The National Pharmaceutical Pricing Authority (NPPA) has directed all the manufacturers and importers of pulse oximeter and oxygen concentrator to submit maximum retail price (MRP) of respective products. This has been done to do price monitoring under Para 20 of Drugs Price Control Order (DPCO)-2013 to ensure that no manufacturer/importer can increase more than ten per cent of MRP during the next 12 months.
Drugs Price Control Order – 2013
Through an office memorandum (OM), all the manufacturers or importers of pulse oximeters and oxygen concentrators have been directed under para 29 of DPCO 2013 to submit MRP details in the prescribed format within 10 days of issue of this order. A soft copy of the same shall also be sent to the medicaldevices-nppa@gov.in manufacturers/importers of medical devices are supposed to ensure compliance of the provisions of para 20 of DPCO 2013 failing which action may be initiated for violation of provisions of DPCO 2013 read with Essential Commodities (EC) Act 1955.
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“This is with reference to the gazette notification dated March 31, 2020 wherein it was notified that medical devices which have been notified as drugs under the provisions of DPCO 2013 with effect from April 1, 2020. In this regard, this is to reiterate that with effect from April 1, 2020 MRP of pulse oximeter and oxygen concentrator shall be monitored under Para 20 of DPCO -2013 to ensure that no manufacturer and importer can increase the MRP more than 10% of MRP during the next 12 months,” the order stated.
NPPA had earlier 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).
A soft copy of the aforesaid format containing MRP details shall also be emailed to the following email id-medicaldevices-nppa@gov.in. To ensure the availability of N-95 masks at the revised MRPs as per price control compliance, NPPA had earlier issued a list of price reduction in N-95 masks by four major N-95 mask manufacturers, namely Venus Safety and Health Pvt Ltd, Magnum Health and Safety, Yash Care Life Sciences and Joseph Leslie & Co.
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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