NPPA directs Pulse Oximeter & Oxygen Concentrators to submit MRP

This notice is in reference to the Gazette Notification dated March 31, 2020 issued by NPPA for regulation of medical devices under DPCO-2013

The National Pharmaceutical Pricing Authority (NPPA) has directed all manufacturers / importers of Pulse Oximeter and Oxygen Concentrators to submit maximum retail price (MRP) details as per Para 29 of the Drugs Prices Control Order (DPCO) 2013 in the prescribed format within seven days i.e. latest by May 22, 2021 to regulate prices of these medical devices in the wake of C-19 pandemic.

This notice is in reference to the Gazette Notification dated March 31, 2020 issued by NPPA for regulation of medical devices under DPCO-2013 read with Essential Commodities (EC) Act, 1955 with effect from April 1, 2020.

 

Accordingly, MRP of medical devices cannot be increased more than ten per cent (10%) in a year.

In view of the above, all manufacturers or importers of aforesaid medical devices are hereby advised to ensure compliance of the provisions of Para 20 of the DPCO, 2013 failing which action may be initiated for violation of provisions of DPCO, 2013 read with EC Act, 1955.

“Medical devices industry associations of Pulse Oximeter and Oxygen Concentrator namely MTaI, AiMeD, CII, FICCI, USIBC, AMCHAM, AdvaMed are hereby directed to disseminate this office memorandum among its member companies and shall ensure compliance of the same,” NPPA in a notice stated.

 

NPPA had last year also directed manufacturers and importers of medical N-95 masks to submit MRP of medical N-95 masks. Manufacturers of N95 masks were also advised to obtain requisite certification from Bureau of Indian Standards (BIS) expeditiously.

Major manufacturers and importers of medical N95 masks have reduced their prices up to 67% of the MRP (the details of such manufacturers/importers has also been shared by the NPPA).

The national drug price regulator also shared the revised MRPs reported by these manufacturers of N-95 masks with the state drug controllers (SDCs).

The list indicates that the makers of N-95 masks reduced the cost of their products, some even up to 47 per cent, after NPPA issued an advisory on May 21, 2020 recommending manufacturers to voluntarily lower prices.

NPPA had also asked manufacturers, importers, suppliers of the N-95 masks to maintain parity in prices for non-government procurement and make them available at the same reasonable prices.

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