NPPA panel fixes price of Dapagliflozin, Metformin FDC marketed by Mankind 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 11.30 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 9.78 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 33rd meeting of Multidisciplinary Committee of Experts held on 21.06.2021. 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 was deliberated during the meeting.

In the latest Multidisciplinary Committee meeting, the committee noted that the patent for Dapagliflozin had expired on 02.10.2020, making it an off-patent drug.

The panel further noted 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.

Also Read: Dapagliflozin Going Off-Patent- NPPA Brings Dapagliflzin, Metformin Combination Under Price Control

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 the case of formulations becoming off-patent ought to be passed on to the consumers in the public interest and decided to fix the retail price of FDCs of Metformin and Vildagliptin tablets 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 Vi/dagliptin to consumers."

As a result, previously, at the 82nd meeting, in line with the decision taken in the 72nd meeting on 20.01.2020 regarding the retail price fixation of FDC of Metformin and Vildagliptin tablets, the Authority had deliberated upon the matter in detail and decided to fix the retail price of FDC of Dapagliflozin and Metformin Hydrochloride (Extended Release) tablets.

Accordingly, during the 82nd meeting, the authorities explained the method of price fixing for FDC of Dapagliflozin and Metformin Hydrochloride (Extended Release) tablets, noting,

"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."

In light of the foregoing theories, after detailed deliberation, the committee decided 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.

In view of the above decision, the Committee has recently noted that for each film coated bilayered tablet containing Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 5 mg and Metformin Hydrochloride IP (extended release) 1000 mg, Rs. 8.04 excluding GST per tablet has been claimed by the applicant.

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 Mankind Pharma Ltd. (marketer) at Rs. 7.54 per tablet excluding GST.

Similarly, for each film coated bilayered tablet containing Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10 mg and Metformin Hydrochloride IP (in extended release form) 1000 mg, the applicant has claimed a price of Rs. 11.53 per tablet excluding GST.

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 Mankind Pharma Ltd. (marketer) at Rs. 11.30 per tablet excluding GST.

Further, the committee noted that the applicant company has claimed a price of Rs. 9.98 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) 500 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) 500 mg for M/s Synokem Pharmaceuticals Ltd. (manufacturer) and M/s Mankind Pharma Ltd. (marketer) at Rs. 9.78 per tablet excluding GST.

Lastly, for each film coated bilayered tablet containing Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 5 mg + Metformin Hydrochloride IP (in extended release form) 500 mg, the committee noted, Rs. 6.65 excluding GST has been claimed by the applicant company.

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 Mankind Pharma Ltd. (marketer) at Rs. 6.25 per tablet excluding GST.