The National Pharmaceutical Pricing Authority (NPPA) will take stringent action against the manufacturers of notified orthopaedic implants if they are found to be charging exorbitant prices from the consumers in violation of Drugs & Cosmetics Act.

To examine the price violation, if any, in respect of notified medical devices, manufactured, imported or marketed by the companies, the national drug price regulator has sought detailed information about the prices of notified orthopaedic implants from the manufacturers. The NPPA's action in this regard comes in the wake of the reports in certain sections of print media that the prices of orthopaedic implants regulated as 'drugs' under Drugs & Cosmetics Act & Rules thereunder, are sold at exorbitant price with high profit/trade margin.

The NPPA has asked the manufacturers of notified orthopaedic implants to provide details like product specification with brief description/literature for different types of notified medical devices manufactured/imported by the company and other details like ex-factory price/landed cost (including applicable duties); distributor cost; Maximum Retail Price (MRP); and percentage of increase in MRP (year to year) in the last three years.

The NPPA said that Para 20 of the DPCO, 2013 provides for monitoring the prices of non-scheduled formulations and to ensure that no manufacturer/importer/distributor is allowed to increase the MRP of a non-scheduled drug more than ten percent of MRP during preceding twelve months and where the increase is beyond ten percent, it shall reduce the same to the level of ten percent of maximum retail price for next twelve months. The manufacturers/importer/distributor shall be liable to deposit the overcharged amount along with interest thereon, from the date of increase in price in addition to the penalty.

Further, Para 25 of DPCO, 2013 provides that every manufacturer/importer shall issue a price list and supplementary price list in Form V to the dealer, State Drugs Controller and the Government from time to time. As provided in Para 26 of the said order, no person is authorized to sell any formulation including medical devices regulated as drugs to any consumer at a price exceeding the price specified in the current price list or price indicated on the label of the container or pack thereof, whichever is less.