Introduction
The medical devices sector in India is undergoing rapid transformation, driven by evolving regulations, technological advancements and growing healthcare demands. It is expected to grow to $20.51 billion by 2029. The demand for imported medical devices increased by 21% between November 2022 and October 2023, totalling medical device imports of INR 61,262.84 crore ($7.23 billion)[1]. The regulatory ambit governing medical devices in the country has seen significant reforms aimed at ensuring safety, quality and accessibility. For healthcare products, where precision and reliability are vital, stringent labelling regulations serve as a cornerstone for ensuring safety, quality, and consumer confidence. The regulatory framework for labelling of medical devices in India is governed by multiple legislative frameworks, each designed to uphold stringent standards.
As India pushes for self-reliance in medical device manufacturing under the ‘Make in India’ scheme and the Government’s targeted focus on improving ease of doing business in the country, aligning labelling norms with global standards has become crucial for both domestic market expansion and international trade. This blog delves into key labelling requirements and the evolving legal landscape shaping the medical devices industry in India.
Labelling Regulatory Framework
Medical Devices Rules, 2017
The Drugs and Cosmetics Act, 1940 (“D&C Act”), which is the umbrella legislation in India, regulates approvals pertaining to manufacturing, imports, and distribution of drugs. In terms of Section 3(b)(iv) of the D&C Act, read with Gazette Notification no. SO 648(E), dated February 11, 2020, all devices (including software) intended by its manufacturer to be used especially for human beings or animals that do not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of inter alia diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorderhave been notified as ‘drugs’, with effect from April 1, 2020.
Accordingly, all medical devices fall within the general ambit of drugs under the D&C Act framework. The Medical Devices Rules, 2017 (“MD Rules”), regulate the classification, manufacturing, importation, sale and distribution of medical devices in India. Further, the MD Rules lay down a comprehensive framework for labelling of medical devices and Chapter VI thereunder provides detailed labelling requirements aimed at ensuring product safety, effective use, and traceability.
Under the MD Rules, the label on the shelf pack or the outer cover of the medical device (along with every outer covering in which the medical device is packed) is required to state (in indelible ink) the name of the medical device and the details necessary for the user to identify the device and its use. Furthermore, the prescribed labelling particulars are required to include the name of the manufacturer, address of the manufacturing premises, the net quantity of the device, the month and year of manufacturing and expiry (or the shelf-life of the product). In case of sterile devices, the date of sterilisation must be provided.
Additionally, the label must also mention distinctive batch numbers, along with the manufacturing license number, specific storage or handling conditions, and any warnings or precautions for the consumer. For imported devices, it is necessary to state the import license number, name and address of the importer, address of the manufacturing premise, and the date of manufacturing. Additionally, from the notified date, all medical devices are required to state a unique device identification.
Legal Metrology (Packaged Commodity) Rules, 2011
The Legal Metrology (Packaged Commodity) Rules, 2011 (“LM Rules”), promulgated under the Legal Metrology Act, 2009, aim to ensure consumer transparency and accountability in the labelling of pre-packaged goods. The LM Rules are designed to safeguard consumer interests by mandating clear and accurate labelling. It is interesting to note that while drugs are exempted from the LM Rules, such exemptions do not extend to medical devices.
Under the LM Rules, every package is required to state certain prescribed declarations on the principal display panel of the package, wherein the declarations are required to be grouped together and mentioned in one place. The height of any number and letter in such declarations is required to comply with the specifications prescribed under the LM Rules. The prescribed declarations are to be made in a definite, plain, and conspicuous manner. It also inter alia needs to include the name and address of the manufacturer/ importer, country of origin, generic name of the product, net quantity, month and year in which the commodity is manufactured, best before date (if applicable) and retail sale price, indicating the MRP (inclusive of all taxes). Further, to facilitate ease of doing business for importers, the LM Rules permit affixation of stickers (stating the mandated declarations) on the package. Additionally, the LM Rules also require e-commerce entities (or the seller entity, as the case may be) to display the prescribed declarations in respect of the packages being displayed to consumers on online platforms/ websites.
In response to increasing medical device imports and improving ease of doing business for importers/ distributors of medical devices in India, the Department of Consumer Affairs, on February 10, 2025, has published the Draft Legal Metrology (Packaged Commodities) Amendment Rules, 2025[2](“Draft LM Rules”), for stakeholder comments till March 12, 2025. These amendments aim to simplify the labelling requirements of medical devices, making them consistent with the declarations required under both LM Rules and MD Rules. For instance, regarding the requirement to make declarations on the principal display panel under the LM Rules, the Draft LM Rules suggest that for packages containing medical devices, the MD Rules will apply for declarations anywhere on the package. Additionally, it is proposed that packages containing medical devices will adhere to the provisions of the MD Rules in relation to the height and width of any numeral and letter used in declarations.
Concluding Thoughts
The labelling requirements for medical devices, as outlined in the MD Rules and the LM Rules, share several common objectives, including ensuring product safety, traceability, and consumer protection. However, these overlapping regulations present challenges for manufacturers and importers of medical devices, who are required to navigate two labelling regulatory regimes. This may lead to increased complexity in label design and production, as stakeholders must ensure that all required information is stated in accordance with the specifications of both sets of regulations. Furthermore, differences in specific requirements for information placement and declaration formats may further complicate compliance efforts.
The introduction of the Draft LM Rules is an attempt to bridge the gap between the two sets of labelling regulations as the amendments propose that the MD Rules are to be followed for certain aspects of labelling, such as placement of declarations and the height and width of numerals and letters, instead of the LM Rules. This effort will simplify the compliance process and help stakeholders streamline their operations. As the regulatory landscape continues to evolve, these initiatives hold promise for creating a more navigable and efficient framework. Such Government initiatives are also in-line with the policy objectives of regulatory streamlining envisaged under the National Medical Devices Policy, 2023 (refer to our previous blog post – The National Medical Devices Policy, 2023: A Closer Look at Strategy and Implementation).