The Department of Pharmaceuticals (DoP), 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, according to a statement by the Indian Drugs Manufacturers Association (IDMA).
The order is with regard to the Indian Drugs Manufacturers Association’s (IDMA) views on notification No. S.O. 3249 (E), dated 12th August, 2021, relating to amendment in DPCO 2013, Para 18(i).
The statement by the IDMA said, “The 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.”