Ministry of Consumer Affairs issues Direction for implementation of exemptions under the Legal Metrology (Packaged Commodities) Rules, 2011 on Medical Device

The Ministry of Consumer Affairs (“Ministry”) has issued an order reiterating the following provisions of the Legal Metrology (Packaged Commodities) Rules, 2011 (“Rules”) (on Medical Devices) to ensure implementation of the same:

1. Rule 26 which deals with Exemption in respect of certain packages-

The Rules will not apply to the packaged commodities if it contains scheduled formulations and non-scheduled formulations covered under the Drugs (Price Control) Order, 2013 made under section 3 of the Essentia/ Commodities Act, 1955 (10 of 1955)

The Rule further provides that no exemptions will be applicable to medical devices declared as “Drugs”.

2. Rule 6(1)(e) which deals with retail sale price of the package-

The retail sale price of the package should clearly indicate the maximum retail price, inclusive of all taxes in Indian currency.

The Rule further provides that for packages containing alcoholic beverages or spirituous liquor, the State Excise Laws and the rules made there under will be applicable within the State in which it is manufactured and where the state excise laws and rules made there under do not provide for declaration of retail sale price, the provisions of these rules will apply.

The Ministry has further requested Controller of Legal Metrology of States and Union Territories to issue suitable directions to field Officers to ensure the compliance of the said provisions of Rules. If the prices are allowed to be revised by the Government/ NPPA/ any other Statutory Body, then the industries may be allowed to revise the prices as per the Notification issued by Government/ NPPA/ any other Statutory Body.

Please refer to the document hyperlinked below for a detailed read of the Order.

Source: The Ministry of Consumer Affairs

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