In a significant stride toward strengthening consumer protection and promoting regulatory coherence, the Department of Consumer Affairs, under the Ministry of Consumer Affairs, Food and Public Distribution, has notified the Legal Metrology (Packaged Commodities) Amendment Rules, 2025. This landmark reform aligns the Legal Metrology (Packaged Commodities) Rules, 2011 with the Medical Devices Rules, 2017, creating a unified framework for the packaging and labelling of medical devices in India.
The amendment, reflecting the Government’s vision of Ease of Living and Ease of Doing Business, ensures that both consumers and manufacturers benefit from clarity, consistency, and transparency. By harmonizing standards, the new Rules pave the way for “Atmanirbhar Bharat through Regulatory Harmony”, fostering trust, accountability, and predictability in India’s healthcare ecosystem.
Harmonisation with Medical Device Rules: Clarity for All Stakeholders
The key highlight of the amendment is the alignment of packaging and labelling provisions for medical devices with those under the Medical Devices Rules, 2017. It specifies that for packages containing medical devices, the height and width of numerals and letters used for mandatory declarations shall conform to the standards prescribed in the Medical Devices Rules.
While the Legal Metrology framework continues to mandate essential consumer declarations — such as name, manufacturer details, quantity, and price — the font size and format will now follow the medical device-specific standards. This ensures clarity, accuracy, and readability, particularly for consumers purchasing critical healthcare products.
Moreover, the amendment provides that the relaxations available under Rule 33 of the Legal Metrology (Packaged Commodities) Rules, 2011, will not apply when the Medical Devices Rules, 2017, are in force. This distinction removes ambiguity, preventing overlaps between the two regulatory frameworks.
Another key clarification relates to Principal Display Panel declarations — these are no longer mandatory under the Legal Metrology Rules for medical devices, as the Medical Devices Rules already prescribe comprehensive display norms tailored to healthcare products.
Consumer Protection through Consistent Standards
This harmonisation ensures that consumers receive clear, accurate, and standardized information across all medical device packaging. By removing confusion arising from overlapping rules, it strengthens consumer trust and facilitates informed purchasing decisions.
Consumers will now benefit from consistent labelling designed specifically for medical devices, helping them easily identify key product details such as model number, manufacturing date, and usage instructions. This clarity is especially vital in the healthcare sector, where accurate information can directly influence health and safety outcomes.
Ease of Doing Business: Simplifying Compliance for Industry
For industry stakeholders, the amendment delivers a major boost to Ease of Doing Business. It eliminates the need for dual compliance with two separate rule sets, reducing administrative burden and ensuring predictability. Manufacturers and importers can now adhere to a single, specialized set of standards, thereby avoiding duplication of effort and potential regulatory conflicts.
This streamlined approach not only reduces compliance costs but also encourages innovation and investment in India’s growing medical device sector — a cornerstone of Atmanirbhar Bharat.
Strengthening Enforcement and Transparency
For regulators and Legal Metrology Enforcement Officers, the amendment provides clear jurisdictional boundaries, ensuring simplified, uniform enforcement across states. With one consistent standard in place, oversight becomes more efficient and transparent, promoting accountability across the supply chain.
Towards a Transparent and Healthy India
The Legal Metrology (Packaged Commodities) Amendment Rules, 2025 symbolize a forward-looking approach to regulation — one that balances consumer protection, industrial facilitation, and administrative efficiency. By aligning packaging and labelling standards for medical devices with domain-specific regulations, the Government reinforces its commitment to a transparent, healthy, and self-reliant India.
This reform is not just a technical alignment — it is a statement of intent: to build consumer confidence, empower industry, and strengthen the nation’s healthcare ecosystem through clear declarations and harmonized standards.