Indian Medical Device Industry Opposes Draft Bill Treating Devices as Drugs
Indian medical device firms challenge a draft bill that equates devices with drugs, fearing it will stifle innovation and investment.
The Indian medical device sector, alongside healthcare providers and patient safety groups, is raising strong objections to the proposed Drugs, Medical Devices and Cosmetics Bill of 2026. Industry representatives argue that the draft legislation, which applies pharmaceutical-like regulations to medical devices, could negatively impact manufacturing, investment, and innovation.
Industry Pushback Against Pharmaceutical Classification
Key stakeholders, including various associations that represent manufacturers, traders, and healthcare providers, have communicated their concerns to the Union Health Minister. They argue that the draft bill treats medical devices as pharmaceutical products, a move they believe is misguided given the fundamental differences between the two categories. Medical devices, they emphasize, are engineering products and not drugs, necessitating a distinct regulatory approach.
The industry’s primary concern is that the draft bill fails to establish a conducive regulatory foundation for the growth and global competitiveness of India's medical devices sector. The bill currently under inter-ministerial consultation is seen as an obstacle to India's ambition of becoming a global hub for medical devices.
Concerns Over Regulatory Language and Penalties
Industry leaders have highlighted the draft's reliance on pharmaceutical-centric terminology, using terms like “adulterated,” “spurious,” and “misbranded,” which they believe are inappropriate for engineering deviations in medical devices. The draft also proposes severe criminal penalties, including imprisonment ranging from one to seven years for issues such as labelling errors, documentation lapses, and licensing issues, even if no harm results from these lapses.
This approach starkly contrasts with international norms, where administrative enforcement, rather than criminal penalties, is the standard. Countries like the EU, the US, Japan, the UK, and Australia regulate medical devices through risk-based conformity assessments, quality management systems, post-market surveillance, and recalls.
Call for a Rethink of the Draft Bill
On August 8, industry associations submitted a letter to the government, urging a reevaluation of the draft bill. They stress the need for regulations that recognize the scientific, engineering, and regulatory distinctions between pharmaceuticals and medical devices. The letter calls for a regulatory framework that fosters innovation and supports the sector's growth without imposing undue burdens.
The ongoing debate highlights the crucial need for a balanced regulatory approach that ensures patient safety while promoting the advancement of the medical device industry. As discussions continue, stakeholders hope for adjustments to the draft bill that align with global best practices and support the sector's development.