1 / 4

NPPA Releases Office Memorandum On Monitoring Of Mrps For Medical Devices

The MRP of a non-scheduled medical device is under the regulation under the Drugs and Cosmetics Act, 1940. They are under the governance of provisions of para 20 of the DPCO 2013.

dollyd
Download Presentation

NPPA Releases Office Memorandum On Monitoring Of Mrps For Medical Devices

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. NPPA Releases Office Memorandum On Monitoring Of Mrps For Medical Devices NPPA or The National Pharmaceutical Pricing Authority, while exercising its authority of para 29 of Drugs Prices Control Order or DPCO-2013, has ordered all manufacturers as well as importers of non- scheduled medical devices to provide all price-based information. The manufacturers and importers have to submit in a given format, which a practicing chartered accountant duly recognizes. The submission has to be done within 21 days of issuing an office memorandum dated 16.2.2021. It has been implemented for the sole purpose of price checking exercises. The MRP of a non-scheduled medical device is under the regulation under the Drugs and Cosmetics Act, 1940. They are under the governance of provisions of para 20 of the DPCO 2013. In addition, para 25 of DPCO 2013 directs that all manufacturers and importers must issue a complete list of prices along with a supplementary list of prices. They have to issue this in Form V to the dealer state drugs controllers as well as infrequent government intervals. Contact No: +91 7672005050 Email: contact@cliniexperts.com

  2. In the earlier notification, NPPA said that all medical devices are drugs per the DPCO 2013 from April 2020. It is in continuation of the notification dated February 11, 2020. To keep an eye on the maximum retail price of non-scheduled medical devices beneath para 20 of DPCO 2013 through OM dated May 12 2017.NPPA accumulated all price-based information for every 19 categories of non-scheduled medical devices. It was for the year 2014 - 2017. Then again, the union health ministry, through a notification dated 3, 2018 and December 27, 2019, notified another four medical devices. So, effective from April 1 2020, every medical device must be under the Contact No: +91 7672005050 Email: contact@cliniexperts.com

  3. Government's regulation as drugs for the sole purpose of quality control and price supervision. Thus, we can say that the MRPS of all medical devices will remain under the supervision of the Government under the provision Para 20(1) of the DPCO 2013. It makes sure that no manufacturer or importer can Contact No: +91 7672005050 Email: contact@cliniexperts.com

  4. enhance the MRP of the drug more than a total of ten per cent of the MRP during the previous 12 months. Furthermore, where enhancement in price exceeds ten per cent of the overall retail price, it will decrease the same to a level of ten per cent of the extreme retail price for the coming twelve months. Both manufacturer and importer are also liable for deposing the overcharged price in addition to the interest from the date of enhancement in price along with the penalty. Government is responsible for regulating about 24 types of medical devices, which are notified as drugs as per the D&C Act, 1940 and D&C rules 1945. Contact No: +91 7672005050 Email: contact@cliniexperts.com

More Related