatory framework, dating back 86 years, is seen by some as outdated, necessitating a modernized approach that distinguishes between pharmaceuticals and medical devices.
As the draft bill undergoes further consultation, the medical device industry continues to advocate for revisions that better reflect the unique nature of their products and align with international regulatory practices.