NPPA fixes ceiling prices of 79 scheduled formulations, retail price of 74 new drugs

New Delhi, March 2, 2023 :

The National Pharmaceutical Pricing Authority (NPPA) has revised and fixed the ceiling price of 79 scheduled formulations in the revised Schedule I of the Drugs (Prices Control) Order, 2013, based on the National List of Essential Medicines (NLEM), 2022.

The Authority, in its latest meeting held on February 21, 2023, considered 84 formulations, for which it had earlier released the draft working sheets and completed the 10-day time frame allowed by the price regulator for the companies to respond to the draft work sheets.

Of the 84 formulations, the Authority differed on the fixation of ceiling prices for five formulations, for various reasons, while the rest were considered and approved by the Authority after considering the industry representations.

NPPA said that it has received a total of 920 representations till February 17, 2023 and companies have submitted a copy of invoice showing the revised Price to Retailer (PTR) and snapshots of sample packs showing revised Maximum Retail Price (MRP). The representations were broadly covered under two categories - those related to data in worksheets such as that the PTR considered as per July, 2022 Pharmatrac database is not reflecting the Wholesale Price Index increase availed by the company in April, 2022 and others; and those related to methodology, which the Authority said that it has deliberated already in the previous meetings.

It has cross-checked the claims related to the data in worksheets and revised ceiling prices of 38 of the 79 formulations as compared to the ceiling prices reflected in the draft uploaded working sheets.

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.

From the formulations it considered during the meeting, it decided to recheck the ceiling price of cancer drug oxaliplatin injection 5 mg/mL in 20 ml vial. Similarly, it has also decided to defer the price fixation of four formulations of antibiotic drug gentamicin injection, pointing out that the NLEM 2022, unlike in the previous list, has provisions to fix the ceiling prices on per ml basis. Under the NLEM, 2015, the prices of the formulations were fixed on a per pack basis.

The Authority in the draft work sheets, uploaded the prices on a per pack basis for different ranges of pack sizes.

“However, considering the fact that the formulations are available in different pack sizes, the ceiling prices are proposed on a per ml basis for different ranges of pack sizes. The Authority deliberated on the matter and directed that draft work sheets for these formulations may be uploaded again for 10 working days,” said the Authority. Accordingly, the proposed ceiling prices of the items were deferred by the Authority.

It may be noted that the NPPA has so far approved prices of 400 out of the 509 formulations for which the draft working sheets were uploaded in its website, and with the addition of these 79 drugs, the total number of ceiling prices revised or fixed as per the revised Schedule I of the DPCO, 2022 is around 479 formulations.

The Authority, in its latest meeting, has also fixed retail price of 74 new drugs, including anti-diabetes drug combination comprising of dapagliflozin and vildagliptin, sitagliptin and metformin combination and teneligliptin and pioglitazone formulations from some other companies.

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. Pharmabiz