Medical Device Industry Challenges Bill Equating Devices to Pharma
India's medical device sector opposes a draft bill aligning device regulations with pharmaceuticals, citing potential harm to innovation and investment.
The medical device industry in India has raised significant concerns over the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which aims to regulate medical devices similarly to pharmaceuticals. Stakeholders argue that this approach could negatively impact the sector's growth and innovation.
Industry Pushback Against Draft Bill
The draft bill, currently under inter-ministerial review, has drawn criticism from various associations representing manufacturers, traders, healthcare providers, and patient groups. These organizations have collectively urged the Union health minister to reconsider the proposal, emphasizing that such regulations could deter investment and hinder India's ambitions of establishing itself as a global hub for medical device manufacturing.
Critics of the bill highlight that medical devices are fundamentally engineering products, distinct from pharmaceuticals in both design and function. The industry argues that the draft fails to acknowledge these distinctions, instead continuing to treat medical devices as mere extensions of pharmaceuticals.
Concerns Over Regulatory Language
The medical device sector has expressed particular concern over the draft's use of drug-centric terminology, including terms like "adulterated," "spurious," and "misbranded." The bill also proposes criminal penalties, including imprisonment for labeling errors and documentation lapses, which the industry argues are more appropriately addressed through administrative measures.
Globally, medical devices are regulated through frameworks that focus on risk-based conformity assessments, quality management systems, post-market surveillance, and recalls. Such frameworks are employed by regulatory bodies like the European Union's MDR, the US FDA, Japan's PMDA, the UK's MHRA, and Australia's TGA, which prefer administrative enforcement over criminalization.
Potential Impact on Innovation and Investment
The associations' letter to the health ministry, dated August 8, underscores that the draft bill does not provide the necessary regulatory foundation for the medical device sector to thrive. They warn that the proposed regulations could stifle innovation and discourage investment, ultimately impacting the industry's ability to compete on a global scale.
As the government seeks to replace the 86-year-old law governing pharmaceutical regulations, the medical device industry remains hopeful that its concerns will be addressed. The sector continues to advocate for a regulatory framework that recognizes the unique nature of medical devices and supports the industry's growth and innovation potential.