The National Pharmaceutical Pricing Authority (NPPA) has released the second set of draft ceiling price calculations, for 43 formulations, as part of fixing the ceiling prices for the medicines under the National List of Essential Medicines, which were added into the Schedule-1 of DPCO, 2013.

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 now, the Phase II list has been released seeking industry response.

Out of the 43 formulations in the second list, almost 28 are proposed to have a price reduction of between 10-20 per cent compared to the current ceiling price, while eight will have the prices reduced below 10 per cent and six with reduction between 20-30 per cent from the current ceiling prices. One drug will see the ceiling price decline by more than 30 per cent, in the list.

The combination of piperacillin 4 gm and tazobactam 500 mg powder for injection has been recommended at Rs. 315.82 per unit as compared to the current ceiling price of Rs. 487.76, with a reduction of 35.25 per cent according to the draft working paper. There are around 16 companies which have a market share of one per cent and above for the drug, which has a Moving Annual Total (MAT) of Rs. 423.17 crore considered for price calculation.

The lowest price reduction, according to the second list is for prednisolone 5 mg tablet, proposed at Rs. 0.61 per tablet, as compared to Rs. 0.62 per tablet current ceiling price, which is a 1.61 per cent reduction. While there are two companies which have a market share of one per cent and above for the drug, the draft calculation sheet has listed out ten brands from pharma players including Pfizer, Lupin, Mankind Pharma, Macleods Pharma, Medopharm, Psychotropics India, among others.

For antibiotic formulation cefixime 200 mg, which has a total MAT of around Rs. 591 crore and 13 major players with market share of one per cent and above, the prices has been fixed at Rs. 8.40 per tablet, as compared to Rs. 10.66 per tablet, with a 21.20 per cent reduction. The NPPA also lists out around 222 brands for the formulation with the specified strength and different package size, being in the market at present.

The first list of draft calculation of ceiling prices of 121 drugs, including many of the commonly used essential drugs, released by NPPA earlier had almost 44 per cent witnessing a price reduction between 10-20 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.

Around 54 drugs out of the 121 are proposed to have their prices reduced between 10-20 per cent, while another 28 are expected to see the prices reduced by 20-30 per cent. Around 11 drugs are proposed to 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.

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.

“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 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.
https://thehealthmaster.com/2022/12/02/nppa-releases-2nd-list-with-draft-ceiling-prices-for-43-formulations/