Last Updated on December 31, 2023 by The Health Master
The National Pharmaceutical Pricing Authority‘s (NPPA’s) expert panel has advised retail price fixing for a number of anti-diabetes formulations containing the following salts in a variety of dosages, strengths, and delivery models using the methodology of a 50% discount on the cost of the patented, but no longer available, components:
In response to three applications submitted by Sun Pharma Laboratories and Mankind Pharma Ltd, which produce the products through Exemed Pharmaceuticals, the Multi Disciplinary Committee (MDC) of Experts for NPPA has recommended the retail price of fixed dose combinations (FDCs) of:
- Dapagliflozin,
- Sitagliptin,
- Metformin tablets.
The Authority said that the retail price of these FDCs has been attempted in line with the principles adopted last year, which is reduction of 50 per cent from the patented component (dapagliflozin and sitagliptin) and then adding the ceiling price of the scheduled components as applicable six month earlier from the date of application.
The price arrived at for the two patent components after a 50% reduction and the ceiling price of metformin was also taken into consideration. Additionally, it calculated a reduction of 20% for the lowest of the three components in accordance with the Pronab Sen Committee’s recommendation, which was also provided when setting the price.
It may be noted that the methodology was decided in a meeting held on March 24, 2022 based on the recommendation of the Committee of Experts in a meeting held on March 14, 2022 for calculation of retail price of the FDC which has a component which has become or is on the verge of becoming off-patent.
The methodology was developed with the understanding that if the retail price is calculated using six-month prior market data, the price of the patented period will be taken into account, and the benefit of price reductions due to medicines going off-patent will not be passed on to consumers.
The MDC recommended on March 14, 2022, after carefully considering the issue of determining the retail price of an FDC containing sitagliptin, “The Committee deliberated upon the matter in detail and is of the opinion that the price of drugs be reduced with regard to drugs that have become or are about to become off-patent in order to pass the benefit of price reduction to the consumers and that a reduction of 50% to be allowed on the patented component of FDCs.”
The methodology has been followed by the MDC for the other FDCs which have one of the components recently went off patent, since then.
Similarly, in its latest meeting, the MDC recommended retail price fixation for the FDCs comprising dapagliflozin, vildagliptin and metformin as sustained release tablets, against 18 applications it has received from various companies. The Committee noted that the components dapagliflozin and vildagliptin of the FDCs were patented and the patent expired on October 2, 2020 and December 9, 2019 respectively.
The retail prices fixed for the combinations marketed by Exemed Pharmaceuticals and marketed by Eris Lifesciences, Intas Pharmaceuticals, USV Pvt Ltd, Zydus Healthcare Ltd, Cipla Ltd, Micro Labs Ltd, Lupin Ltd, Emcure Pharmaceuticals, Lupin Ltd, and Abbott Healthcare Pvt Ltd.
Besides, it has also recommended retail price fixation for FDCs of dapagliflozin and teneligliptin tablet against two applications – an FDC of dapagliflozin 5 mg and teneligliptin hydrobromide hydrate IP equivalent to teneligliptin 20 mg and another of dapagliflozin 10 mg and teneligliptin hydrobromide hydrate IP equivalent to teneligliptin 20 mg, both manufactured by Ravenbhel Healthcare for Mankind Pharma Ltd.
The Committee meeting also recommended retail price for the FDC of sitagliptin 100 mg and metformin 500 mg (extended release) tablet, in which the patent of sitagliptin was expired by July, 6, 2022, under the same methodology. It has fixed the retail price based on two applications – one filed by Pure and Care Healthcare as manufacturer and Abbott Healthcare as marketer and another filed by Ravenbhel Healthcare Ltd as manufacturer and Lupin Ltd as marketer.
It should be noted that the MDC stated in April 2022 that it is investigating whether the benchmark of the 50% reduction may be examined on a case-by-case basis by the Committee for medicines that have become or are about to become off patent. This statement came after the MDC decided to reduce the price of the patented compound by 50% after the patent exclusivity had expired.
Latest on National Pharmaceutical Pricing Authority (NPPA)
Latest notifications – DPCO / NPPA
NPPA updated price lists: Download
Latest Notifications: EC Act (Essential Commodities Act)
FAQs – On DPCO: Drugs (Prices Control) Order, 2013
National List of Essential Medicines (NLEM)
PowerPoint Slide Shows for Regulators and Industry
USFDA to develop a new framework to ensure safe use of Cannabis compound
CDSCO Panel nod for Cholecalciferol Aqueous Injection
USFDA approves this drug for rare blood cancer
USFDA issues zero observations for Gland Pharma API Facility
Maha FDA: Action on illegal sale of drugs misused for body building
Drug: Recall: 10,052 bottles of Levofloxacin tablets recalled due to this reason
Area required for manufacturing of Drugs, Cosmetics, Homoeopathic & Blood Centre
BA / BE Studies: Bioavailability & Bioequivalence
Latest Notifications regarding Pharmaceuticals
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
