The National Pharmaceutical Pricing Authority (NPPA) has released the third phase list of draft ceiling price calculations for 51 formulations, 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.

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Along with the 164 medicines for which the Authority released draft ceiling price calculations in two previous lists, the total number of formulations for which a ceiling price calculation has been released for industry response is now 215.

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The third phase of the list includes the computation of ceiling prices for:

- Thalidomide 50 and 100 mg capsules with a reduction of 29.09% and 18.47% respectively from the current ceiling price,

- Clonazepam 0.25 mg, 0.5 mg, and 1 mg (15.76%, 14.16%, and 14.89%),

- Metronidazole 200 mg, and 400 mg (3.95% and 4.23%),

- Ibuprofen 200 mg (23.08%),

- Acetazolamide 250 mg (16.95%),

- Azithromycin 250 mg - which has around 179 brands in the market (17.66%) and azithromycin 500 mg with around 253 brands (17.68%),

- Ciprofloxacin 250 mg (21.30%),

- Imatinib 100 mg (29.45%),

- Salbutamol 2 mg and 4 mg (16.67% and 10%),

- Amoxicillin + clavulanic acid 500mg+125 mg, which is sold in around 302 brands in the market (22.66%)

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The list also has the newly added medicine in NLEM 2022, the antiviral drug tenofovir alafenamide fumarate (TAF) 25 mg, with a ceiling price of Rs. 42.73 per tablet, without goods and services tax (GST).

Prices for the antibiotic rifampicin 450 mg are proposed to be reduced by 11.86% per capsule compared to the current ceiling price of Rs. 5.48 per capsule.

Prices for the antiretroviral combination lamivudine 150 mg + zidovudine 300 mg are proposed to be reduced by 17.73% from the current ceiling price of Rs. 22.28 per tablet.

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, as 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 was released seeking industry response.

Click 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 for 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 the 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 the 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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