Medical Device Firms Oppose Draft Bill Equating Them with Pharma
India's medical device sector criticizes a draft bill for treating devices like drugs, citing potential harm to innovation and investment.
India's medical device industry, alongside healthcare providers and patient safety organizations, is voicing strong opposition to the proposed Drugs, Medical Devices, and Cosmetics Bill, 2026. The bill, which is currently under inter-ministerial review, has sparked concern due to its approach of regulating medical devices in the same manner as pharmaceutical products.
Industry Pushback Against Regulatory Approach
Key industry associations have addressed a letter to the Union Health Minister, expressing that the bill's current form could stifle innovation, deter manufacturing, and negatively impact investment in the sector. They argue that medical devices, being engineering products, require distinct regulatory measures compared to pharmaceuticals.
The draft legislation continues to apply drug-centric terminology such as "adulterated," "spurious," and "misbranded" to medical devices, extending criminal penalties for regulatory non-compliance. Industry representatives warn that this could lead to imprisonment for issues like labeling errors or documentation mistakes, even when no actual harm is caused.
Global Standards and Recommendations
Critics of the draft bill highlight that globally, medical devices are governed through risk-based assessments and quality management systems, rather than criminal penalties. Regulatory frameworks in regions such as the EU, US, Japan, UK, and Australia focus on administrative enforcement and post-market surveillance.
The letter from industry associations, dated August 8, emphasizes the need for a regulatory foundation that supports growth and innovation in India's medical device sector, aiming for the country to become a global hub for medical device manufacturing.
As the government seeks to update the 86-year-old law governing pharmaceutical regulations, stakeholders are urging a reevaluation of the draft to ensure it aligns with international best practices and supports the unique nature of medical devices.