Based on the National List of Essential Medicines (NLEM), 2022, the National Pharmaceutical Pricing Authority (NPPA) updated and established the ceiling price for 79 scheduled formulations in the revised Schedule I of the Pharmaceuticals (Prices Regulation) Order, 2013. The Authority evaluated 84 formulas at its most recent meeting on February 21, 2023, for which it had already made draught working sheets available and had used the pricing regulator’s allotted 10-day period for companies to react. The Authority evaluated and accepted the remaining 84 formulations after taking the industry submissions into account. Of the 84 formulations, the Authority disagreed on the establishment of ceiling pricing for five formulations for various reasons.
920 representations have been made, according to the NPPA, and companies have submitted copies of invoices with revised Price to Retailer (PTR) and screenshots of sample packets with revised Maximum Retail Price (MRP). The complaints fell into two categories: those relating to worksheet data, such as the PTR considered as of July 2022 Pharmatrac database is not reflecting the Wholesale Price Index increase accessed by the company in April 2022, and others; and those relating to methodology, which the Authority claimed it had already discussed in previous meetings.
It has compared the updated ceiling prices of 38 of the 79 formulations to the ceiling prices shown in the draught uploaded working sheets and cross-checked the claims relating to the data in worksheets. The drugs for which ceiling prices were fixed include cyclosporine capsule 50 mg and 100 mg, adrenaline injection 1 mg/ml, morphine injection 10 and 15 mg/ml, filgrastim injection 300 mcg, erythropoietin Injection 2000 and 10000 IU/ML, glucose injection 25%, prednisolone drops 1%, gentamicin injection 10 mg/ml, atropine drops 1% and ointment 1%, ciprofloxacin ointment 0.3%, insulin intermediate acting (NPH) injection 40IU/ml, rifampicin oral liquid 100mg/5ml, rabies vaccine, salicylic acid ointment 6%, among others.
It was resolved to re-evaluate the ceiling price of the cancer medicine oxaliplatin injection 5 mg/mL in 20 ml vial based on the formulations it had taken into consideration during the meeting. The price fixation of four formulations of the antibiotic medicine gentamicin injectable has also been postponed, with the decision made on the grounds that the NLEM 2022, unlike the previous list, contains provisions to fix the ceiling pricing on a per-ml basis. The costs of the formulations were set on a per-pack basis under the NLEM, 2015. The Authority published the pricing per pack for various ranges of pack sizes in the draught work sheets.
“However, given that the formulations come in a variety of container sizes, the ceiling pricing are proposed on a per-ml basis for various pack size ranges. After considering the issue, the Authority decided that the draught work sheets for these formulations might be uploaded again for ten working days. As a result, the Authority postponed the planned ceiling prices for the commodities.
It should be noted that the NPPA has already approved the prices for 400 of the 509 formulations for which the draught working sheets were uploaded on its website. With the addition of these 79 medications, there will be approximately 479 formulations with ceiling prices revised or fixed as per the revised Schedule I of the DPCO, 2022. A total of 74 new medications, including an anti-diabetes drug combination consisting of dapagliflozin and vildagliptin, a sitagliptin and metformin combination, and formulations from other companies’ Teneligliptin and Pioglitazone, have had their retail prices set by the Authority at its most recent meeting.
After revising the Schedule to replace the National List of Essential Medicines (NLEM), 2015 with the most recent NLEM, 2022, the NPPA is now determining the ceiling pricing for the formulations listed in Schedule I of the DPCO, 2013. The Authority previously said that there are 954 formulations in 388 medicines that are covered by the updated Schedule I, including 56 newly added pharmacological formulations. Around 763 of the formulations from NLEM, 2015 are still in use, and there are a total of 819 distinct formulas for which ceiling prices need to be set. The number of formulations, however, may rise from 954 formulations to close to 1000 formulations in light of the expansions to the updated Schedule 1 and other factors.
