2025 LMPC Amendment Frees Medical Devices from Packaged Commodities Labelling Rules.

2025 LMPC Amendment Frees Medical Devices from Packaged Commodities Labelling Rules.

(Article by YAGAY and SUN – Consultants, Environmentalist, Cyclist)

In a quiet but transformative regulatory shift, the Legal Metrology (Packaged Commodities) Amendment Rules, 2025 have formally removed all medical devices from the scope of India’s packaged-commodities labelling regime. This one-page notification effectively untangles a decade of overlap, ending a tug-of-war that confused manufacturers, importers, distributors, and even field inspectors since 2017.

The amendment marks the first time in fourteen years that medical devices—ranging from glucometers and stents to surgical tools and imaging supplies—are no longer governed by the stringent display requirements originally designed for everyday retail items like snacks, soaps, and household goods.

A Quiet Notification with Big Consequences

For years, medical-device companies were expected to comply with the Legal Metrology (Packaged Commodities) Rules, 2011 (LMPC), an architecture created to protect consumers through standardized declarations such as:

• Typeface height and width-to-height ratios
• MRP placement norms
• Net quantity units
• Mandatory label area
• Standardized display formats

These rules were appropriate for fast-moving consumer goods (FMCG) sold in supermarkets — but in the medical device industry, they clashed with technical, clinical, and regulatory realities.

The 2025 amendment severs this link completely. By removing medical devices from LMPC’s jurisdiction, it leaves their labelling fully under the Medical Devices Rules (MDR), 2017 — a framework designed specifically for risk-based, healthcare-critical products.

Why the Change Was Needed

1. Dual Compliance Was Legally Illogical

Medical devices became regulated as “drugs” under the Drugs and Cosmetics Act in 2017. This shifted their governance into a clinical and quality-focused domain. But LMPC requirements still applied on top of MDR, creating two parallel rulebooks — each with conflicting demands.

2. Packaging Formats Often Made LMPC Impractical

Medical devices vary widely in size, shape, sterility and packaging type:

• Sterile blister packs
• Unit-dose diagnostic kits
• Micro-packaged implants
• Multi-layer cleanroom-sealed devices

Applying FMCG-style font-size ratios or fixed MRP display positions was often physically impossible without compromising sterility, readability, or international packaging standards.

3. Field Inspectors Often Conflicted with Drug Regulators

Inspectors enforcing LMPC rules would demand changes that clashed with MDR-compliant labels approved by drug regulatory authorities. Manufacturers routinely faced contradictory instructions.

4. Importers and Global OEMs Faced Severe Delays

Global medical-device companies were forced to produce India-specific packaging simply to meet LMPC formatting rules, causing:

• Higher costs
• Slower market entry
• Risk of non-compliance
• Re-labelling delays at ports

The amendment eliminates this pain point.

What the 2025 Amendment Achieves

1. Establishes Single-Regulator Oversight

Medical device labelling is now a fully Drugs and Cosmetics Act ? MDR 2017 responsibility. This places all declarations — from unique device identification (UDI) to sterility, usage warnings, shelf-life and manufacturer information — solely under health-centric regulation.

2. Reduces Compliance Burden

Manufacturers no longer need to navigate:

• LMPC font/ratio rules
• package-display requirements
• size-of-letter regulations
• hierarchy of declarations
• contradictory state-level LMPC interpretations

The packaging can now align with global medical device standards (ISO 15223, UDI, IEC norms).

3. Eliminates Conflicts During Inspection

Drug inspectors and LMPC officers will no longer issue contradictory requirements. Enforcement becomes aligned, predictable, and professionally specialized.

4. Enables Faster Market Access for Imported and Domestic Devices

Importers can now use globally standardized labels without India-specific LMPC formatting changes. Domestic manufacturers also gain agility to innovate packaging.

Implications for the Healthcare Industry

For Manufacturers & Importers:

• Simplified compliance regime
• Faster product release
• Lower packaging alteration costs
• Fewer bottlenecks during import documentation

For Hospitals and Distributors:

• Clearer, more standardized labels
• Reduced disputes during procurement audits
• Better alignment with clinical documentation

For Patients:

• Labels designed for medical clarity, not retail aesthetics
• Higher confidence in authenticity and regulatory legitimacy

For Regulators:

• Eliminated overlap between Legal Metrology and Drug Regulators
• Stronger enforcement clarity
• Reduced compliance disputes and litigation

A Long-Awaited Victory for the Medical Device Sector

The friction between LMPC norms and MDR requirements had become a sustained compliance headache. Even though medical devices were reclassified as drugs in 2017, LMPC continued to impose non-clinical packaging requirements that made little sense in a sterile, high-precision domain.

The 2025 amendment finally draws a clear boundary:
Healthcare products deserve healthcare-focused regulation.

Conclusion: Regulatory Clarity Restored

The Legal Metrology (Packaged Commodities) Amendment Rules, 2025 represent a restoration of regulatory logic. By freeing medical devices from the constraints of FMCG-style packaging rules, India has:

• Ended a 14-year confusion streak
• Streamlined compliance for manufacturers
• Reduced costs and delays in market access
• Improved alignment with global medical device standards
• Strengthened the MDR 2017 regulatory framework

The result is a cleaner, clearer, and more functional regulatory ecosystem — precisely what a rapidly growing medical devices sector needs as it scales toward global competitiveness.

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