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54 out of 121 formulations have seen their prices reduced between 10-20% from current ceiling price

Gireesh Babu, New Delhi
Wednesday, November 30, 2022, 08:00 Hrs  [IST]

Almost 44 per cent of the 121 drugs for which the drug price regulator has released the draft version of calculation of ceiling prices under the revised Schedule I of Drug (Prices Control) Order, 2013 have seen their prices reduced between 10 to 20 per cent from the current ceiling price. Two formulations have seen prices reduced by more than 50 per cent and three others between 40-50 per cent, according to the draft calculation sheet.

The National Pharmaceutical Pricing Authority (NPPA), as part of fixing the ceiling price based on the revised Schedule-1 of DPCO, 2013 as per the National List of Essential Medicine (NLEM) 2022, released the calculation sheet for 121 drugs including many of the commonly used essential drugs.

Among this, around 54 formulations have seen their prices being reduced between 10-20 per cent under the price calculation. Another 28 out of the 121 formulations have seen the prices reduced by 20-30 per cent, while 11 will have prices reduced below 10 per cent from the existing ceiling prices. Nine formulations will see their prices reduced by 30-40 per cent, if the draft gets through in the current form.

Three formulations - Letrozole 2.5 mg tablet (a reduction of 43.45% from the current ceiling price), temozolomide capsule 20 mg (40.57%), and risperidone 4 mg (43.42%) - has seen the prices reduced by more than 40 per cent of the current ceiling prices.

Ceiling price of vecuronium powder 10 mg for injection, for which there are two companies with a market share of one per cent or above, has been calculated at Rs. 99.45 per vial, which is a 52.63 per cent reduction from the current ceiling price. Ceiling price of bicalutamide 50 mg, for which there are five companies with market share of one per cent and above, has been fixed at Rs. 37.26 per tablet, at 51.09 per cent lower than the current ceiling price.

For the formulations which the ceiling prices has been reduced between 10-20 per cent include paracetamol 650 mg, hydroxychloroquine 400 mg, carbamazepine 400 mg, clobazam 5 mg and 10 mg, levitiracetam 250, 500 and 750 mg, lorazepam 1 and 2 mg, diethylcarbamazine 100 mg, cefadroxil 500 mg, cefixime 400 mg, cycloserine 250 mg, ethionamide 250 mg, levofloxacin 250 mg, 500 mg, and 750 mg, linezolid 600 mg, abacavir 300 mg, nevirapine 200 mg, entecavir 1 mg, clindamycin 150 mg, among others.

Ceiling price of sofosbuvir 400 mg is being calculated at Rs. 468.32 per tablet, with a 36.81 per cent reduction from the current ceiling price, while for darunavir 600 mg it is Rs. 137.73 per tablet with a 25.68 per cent reduction from the current ceiling price.

For 14 formulations, the calculation sheet does not share any indication on the reduction from the current ceiling price.

The Authority in a recent meeting decided to release the draft working sheets for 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.

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 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 (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 the ceiling prices are fixed 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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