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by Arazy Group | Mar 30, 2017
India’s National Pharmaceutical Pricing Authority (NPPA) has now made it mandatory for manufacturers and importers to print maximum retail prices (MRP) on the packaging of 22 medical devices that are classified as drugs under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945.

The listed devices/drugs, which include catheters, heart valves, tubal rings and surgical dressings, are non-scheduled formulations as per para 2(v) of the Drugs Price Control Order (DPCO), 2013 issued under section 3 of Essential Commodities Act (E.C. Act), 1955, and accordingly, the sale of these is governed by the provisions of DPCO, 2013.  All manufacturers are advised to ensure compliance with the provisions of DPCO, 2013 in sale of aforesaid non-scheduled formulations to avoid action against any violation under the provisions of the order read with E.C. Act 1955.

A memorandum issued by the NPPA states that paragraph 25 of DPCO, 2013 casts an obligation on every manufacturer in respect of display of prices of non-scheduled formulations and pricelist thereof. In addition, it states: “As per paragraph 25[1], every manufacturer of aforesaid non-scheduled formulations intended for sale shall display indelible print mark, on the label of the container of the formulation and the minimum pack thereof offered for retail sale, the maximum retail price (MRP) with the word “Maximum Retail Price” preceding it and the words ‘inclusive for all taxes’ succeeding it.

“As per paragraph 25(2) of DPCO, 2013, every manufacturer shall issue a price list of the above non-scheduled formulations in Form – V to the Dealers, State Drug Controllers and the Government indicating changes, from time to time. Every retailer and dealer are required to display the price list under paragraph 25(3) of the DPCO, 2013.”

No person shall sell any formulation to any consumer for higher than the price specified in the current price list of price indicated on the label of the container or pack thereof, whichever is less.

The government monitors the prices of such non-scheduled formulations. Every manufacturer is required to mandatorily comply with the provisions of paragraph 20(1) of the DPCO, 2013, by not increasing the MRP more than 10% of MRP during the preceding 12 months. If they do not comply, they shall be liable to deposit the overcharged amount with interest thereon from the date of increase in price addition to the penalty as per paragraph 20(2) of DPCO, 2013. 

Contact us today to discuss the MRP requirements and to discover how regulatory intelligence and registration management system LICENSALE.COM® assists MedTech firms in gaining access to 100+ markets faster and more cost-effectively than ever before.



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