DoP takes measures to mandatorily revise ceiling prices of drugs every five years

Amends Para 18(i) of DPCO 2013 as per a notification issued on August 12, 2021
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The Department of Pharmaceuticals, under the Ministry of Chemicals and Fertilizers, has decided that the ceiling price for formulations specified under SCHEDULE – I will be mandatorily fixed every five years. This order has been brought to effect with an amendment in paragraph 18 of the Drugs Prices Control Order (DPCO), 2013, as per a notification issued on August 12, 2021.

It also informed that this Order may be called the Drugs (Prices Control) Third Amendment Order, 2021 and shall come into force on the date of its publication in the Official Gazette.

The Indian Drug Manufacturers Association (IDMA) lauded this and said that this move will bring down drug prices further. In a statement, it informed, “Para 18(i) of the DPCO 2013 entailed revision of the ceiling price, either when the NLEM is revised or five years from the date of fixing the ceiling price, whichever was earlier. The notification dated 12th August 2021 delinks the NLEM from Para 18(i). The implication is that although ceiling prices are revised every year, they will be further mandatorily revised every five years. This will result in bringing down prices below the notified ceiling price as many brands of scheduled formulations are sold below the ceiling price. The IDMA has made multiple representations to all the regulatory authorities requesting Para 18(i) to be deleted and that pharmaceutical companies be allowed to apply the notified ceiling price from the next prospective batch to ensure ease of doing business.”

DoPDPCO 2013drug pricingDrugs (Prices Control) OrderIDMAIndian Drug Manufacturers' AssociationMinistry of Chemicals and FertilizersPara 18(i)
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