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DoP upholds ceiling price fixation of clotrimazole cream 1%
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Gireesh Babu, New Delhi
October 31 , 2024
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The Department of Pharmaceuticals (DoP) has upheld the ceiling price fixed by National Pharmaceutical Pricing Authority (NPPA) for antifungal medicine clotrimazole cream 1% against a review application filed by Mumbai-based Glenmark Pharmaceuticals.
The company approached the review authority in April, 2023, against the NPPA's order in March, alleging that the pricing authority had erred in determining the ceiling price of the drug.
While the company submitted its representation regarding certain anomalies in the data considered for calculation of the ceiling price of the drug, along with supporting documents like pack shots indicating correct price, following the release of the draft calculation sheet, the NPPA went ahead with the final notification without considering the correct Price to Retailer (PTR), it alleged.
It pointed out that the PTR of Franco Indian Pharmaceuticals' Surfaz 1% cream 15 gm and Hetero Drugs' Imidil Skin 1% cream 15 gm was calculated at Rs. 32.29 and Rs. 25.11, while the actual PTR to be considered in the working sheet was Rs. 35.71 and Rs. 27.68, argued the company.
Besides, the Authority did not consider some products having market share of more than 1% for calculating the ceiling price of the subject formulation, it said. For instance, it argued, the price of New Itch Guard 1% cream 15 gm from Reckitt Benckiser and Clean and Dry 1% cream 15 mg from Midas Care were not considered, it added.
NPPA informed the review authority that the PTR of Hetero and Franco-Indian Pharmaceuticals' products submitted by Glenmark Pharma are higher than the Pharmatrac data used in calculation of the ceiling price. It said that Hetero did not file either Form II or Form V, while Franco-Indian Pharmaceuticals filed Form V on June, 2022, that is after the cut off date of May 15, 2022, and did not file Form II. Hence, these price revisions have not been considered, it added.
The price revisions following WPI change have to be implemented by the companies and the information should be submitted to the government in Form II within a period of 15 days of such revision. This implies that Form II for price revision based on WPI may be submitted latest by May, 15, said the Authority.
Besides, NPPA said that the product from Reckitt Benckiser, according to Pharmatrac contains benzyl alcohol and terbinafine, and not clotrimazole. The brand from Midas Care, as per the web sources, is a composition of clotrimazole 2% cream base selling at MRP of Rs. 119. Hence these two products were not considered for ceiling price calculation of clotrimazole 1% cream.
The review authority, after hearing both the arguments, observed that the NPPA has followed the provisions of the Drugs Prices Control Order, 2013 while fixing the price of the drug. It also accepted the NPPA's argument that the two products from Reckitt Benckiser and Midas Care are not clotrimazole 1% and hence, the pricing authority did not consider them for price calculation.
With this observation, Awadhesh Kumar Choudhary, senior economic adviser with the DoP, ordered that the action of NPPA fixing the ceiling price of the formulation on March 31, 2023 is upheld and the review application under consideration is rejected.
It may be noted that the DoP has issued orders on several review applications submitted by individual firms, including Pfizer, AstraZeneca, Abbott Healthcare, Cipla, Lupin and others during the month of October.
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