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NPPA expert panel fixes retail price for diabetes drug combination dapagliflozin & sitagliptin
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Gireesh Babu, New Delhi
October 27 , 2022
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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 of late, on a total of 10 applications from marketers including Lupin Ltd, Mankind Prime Labs, Unison Pharmaceuticals, Sun Pharma Laboratories, among others.
The MDC, in a 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 of 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 has been attempted in line with principle it has adopted earlier under which it has reduced the price of patented component by 50 per cent and then added the ceiling price of the scheduled components as applicable six month earlier from the date of application.
“From the total, a reduction of 20 per cent of the lower of three components in line with the recommendation of the Pranab Sen Committee is provided,” it added.
Earlier, the drug price regulator has decided to reduce the price of patented component sitagliptin by 50 per cent while calculating the retail price for its FDCs. The expert committee is also deliberating on whether the price reduction on patent expired components be fixed at 50 per cent or decide 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 price for each coated bilayered 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 bilayered 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, while the combination of sitagliptin 50 mg + metformin hydrochloride IP 1000 mg as extended release from the same firms were fixed at Rs. 20.06 per tablet.
For the combination of sitagliptin 100 mg + metformin hydrochloride IP 500 mg as extended release from the same firms has been fixed at Rs. 20.17 per tablet, and the combination of sitagliptin 100 mg + metformin hydrochloride IP 1000 mg as 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, and the combination of sitagliptin 50 mg + metformin hydrochloride IP 1000 mg for the same firms is fixed at Rs. 20.02 per tablet.
Similarly, for 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 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, retail price has been fixed at Rs. 30.70 per tablet excluding GST.
During the meeting, among other decisions, the MDC has fixed retail price of sachet containing pantoprazole sodium equivalent to pantaprazole 40 mg (sodium bicarbonate as buffer) manufactured and marketed by Alkem Laboratories at Rs. 9.05 per sachet of 5 gram finished formulation.
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