NPPA fixes retail price of Vildagliptin, Metformin Hydrochloride FDCs made by Macleods

This came after the Multidisciplinary Committee of Experts deliberated on the retail price fixation of the popular diabetes drug from various companies during the Authority meeting held in February. The Committee was examining the submission of Macleods Pharmaceuticals Limited (marketer) and Mascot Health Series Pvt. Ltd (manufacturer) for the said formulations including;

(i) Uncoated bilayered tablet containing Vildagliptin 50 mg + Metformin Hydrochloride 500 mg (Sustained Release)

(ii) Uncoated bilayered tablet containing Vildagliptin 50 mg + Metformin Hydrochloride 1000 mg (Sustained Release)

After examination, It fixed the retail price of Vildagliptin 50 mg + Metformin, 500 mg at Rs 6.45, and Vildagliptin 50 mg + Metformin1000 mg tablet at Rs 7.10 per tablet, excluding GST in both cases.

The Committee noted that a separate ceiling price has been fixed for Metformin Immediate release tablet and Metformin Controlled release tablet. It further noted that 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.

During the meeting, it proposed the following two options 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 percent 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.

NPPA observed that the subject formulations are off-patent items and any fixation of retail prices on the basis of para 5 of DPCO 2013 by taking six-month prior data (when the patent was in force) would result in extending the price of patented products to off-patent products. Hence, the benefit of price reduction due to patent expiry would not be made available to the public. It concluded 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.

Subsequently, it decided to fix the retail price as per the Price To Retailer (PTR) based on Form-V data submitted by the companies for whom retail prices were earlier approved for these subject FDCs, i.e. the second option.