The National Pharmaceutical Pricing Authority (NPPA) has warned of strict action against the medical devices manufacturers who are found to be violating the mandatory printing of maximum retail prices (MRP) on notified medical devices as 'drugs' under the Drugs and Cosmetics Act (D&C Act), 1940 and the Drugs and Cosmetics Rules, 1945 and other instructions.

The national drug price regulator's warning comes in the backdrop of the fact that it has come to the knowledge of NPPA that several medical devices are available in the market and also being used in healthcare facilities where no MRP is printed on the package by manufacturers/importers, which is a blatant violation of law of the land.

The government had notified 22 medical devices as drugs under the D&C Act. Aforesaid medical devices/drugs 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 (EC Act), 1955. Accordingly, the sale of these medical devices (non-scheduled formulations) are governed by the provisions of DPCO, 2013.  

The medical devices classified as 'drugs' are Disposable Hypodermic Syringes,  Disposable Hypodermic Needles, Disposable Perfusion Sets, In vitro Diagnostic Devices of HIV HBsAg and HCV, Catheters, Intra Ocular Lenses,  I.V.Cannulae, Bone Cements, Heart Valves, Scalp Vein Set, Orthopaedic implants, Internal Prosthetic Replacements, Blood Grouping Sera, Ligatures, Sutures and Staplers, Tubal Rings,  Surgical Dressings, Umbilical Tapes, Blood/Blood Component Bags, Drug Eluting Stent, Cardiac Stents (BMS), Condoms and Intra Uterus Devices.

Out of this list, Drug Eluting Stent, Cardiac Stents (BMS), Condoms and Intra Uterus Devices are 'scheduled drugs' under DPCO, 2013 and under price control of NPPA.
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The NPPA further said that paragraph 25 of DPCO, 2013 casts an obligation on every manufacturer in respect of display of prices of non-scheduled formulations and price list thereof. 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 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.

As per paragraph 26 of DPCO, 2013, no person shall sell any formulation to any consumer at a price exceeding the price specified in the current price list of price indicated on the label of the container or pack thereof, whichever is less, it said.

It is pertinent to mention here that, the prices of such non-scheduled formulations are monitored by the Government under paragraph 20 of DPCO, 2013. 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 preceding twelve months, otherwise 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.

All the manufacturers are advised to ensure compliance of provisions of DPCO, 2013 in sale of aforesaid non-scheduled formulations to avoid action against any violation under the provisions of DPCO, 2013 read with EC Act 1955, it warned.