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NPPA proposes revised ceiling price of gentamicin injection 10m/ml by over 70%

Gireesh Babu, New Delhi
Tuesday, January 31, 2023, 08:00 Hrs  [IST]

The National Pharmaceutical Pricing Authority (NPPA) has proposed a ceiling price reduction of over 70 per cent for a certain formulation of antibiotic drug gentamicin injection from the current price, while leaving the ceiling price of certain compositions of formulations like anticholinergic drug atropine ointment and dermatology drug betamethasone cream unchanged.

The Authority has proposed revising or fixation of ceiling price for 45 formulations as part of its efforts to finalise the ceiling price of formulations included in the revised Schedule I of the Drugs (Prices Control) Order, 2013, which was amended in November by including the National List of Essential Medicines (NLEM), 2022.

According to the draft version of calculation of ceiling price under the revised Schedule I, the price of gentamicin injection 10 mg/ml has been reduced from the current ceiling price of Rs. 3.53 per ml to Rs. 1.04 per ml with a reduction of 70.54%, observing that the minimum price is Rs. 0.90 per ml for Wockhardt's Genta 1 MG injection 20 ml.  The Authority has considered only one pack from Wockhardt while calculating the ceiling price. The maximum permissible price to retailer (PTR) as on March 30, 2022 was Rs. 3.04 per ml, for the formulation.

Ceiling price of atropine ointment 1% has been fixed as Rs. 4.20 per gram, without any change from the current ceiling price. Interestingly, the two products considered during the calculation - one from Jawa Laboratories and another from Bell Pharma - has shown the price per unit at Rs. 5.26 and Rs. 5.05 as compared to the maximum permissible PTR of Rs. 3.62 per gram.

For betamethasone cream 0.1%, the price has been proposed as Rs. 0.93 per gram, which is the same as the current ceiling price. The maximum permissible PTR was 0.80 and the only product listed in the calculation sheet has shown a price per unit of Rs. 3.71, from East West Pharma. NPPA has said that for those products for which the price per unit is higher than the maximum permissible PTR, the Authority has restricted the prices for consideration to the maximum permissible PTR.

The Authority has also proposed ceiling price for newly added formulations in the NLEM, such as the amoxicillin oral liquid 125 mg/5ml, suggesting Rs. 0.92 per ml as ceiling price.

Among other formulations, the NPPA has also proposed a ceiling price of sodium valproate modified release tablets 300 mg at Rs. 5.22 per tablet with around 25.32 per cent reduction from the current ceiling price of Rs. 6.99 per controlled release tablet.

The Authority in its 106th meeting held on December 30, 2022, has said that it has considered the revision of ceiling price of sodium valproate tablet 300 mg, which was notified as a scheduled formulation by the government on December 19, 2022, and decided that the price shall continue to prevail as notified at the time of notification, deferring the agenda to revise the ceiling price.

The Authority has revised and fixed ceiling price of 128 scheduled formulations earlier in January, while it has completed the same procedure for 119 formulations in the month of December, 2022.

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 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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