Industry Pushback: Medical Devices Not Pharma, Companies Argue
Medical device firms challenge a draft bill equating devices with drugs, fearing impacts on innovation and investment.
India's medical device industry, alongside healthcare providers and patient safety groups, is voicing strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026. The proposed legislation, which aims to classify medical devices similarly to pharmaceutical products, has sparked concerns over its potential to stifle manufacturing growth, deter investment, and impede innovation.
Concerns Over Regulatory Approach
Industry representatives argue that treating medical devices like pharmaceuticals ignores the fundamental differences between the two sectors. Medical devices, they assert, are engineering products that require a distinct regulatory framework. The draft bill’s approach, which includes imposing criminal penalties for regulatory lapses akin to those applied in the pharmaceutical industry, has been criticized for being unnecessarily harsh.
In a letter addressed to the Union Health Minister on August 8, various associations representing manufacturers, traders, and healthcare providers highlighted their concerns. They warned that the bill, in its current form, could undermine India's ambitions of becoming a global hub for medical devices. The letter emphasized that the draft fails to provide a conducive regulatory environment for growth and innovation in the sector.
Industry's Call for Risk-Based Regulation
The medical device industry advocates for a regulatory framework that aligns with international standards, where risk-based conformity assessments and quality management systems are the norm. The draft bill's language, however, remains rooted in pharmaceutical-centric terms, such as "adulterated", "spurious", and "misbranded", which do not apply to engineering products.
Critics of the draft also point out that the proposed penalties, which include imprisonment for infractions like labeling errors and documentation mistakes, are disproportionate. Such measures are not practiced in regions with advanced medical device regulations, such as the European Union, the United States, Japan, the United Kingdom, and Australia, where administrative enforcement is favored.
Stakeholders Advocate for Revisions
The draft bill is currently undergoing inter-ministerial consultations, with stakeholders continuing to push for significant revisions. The industry stresses the need for a regulatory framework that recognizes the unique nature of medical devices and supports their development through appropriate guidelines and enforcement mechanisms.
As the dialogue between the government and industry stakeholders progresses, the outcome will be closely watched by those invested in the growth and innovation of India's medical device sector.