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Writer's pictureSanjay Trivedi

Medical devices declared as drugs

The rules come in to force with effect from 1st January, 2018

Use of proper, accurate and standard weights and measures are very important for effective functioning of any economy, as it plays an indispensable role in consumer protection as protection from malpractices of under-weight or under-measurement, is an important function of the Government.

The Legal Metrology (packaged Commodities) Rules, 2011 are framed to regulate the pre-packaged commodities. Under these rules, the pre-packaged commodities have to comply with certain mandatory lebelling requirements. Based on the experience of implementation of the Rules and after a detailed stakeholder consultation, the Department has amended the rules, aimed at enhanced consumer protection, but at the same time balancing with the requirement of ease of doing business. Some of the salient features of the amendments are as below:

  • Goods displayed by the seller on e-commerce platform shall contain declarations required under the Rules like name & Address of the manufacturer, packer and importer, name of the commodity, net content, retail sale price, consumer care complaint, dimention etc.

  • Specific mention is made in the rules that no person shall declare different MRPs (dual MRP) on an identical pre-packaged commodity, unless allowed under any law. This will benefit consumers at large as they are having complaint regarding dual MRP for item depending upon different type of public places like Cinema Hall, Airport, Malls etc.

  • Size of letters and numerals for making declaration is increased, so that consumer can easily read the same.

  • The net quantity checking is made more scientific, with introduction of e-coding.

  • Bar Code/QR Coding is allowed on voluntarily basis.

  • Provisions regarding declarations on Food Products have been harmonized with labelling regulations under the Food Safety & Standards Act, 2006.

  • Medical devices which are declared as drugs: Medical Devices such as stent, valve, orthopaedic implants, syringe, Tools for operations etc. Consumers at large were facing difficulty as prices of devices were sold according to the paying capacity of the consumer. Even after capping of MRP many companies were not displaying. Also there are important declarations other than MRP that need to be displayed, are brought into the purview of declarations to be made under the rules.

  • The definition of Institutional Consumer has been changed to prevent any scope for commercial transactions/retail sale of commodities sourced by the institution for their own use.

  • The rules shall come in to force with effect from 1st January, 2018.

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