New Delhi : The drug price regulator has sought the pharmaceutical manufacturers and marketers to submit price details of a list of 63 formulations as part of its ongoing efforts to fix the ceiling price of the drugs as per the revised Schedule I of the Drugs (Prices Control) Order, 2013.
The National Pharmaceutical Pricing Authority (NPPA) is in the process of fixing the ceiling prices of the formulations listed in the Schedule I of the DPCO, 2013, after it has revised the Schedule replacing the National List of Essential Medicines (NLEM), 2015 with the latest NLEM, 2022.
The Authority has requested all the concerned manufacturers and marketing companies to furnish the Price to Retailer (PTR) and Moving Annual Turnover (MAT) in value terms for the month of July, 2022 in the format it has published in its website. It added that the information may be furnished positively within seven days from the issue of the Office Memorandum in respect to the 63 formulations it has listed based on the NLEM, 2022 revised Schedule I, for enabling the NPPA to take appropriate action for fixation of ceiling prices.
It has sought the details including the name and brand of formulation, composition and strength, dosage and specification, PTR for July, 2022 and MAT sales value as on July, 2022, which is the total sales during August, 2021 to July, 2022.
The list of medicines it has sought the details include zinc sulphate dispersible tablet 20 mg; combination of zidovudine 60 mg, Lamivudine 30 mg, and nevirapine 50 mg; pyridoxine (vitamin B6) 50 mg; midazolam 7.5 mg and 15 mg; labetalol 50 mg; haloperidol 2 mg; griseofulvin 125 mg; folic acid 1 mg; clarithromycin 750 mg; cefadroxil 100 mg; calcium carbonate 625 mg; abacavir 60 mg; vancomycin 125 mg capsule; valganciclovir 450 mg; verapamil injection 50 mg/ml; cyclosporine Injection 50 mg/ml; paromomycin injection 375 mg/ml; morphine injection 10mg and 15 mg/ml; amikacin injection 500 mg/ml; combination of darunavir 600 mg and ritonavir 100 mg; rifampicin capsule 150 mg and 300 mg; diazepam 2 mg; ibuprofen 400 mg; omeprazole 10 mg capsule; zidovudine 300 mg; pyrazinamide 1500 mg; daclatasvir 30 mg; among others.
Recently, for the same purpose, the NPPA has sought all the concerned manufacturers and marketing companies producing and selling oxygen and nitrous oxide for medicine use to furnish the PTR and MAT in value terms for the month of July, 2022 in a prescribed format, within seven days. The Authority said that the information will help it to take appropriate action for fixation of ceiling prices pursuant to the issue of revised Schedule I of DPCO, 2013.
The list of formulations it then sought information include oxygen (for medicinal use) containing not less than 99.0% v/v of O2; Oxygen 93% (for medicinal use); Oxygen (for medicinal use) containing not less than 99.0% v/v of O2 in cylinder; Oxygen 93% (for medicinal use) in cylinder; and nitrous oxide (for medicinal use) containing not less than 98% of N2O. The industry was also asked to enclose a copy of the license.
The Department of Pharmaceuticals, through a notification on November 11, 2022, issued the Drugs (Prices Control) Amendment Order, 2022 revising the Schedule I of the DPCO 2013 with the NLEM 2022. The NLEM 2022 contains 384 medicines, compared to 376 medicines in NLEM 2015.
It has already notified revised ceiling prices of 119 formulations, after releasing a draft calculation sheet and bringing in changes to the draft based on the industry feedback.
While the total unique formulations for which ceiling prices are to be fixed through the move are around 819, in view of the expansions to the revised Schedule 1 and others, the number of formulations may increase beyond 954 formulations to around 1,000 formulations, said the Authority earlier. The NLEM 2022 has 56 formulations of newly added drugs, while around 763 are continued from NLEM, 2015. As per the provisions of the DPCO, 2013, the ceiling prices for the medicines in the Schedule I has to be fixed within 60 days from the notification of the Schedule.
While the general practice is that the ceiling prices are fixed by considering the market-based data for fixing the ceiling price of schedule formulation due to revision in the First Schedule shall be the data available for the month ending immediately before six months of notification of revision in the first schedule, the Authority used the data from July, 2022, paying heed to the representations of the industry associations.