The national drug pricing regulator National Pharmaceutical Pricing Authority (NPPA) has directed Importers and Manufacturers of Orthopaedic Knee Implants for Orthopaedic Knee Replacement System to furnish price data by August 12, 2021 for price monitoring purpose.
The move is aimed at regulating prices of orthopaedic implants used in knee surgeries to prevent unethical profiteering and to ensure affordable and quality healthcare to the masses.
“The requisite data on Orthopaedic Knee Implants for Orthopaedic Knee Replacement System in the prescribed format shall be emailed to email@example.com,” as per a NPPA notice.
NPPA has also directed all medical devices associations to disseminate the information among their member companies and has also shared the format for pricing data of Orthopaedic Knee Implants for Orthopaedic Knee Replacement System
The details have to be submitted on all 18 categories of orthopaedic knee implant products made of different materials along with the name of the company, whether importer or manufacturer, address and contact details, signature, name of the authorized signatory, e-mail id and contact number.
“If imported, specify the actual manufacturer’s name and address, legal manufacturer’s name and address, India authorized agent representative with attached relevant license as per the provisions of Medical Device Rules (MDR – 2017) and renewal/endorsement letter, if any along with the attached copy of bill of entry,” NPPA stated.
The categories specified by NPPA are Femoral (Primary) (Cobalt Chromium alloy), Femoral (Primary)(Titanium alloy), Femoral (Primary)(Oxidized Zirconium alloy), Femoral (Primary) (With Hi Flex Feature), Femoral (Revision), Tibial (Primary) (Cobalt Chromium alloy), Tibial (Primary) (Titanium alloy), Tibial (Primary) (Oxidized Zirconium alloy), Tibial (Primary)(With Hi Flex Feature), Tibial (Revision), Insert (Primary/Revision), Patella (Primary/Revision), Articulating Surface (Primary/Revision), Wedge (Primary/Revision), Augument (Primary/Revision) p) Stem (Primary/Revision) and Bone Cement among others.
The manufacturers and importers also have to specify whether it is imported or domestically manufactured among other details like the price to distributor (PTD) or the price to stockist (PTS) on June 30, 2021, maximum retail price (MRP) on June 30, 2021, quantity sold and moving annual turnover (MAT) for the period from July 2020 and June 2021 and from July 2019 to June 2020.