NPPA Extends Ceiling Price On Knee Implants Upto September 15

Mumbai, 18 Aug 2020:

The national drug pricing regulator, National Pharmaceutical Pricing Authority (NPPA) has extended ceiling price on knee implants from the earlier date of August 15, 2020 to September 15, 2020 which was earlier applicable for a period of one year from August 16, 2019 till August 15, 2020.

This is in continuation to the notifications issued by NPPA dated August 16, 2017 and dated August 13, 2018 regarding fixation of ceiling price of orthopaedic knee implants issued under Para 19 of the Drug Price Control Order (DPCO-2013).

As per a notification, NPPA stated that ceiling price of orthopaedic knee implants will be monitored as per the provisions of Paragraph 20(1) of the DPCO- 2013. NPPA has reviewed the matter of price monitoring of knee implants and found that knee implants have become affordable because of price capping exercise as per DPCO-2013. As per the data submitted by manufacturers and importers, there has been an increase of 30 per cent in the sales of knee implants during July 2018 to June 2019 due to price control.

The NPPA has directed companies manufacturing and importing orthopaedic knee implants to furnish price data by July 26, 2020 for price monitoring purpose. As per a NPPA notice recently, importers and manufacturers of knee implants for knee replacement system were directed to furnish data relating to orthopaedic knee implants by July 26, 2020. The requisite data in the prescribed format shall be emailed on medicaldevices-nppa@gov.in.

A format was released by the NPPA asking for details from these companies like whether implant is imported or domestically manufactured, last import price or manufacturing cost as on June 30, 2020, price to distributor or price to stockist (PTD/PTS), price to retailer as on 30 June, 2020, maximum retail price (MRP) as on 30th June, 2020, quantity sold and moving annual turnover (MAT) as on 30th June, 2020.

Government fixed the ceiling prices of orthopaedic implants used in knee surgeries to prevent unethical profiteering and ensure affordable and quality healthcare for the common man.

NPPA had imposed price ceiling on knee replacement systems and categorized knee implants into two major categories - Primary Knee Replacement Systems and Revision Knee Replacement Systems.

In each category, there are four sub-categories - Femoral Component, Tibial Component or Tibial Tray, Articulating Surface or Insert and Patella. Under four sub-categories, there are super-sub-categories distinguishable on the basis of feature or material such as titanium alloy, oxidized zirconium, Hi-flex, cobalt chromium, polyethene etc.

As per the data analysis of NPPA, there was huge margin in trade which was found to be unreasonable and in a way unethical profiteering. NPPA, while fixing the ceiling prices, has kept all the new technology implants in mind and prices have been fixed accordingly. NPPA had earlier notified that ceiling price of orthopaedic knee implants should not be increased beyond 10 per cent in a given year. Orthopaedic knee implants were brought under price control two years ago to make it affordable to the common man.

As per the data analysis of NPPA, price control was required as there was huge margin in trade of orthopaedic knee implants which led to unreasonable and unethical profiteering. “In continuation to the Notifications issued by National Pharmaceutical Pricing Authority, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India vide S.O. 2668(E) dated August 16, 2017, S.O. 3987(E) dated August 13, 2018 and S.O. 2934(E) dated August 13, 2019 regarding fixation/revision of ceiling prices of the orthopaedic Knee Implants for Knee Replacement System issued under Para 19 of the DPCO, 2013, the ceiling prices as applicable to the orthopaedic Knee Implants for Knee Replacement System up to August 15, 2020 are hereby extended up to September 15, 2020, the NPPA notification stated. Pharmabiz