Last Updated on January 8, 2024 by The Health Master
The National Pharmaceutical Pricing Authority (NPPA) has released a new list of draft calculations of ceiling prices for 69 formulations, as part of fixing the ceiling prices of medicines under the National List of Essential Medicines (NLEM), 2022, which was amended into the Schedule-I of the Drugs (Prices Control) Order, 2013, earlier this year.
Along with the 230 formulations for which the Authority released draft ceiling price calculations in four previous lists, the total number of formulations having a ceiling price calculation released for industry response is now 299.
The latest list, which has been released in three parts, includes draft calculation sheets for ceiling price fixation for:
- Leuprolide acetate power for injection 11.25 mg and 22.5 mg, which are new additions to the NLEM;
- Levothyroxine 62.5 mcg with a price recommendation of Rs 1.44 per tablet (with a 7.69 percent reduction from the current ceiling price);
- Ondansetron 4 mg at Rs. 4.20 per tablet (with a 19.69 percent reduction from the current ceiling price);
- Clindamycin 300 mg at Rs. 16.92 per tablet (0.06%);
- Prednisolone 40 mg at Rs 3.04 per tablet (2.56%);
- Zoledronic acid powder for injection 4 mg at Rs. 2,133.32 per vial (54.27%);
- Adenosine injection 3 mg/ml at Rs. 82.81 per ml (24.26%);
- Ciprofloxacin drops 0.30% at Rs. 1.30 per ml (23.08%);
- Isoflurane liquid for inhalation at Rs. 8.61 per ml (25.84%), among others.
NPPA releases 4th list of draft ceiling prices for 15 formulations
NPPA releases 3rd list with draft ceiling prices for 43 formulations
NPPA releases 2nd list with draft ceiling prices for 43 formulations
NPPA releases draft working sheets for ceiling price fixation of 954 formulations
The ceiling price revision was announced recently after the revision of Schedule 1 of the Drugs (Price Control) Order, 2013 replacing NLEM 2015 with NLEM 2022, notified by the Department of Pharmaceuticals (DoP) on November 11, 2022.
On November 25, it released the draft calculation sheet for 121 drugs as the first phase, and later, a phase II list of 43 formulations and a third phase list of 51 formulations were released seeking industry response.
Click the below link to download the NLEM lists
National List of Essential Medicines (NLEM)
In a recent meeting, the Authority decided to release the draft working sheets for the fixation of ceiling prices of around 954 formulations, comprising 388 medicines, based on the database from market research firm Pharmatrac for the month of July 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 the draft worksheet,” said the Authority.
Further issues regarding the methodology that is likely to come up during the price fixation may be taken up for deliberation in the subsequent meetings of the Authority, it added.
While the total number of unique formulations for which ceiling prices are to be fixed through the move is 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.
The NLEM 2022 has 56 formulations of newly added drugs, while around 763 are continued from NLEM, 2015.
The ceiling price revision is following the revision of Schedule 1 of the Drugs (Price Control) Order, 2013 replacing NLEM 2015 with NLEM 2022, notified by the Department of Pharmaceuticals on November 11, 2022.
As per the provisions of the DPCO, 2013, the ceiling prices for the medicines in Schedule I have to be fixed within 60 days of the notification of the schedule.
While the general practice is that ceiling prices are fixed using 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 the revision in the first schedule, the authority used data beginning in July 2022, paying attention to industry associations’ representations.
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