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NPPA reiterates its revised retail price notification for Mankind Pharma’s respiratory disease drug
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Gireesh Babu, New Delhi
August 24 , 2022
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The National Pharmaceutical Pricing Authority (NPPA) has reiterated its stand on revising the retail price of the respiratory disease drug formoterol fumarate combination marketed by Mankind Pharma, stating that the authority cannot be prohibited from making any rectification in the notified retail price on account of an error occurred only due to nomenclature issue of the data.
The reiteration comes after the Authority recalculated the price of formoterol fumarate 12 mcg + budesonide IP 400 mcg hard gelatin capsule manufactured by Biodeal Pharmaceuticals and marketed by Mankind Pharma Ltd, in its previous meeting on June 28, 2022.
The Authority fixed the price of the drug at Rs. 7.10 per capsule excluding GST, in November, last year, based on the company’s application. The retail price was calculated as per the provisions of Drug (Prices Control) Order 2013 based on the Pharmatrac data for capsule only, while Mankind Pharma quoted the data from another market research firm IQVIA, which is not considered by NPPA as per current practice.
According to the price calculation sheet with the NPPA, published in November 2, 2021, the claimed retail price was of Rs 15 per capsule excluding GST, while the worked out retail price was of Rs. 7.10 per capsule. Macleods Pharma (brand Budetrol) and Intas Pharmaceuticals (Quikhale FB) who have over one per cent of the market share of the drug which has a Moving Annual Total of Rs. 5.15 crore in the market, according to the calculation sheet, sells the drug at Rs. 6.63 and Rs. 5.61 per capsule.
Following the price fixation, Mankind Pharma again represented against the notified retail price to the Department of Pharmaceuticals and the Department forwarded the representation to the NPPA for necessary action. NPPA sought clarification from Pharmatrac and the market analysis firm clarified that Transcap, Rotacap and Respicap are also capsules and based on the clarification, the authority recalculated the price to Rs. 9.35 per capsule excluding GST in the meeting on June 28.
The company again approached the NPPA with its contentions and the Authority deliberated upon the matter in detail in the last meeting held on August 5, 2022. It observed that the revised retail price has been worked out to rectify an error of selection of the data that was used for calculation of retail price and the data was available but under different drug types, which are Transcap, Rotacap and Respicap etc. Based on the clarification from Pharmatrac that Transcap, Rotacap and Respicap are also capsules, the data of the drug types has been considered to calculate the correct retail price.
“It was also noted that Authority cannot be prohibited from making any rectification in the notified retail price on account of an error that has occurred only due to nomenclature issue of the data. Also, such rectification of error does not take away the right of the applicant to file for a review application, if it desires so,” it added.
With this remark, the Authority stated that it reiterates the earlier stand and decided to correct and revise the retail price of the combination at Rs. 9.35 per capsule excluding GST.
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