Medical Device Industry Challenges India's Draft Bill

India's medical device industry, along with patient safety advocates and healthcare providers, has voiced strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. Industry representatives argue that the draft legislation erroneously categorizes medical devices alongside pharmaceuticals, a move they believe could stifle manufacturing, deter investment, and impede innovation.

Industry Concerns Over Regulatory Approach

In a concerted effort, various associations representing manufacturers, traders, and healthcare providers have reached out to the Union Health Minister. They urge a reconsideration of the draft bill, warning that its current form could undermine India's goals to establish itself as a global hub for medical devices. The industry insists that medical devices, which are fundamentally engineering products, should not be regulated under the same framework as drugs.

Associations have highlighted that the draft bill lacks the necessary regulatory foundation to foster growth and competitiveness in the medical devices sector. The letter to the Health Ministry pointed out that the bill continues to treat medical devices as an extension of pharmaceuticals, despite clear distinctions in scientific and regulatory requirements.

Criticism of Drug-Centric Language

The draft bill's use of pharmaceutical-centric terms such as "adulterated," "spurious," and "misbranded," has drawn criticism from industry stakeholders. They argue these terms are inappropriate for medical devices, which are typically governed by quality management systems, risk-based conformity assessments, and post-market surveillance.

Furthermore, the draft bill proposes severe penalties, including imprisonment for labeling and documentation errors, licensing issues, and engineering defects, even in the absence of harm. This approach contrasts with international norms, where administrative enforcement is the standard practice. For instance, regulatory bodies like the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA focus on administrative actions rather than criminal penalties.

Call for a Separate Regulatory Framework

The medical device industry's pushback emphasizes the need for a distinct regulatory framework that acknowledges the unique characteristics of medical devices. Current global practices involve risk-based assessments and quality controls tailored specifically to devices, allowing for innovation while ensuring safety and efficacy.

The draft bill is currently under inter-ministerial consultation, with stakeholders hopeful that their feedback will lead to a more nuanced regulatory approach. The outcome of these consultations could significantly impact the future landscape of India's medical device industry.