Medical devices will have to display key information, including retail price, country of origin, customer care details and dimension on the packing itself to allow consumers to make informed decisions when purchasing the items.
According to a report by The Economic Times (ET) on Friday, the Department of Pharmaceuticals (DOP) was informed of this through a letter sent from the Department of Consumer Affairs (DoCA).
According to the report, DoCA is enforcing a provision in the Legal Metrology Act of 2009 and the Legal Metrology (Packaged Commodities) Rules of 2011 on medical devices. Legal Metrology (Packaged Commodities) Rules, 2011 mandate a proper declaration of the price, size, dimension and country of origin either on the packaging itself or on a secure label attached to the package.
The size and dimension are only applied to products where the size may be relevant either in relation to the unit sale price or by way of customer care details according to the tender.
The Association of Indian Medical Device Industry (AiMeD), Association of Diagnostic Manufacturers of India (ADMI), and Surgical Dressings Manufacturers Association of India (SDMAI) requested that the ministry of health and Central Drugs Standard Control Organisation (CDSCO) be allowed to amend the packaged commodity rules for drugs, cosmetics and medical devices.
These associations had also requested that DoCA enforce and regulate Legal Metrology (Packaged Commodities) Rules, 2011, to ensure consumer protection, as reported by the ET.
Also Read
These forms of discussion and regulations have allowed DoCA to take decisive steps in order to enforce the Act that has been present for over 10 years now.
The changes should come as a relief to consumers who are looking to make more informed decisions when purchasing pharmaceutical products, as the market and range of products have expanded considerably.
Legal Metrology Act, 2009 aims to establish, govern and enforce weight and measurement standards for trade and commerce. It can apply to individuals who use any weight or measure for a transaction or industrial production, as well as manufacturers, retailers, dealers, etc, who work with weight, measure or number-related items.
The packaged commodities rules extend to all retailers, dealers and importers who sell, distribute, display or store for the purpose of selling any commodity. They are required to follow the packaging provisions and rules respective to the item and industry.
