Introduction
In a significant move to streamline regulatory compliance, the Government of India, through the Ministry of Consumer Affairs, Food and Public Distribution, has introduced the Legal Metrology (Packaged Commodities) Amendment Rules, 2025 ("Amendment Rules"). Published in the Official Gazette on October 24, 2025, this amendment carves out a specific regulatory pathway for medical devices, resolving long-standing ambiguities that arose from the overlapping jurisdictions of the Legal Metrology (Packaged Commodities) Rules, 2011 ("LMPC Rules") and the Medical Devices Rules, 2017 ("MDR, 2017"). This article analyzes the historical context of this dual regulatory framework, details the changes introduced by the amendment, and evaluates its profound impact on the medical devices industry and consumers in India.
The Amendment Rules introduce a pivotal change for the medical device industry by exempting packages containing medical devices from the purview of the LMPC Rules. Instead, such packages will now be exclusively governed by the provisions of MDR, 2017. This move aims to streamline the regulatory landscape, eliminate overlapping compliance requirements, and align packaging and labelling norms with specific regulations designed for the healthcare sector.
Historical Context: A Dual Regulatory Framework
Historically, manufacturers and importers of medical devices in India navigated a complex regulatory landscape. On one hand, the LMPC Rules, enacted under the Legal Metrology Act, 2009, established a general framework for all pre-packaged commodities, mandating specific declarations on packages to protect consumer interests.
On the other hand, the introduction of the MDR, 2017, under the Drugs and Cosmetics Act, 1940, marked a paradigm shift towards a specialized, robust framework exclusively for medical devices. The MDR, 2017, focused on critical aspects which aimed to protect patient safety and traceability, such as the Unique Device Identifier (UDI), warnings, and other device-specific information.
This dual applicability created significant challenges for the industry. Manufacturers were often required to comply with both sets of rules, leading to redundant declarations, conflicting requirements (especially concerning font sizes and declaration formats), and an increased compliance burden.
The 2025 Amendment Rules: Key Changes and Clarifications
The Amendment Rules, significantly streamline medical device regulation by establishing the primacy of the MDR, 2017 over the general LMPC Rules. Specifically, a new proviso to Rule 2(h) mandates that all declarations on medical device packages must comply with the MDR, 2017, overriding the LMPC Rules. Furthermore, provisos to Rules 7(2) and 7(3) ensure that font size and dimension specifications for these declarations are also governed by the MDR, 2017, eliminating previous conflicts and ensuring uniformity. Lastly, a new sub-rule (2) to Rule 33 clarifies that the Central Government's power to grant relaxations under the LMPC Rules will not apply to medical devices.
Impact on the Industry and Consumers
The amendment significantly benefits the medical devices industry by streamlining compliance through a single regulatory source (MDR, 2017), thereby reducing the burden of cross-referencing and mitigating non-compliance risks. This harmonization also leads to reduced operational costs by eliminating the need for dual-compliance checks and varied packaging designs. Furthermore, the clear delineation of applicable law enhances legal certainty, fostering a more predictable business environment, crucial for investment, innovation, and growth within India's medical technology sector.
For consumers and healthcare providers, the amendment ensures greater consistency and clarity in medical device labeling, as all information, including critical data like expiry dates, UDI, warnings, and instructions for use, will now adhere to the single, comprehensive standards of the MDR, 2017. This standardization enhances usability, transparency, and, most importantly, strengthens patient safety by ensuring that clinically relevant information is prioritized and clearly presented on all medical device packaging.
The amendment is a positive step in the evolution of India's regulatory landscape. By resolving the long-standing conflict between the LMPC Rules and the MDR, 2017, the government has provided immense relief to the industry and strengthened protection for consumers. One may see this principle of legislative harmonization extended to other specialized sectors, such as pharmaceuticals or specific food products. This thoughtful amendment not only streamlines compliance but also reinforces India's commitment to creating a clear, predictable, and robust regulatory environment conducive to the growth of the vital medical devices sector.
Authors:
Sidhartha Srivastava, Senior Partner
Yasmeen Sabir, Principal Associate
Jahnvi Pandey, Associate
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