Last Updated on January 4, 2024 by The Health Master
The National Pharmaceutical Pricing Authority (NPPA) has released the fourth list of draft ceiling price calculations for 15 more drugs, as part of fixing the ceiling prices of medicines under the National List of Essential Medicines (NLEM), 2022, which was amended into Schedule-I of the Drugs (Prices Control) Order, 2013.
Along with the 215 medicines for which the Authority had released draft ceiling price calculations in three previous lists, the total number of formulations having a ceiling price calculation released for industry response is now 230.
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The latest list includes ceiling price calculation sheets for:
- Antidepressant escitalopram 5 mg, 10 mg, and 20 mg (proposed ceiling price of Rs. 4.17 per tablet with 17.5% reduction from current ceiling price, Rs. 7.47 per tablet with 16.91% reduction and Rs. 11.76 per tablet after reduction of 17.24%, respectively),
- Cancer drug gemcitabine power for injection of 200 mg (Rs. 1,018.58 at 21.70% reduction),
- Skin medicine griseofulvin 250 mg (Rs. 1.58 per tablet with 10.73% reduction),
- Antibiotic ceftazidime power for injection 1000 mg (Rs. 190.02 per vial with 18.23% reduction),
- Paracetamol 500 mg (Rs. 0.77 per tablet with 23.76% reduction),
- Nonsteroidal anti-inflammatory drug (NSAID) diclofenac 50 mg (Rs. 1.82 per tablet at 14.55% reduction),
- Anti-convulsant drug carbamazepine 200 mg (Rs. 1.40 per tablet with 9.68% reduction), among others.
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.
In a recent meeting, the Authority decided to release the draft working sheets for the 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.
National List of Essential Medicines (NLEM)
“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 1000 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 (DoP) 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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