The NPPA Sets a Price Cap on Nine Planned Formulations, one of which is a Medication for Brain Cancer

Nine more formulations have had their ceiling prices set by the National Pharmaceutical Pricing Authority (NPPA), bringing the total number of formulations notified with updated prices under the Drugs (Prices Control) Order (DPCO), 2013—a revised Schedule I based on the National List of Medicines (NLEM), 2022—to 700. At its most recent gathering, the Authority determined to implement the DPCO, 2013’s monopoly rules while fixing the prices of temozolomide 20 mg and 250 mg formulations for brain cancer drugs, with approximate price reductions of 27-8.5% and 21.15%, respectively.

Additionally, since all of the businesses that were taken into consideration for the draught worksheet stated that their products were capsules rather than tablets as stated in the uploaded draught worksheet, it removed the suggested pricing of 100 mg temozolomide tablets from the discussions to determine the costs. It should be mentioned that this formulation received one of the sharpest price reductions of any of the lot, with the 100 mg temozolomide tablet being suggested to be priced at Rs. 594.10 per unit instead of the current ceiling price of Rs. 1,925.47. The recent meeting that set the cap prices for the other nine scheduled formulations did not discuss this suggestion.

The cost of temozolomide 20 mg was lowered from 466.49 to Rs. 336.63 per tablet, with a 27.8% reduction, and the cost of temozolomide 250 mg was lowered from Rs. 4,765.73 to Rs. 3,757.94, with a 21.5% reduction. The draught worksheet recommended a 30% drop to Rs. 330.51 for temozolomide 20 mg tablets and a 35% cut to Rs. 3,098.21 for temozolomide 250 mg tablets. The NPPA claimed that under Paragraph 6 of the DPCO, 2013, the ceiling prices for these two formulations were uploaded without the use of monopoly discounts.

However, only one company qualified with a market share of more than 1% based on the representation received on the inappropriate dosage form. As a result, ceiling price is set by implementing monopoly reduction in accordance with DPCO, 2013 Paragraph 6(1),” the NPPA stated following the meeting. The draught worksheet took into account the pricing for temozolomide 20 mg from two different companies: Samarth Life Sciences, which had 1.39 percent brandwise MAT (Rs. 180 per tablet), and Cadila Pharmaceuticals, which had 98.61 percent brandwise MAT (Rs. 328.24 per tablet). The average of these costs was then calculated.

Similar to this, the cost of the 250 mg temozolomide tablets was determined by taking into account the prices of two manufacturers: Samarth Life Sciences, which had a 3.50 percent brand-wise MAT (costing Rs. 1,100 per tablet), and Dr. Reddy’s Laboratories, which had a 96.47 percent brand-wise MAT (costing Rs. 3664.22 per tablet), and averaging these costs. On October 16, 2023, the price control authority proposed a revised price for the antibacterial drug combination cotrimoxazole, the immunosuppressive drug tacrolimus, the painkiller tramadol, and zinc sulphate in the 17th lot of the draught version of the ceiling price calculation.

According to the Authority, it received seven representations for five formulations from different companies. These representations included the following: the calculation sheet indicated the incorrect dosage form; the price to retailer considered as per the July, 2022 Pharmatrac database is not reflecting the Wholesale Price Index increase availed by the companies in April, 2022; and the related matter of taking into account the MR variant in addition to the conventional variant when the MR variant is separately included in the schedule. The Authority stated that these representations and claims have been cross-checked against the Form-II/Form V that the corporations filed in the Integrated Public Database Management System (IPDMS) till May 15, 2022.

The costs of 691 formulations included on the National List of Essential Medicines (NLEM) 2022 have been announced by the Authority. With the nine additional formulas’ ceiling prices set, 700 amended prices have been notified in total. According to Schedule I of the DPCO, 2013, which was updated in November 2022 based on the NLEM, 2022, the NPPA has started adjusting the ceiling prices. The Authority said in July that the pricing of 915 scheduled formulations would remain fixed until the middle of the month.

691 of the 915 planned formulations with ceiling prices set until July 17, 2023, were changed using the NLEM, 2022, while 224 were revised using the NLEM, 2015. Compared to the ceiling pricing set under NLEM, 2015, the average drop in ceiling price for 600 formulations—aside from the 91 newly added formulations out of the 691 formulas—due to price refixation under NLEM, 2022 comes out to be 16.71 percent. With the Wholesale Price Index (WPI) rising by 12.1218 percent starting on April 1, 2023, the refixation of ceiling prices under NLEM 2022 led to a net reduction of 6.73 percent.

Note that the NPPA published a draught calculation sheet in November of last year, which sets the ceiling prices for scheduled formulations under the amended Schedule I in multiple lots. Following the distribution of the draught calculation sheet, the stakeholders had ten days to provide their representation. According to the NPPA, the corporations have made many statements to it about the calculation and the technique used for price fixing. The Authority introduced a methodology to fix prices based on the principles of the DPCO, 2023, after taking into consideration a number of trends, including the high inter-brand price variation among the same formulations from a single company. The Authority provided several explanations and made a few additions to the methodology.

Based on the database from the market research firm Pharmatrac for the month of July 2022, the Authority stated in November 2022 that new prices will be determined for about 954 formulations in total, encompassing 388 medicines in total, as part of the ceiling price fixing and revision operation. The Authority stated that although there are around 819 distinct formulations for which ceiling prices must be set by the change, the number of formulas may rise to approximately 1,000 due to the expansions to the new Schedule 1 and other areas.

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