NPPA extended the deadline to April 15 for manufacturers of non-scheduled medical devices for submitting the price related data for the sole purpose of supervising price exercise.
The earlier deadline was March 11, 2021, but it got extended to April 15 2021. On February 16, 2021, NPPA published an office memorandum that ordered them to submit all price based data in a perfect format for about 24 categories of Non-scheduled medical devices.
Prior to the notice, NPPA obtained representation from several companies as well as industry associations for extending the submission date for depositing the required data. As a result, a consultation meeting was held along with the industry associations on March 11, 2021, about the whole matter. A decision was taken to extend the date to April 15.2021.
The maximum retail price or MRP of a non-scheduled medical device under the regulation of Drugs and Cosmetics Act 1940 is under the governance of Para 20 of DPCO 2013. Furthermore, Para 25 of DPCO 2013 offers that all manufacturers and importers must issue a price list and a supplementary list of prices in form V of the dealer state drug controller and Government frequently.
All this is done to effectively monitor the price program of about 19 medical devices out of a total of 23 medical devices, which is considered as drugs as per the Drugs and Cosmetics Acts. NPPA said it in a memorandum.
These devices mainly include
- Catheters
- Heart Valves
- Disposable intravenous syringes as well as needles
- Surgical dressings.
It was observed that several manufacturers and importers have not to submit the required data in a proper format. Therefore, for exercising the price movement of medical devices, the step was undertaken to give ample time to companies to make their submissions.
