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The National Pharmaceutical Pricing Authority (NPPA) has released the tenth lot of draft working sheets for 55 scheduled formulations including 17 new formulations and strengths as part of fixing the ceiling prices for the formulations under the revised Schedule I of the Drugs (Prices Control) Order, 2013.
The draft working sheets are published to collect response from the industry on the calculations and the revised ceiling prices, as part of its exercise to revise the prices based on the amended Schedule I, which replaced the National List of Essential Medicines (NLEM), 2015 with the NLEM, 2022, in November, 2022.
The new formulations for which the draft work sheets are published include antibiotic cefuroxime 500 mg, for which around 129 brands are available in the market, cefuroxime injection 1,500 mg, terbinafine cream 1%, ormeloxifene (centchroman) 30 mg tablets, meropenem powder for injection 500 mg and 100 mg (as trihydrate), and nicotine (fornicotine replacement therapy) oral dosage forms 2 mg and 4 mg per lozenge and per gum.
Draft ceiling price calculation for newly added strength of labetalol 100 mg, human chorionic gonadotropin injection 10,000 IU and 2000 IU among others also included in the new lot of calculation sheets.
For insulin glargine 100 IU, newly added medicine in the list of NLEM 2022, the NPPA noted that there are five companies with market share of one percent and above, and the MAT value considered for the price calculation was Rs. 702.78 crore. The ceiling price for the drug is proposed to be fixed at Rs. 189.99 per ml, considering that the minimum price was for Biocon Ltd brand Basalog at Rs. 125.30 per ml and the maximum price is for Sanofi India Ltd’s Lantus at Rs. 232.90 per ml. The average of all prices considered was Rs. 163.78 and with an addition of 16 per cent retailer margin, the Ceiling price without GST was fixed at Rs. 189.99 per ml.
The draft working sheet also proposed price of pain management drug morphine injection 15 mg to be brought down close to 60 per cent from the current ceiling price of Rs. 32.91 per ml to Rs. 13.32 per ml. Ceiling price for cancer medication oxaliplatin injection 5 mg/ml has been proposed to be brought down almost 50 per cent from the current ceiling price of Rs. 4,962 per vial of 20 ml, to Rs. 2,500.38 per vial of 20 ml.
It may be noted that the NPPA has so far approved revision of the ceiling prices of a total of 398 scheduled formulations, listed in the revised Schedule I of DPCO, 2013.
The Authority earlier said that the number of formulations covered in revised Schedule I include 954 formulations in 388 medicines, with 56 newly added drug formulations and ceiling price of all these formulations may undergo a revision with the revised Schedule I of DPCO, 2013. The formulations continued from NLEM, 2015, are around 763 and total unique formulations for which ceiling prices are to be fixed are around 819. However, in view of the expansions to the revised Schedule 1 and others, the number of formulations may increase beyond 954 formulations to around 1000 formulations.
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.
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