The National Pharmaceutical Pricing Authority (NPPA) has directed all the manufacturers and importers of the medical devices to submit the maximum retail price (MRP) of the respective products within the next 10 days.
The decision came after the demand for pulse oximeters and oxygen concentrators is on the rise due to the increase in Covid-19 cases.
The move is being seen as a bid to ensure their prices do not escalate and there is no artificial shortage of these products in the market.
The manufacturers or importers of these devices have to comply within next ten June, failing which action may be initiated for violation of provisions of DPCO 2013 read with Essential Commodities (EC) Act 1955.
A pulse oximeter measures blood oxygen saturation and heart rate. If the body is deprived of adequate oxygen supply, which happens in the case of pneumonia caused by COVID-19, it is immediately detected by the device while oxygen concentrator is the vital piece of equipment that supports severe and critical patients who cannot get enough oxygen into their blood by breathing normally.
The Delhi Government had recently announced that it will make arrangements for sending pulse oximeter and oxygen concentrators to Covid-19 patients under home isolation in case their oxygen saturation levels drop.
“This (seeking MRP from the manufacturer and importers) 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,” said an office memorandum (OM) issued by the national drug price regulator NPPA on June 29.
“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 per cent of MRP during the next 12 months,” the order stated.
The NPPA had earlier also directed manufacturers and importers of medical N-95 masks to submit MRP of their products and were also asked 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 WHO had on June 25 warned that many countries are experiencing difficulties in obtaining oxygen concentrators.
WHO Director General Tedros Adhanom Ghebreyesus said that “80 percent of the market is owned by just a few companies, and demand is currently outstripping supply.”