In line with its efforts to revise the ceiling price of formulations under the revised Schedule I of the Drugs (Prices Control) Order, 2013, which was amended last year with the National List of Essential Medicines (NLEM), 2022, the National Pharmaceutical Pricing Authority (NPPA) revised or fixed ceiling prices for over 160 scheduled formulations in its most recent meeting. Following the application of the Wholesale Price Index (WPI) rise of 12.128% in accordance with the Authority’s ruling on March 27, 2023, the new ceiling prices for all formulas may be announced.
The Authority took up issues for finalising the ceiling prices of 171 formulations in its meeting held on March 29, 2023, after having uploaded the revised or newly fixed ceiling price calculation sheet for approximately 659 formulations up until March 20 and approving 481 of them in previous meetings. It has received a total of 1065 submissions from businesses about the data in worksheets and those concerning methodology within the allotted time frame of 10 working days up through March 21, 2023.
In accordance with Paragraph 4 of the DPCO, 2013, which deals with the calculation of the ceiling price of a scheduled formulation of a specified strengths and dosages based on the calculation methods mentioned in the Paragraph, the Authority approved the ceiling prices for 80 scheduled formulations following consideration. This include certain strengths and dosage forms of ivermectin, diltiazem, clotrimazole, amoxicillin, cholecalciferol, bupivacaine, azithromycin, pheniramine, esmolol, permethrin, iohexol, caffeine, tetanus toxoid, vitamin A, vitamin C, dexamethasone, acetylsalicylic acid, haloperidol, doxorubicin, methotrexate, ifosfamide, loperamide, metoprolol, among others.
The price fixation has been postponed for the formulations of gentamicin injection 40 mg/ml (pack of 2 ml) and dexamethasone injection 4 mg/ml (pack of 20 ml), as the Authority instructed to revise the worksheet for these two formulations because the ceiling prices may be fixed on a per ml basis for various pack sizes already available on the market rather than making the range for pack sizes as proposed. The Authority considered the price fixation and set prices based on the pricing of the other strengths of the same formulation for some formulations, including budesonide respirator solution, paclitaxel injection, and various strengths of enoxaparin injection.
Under Section 6 of the DPCO, 2013, it has also set the ceiling price for 54 scheduled formulations, including specific strengths of ethambutol tablet, tramadol capsule, omeprazole capsule, cyclophosphamide tablet, haloperidol tablet, nitrofurantoin oral liquid, azathioprine tablet, lorazepam injection, amoxicillin powder for injection, mannitol injection, diltia. It has to do with setting the maximum price for a scheduled formulation in the event that there is no price decrease brought on by a lack of competition. The Authority also denied the claim made in some submissions that two different techniques had been used for commonly used formulas and newly added formulations under NLEM, 2022, claiming that it was “not tenable.” The comment relates to the setting of the ceiling price for newly added formulations in NLEM 2022, where interbrand variance is observed to be greater than 10%.
The NPPA previously resolved to lower the price difference while fixing the ceiling pricing of the formulations by capping the price of the least expensive brand or pack size + 10% after seeing substantial inter-brand differences of the same formulation of a company. “According to Paragraph 20(1) of DPCO, 2013, the producer must lower prices for non-scheduled formulations to a level equal to 10 percent of MRP for the following twelve months if price increases exceed 10 percent of MRP. Therefore, in situations where non-scheduled formulations have become subject to NLEM, 2022 for the first time, the manufacturers must lower the price to the level of 10% if there is a price difference between brands for the same formulation of a company that is greater than 10%, according to the Authority.
“In light of this, for formulations that have been included under NLEM 2022 for the first time, the PTR of various brands or pack sizes of a formulation of a particular company have been capped at price of the lowest brand or pack size plus 10%, an existing reference under DPCO, 2013, and the ceiling prices have been calculated as per the methodology prescribed as per Paragraph 4 or Paragraph 6, as the case may be, of DPCO, 2013. Furthermore, monitoring under Paragraph 20 is carried out at the formulation level, not the brand level. Any infraction of Paragraph 20 should not serve as a foundation for setting price ceilings in accordance with NLEM, 2022. In light of this, the current technique complies with DPCO, 2013’s rules. Since two separate approaches have not been used for Common Formulations and Newly Included Formulations under NLEM 2022, the assertion made in the submissions that they have is unjustifiable, the Authority continued. The Authority then decided to announce the prices of the 27 newly added formulas. Together with other things, it has set the maximum price for atracurium injection (10 mg/ml) and dobutamine injection (50 mg/ml).
