The Ministry of Consumer Affairs, Food and Public Distribution has issued a notice clarifying the applicability of Legal Metrology (Packaged Commodities) Rules, 2011 in respect of Medical Devices.
Rule 26 of the Legal Metrology (Packaged Commodities) Rules, 2011 states the ambit of exemption from the purview of the Rules. One of its clauses stipulate that the rules do not apply to a commodity if it contains scheduled or non-scheduled formulations under the Drugs (Price Control) Order, 2013. However, no exemption is provided to medical devices declared as drugs.
Hence, the notice emphasizes that as per the Legal Metrology (Packaged Commodities) Rules, 2011 if the retail sale price of any essential commodity is fixed and notified by the competent authority under the Essential Commodities Act, 1955, it shall apply.
Therefore, if the Government or National Pharmaceutical Pricing Authority (NPPA) or any other statutory body revises the prices of such commodities, the industries must be permitted to revise their prices as per the notifications issued by such bodies.