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Gireesh Babu, New Delhi January 10 , 2023
The National Pharmaceutical Pricing Authority (NPPA) has released the draft version of calculation of ceiling prices for 45 formulations under the revised Schedule I of the Drugs (Prices Control) Order, 2013. The list is released after the Authority has fixed and notified the ceiling price of 97 formulations in its meeting held on December 30, 2022.

The list includes prices calculated for almost nine formulations with a Moving Annual Turnover (MAT) of over Rs.100 crore, which are expected to see a downward revision of ceiling price, according to the draft calculation sheet released by the Authority.

Those formulations in the over Rs.100 crore segment include amoxicillin 200 mg + clavulanic acid 5 ml (Rs. 287.17 crore MAT) with a calculated ceiling price of Rs. 1.70 per ml (15% reduction from the current ceiling price); carboxymethylcellulose drops 0.5 per cent (Rs. 286.20 crore MAT) with a calculated ceiling price of Rs. 10.66 per ml (24.88% reduction); rituximab injection 10 mg/ml (Rs. 160.10 crore MAT) with a calculated ceiling price of Rs. 593.84 per ml (29.49% reduction); erythropoietin injection 10000 IU/ml (Rs. 141.35 crore MAT) with a calculated ceiling price of Rs. 1,698.39 per ml (41.20 % reduction); ondansetron injection 2 mg/ml (Rs. 135.28 crore MAT) with a calculated ceiling price of Rs. 4.91 per ml (24.35% reduction); and azithromycin oral liquid 200mg/5ml (Rs. 130.07 crore MAT) with a calculated ceiling price of Rs. 2.83 (17.25% reduction).

The others above Rs. 100 crore MAT in the list include salbutamol inhalation (MDI/DPI) 100 mcg/dose (Rs. 105.83 crore MAT) with a calculated ceiling price of Rs. 0.44 per MDI without any price reduction; Cefixime oral liquid 100 mg/5ml (Rs. 104.34 crore MAT) with a calculated ceiling price of Rs. 2.11 per ml (11.72% reduction); and cefixime oral liquid 50mg/5ml (Rs. 101.16 crore MAT) with calculated ceiling price of Rs. 1.42 per ml (12.35% reduction). The Authority said that this is the eighth lot of draft version of calculation sheets it has released in order to revise the ceiling prices of the scheduled formulations under the revised Schedule I of the DPCO, 2013, based on the National List of Essential Medicines (NLEM), 2022.

The Authority had finalised the methodology of ceiling price fixation in a meeting held on November 23, 2022 and finalised the prices of 117 formulations through notifications on December 19. In its latest meeting held at the end of December the Authority once again revised the prices of 31 out of these 117 formulations based on the data submitted by the companies.

The meeting on December 30, also approved the revised ceiling prices of 97 scheduled formulations as part of its efforts to fix the price of the formulations.

The 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.

“Companies may submit their representations to NPPA on the draft working sheets supporting their Price to Retailer (PTR) and Moving Annual Turnover (MAT) data along with supporting documents like copies of invoices to retailers and samples of July, 2022 in order to take necessary action in this regard. Such representations should reach NPPA within 10 working days of the upload of draft worksheet,” added the Authority. Further issues regarding methodology that are likely to come up during the price fixation may be taken up for deliberation in the subsequent meetings of the Authority, it maintained.

The Authority has earlier said that the number of formulations covered in revised Schedule I include 954 formulations in 388 medicines, with 56 newly added drug formulations. 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 1,000 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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