NPPA’s move to Fix Prices on Anti-Diabetic FDCs

After considering the matter, the Authority noted that the prices of these FDCs had started appearing in the market database within a year.

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NPPA National Pharmaceutical Pricing Authority
Picture: Pixabay

I. FDCs

In a recent development, the National Pharmaceutical Pricing Authority (NPPA) has decided to take a decisive step in fixing the retail prices of certain anti-diabetic fixed dose combinations (FDCs).

This move is based on market data under the provisions of the Drugs (Prices Control) Order, 2013.

II. Background

A. Recent Amendments

The decision comes in the wake of amendments made in the DPCO, 2013, on May 11, 2023.

These amendments introduced specific provisions regarding the fixation of retail prices for new drugs or those containing components that have recently gone off-patent.

B. Market Database Observations

Despite only a year passing since the initial price notification on these drugs, the NPPA observed that the prices had already started surfacing in the market database.

III. Focus on Specific Anti-Diabetic FDCs

A. Dapagliflozin + Vildagliptin + Metformin SR

The NPPA examined applications for fixing the retail prices of FDCs, such as dapagliflozin 10 mg + vildagliptin 100 + metformin SR 500 mg. Market data for these combinations was readily available.

B. Sitagliptin + Pioglitazone + Metformin SR

Similarly, the retail prices for FDCs like sitagliptin 100 mg + pioglitazone 15 mg + metformin SR 500 mg/1000 mg were under consideration.

These prices were initially fixed by the NPPA in previous meetings.

IV. Provisions of Para 5(3) of DPCO

The NPPA based its decisions on the provisions outlined in Para 5(3) of the DPCO, inserted last year.

This includes the calculation of 50% of prices fixed under para 4(1) initially.

V. Market Data Application

A. Initial Retail Price Fixation

According to Para 5(3)(i), if market-based data is available within a year of initial price fixation, prices are to be determined by calculating 50% of prices fixed under para 4(1).

B. Post One-Year Period

After one year, prices are to be fixed based on the methodology for regular cases, excluding patent or license holder prices, as per Para 5(3)(ii).

VI. Decision-Making Process

After considering the matter, the Authority noted that the prices of these FDCs had started appearing in the market database within a year.

However, only the prices of manufacturers who had their retail prices fixed by the NPPA with a 50% reduction were visible.

VII. Further Reduction Considerations

The Authority observed that if prices were fixed under Para 5(3)(i), they should be further reduced by 50% from the earlier fixed prices by the NPPA.

After detailed deliberations, it was decided that the retail prices should be based on the market database, excluding patent or license holder prices, under the provisions of Para 5(3)(ii) of the DPCO, 2013.

VIII. Evolution of Price Fixation

A. Generic FDCs of Sitagliptin and Linagliptin

The price fixation process for generic FDCs of drugs like sitagliptin and linagliptin, which recently went off-patent, has been evolving. Discussions within the Authority meetings date back to at least 2022.

B. Methodology Development

In the first half of 2022, the NPPA fixed prices with a 50% reduction on the patented component for sitagliptin and linagliptin.

This methodology was then applied to fix prices for other drugs that went off-patent.

IX. Multi Disciplinary Committee’s Role

The Multi Disciplinary Committee (MDC) of Experts for NPPA played a pivotal role in developing the methodology.

They emphasized that the retail price should be calculated based on six-month prior market data to consider the patented period, ensuring consumers benefit from the price reduction due to medicines going off-patent.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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