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Showing posts with the label Medical device regulations India

NPPA Caps Prices Of Oxygen Concentrators Through Trade Margin Rationalization

  The National Pharmaceutical Pricing Authority or NPPA has capped the price for oxygen concentrators. With the help of the trade margin rationalization approach. It has been capped at the first point of sale of a product known as the price to the distributor according to the prescribed formula by invoking paragraph 19 of Drugs Prices Control Order 2013. It is because of the enhancement in demand because of the pandemic. An oxygen concentrator is a non-listed medical device and, at present, under the individual licensing framework of CDSCO. It falls under the purview of medical device regulations in India . Moreover, due to the pandemic, the government has marked it as an important commodity and fixed its price. The formula that has been prescribed for the Maximum retail price is Price to distributor + (PTD *TM) + applicable GST, TM = Trade margin that does not exceed 70%. It is also recommended that the manufacturer's cap MRP of the oxygen concentrator submit all data contai