The National Pharmaceutical Pricing Authority (NPPA) has recently decided to determine the retail prices of specific anti-diabetic fixed-dose combinations (FDCs) containing dapagliflozin, vildagliptin, and sitagliptin, which have recently gone off-patent. This decision, made under the provisions of the Drugs (Prices Control) Order, 2013, is a significant move following the amendment in the DPCO, 2013, on May 11, 2023.

According to media reports, in a recent meeting, the authority observed that although one year has passed since the initial price notification on these drugs, the prices have already surfaced in the market database. This decision gains importance in light of the specific provisions added to the DPCO, 2013, on May 11, 2023, concerning the fixation of retail prices for new drugs or drugs containing components that have become off-patent.

The Authority examined applications for fixing retail prices for FDCs, such as dapagliflozin 10 mg+vildagliptin 100+metformin SR 500 mg and sitagliptin 100 mg+pioglitazone 15 mg+metformin SR 500 mg/1000 mg, for which market data is available.

It may be recalled that the retail prices for these FDCs were initially established by the NPPA in its 109th meeting on February 24, 2023, and 114th meeting on June 19, 2023.

Under the provisions of Paragraph 5(3) of the DPCO, introduced last year, retail prices for new drugs or those containing off-patent components are to be fixed based on market data, calculated as 50% of the prices fixed under Paragraph 4(1). However, after one year, the retail prices will be fixed based on the regular pricing methodology, excluding patent or licence-holder prices.

Considering the matter, the Authority noted that although one year has not elapsed since the price notification, the prices of these FDCs are already in the market database, excluding prices from patent or licence holders. After deliberations, the Authority decided to fix the retail prices of these formulations based on the market database, excluding patent or licence holder prices, as per the provisions of Paragraph 5(3)(ii) of the DPCO, 2013.

The price fixation for generic FDCs of drugs like sitagliptin and linagliptin, which recently went off-patent, has been an evolving process. Discussions within the Authority meetings regarding this began at least in 2022. In the first half of 2022, the NPPA fixed prices for sitagliptin and linagliptin with a 50 per cent reduction on the patented component. This methodology was later accepted for fixing prices for other drugs that also went off-patent. The Multi-Disciplinary Committee (MDC) of Experts for NPPA developed this methodology to ensure that the benefit of price reduction due to off-patent medicines is passed on to consumers.