Last Updated on December 31, 2023 by The Health Master
New Delhi: In a major respite to Cipla Ltd., embroiled in a legal battle for almost three years over the price of an Asthma inhaler drug, the Department of Pharmaceuticals (DoP) has directed the National Pharmaceutical Pricing Authority (NPPA) to consider the application of the pharma major for fixing the retail price of the following combination drug:
- Formoterol Fumarate Dihydrate 6mcg + Beclomethasone Dipropionate IP 100 mg inhaler (MDI).
The Fixed Dose Combination (FDC) drug sold under the brand Novello inhaler is indicated in the regular treatment of asthma where the use of a combination product is appropriate.
The altercation started in 2019 after Cipla filed an application seeking the retail price of Rs 730 for 120 metered doses of formoterol fumarate dihydrate 6mcg + beclomethasone dipropionate IP 100 mg inhaler (MDI)
The NPPA published a draft working sheet recommending a retail price of Rs. 1.46 per dose for the product after considering the price to the retailer of a competitor company.
Cipla objected to the same and sought an opportunity to make personal representation.
In a meeting on July 31, 2019, MDC noted that the composition of the product was the same as that of Lupin Ltd, as included in the working sheet and the documents submitted by Cipla did not substantiate the study reports related to its product.
Furthermore, Cipla reiterated its recommendation for a retail price of Rs.1.46 per metric dose while denying having a separate license from the Drugs Controller General (India), which is necessary in the case of a new drug.
Apart from filing a review application against the retail price which was notified on August 14, 2019, claiming it as erroneous and seeking directions to be issued to the NPPA to recalculate and re-fix the retail price, Cipla simultaneously approached the Delhi High Court for a remedy.
In an order dated October 21, 2019, the High Court directed the department to consider the review application on merit and being in the applicant that during the pendency of the same, it would implement the price notification.
However, Cipla in November, 2019, said that it had launched the product without implementing the notified price, as it was not mandatory.
The NPPA, in January 2020, rejected the review application citing non-implementation of the retail price it notified.
The Mumbai-based pharma major again challenged the order in the Delhi High Court and received a favorable order in February 2020, which directed the DoP to decide on the application afresh and on merit.
NPPA, during the hearing with the reviewing authority of DoP, submitted that ” The applicant has represented its case before 12th MDC, though it was not put in the minutes of the meeting.”
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