Medical Device Industry Rejects Draft Bill's Pharma Approach
India's medical device sector opposes a draft bill equating devices with drugs, citing risks to innovation.
The medical device industry in India is raising concerns over the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. Industry representatives argue that the bill's approach of treating medical devices like pharmaceuticals could stifle innovation and investment. Stakeholders, including manufacturers, healthcare providers, and patient safety groups, have voiced their opposition, stating that the draft bill's framework is not suitable for the unique nature of medical devices.
Concerns Over Regulatory Approach
The draft bill, currently under inter-ministerial review, has drawn criticism for its drug-centric language and punitive measures. Industry bodies argue that medical devices, which are engineering products, should not be regulated with the same framework used for pharmaceuticals. The draft bill proposes criminal penalties for issues such as labeling errors and documentation lapses, with potential imprisonment of up to seven years, even when no harm is caused.
In a letter to the Union health minister dated August 8, industry associations highlighted that such regulatory measures could deter investment and hinder India's ambition of becoming a global hub for medical devices. The letter emphasized that globally, medical devices are regulated through risk-based assessments, quality management systems, and post-market surveillance, rather than criminalization.
Call for a Distinct Regulatory Framework
The industry is urging the government to develop a regulatory framework that recognizes the scientific and engineering distinctions between medical devices and pharmaceuticals. The current draft is seen as an extension of the 86-year-old law governing pharmaceuticals, which does not cater to the advancements and specificities of the medical device sector.
Stakeholders argue that the draft bill's use of terms such as "adulterated," "spurious," and "misbranded" is inappropriate for devices and mirrors a pharmaceutical-centric mindset. They point out that major regulatory bodies like the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA focus on administrative enforcement rather than criminal penalties for regulatory compliance issues.
Industry's Push for Revisions
The medical device industry is advocating for revisions to the draft bill that would align more closely with international standards and practices. They stress the importance of creating a conducive environment for innovation and growth, warning that the current draft could have adverse effects on the sector's development.
As the draft bill awaits further consultation, the industry remains hopeful that the government will consider their recommendations and establish a regulatory framework that supports the unique needs of the medical device sector, fostering its growth and contribution to healthcare advancements.