New Delhi: The National Pharmaceutical Pricing Authority (NPPA) has sought the manufacturers and marketing companies of 134 scheduled formulations and four IV fluids to furnish pricing data related to these products for the month of October, 2023.
This is in line with the Authority’s earlier decision to fix ceiling price of formulations based on the price database for October, 2023, instead of its previous mandate to take the database for the month July, 2022. The ceiling prices under the revised Schedule had been fixed till the second half of January, 2024, using the July, 2022 database.
However, in an Authority meeting held on January 24, 2024, it has decided to use the price database from October 2023 for fixation of ceiling prices for the rest of around 225 formulations for which it has to fix ceiling price under the revised Schedule I of the Drugs (Prices Control) Order (DPCO), 2013.
The NPPA has now directed the concerned manufacturers and marketing companies to furnish the data in respect of Price to Retailer (PTR) and Moving Annual Turnover (MAT) (total sales during November 2022 to October, 2023) in value terms for the month of October, 2023 in a format provided by the price regulator. The information was sought to be furnished positively within ten days from the issue of the Office Memorandum, which was released on June 5, 2024. The details has been sought for 134 formulations and four IV fluid formulations including glucose, glucose+sodium chloride, sodium chloride, and ringer lactate.
The Authority, in its meeting in January, 2024, observed that based on the decision in a meeting held on November 23, 2022, till January 24, 2024, it has fixed ceiling prices of 700 formulations under the National List of Essential Medicines (NLEM), 2022 using the July, 2022 database. Further, ceiling prices of around 225 formulations were to be fixed with the new database.
Drawing a comparison to the previous ceiling price revision exercise based on the NLEM, 2015, the Authority noted that the NLEM was notified as Schedule I in March, 2016 and the database of August 2015, which is six months prior to date of notification of the Schedule I, was considered while fixing the prices. However, after promulgation of Para 9(7) with effect from January 3, 2019, ceiling prices were fixed under NLEM, 2015 considering the database of the month of August 2015 as well as other months.
It also observed that the October 2023 database used for price fixation would capture the PTR duly revised based on the Wholesale Price Index (WPI) for 2023 as availed by the companies.
“Accordingly, it was decided to use October 2023 database and the month of October, 2023 for fixation of ceiling prices of remaining formulations under NLEM, 2022 under Para 9(7) of DPCO, 2013,” added the Authority after the meeting.
The Para 9(7) of the DPCO, 2013, which was added to the Order through an amendment in January 3, 2019, states that notwithstanding anything contained in this paragraph, for fixing or revising the ceiling price for formulations, the Government may, if it is necessary so to do, consider market based data available for any month, as deemed fit.
The Authority has so far been fixing the ceiling prices under the revised Schedule I of the DPCO, which was amended last year replacing the National List of Essential Medicines (NLEM), 2015 with the NLEM, 2022, and notified by the Department of Pharmaceuticals (DoP) on November 11, 2022.
When the NPPA announced its methodology for the revision of prices based on the revised Schedule I, in November, 2022, it decided that data for July, 2022 and Pharmatrac database of July, 2022 shall be considered for fixation of ceiling prices under the latest NLEM.
The Authority has in November, 2022 said that the ceiling price fixing and revision exercise would see new prices fixed for around 954 formulations in total, comprising 388 medicines in total, based on the database from the 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.