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 tag information by August 12, 2021 for price tag monitoring objective.
The move is aimed at regulating costs of orthopaedic implants utilised in knee surgeries to protect against unethical profiteering and to make certain economical and top 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 protected],” as per a NPPA notice.
NPPA has also directed all healthcare devices associations to disseminate the details amongst their member firms and has also shared the format for pricing information of Orthopaedic Knee Implants for Orthopaedic Knee Replacement System
The particulars have to be submitted on all 18 categories of orthopaedic knee implant items made of various components along with the name of the corporation, no matter if importer or manufacturer, address and speak to particulars, signature, name of the authorized signatory, e-mail id and speak to quantity.
“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 amongst other individuals.
The producers and importers also have to specify no matter if it is imported or domestically manufactured amongst other particulars like the price tag to distributor (PTD) or the price tag to stockist (PTS) on June 30, 2021, maximum retail price tag (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.