NPPA directs N95 Mask manufacturers, importers to obtain BIS certification, share details

New Delhi: Through a recent Office Memorandum (OM), the National Pharmaceutical Pricing Authority (NPPA) has directed all the manufacturers and importers of N95 Masks to obtain the requisite certification from Bureau of Indian Standards (BIS) expeditiously and submit the requisite information in the prescribed format (Annexure-II) under Para 20 of the DPCO, 2013 by July 3, 2020.

The notification further stated that a soft copy of the said format containing MRP details should also be e-mailed to medicaIdevices-nppat@gov.in.

The details of the prescribed format read;

This came after it was observed that non-standard Medical N-95 flasks are being supplied in the market. In this regard, it is stressed that the Government promotes the selling of certified MedicaI N-95 Masks (BIS/NIOSH/FFP-2) only. Thus, the manufacturers of Medical N-95 Masks are advised to obtain the requisite certification from the Bureau of Indian Standards (BIS) expeditiously.

The OM also directed to refer to the Gazette Notification issued by NPPA wherein it was notified that Medical Devices which have been notified as Drugs shall be governed under the provisions of DPCO, 2013 w.e.f. 1st April 2020.

"In this connection, this is to reiterate that w.e.f. 1st April 2020, Maximum Retail Prices (MRPs) of Medical N-95 Masks shall be monitored under Para 20 of the DPCO, 2013 to ensure that no manufacturers/importers can increase the MRP more than ten percent of MRP during the next twelve months," NPPA said.

Further, it is informed that after issuing an Advisory by the Government, major manufacturers/importers of Medical N-95 Masks have reduced their prices up to 67% of the MRP. In this connection, other manufacturers/importers of Medical N-9S Masks are also advised to bring down the retail price in the public interest due to pandemic conditions prevailing in the country.

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