Draft Bill Sparks Controversy Over Medical Device Regulation

The Indian medical device industry is raising alarms over the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which proposes to regulate medical devices under the same framework as pharmaceuticals. Industry representatives and healthcare groups argue that this approach could significantly impede manufacturing, investment, and innovation within the sector.

Industry Pushback Against the Draft Bill

Several associations representing manufacturers, healthcare providers, and patient safety groups have submitted a formal objection to the Union Health Minister. They argue that the draft bill's approach overlooks the fundamental differences between medical devices and pharmaceuticals, potentially harming India's ambition to become a global leader in medical device manufacturing.

The industry contends that medical devices should not be subjected to the same regulatory conditions as pharmaceuticals, as they are fundamentally engineering products. The draft bill's use of pharmaceutical-centric language and its proposal to impose criminal penalties for regulatory lapses is seen as particularly problematic.

Concerns Over Regulatory Language and Penalties

The draft legislation has been criticized for its use of terms like "adulterated," "spurious," and "misbranded," which are typically associated with drugs. Furthermore, the bill proposes severe penalties, including imprisonment for up to seven years, for infractions such as labeling errors or documentation lapses, even in cases where no harm has occurred. This approach is contrary to international practices, where administrative enforcement is generally preferred.

Globally, countries like those in the European Union, the United States, Japan, the United Kingdom, and Australia regulate medical devices through risk-based conformity assessments and quality management systems. The industry's letter to the government emphasizes that adopting a similar regulatory framework would be more appropriate and beneficial for the sector's growth.

Call for a Distinct Regulatory Framework

The current draft, which is under inter-ministerial consultation, fails to provide the regulatory foundation necessary for the medical device sector to thrive. Industry leaders argue that a distinct regulatory framework, separate from that of pharmaceuticals, is essential to foster innovation and competitive growth in the global market.

The pushback from the medical device industry highlights a critical debate on how best to regulate a sector that is rapidly evolving and plays a crucial role in modern healthcare. The outcome of this regulatory discussion could have far-reaching implications for India's position in the global medical device market.