Last Updated on December 31, 2023 by The Health Master
The Multi-Disciplinary Committee (MDC) of experts advising the National Pharmaceutical Pricing Authority (NPPA) has fixed the retail price of anti-diabetes drug combinations comprising sitagliptin and dapagliflozin, which met patent expiry as of late, on a total of 10 applications from marketers including Lupin Ltd, Mankind Prime Labs, Unison Pharmaceuticals, and Sun Pharma Laboratories, among others.
The MDC, in the latest meeting held on October 19, considered seven applications for retail price fixation of four fixed-dose combinations (FDCs) of sitagliptin and metformin tablets and three applications for two FDCs of dapagliflozin, sitagliptin, and metformin tablets.
It observed that the formulation sitagliptin has become off-patent on July 5/6, 2022, while dapagliflozin went off-patent on October 2, 2020.
The retail price of FDCs of dapagliflozin + sitagliptin + metformin tablets was attempted in accordance with the previous principle, under which it reduced the price of the patented component by 50% and then added the ceiling price of the scheduled components as applicable six months prior to the date of application.
“From the total, a reduction of 20 percent of the lower three components in line with the recommendation of the Pranab Sen Committee is provided,” it added.
Earlier, the drug price regulator decided to reduce the price of the patented component sitagliptin by 50 percent while calculating the retail price for its FDCs.
The expert committee is also deliberating on whether the price reduction on patent-expired components should be fixed at 50 percent or decided on a case-by-case basis.
The price fixation is also in line with the retail prices fixed for the combinations including these drugs in the previous meetings.
Based on the discussions, the Committee fixed the price for:
- Each coated bi-layered tablet containing sitagliptin phosphate monohydrate equivalent to sitagliptin 100 mg + metformin hydrochloride IP 1000 mg as extended-release manufactured by Ravenbhel Healthcare and marketed by Lupin Ltd at Rs. 21.56 per tablet, excluding goods and services tax (GST).
- Each film-coated bi-layered tablet containing sitagliptin phosphate monohydrate equivalent to sitagliptin 50 mg + metformin hydrochloride IP 500 mg as extended-release manufactured by Ravenbhel Healthcare and marketed by Unison Pharmaceuticals was fixed at Rs. 18.67 per tablet.
- Combination of sitagliptin 50 mg + metformin hydrochloride IP 1000 mg as extended-release manufactured by the same firms was fixed at Rs. 20.06 per tablet.
- For the combination of sitagliptin 100 mg + metformin hydrochloride, IP 500 mg as an extended release from the same firms has been fixed at Rs. 20.17 per tablet.
- A combination of sitagliptin 100 mg + metformin hydrochloride, IP 1000 mg as an extended-release for the same firms has been fixed at Rs. 21.56 per tablet.
- Each film-coated tablet of sitagliptin 50 mg + metformin hydrochloride IP 500 mg manufactured by Mediforce Healthcare and marketed by Mankind Prime Labs has been fixed at Rs 18.34 per tablet.
- The combination of sitagliptin 50 mg + metformin hydrochloride IP 1000 mg for the same firms is fixed at Rs. 20.02 per tablet.
- Similarly, each film-coated tablet of dapagliflozin 10 mg + sitagliptin phosphate monohydrate equivalent to sitagliptin 100 mg + metformin hydrochloride IP 1000 mg as extended-release manufactured and marketed by Sun Pharma Laboratories has been fixed at a retail price of Rs. 22.32 per tablet excluding GST.
- Each film-coated bilayered tablet of dapagliflozin 10 mg + sitagliptin 100 mg + metformin hydrochloride IP 500 mg as extended-release, manufactured and marketed by Alkem Laboratories, has been fixed at a retail price of Rs. 29.31 per tablet.
- For each film-coated bilayered tablet of dapagliflozin propanediol monohydrate equivalent to dapagliflozin 10 mg + sitagliptin phosphate monohydrate equivalent to sitagliptin 100 mg + metformin hydrochloride IP 1000 mg as extended-release manufactured and marketed by Alkem Laboratories, the retail price has been fixed at Rs. 30.70 per tablet excluding GST.
- A sachet containing pantoprazole sodium equivalent to pantoprazole 40 mg (sodium bicarbonate as a buffer) manufactured and marketed by Alkem Laboratories at Rs. 9.05 per sachet of 5 grams of the finished formulation.
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