DoP rejects Glenmark's appeal on price cap of Clotrimazole Cream
New Delhi: The Department of Pharmaceuticals has upheld the National Pharmaceutical Pricing Authority's (NPPA) decision on the price cap for Clotrimazole Cream 1%, dismissing an appeal from Glenmark Pharmaceuticals.
Glenmark had filed a Review Application on April 27, 2023, under the Drugs (Prices Control) Order, 2013, contesting the NPPA's March 31 price fixation order. The NPPA's order, issued under S.O. No. 1577(E), set a ceiling price for the medication, which Glenmark argued was incorrectly calculated.
During a hearing on September 14, Glenmark raised several points. The pharmaceutical company claimed that the NPPA failed to consider correct pricing data it had submitted, citing differences in the calculated Price to Retailer (PTR) for products like Franco's "Surfaz 1% Cream 15 gm" and Hetero’s "Imidil Skin 1% Cream 15 gm."
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Glenmark pointed to several differences in the pricing data for two products in particular:
| Product Name | Company | PTR as per NPPA working sheet | Actual MRP | Actual PTR to be considered in the working sheet by NPPA |
|---|---|---|---|---|
| Surfaz 1% Cream 15 gm | Franco | 32.29 | 50.00 | 35.71 |
| Imidil Skin 1% Cream 15 gm | Hetero | 25.11 | 38.75 | 27.68 |
Glenmark contended that these differences led to an inaccurate ceiling price. Additionally, Glenmark argued that the NPPA did not include certain products with market shares above 1%, like Reckitt Benckiser’s “New Itch Guard 1% Cream” and Midas Care's “Clean and Dry Cream,” in the ceiling price calculations.
Glenmark argued that the NPPA overlooked certain products with more than a 1% market share in the ceiling price calculations, as shown in the following table:
| Product Name | Company Name | Pack Size | Actual PTR in Jul'22 (Pharmatrac) | Market Share MAT% (Pharmatrac) |
|---|---|---|---|---|
| New Itch Guard 1% Cream 15 gm | Reckitt Benckiser | 15 gm | 63.02 | 5.5% |
| Clean and Dry 1% Cream 15 gm | Midas Care | 15 gm | 88.54 | 4.3% |
In response, NPPA asserted that the pricing decisions were consistent with DPCO regulations, specifically under Paras 16(2) and 16(3). These provisions allow manufacturers to revise MRP annually based on the Wholesale Price Index (WPI) in April, with revised pricing submitted to NPPA in Form-II or Form-V by May 15. NPPA clarified that while Franco submitted Form-V after the deadline, Hetero did not file either form. NPPA also noted that "New Itch Guard 1% Cream" from Reckitt Benckiser contained "Benzyl Alcohol + Terbinafine" rather than Clotrimazole, and "Clean and Dry Cream" from Midas Care contained Clotrimazole 2%, not Clotrimazole 1%, making these products ineligible for consideration in the price calculations.
After reviewing the arguments, the Department of Pharmaceuticals ruled in favor of NPPA’s methodology and adherence to DPCO guidelines, stating that the ceiling price was accurately calculated. It noted;
“In fixing the ceiling price of Scheduled formulations, NPPA has followed the due provisions of DPCO. Thus, NPPA has taken due cognizance of the provisions under Para 16(2) and 16 (3) of DPCO which provides that manufacturers may avail the increase in MRP of scheduled formulations once in a year, in the month of April, on the basis of the WPI; and, that such information about the revision, if carried out, shall be forwarded to the Government on IPDMS in Form-Il and Form V within a period of fifteen days. DPCO also expressly maintains that non-submission of information under Para 16 (3) shall be construed as non-revision of MRP. NPPA has taken the relevant prices following these provisions of DPCO.”
“Further, composition of the brands of "New Itch Guard 1% Cream 15 gm" of M/S Reckitt Benckiser, and "Clean and Dry Cream 15 gm" of M/S Midas Care is not Clotrimazole 1% and hence, NPPA did not consider these for Ceiling price calculation of the subject formulation.”
The Department thus rejected Glenmark's application, confirming NPPA's pricing decision for Clotrimazole Cream 1%. It held;
“The action of NPPA fixing the ceiling prices of Clotrimazole Cream I % vide SO no. 1577(E) dated 31.03.2023 is upheld and the Review Application under consideration is accordingly rejected.”
