Medical Device Firms Oppose Draft Bill Equating Devices with Drugs
India's medical device sector criticizes a draft bill that likens devices to drugs, fearing it will stifle growth.
The Indian medical device industry is sounding alarms over the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, which they claim improperly regulates medical devices under the same framework as pharmaceuticals. Industry insiders and healthcare organizations argue that this approach will negatively impact the sector by hindering manufacturing, innovation, and investment.
Industry Concerns Over Regulatory Approach
Industry representatives have expressed significant concerns that the draft legislation subjects medical devices to pharmaceutical-style regulation, including criminal penalties for regulatory breaches. In a letter to the Union health minister, various associations underscored the critical differences between medical devices and pharmaceuticals, advocating for a separate regulatory framework that acknowledges these distinctions.
“The draft continues to treat medical devices as an adjunct to pharmaceuticals, despite clear scientific, engineering, and regulatory distinctions between the two categories,” the letter noted. The associations argue that the proposed regulations could deter investment and undermine India's goal of becoming a global leader in medical device manufacturing.
Global Standards vs. Proposed Domestic Regulations
The draft bill suggests penalties including imprisonment for infractions such as labeling errors and documentation lapses, even when no harm results. Industry representatives argue that this approach contrasts sharply with international practices. In regions like the EU, US, Japan, UK, and Australia, enforcement typically involves administrative measures rather than criminal consequences.
The industry insists that medical devices should be regulated through risk-based assessments, quality management systems, and post-market surveillance. They emphasize that the draft bill's drug-centric language, using terms such as “adulterated” and “misbranded,” is inappropriate for engineering-driven products.
Call for a Revised Framework
The medical device sector is urging the government to revise the draft to provide a regulatory foundation that supports growth and innovation. They advocate for a framework similar to those used in other advanced markets, which could enable the Indian medical device industry to compete globally.
As the bill undergoes inter-ministerial consultation, stakeholders are keenly watching for revisions that align more closely with international standards and practices. The outcome could significantly influence the future landscape of India’s burgeoning medical device industry.