The National Pharmaceutical Pricing Authority (NPPA) has released the draft calculation sheet for ceiling price revision of 35 formulations, based on their prices in July, 2022, under the revised Schedule I of Drugs (Prices Control) Order (DPCO), 2013.

The list includes downward price revision proposed for some of the major drugs which have a moving annual total (MAT) of over Rs. 100 crore.

The draft calculation sheet include a 10.66 per cent cut from the current ceiling price of Rs. 1.22 per ml for Lactulose oral liquid 10g/15 ml, to treat chronic constipation and hepatic encephalopathy, which has a total MAT of Rs. 457.40 crore.

There are seven companies with a market share of one per cent and above and the MAT value considered for the price calculation is Rs. 440.87 crore.

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For paracetamol oral liquid 250 mg/5ml, the price has been calculated at Rs. 0.58 per ml, around 12.12 per cent lower than the current ceiling price of Rs. 0.66 per ml. The formulation has a total MAT of Rs. 263.76 crore and the drug price regulator has listed 88 brands available in the market.

Out of this, eight companies have one per cent or more market share for the product and the sum of MAT value considered for price calculation is Rs. 242.4 crore.

The calculation sheet shows a 17.01 per cent price reduction for tranexamic acid 500 mg, the formulation to treat excessive blood loss, from the current ceiling price of Rs. 19.28 per tablet to Rs. 16 per tablet.

Around nine companies have a market share of one per cent or above and the total MAT of the drug is Rs. 115.59 crore.

Mifepristone 200 mg, a medication used along with another medicine to end an early pregnancy, which has four companies with a market share of one per cent or above in the market at present and a total MAT of Rs. 110.40 crore, is proposed to have a price of Rs. 312.96 per tablet, 12.39 per cent reduction from the current ceiling price of Rs. 357.21 per tablet.

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Vitamin B formulation folic acid 5 mg, for which four companies has one per cent or above market share in the country and has a total MAT of Rs. 117.87 crore, is proposed to have a 14.84 per cent price cut to Rs. 1.32 per tablet as against Rs. 1.55 per tablet at present.

The drug regulator has listed out 52 brands which are present in this market.

On December 20, the authority released a draft version of calculation of ceiling price for 31 formulations under revised Schedule I, of DPCO, 2013.

It may be noted that in December, the NPPA has approved the ceiling prices of 119 formulations as part of fixing the ceiling price of formulations in the National List of Essential Medicine (NLEM), 2022, which was recently amended into the Schedule I of the DPCO, 2013.

It has revised the ceiling prices of 69 formulations as compared to the ceiling prices reflected in the draft working sheets uploaded earlier, following representation from various pharma players.

The 119 formulations for which the ceiling prices has been approved include specific strengths of paracetamol, allopurinol, hydroxychloroquine, carbamazepine, clobazam, levetiracetam, lorazepam, mebendazole, cefadroxil, artemether and lumefantrine combination, cefixime, ethionamide, among others.

Out of the 121, fixation of ceiling prices of two formulations dabigartan 110 mg and 150 mg tablets were deferred following representation from Glenmark Pharmaceuticals.

The company submitted that their product is capsule and not tablet in respect of these two formulations and the same was confirmed with Pharmatrac with web sources.

The Authority, in an earlier meeting said that it is planning to fix the 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 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 added.

While the total unique formulations for which ceiling prices are to be fixed through the move are 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 the Schedule I has to be fixed within 60 days from 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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