New Delhi: The National Pharmaceutical Pricing Authority (NPPA) has revised the ceiling price of asthma inhaler drug combination formoteral 6 mcg and budesonide 400 mcg dry power inhaler (DPI) under the provisions of suo-moto correction, after three companies submitted their representations.
The price of the particular strength of the combination was notified at Rs. 6.62 per dose through a notification on February 28, 2024, and has now been revised to Rs. 6.95 per dose.
Following the ceiling price fixation through the notification in February, Zydus Healthcare, Glenmark Pharma and Mankind Pharma filed representations with the NPPA, stating that Mankind’s metered dose inhaler (MDI) was included in the calculation of the DPI product. The Authority also received request for suo-moto correction as per the framework approved already.
Mankind Pharma informed the regulator that it had only two Stock Keeping Units (SKUs) in the product, one a MDI and other a DPI. The Authority was also informed that Mankind had earlier based on the draft worksheet uploaded in the NPPA website on February 5, 2024, represented that one of its DPI SKU has been wrongly reported in MDI and needs to be considered in DPI and also requested for correction in the pack size of the same. It was after considering this request, the Authority fixed the ceiling price at Rs 6.62 per dose, it said.
However, the Authority received another representation from Mankind after the notification and NPPA sought clarification from both the company and Pharmatrac, the agency which provides market data to the price regulator, to provide complete details of products sold for both MDI and DPI formulations.
Pharmatrac provided the details of three SKUs of which two are DPI formulations sold by Mankind, but the agency revised the pack size from 400 to 30 and price to retailer of combihale FB 6/400 mcg inhaler 400 DPI to Rs 154.47. NPPA says that Mankind Pharma clarified that there is only one product of DPI formulation marketed by them as on date and that earlier the same product was marketed by Dr Reddy’s Lab and was acquired by them in February, 2022.
“Since Mankind Pharma Ltd gave conflicting statements about their product, in two different representations, the price was worked out based on confirmation from Pharmatrac and ceiling price was uploaded on website on March 28, 2022 at Rs. 6.95 per dose,” said NPPA.
The Authority also referred the decision taken in its meeting in December 2022 that NPPA may carry out suo moto correction even after notification where errors are duly acknowledged by Pharmatrac and/or correct data is confirmed from the companies.
The Authority also rejected the representation that this SKU should not be considered as it has been discontinued and has low market share. It noted, since the SKU is appearing in October, 2023 database, the same has been considered in calculation of ceiling price by adding two SKUs with same brand name in line with practice followed.
Meanwhile, it also noted that Cipla had withdrawn the review application it filed against the price fixation of the same formulation. The NPPA has also informed the Department of Pharmaceuticals regarding the revised draft sheet under suo-moto correction, on April 22, 2024.
“The matter was deliberated in detail and in view of the above it as decided to device the ceiling price of formoteral 6mcg+budesonide 400 mcg (DPI) to Rs. 6.95 per dose,” it said. The revised dose has been notified after considering the impact of the Wholesale Price Index (WPI) revision at 0.00551 per cent effective from April 1, 2024, it added.
The combination is used for the treatment of chronic obstructive pulmonary disease, and various strengths of the combination is sold by companies including Cipla, Lupin, Zydus Healthcare, Glenmark Pharmaceuticals, Mankind Pharma, Intas Pharmaceuticals, Sun Pharmaceutical Industries, among others.
