DoP upholds NPPA ceiling price fixation for Azoran 50mg tablet

The NPPA's original order, issued on January 6, 2023, fixed the ceiling price for the Azoran 50mg tablet pack, which contains Azathioprine, a medication primarily used for treating autoimmune diseases such as multiple sclerosis. RPG Life Sciences argued that the NPPA had incorrectly included a discontinued 10-tablet pack in its price calculations, asserting that the 20-tablet pack was the only product still being marketed since May 2021.

The Mumbai-based drug maker contended that NPPA erred in determining ceiling price of the said drug and should be directed to revise the same.

The drug maker stated that the formulation "Azathioprine 50mg" was included in Schedule-I of DPCO, 2013 with effect from 11 November, 2022, and hence, the formulation "Azoran 50mg Tablet 10's" was also included in the draft calculation of ceiling price released by NPPA on December 1, 2022 under the provisions of Para 4, 6, 10, I l, 14, 16, 17 and 18 of DPCO 2013. The pharma firm stated that it submitted the representation in the prescribed format with required documents and within the prescribed time lines of 10 workings days to NPPA.

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RPG Life maintained that in view of the representation from IPC and medical community at large, the pack size of the said formulation was revised from 10' s to 20's pack. Also, that it has never changed the formulation and did not sell 10’s and 20's pack simultaneously in the market. Further, no batches of Azoran 10's was manufactured on or after May 2021. Therefore, NPPA has erred by including their discontinued formulation "Azoran 50mg Tablet 10' s" in its calculation of ceiling price for "Azathioprine 50mg" tablets.

“As per Para 4 of the DPCO 2013, the average Price to Retailer (PTR) is based on the total number of brands of generic version the medicine. The said formulation was only sold in a single brand namely Azoran 50mg. As the change in pack size is not mentioned in Para 4, when considering the price to retailer of the brand as on July 2022, the only price to be considered is of the continuing pack i.e. 20's,” the pharma firm said.

“Hence, the calculation of Azoran 50mg tablet 10’s tablet is incorrect and must be rectified after removing the PTR of their erstwhile brand "Azoran 50mg Tablet 10's",” the drugmaker added.

NPPA on the other side argued that the instant review is not tenable as it considered Pharmatrac database of July, 2022 for calculation of ceiling prices. As per this data, while Azoran 50mg tablet in pack size of 20 had 54.10% market share, its pack size of 10 tablets also had a market share of 26.30%. The confirmation regarding the accuracy of the data was received from the Pharmatrac on April 17, 2023.

Further, the argument that as per Para 4, only continuing pack sizes were to be considered was incorrect. Para 4 (methodology to fix ceiling price) and Para 9 (Reference data & source of market based data) does not differentiate between continuing and discontinued packs. Therefore, NPPA has taken data as per the provision of DPCO for ceiling price calculation of the above mentioned formulation as available in market based data i.e. Pharmatrac and fixed the ceiling price, based on PTR of brands under Para 4 of DPCO, 2013.

Examining the matter, the Department noted that Para 9(5) of DPCO 2013 states that, "The market based data for fixing the ceiling price of a scheduled formulation due to a revision in the first schedule shall be the data available for the month ending immediately before six months of notification of revision in the first schedule. " It nowhere differentiates between continued and discontinued products.

DoP observed;

“The Applicant did not dispute the fact that both of the pack sizes of the said formulation i.e., Azoran 50mg tablet, were available in the market in July 2022, which were captured by the Pharmatrac data and accordingly considered by NPPA for ceiling price calculation. Accordingly, NPPA had used the same for ceiling price calculation of the drugs being considered in the present case as per the provisions of DPCO, 2013.”

Subsequently, the Department said;

“The action of NPPA fixing the ceiling prices of the formulation Azathioprine 50mg vide S.O. No. 87(E) dated 06.01.2023 is upheld and the present Review Application is rejected.”