DoP Directs NPPA to consider Cipla application for retail price fixation of asthma drug combination

The Fixed Dose Combination (FDC) drug sold under the brand Novello inhaler is indicated in the regular treatment of asthma where use of a combination product is appropriate.

The altercation started in 2019 after Cipla filed an application seeking retail price of Rs 730 for 120 metered doses of formoterol fumarate dihydrate 6mcg + beclomethasone dipropionate IP 100 mg inhaler (MDI), and 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 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 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. Besides, Cipla had no separate license from the Drugs Controller General (India), which is required in the case of a new drug, it said while reiterating the recommendation of retail price of Rs.1.46 per metered dose.

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 favourable 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."

It further submitted;

"With respect to Cipla's stand that the formulation is not a new drug, the same is not tenable as the formulation Budesonide + Formoterol is a scheduled formulation as per the provisions of DPCO, 2013. Accordingly, any Fixed Dose Combinations (FDCs) containing "Formoterol" is a new drug as per the para 2(u) of DPCO, 2013 and existing manufacturer is required to apply for prior price approval of such new drug from the Government in Form-I specified under Schedule-11 of this Order under para 15."

Meanwhile, Cipla claimed that the development of the product involves a highly complex manufacturing process, when compared to the conventional formulation of the competitor firm. The product also has an integrated dose counter and the MDC has allotted a separate price to Glenmark in the same meeting on July 31, 2019, on the same ground.

It also said that no new drug license is required as there is no change in composition of the drug and the product is manufactured using advanced technologically advanced inhaler making it different from other products and eligible for a different price.

After hearing the contentions, DoP observed;

" Another significant aspect which needs to be noted at this juncture arises from representing the case before MDC, while NPPAs letter dated 17.10,2019 indicate that the applicant was allowed to make a detailed presentation/ demonstration before the Committee. However, the applicant vide letter dated 12.07.2021 has claimed that no opportunity of hearing before MDC was granted to them. On seeking clarification, NPPA vide their letter dated 21.03,2022 has maintained that the applicant was allowed to make presentation/ demonstration before UDC, but the same was not recorded in its minutes. Both NPPA and the applicant have opposite views and based on the available records, Reviewing Authority cannot establish the facts independently."

It further observed;

"The claim of be applicant about allotting a separate price to Glenmark Limited for product innovation in the same meeting by MDC while rejecting their claim is to be corroborated with complete documentary evidence and technical justification(s), without the same it cannot be deliberated either side."

While remanding the matter back to the MDC, it also observed that the technical details of the product and various study reports submitted by the company need to be considered by the MDC, which has the requisite qualification and expertise to examine the same.

Subsequently, on careful consideration of the entire facts and circumstances, the Reviewing Authority noted;

"The S.O. No. 2944(E) dated 14.08,2019 issued by NPPA warrants interference pursuant to directions of the Hon'ble High Court of Delhi and subsequent developments. Matter requires remand for fresh order on merits by MDC and the NPPA, after analysis of the entire facts to avoid miscarriage of justice. Consequently, the impugned Order is referred back to NPPA to consider the issues raised by the applicant and to pass an appropriate order. The applicant will have liberty to file a Review before the department, if not satisfied by the fresh order passed by NPPA."