Legal Metrology Division urges to ensure compliance of Rules 26 on Medical Devices

This rule deals with exemptions related to certain packaged commodities but excludes any exemption for medical devices that are declared as drugs

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Medical Device
Medical Device

Last Updated on January 2, 2024 by The Health Master

Legal Metrology Division

The Legal Metrology Division, a part of the Union Ministry of Consumer Affairs, Food, and Public Distribution, has recently issued a directive to the Controllers of Legal Metrology in all states and Union Territories.

The directive aims to ensure strict adherence to the provisions outlined in the Legal Metrology (Packaged Commodities) Rules, 2011, specifically concerning medical devices.

Exemption Clarification:

In a letter addressed to the controllers, the Legal Metrology Division highlighted a crucial aspect of Rule 26 of the Legal Metrology (Packaged Commodities) Rules, 2011.

This rule deals with exemptions related to certain packaged commodities but excludes any exemption for medical devices that are declared as drugs.

Rule 26 in detail states:

  • The rules do not apply to any package containing a commodity if it contains scheduled and non-scheduled formulations covered under the Drugs (Prices Control) Order, 2013, which falls under Section 3 of the Essential Commodities Act, 1955 (10 of 1955).
  • However, it is important to note that the exemption does not extend to medical devices that have been classified as drugs.

Retail Sale Price Disclosure:

Additionally, the Legal Metrology Division addressed Rule 6(1)(e) of the Rules, 2011, which pertains to the retail sale price of packaged commodities.

According to this rule, the maximum retail price (MRP), inclusive of all taxes, must be clearly indicated on the package in Indian currency.

The rule provides specific guidelines for packages containing alcoholic beverages or spirituous liquor:

  • The applicable State Excise Laws and the Rules made under them shall be in effect within the state where the package is manufactured.
  • If the state excise laws and the associated rules do not require a declaration of the retail sale price, the provisions of the Legal Metrology (Packaged Commodities) Rules, 2011 shall be applicable.

Furthermore, the rule states that if the retail sale price of any essential commodity is fixed and notified by the Competent Authority under the Essential Commodities Act, 1955, that fixed price shall be applicable.

Compliance Directions:

The Legal Metrology Division has explicitly instructed the Controllers of Legal Metrology to issue suitable directions to their field officers, ensuring full compliance with the Rules.

The directive also addresses the scenario where prices are subject to revision by the Government / NPPA (National Pharmaceutical Pricing Authority) / any other Statutory Body.

In such cases, industries may revise the prices in accordance with the notification issued by the respective Government / NPPA / Statutory Body.

Conclusion:

The recent directive from the Legal Metrology Division emphasizes the importance of adhering to the Legal Metrology (Packaged Commodities) Rules, 2011, with specific attention to medical devices classified as drugs.

Compliance with these rules is vital for ensuring transparency and fairness in the pricing and sale of packaged commodities, ultimately benefiting both consumers and manufacturers alike.

Disclaimer: This article contains information derived from Pharmabiz. Our team utilized an AI language model, to rewrite and present the news / article in a unique format.

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