Archive for month: November, 2024

Abbott Healthcare argued that the NPPA had erred in fixing the ceiling price due to the use of outdated and inaccurate Price-to-Retailer (PTR) data for two major competing brands: Prolomet XL 100mg (by Sun Pharma) and Revelol XL 100mg (by IPCA). According to Abbott, the PTR values used by the NPPA—Rs 112.14 for Prolomet XL and Rs 175.71 for Revelol XL—were lower than the actual figures, which were Rs 121.43 and Rs 202.88 respectively.

The company claimed that these discrepancies resulted in an unjustifiably lower ceiling price for Metoprolol tablets. Abbott also contended that the delay in the implementation of revised MRPs based on the Wholesale Price Index (WPI) was misinterpreted as non-implementation. The company maintained that revised MRPs were reflected in the market data as of September 2022, prior to the Schedule-I revision notification of November 2022, and supported its claims with documentary evidence, including pack shots.

Abbott further argued that the Pharmarack database, used for PTR calculations, initially failed to capture revised pricing and should not have been relied upon for determining the ceiling price. The company asserted that a more accurate dataset was available and should have been considered.

The NPPA countered Abbott’s claims by citing strict adherence to the provisions of the Drugs (Prices Control) Order, 2013 (DPCO). According to the NPPA, the market data used for ceiling price calculation must correspond to the month six months prior to the notification date of the Schedule-I revision. For the S.O. No. 5249(E) notification issued on November 11, 2022, the applicable data would be for April 2022. However, acknowledging potential delays in reflecting WPI-related price changes in market data, the NPPA made an exception and considered July 2022 data under Para 9(7) of the DPCO.

The NPPA also noted that the relevant manufacturers, Sun Pharma and IPCA, had not submitted Form-V for annual price revisions as required under Para 20 of the DPCO, 2013. As a result, the data captured in the Pharmarack database for July 2022 was deemed accurate and valid for calculating the ceiling price.

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Deliberating the matter, the Department of Pharmaceuticals upheld the NPPA’s methodology, emphasizing its compliance with the provisions of the DPCO. It validated the use of July 2022 market data, as well as NPPA’s reliance on the Pharmarack database. The Department dismissed Abbott’s claims that revised pricing from September 2022 should have been considered, citing the timelines and procedural requirements under the DPCO. It observed;

“The Authority in its 104th meeting held on 23.11.2022 had decided, under Para 9(7) of the DPCO 2013, that data for the month of July, 2022 may be considered for calculation of ceiling prices to accommodate for the time lag with which the price changes carried out due to revision in WPI is reflected/captured in the database. Accordingly, prices as captured by the Pharmarack database for the month of July, 2022 were used for fixing the ceiling price of the subject formulation.”

Furthermore, the absence of Form-V submissions from Sun Pharma and IPCA was highlighted as a key factor justifying the PTR data used by the NPPA. It noted;

“Sun Pharma Laboratories Limited and M/S IPCA Laboratories Private Limited did not file Form-V with NPPA for the annual increase as per Para 20 of DPCO, 2013 till July, 2022. Hence, the price as captured by Pharmarack has been taken and price revision has not been considered.”

Subsequently, the Department concluded that Abbott’s arguments did not substantiate any procedural lapses or errors on the part of the NPPA. It held;

“The action of NPPA fixing the ceiling prices of subject formulation is upheld and the Review Application under consideration is accordingly rejected.”