NEWS DETAILS Legal Metrology Division Directs State Controllers To Ensure Compliance Of Rules 26 On Medical Devices

New Delhi : The Legal Metrology Division under the Union ministry of consumer affairs, food and public distribution has requested the Controllers of Legal Metrology in all states and Union Territories to ensure compliance of the provisions under the Legal Metrology (Packaged Commodities) Rules, 2011 on Medical Devices.

The Division, in a letter to the controllers, pointed out that the Rule 26 of the Legal Metrology (Packaged Commodities) Rules, 2011, related to exemption in respect of certain packages, does not provide any exemption to the medical devices declared as drugs.

The Rule 26 states that nothing contained in the rules shall apply to any package containing a commodity if it contains scheduled formulations and non-scheduled formulations covered under the Drugs (Prices Control) Order,2013 made under Section 3 of the Essential Commodities Act, 1955 (10 of 1955).

“Provided that no exemption shall be applicable to medical devices declared as drugs,” says the Rule.

The Rule 6(1)(e) of the Rules,2011 provides that the retail sale price of the package shall clearly indicate that it is the maximum retail price inclusive of all taxes in Indian currency.

This rule provides that for packages containing alcoholic beverages or spirituous liquor, the State Excise Laws and the Rules made there under shall 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, provisions of these Rules shall apply, it said.

“Provided further that if the retail sale price of any essential commodity is fixed and notified by the Competent Authority under the Essential Commodities Act, 1955 the same shall apply,” it added.

“Therefore, it is requested to issue suitable directions to your field officers to ensure the compliance of the 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 the Government/NPPA/any other Statutory Body,” directed the Division.

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