New Delhi, October 29 (IANS). The Department of Consumer Affairs, Ministry of Consumer Affairs, Food and Public Distribution has notified the Legal Metrology (Packaged Commodities) Amendment Rules, 2025. This important step brings specific provisions for packages containing medical devices, fully aligning the 2011 rules of origin with the 2017 medical device rules.
This amendment will be beneficial to consumers, industry and regulators through regulatory harmonisation, thereby increasing clarity and trust in the healthcare sector.
Under the amendment, the standards of Medical Devices Rules, 2017 for the height and width of figures and letters used in declarations (such as weight, quantity, price etc.) on packages containing medical devices will be applicable. Earlier the 2011 Legal Measurement Rules had different dimensional standards, which created confusion. Now mandatory announcements will remain, but the font size and design will be as per medical rules. This will make labeling more accurate and consumer-friendly.
Additionally, the exemption provided under Rule 33 of the 2011 Rules, which allows flexibility in certain declarations, will no longer apply to medical devices. This ensures that there is no relaxation on health-sensitive products, and only the medical framework requirements remain the priority.
Another important change is that declarations as per legal measurement rules on the main display panel will no longer be mandatory. Instead, these will be made in accordance with the provisions of the Medical Devices Rules. This will simplify packaging design, without impacting safety standards.
This amendment will provide consumers with uniform labeling standards, eliminating confusion caused by overlapping regulations. Providing clear and consistent information on health products will increase consumer confidence, especially in the post-pandemic era of health awareness. Consumer protection will be strengthened by establishing uniform standards for a healthy India.
For the industry, this is a big step towards ‘self-reliant India’. Dual rules will reduce compliance burden, bring clarity and ease of doing business. Businesses will only have to follow one set of standards, reducing costs and increasing export competitiveness. Legal measurement enforcement officers will also have defined jurisdiction, allowing uniform enforcement at the state level.
–IANS
SCH