National Pharmaceutical Pricing Authority (NPPA) has allowed medical device companies to submit quarterly stock details for medical devices like Bare Metal Stents, Drug Eluting Stents, Orthopedic Knee Implants and Oxygen Concentrators respectively. This is based on representations received from industry associations that the companies may be allowed to submit quarterly stock details instead of monthly.
A format for submission of quarterly stock details for these medical devices has also been circulated by the NPPA. Medical device manufacturers and importers were earlier directed to submit monthly stock details of these devices. A copy of the order has also been sent to all medical devices associations with a request to disseminate the information among their member companies.
NPPA had in July 2021 fixed the trade margin for five medical devices like Pulse Oximeter, Glucometer, BP monitor, Nebulizer and Digital Thermometer at 70 per cent through a Trade Margin Rationalization (TMR) formula to ensure availability of these devices. In its order dated July 14, 2021, the NPPA had stated that the TMR approach has been taken keeping in mind the extra-ordinary situation as the country is fighting the COVID 19 pandemic.
According to NPPA, 620 products or brands have reported downward revision of MRP by up to 88% after the trade margin rationalization of these 5 medical devices.
The matter was deliberated in the NPPA meeting held on November 15, 2021 and it was decided that the submission of information relating to stock details of aforesaid medical devices may be reported on quarterly basis instead of monthly. Henceforth, the companies are required to submit the stock details of these devices on quarterly basis in the prescribed format starting from quarter ended December 2021.
This is following the Office Memorandum dated February 20, 2018, February 27, 2018, June 09, 2021 in respect of medical devices namely (i) Bare Metal Stents (ii) Drug Eluting Stents (iii) Orthopaedic Knee Implants (iv) Oxygen Concentrators, respectively, wherein, manufacturers/importers were directed to submit monthly stock details.
Format for submission of Quarterly Stock details for medical devices includes name of the company or entity, address of the company or entity, contact details like e-mail id and category of the manufacturer or importer and country of import, stock movement for the quarter (specify the quarter here in MM-YYYY to MM-YYYY format), medical device registration number or license category as per the list issued by CDSCO, product name specification as per DCGI approval, generic name, brand name, imported products specifying the country of origin details of units manufactured and imported with reference to sales and exports and MRP of the product (Rupees Per Unit), signature of the authorized representative, name of the authorized representative, designation with office seal, mobile number and e-mail id.