NPPA panel fixes price of Dapagliflozin, Metformin FDC marketed by Aristo Pharma

The retail price of each film coated bilayered tablet containing Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin and Metformin Hydrochloride IP (Extended Release) has been fixed in two different strengths of Dapagliflozin as well as two different strengths of Metformin which include:

• The price of FDC of Dapagliflozin 5mg and Metformin (ER) 1000 mg tablet is set at Rs 7.54 per tablet excluding GST.

• The price of FDC of Dapagliflozin 10mg and Metformin (ER) 1000 mg tablet at Rs 11.17 per tablet excluding GST.

• The FDC of Dapagliflozin 10 mg and Metformin Hydrochloride IP (in extended-release form) 500 mg tablet has been priced at Rs 9.65 per tablet excluding GST and

• The price of FDC of one tablet Dapagliflozin 5 mg and Metformin (ER) 500 mg tablet has been set at Rs 6.25 excluding GST

The recommendation came during the 35th meeting of the "Multidisciplinary Committee of Experts" which was held on 18.08.2021 under the Convenorship of Sh. N.I. Chowdhury, Adviser (Cost), in NPPA.

The issue of the retail price fixation of each film-coated bilayered tablet containing Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin and Metformin Hydrochloride IP (extended release) for four different strength formulations under Para 5 of the DPCO 2013, manufactured by Synokem and marketed by Aristo Pharmaceuticals, was deliberated during the meeting.

At the meeting, the committee noted that the Patent of Dapagliflozin had expired on 02.10.2020 making it an off-patent drug.

Further, the committee observed that NPPA, in its 82nd meeting dated 23.12.2020, had approved the retail price of Fixed Dose Combinations (FDCs) of Dapagliflozin and Metformin Hydrochloride (Extended Release) tablet in different strengths, where the authority had recalled the decision taken in its 72nd meeting dated 20.01.2020 regarding the retail price fixation of Fixed Dose Combinations (FDCs) of Metformin and Vildagliptin tablets.

While recalling an earlier recommendation regarding retail price fixation of Fixed Dose Combinations (FDCs) of Metformin and Vildagliptin tablets, the authority had observed,

"It 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 tablet by adding 16% 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 tablets to give the benefits of patent expiry of the drug Vildagliptin to consumers."

Accordingly, the authority had decided to fix the retail price of FDC of Dapagliflozin and Metformin Hydrochloride (Extended Release) tablets at the 82nd meeting, in accordance with the decision made at the 72nd meeting on 20.01.2020 regarding the retail price fixation of FDC of Metformin and Vildagliptin tablets.

In continuation, the authorities detailed the procedure of price fixing for FDC of Dapagliflozin and Metformin Hydrochloride (Extended Release) tablets during the 82nd meeting, stressing that

"The Authority approved retail price fixation of FDCs of Dapagliflozin and Metformin Hydrochloride (Extended Release) tablet by adding 16% retailer margin to the average Price To Retailer (PTR) based on the Form-V data submitted by the companies for whom retail prices were earlier approved for FDCs of Dapagliflozin and Metformin Hydrochloride (Extended Release) tablet in public interest so as to extend the benefit of price reduction due to patent expiry to the consumers."

The committee also noted that the retail pricing of FDCs of Dapagliflozin and Metformin Hydrochloride 500mg/ 1000 mg tablet was determined for various companies in the 89th and 91st Authority meetings conducted on 28.06.2021 and 29.07.2021, respectively, using a similar methodology.

In light of the foregoing theory and research, the committee decided, after extensive deliberation, to derive the retail price of each film coated bilayered tablet containing Dapagliflozin and Metformin Hydrochloride IP (in extended release form), in accordance with the Authority's decisions taken at its 82nd meeting on December 23, 2020, by taking data as per Form-V submitted by the companies for which the retail price for the Fixed Dose Combinations (FDCs) of Dapagliflozin and Metformin Hydrochloride (Extended Release) tablet was earlier approved.

Accordingly, the Committee recommended the retail price of each film coated bilayered tablet containing Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 5 mg + Metformin Hydrochloride IP (extended release) 1000 mg for M/s Synokem Pharmaceuticals Ltd. (manufacturer) and M/s Arista Pharmaceuticals Pvt. Ltd. (marketer) at Rs. 7.54 per tablet excluding GST.

Likewise, the applicant has claimed a price of Rs. 26.50 per tablet excluding GST for each film coated bilayered tablet comprising Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 5 mg and Metformin Hydrochloride IP (in extended release form) 500 mg.

Accordingly, the Committee recommended the retail price of each film coated bilayered tablet containing Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 5 mg + Metformin Hydrochloride IP (in extended release form) 500 mg for M/s Synokem Pharmaceuticals Ltd. (manufacturer) and M/s Arista Pharmaceuticals Pvt. Ltd. (marketer) at Rs. 6.25 per tablet excluding GST.

In addition, the committee noted that the applicant company has claimed a price of Rs. 53.40 per tablet excluding GST for each film coated bilayered tablet containing Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10 mg+ Metformin Hydrochloride IP (in extended release form) 1000 mg.

Accordingly, the Committee recommended the retail price of each film coated bilayered tablet containing Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10 mg + Metformin Hydrochloride IP (in extended release form) 1000 mg for M/s Synokem Pharmaceuticals Ltd. (manufacturer) and M/s Arista Pharmaceuticals Pvt. Ltd. (marketer) at Rs. 11.17 per tablet excluding GST.

Lastly, for each film coated bilayered tablet containing Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10 mg + Metformin Hydrochloride IP (in extended release form) 500 mg, the committee noted, Rs. 51.52 excluding GST has been claimed by the applicant company.

Accordingly, the Committee recommended the retail price of each film coated tablet containing Dapagliflozin 10 mg + Metformin Hydrochloride IP/USP 500 mg (extended release) for M/s Synokem Pharmaceuticals Ltd. (manufacturer) and Mis Arista Pharmaceuticals Pvt. Ltd. (marketer) at Rs. 9.65 per tablet excluding GST.

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