NPPA panel fixes price of Vildagliptin, Metformin Hydrochloride FDC marketed by Mankind Pharma
New Delhi: The National Pharmaceutical Pricing Authority (NPPA) Committee has recommended the retail price of Fixed-Dose Combination (FDC) of Vildagliptin and Metformin Hydrochloride IP marketed by Mankind Pharma Ltd. under Para 5 of DPCO, 2013 as Rs Rs. 6.58 per tablet excluding GST.
Each uncoated bilayered tablet of the cocktail diabetes drug contains Metformin Hydrochloride IP (as sustained release form) 500 mg and Vildagliptin 50 mg manufactured by Exemed Pharmaceuticals, while marketed by Mankind Pharma.
The Multidisciplinary Committee of Experts deliberated on the retail price fixation of the popular diabetes drug combination Metformin Hydrochloride IP (as sustained release form) 500 mg & Vildagliptin 50 mg.
This issue was brought up at the 28th meeting of the Multidisciplinary Committee of Experts held earlier this month.
In light of the foregoing, the Committee made the following observations:
• A Separate ceiling prices have been fixed for Metformin Immediate release tablet and Metformin Controlled release tablet.
• As per notification SO.1213(E) dated 25.03.2020, the present ceiling price of Metformin 500 mg controlled-release (CR) tablet is Rs. 0.41 more than Metformin 500 mg immediate-release (IR) tablet. Similarly, the ceiling price of Metformin 1000 mg controlled-release tablet is Rs. 0.05 more than Metformin 1000 mg Immediate release tablet.
• The Committee also noted the minutes of the 72nd Authority meeting held on 20.01.2020 relating to retail price fixation of Fixed Dose Combinations (FDCs) of Metformin and Vildagliptin tablets for various companies.
Regarding the price fixation of Fixed Dose Combinations (FDCs) of Metformin and Vildagliptin tablets, the Medical Dialogues team had earlier reported that two options had been finalized to calculate and fix the retail price of Fixed Dose Combinations (FDCs) of Metformin and Vildagliptin tablets: (i) Under para 5 of DPCO 2013 by taking the data of six months prior to the date of application; (ii) By adding 16 per cent 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 these subject FDCs.
After detailed deliberation, the committee has decided to derive the retail price of each uncoated bilayered tablet containing Vildagliptin 50mg and Metformin Hydrochloride 500mg (as sustained release) at Rs. 6.86 per tablet excluding GST.
However, the Committee noted that the applicant company has claimed a price of Rs. 6.58 per tablet excluding GST.
Accordingly, the Committee recommended the retail price of each uncoated bilayered tablet containing Vildagliptin 50 mg + Metformin Hydrochloride 500 mg (Sustained Release) for Exemed Pharmaceuticals (manufacturer) and Mankind Pharma Ltd. (marketer) at Rs. 6.58 per tablet excluding GST.
