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NPPA fixes retail price of 4 different strengths of anti-diabetic FDC of dapagliflozin & metformin hydrochloride
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Laxmi Yadav, Mumbai
June 29 , 2021
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A multi-disciplinary expert committee of the National Pharmaceutical Pricing Authority (NPPA) has fixed retail price of four different strengths of anti-diabetic fixed dose combination (FDC) of dapagliflozin and metformin hydrochloride (extended release) to provide benefits of the patent expiry of dapagliflozin to consumers.
The patent of anti-diabetic drug, dapagliflozin expired on October 2, 2020 making it an off-patent drug.
The decision to fix retail price of various strengths of the anti-diabetic FDC was taken by the NPPA panel at its 33rd meeting on June 21, 2021.
The panel received two applications for fixation of retail prices of the FDC manufactured by MSN Laboratories & Synokem Pharmaceuticals and marketed by JB Chemicals & Mankind Pharma respectively.
The retail price of FDC containing dapagliflozin 5 mg and metformin hydrochloride XR 1000 mg was fixed by the panel at Rs 7.54 per tablet excluding GST.
The retail price of FDC containing dapagliflozin 10 mg and metformin hydrochloride XR 1000 mg was fixed by the committee at Rs 11.30 per tablet excluding GST.
The retail price of FDC containing dapagliflozin 10 mg and metformin hydrochloride XR 500 mg was fixed by the panel at Rs 9.78 per tablet excluding GST.
The panel also fixed the retail price of FDC containing dapagliflozin 5 mg and metformin hydrochloride XR 500 mg at Rs 6.25 per tablet excluding GST.
While fixing retail price of above strengths of FDC of dapagliflozin and metformin hydrochloride XR, the committee cited NPPA’s approval to retail price of four different strengths of the FDC.
The drug pricing regulator at its 82nd meeting dated December 23, 2020 had approved the retail price of various strengths of FDC of dapagliflozin and metformin hydrochloride XR in line with decision taken at its 72nd meeting dated January 20, 2020 regarding the retail price fixation of FDC of metformin and vildagliptin.
At the 72nd meeting, NPPA emphasized that the benefit of price reduction in case of formulations becoming off-patent ought to be passed on to the consumers in public interest and decided to fix the retail price of FDCs of metformin and vildagliptin by adding 16 per cent retailer margin to the average price to retailer (PTR) based on Form-V data submitted by the companies for whom retail prices were earlier approved for FDCs of metformin and vildagliptin to give the benefits of patent expiry of the drug Vildagliptin to consumers.
Accordingly, at its 82nd meet, the drug pricing regulator approved retail price fixation of FDCs of dapagliflozin and metformin hydrochloride XR by adding 16 per cent retailer margin to the average PTR based on Form-V data submitted by the drug firms for whom retail prices were earlier approved for FDCs of dapagliflozin and metformin hydrochloride XR in public interest so as to extend the benefit of price reduction due to patent expiry to the consumers.
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