NPPA fixes ceiling price of 97 formulations, revises prices of 31 fixed in December

New Delhi, January 7, 2023:

A meeting of the National Pharmaceutical Pricing Authority (NPPA) has approved the revised ceiling prices of 97 scheduled formulations as part of its efforts to fix the price of the formulations under the revised Schedule I of the Drugs (Prices Control) Order, 2013 based on the National List of Essential Medicines (NLEM), 2022.

The Authority, which has finalised the methodology of ceiling price fixation in a meeting held on November 23, 2022 and finalised the prices of 117 formulations through notifications in December 19, has once again revised the prices of 31 out of these 117 formulations in its latest meeting based on the data submitted by the companies.

The Authority, in its 106th meeting held under the Chairmanship of Kamlesh Kumar Pant, chairman of NPPA, on December 30, 2022, observed that the draft ceiling prices for 178 formulations were released by the NPPA for 10 working days to invite comments from December 15 to 27, 2022. Out of this, the Authority approved 97 formulations in the meeting.

This include scheduled formulations such as sulfasalazine tablet 500 mg, digoxin tablet 0.25 mg, ethambutol tablet 600 mg, phenytoin tablet 300 mg, atazanavir 300 mg + ritonavir 100 mg tablet, ceftriaxone powder for injection in 250 mg, 500 mg, 1000 mg and 2000 mg strengths, cefotaxime powder for injection 250 mg, 500 mg, and 1000 mg, piperacillin and tazobactam combinations, ampicillin powder for injection 500 mg, metoprolol tablet 25 mg and 50 mg, among others.

The Authority was appraised that till the date of the meeting, around 620 representations from the companies were received within the prescribed time lines of 10 days and companies have submitted copy of invoice showing the revised Price to Retailer (PTR) and snapshots of sample pack showing revised Maximum Retail Price (MRP).

The representations were broadly related to data in working sheets - such as the Pharmatrac database, which the NPPA relies for price fixation, for the month of July, 2022 was not reflecting the Wholesale Price Index (WPI) increase availed by the companies in April, 2022, incorrect pack sizes being considered among others - and those related to methodology. The representations received on methodology were the same as already deliberated in the previous meeting on December 15, 2022, it added.

The Authority meeting observed that the issues related to methodology was already decided in the 104th meeting.However, it has cross verified the claims by companies through the representations related to data with the Form II and Form V submitted by the companies till May 15, 2022 in its filing system. The one percent market share data has been considered on the basis of Pharmatrac database and any other database, if quoted by any company in its representation, is not considered for assessment, it added.

Based on the representations, the Authority revised the prices of 74 formulations, out of the 97 approved now, as compared to the ceiling prices reflected in the draft uploaded working sheets.

The meeting further looked at the industry requests related to 31 scheduled formulations for which the ceiling prices were fixed based on the revised schedule I of DPCO and notifications were issued on December 19, 2022. These drugs were among the 119 scheduled formulations the Authority approved during the time.

The Authority noted that the companies have complied with the DPCO provisions and submitted the appropriate form within the prescribed time, before revising the prices. The prices were revised for certain strengths of telmisartan, donepezil, amlodipine, glimepride, moxifloxacin, levetiracetam, clarithromycin, levofloxacin, paracetamol, clobazam, risperidone, zolpidem, atorvastatin, haloperidol, metformin, among others.

The NPPA is in the process of fixing the ceiling prices of the formulations listed in the Schedule I of the DPCO, 2013, after it has revised the Schedule replacing the National List of Essential Medicines (NLEM), 2015 with the latest NLEM, 2022.

The Authority has earlier said that the number of formulations covered in revised Schedule I include 954 formulations in 388 medicines, with 56 newly added drug formulations. The formulations continued from NLEM, 2015, are around 763 and total unique formulations for which ceiling prices are to be fixed are around 819. However, 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.

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 by 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. PharmaNews