The Department of Pharmaceuticals (DoP) has directed the National Pharmaceutical Pricing Authority (NPPA) to re-fix the ceiling price of “Clotrimazole Cream 1%” within a period of one month. The NPPA through its notification No. S.O. 1687(E) dated 09/05/2016 issued under Drugs (Prices Control) Order, 2013 (DPCO 2013) had fixed the price of “Clotrimazole 1% Cream”.

Aggrieved by the notification, Glenmark Pharmaceuticals submitted a review application under paragraph 31 of the DPCO 2013 dated 07.06.2016 against price fixation of “Clotrimazole 1% Cream” vide NPPA order No. S.O. 1687(E) dated 09/05/2016 issued under DPCO 2013.

In the review petition, the petitioner contended that full due diligence had not been done to capture data of all brands to calculate the ceiling prices. List of formulations that should have been considered in the first place and have been totally missed in the working sheet while arriving at the ceiling price of Clotrimazole 1% Cream. It further contended that data of this particular brand has erroneously found its way in the database used by NPPA and the working sheet should not have included the data in respect of the Canitross brand unless evidence to the contrary is put before the Authority. And the petitioner asked the reviewing authority, DoP, to take the necessary steps as deemed appropriate and assist in re-fixing of revised ceiling price in respect of Clotrimazole 1 % Cream.

In reply, the NPPA stated that it has fixed the ceiling price for above mentioned pack based on the data submitted by Pharmatrac as per existing practices and fixed the ceiling price under para 4, 10, 11, 14, 16, 17 & 18 of DPCO, 2013.

The contentions of petitioner and the NPPA were heard on 16th June, 2016. In the hearing, the company submitted that ceiling price calculation of Clotrimazole 1% Cream is inaccurate and incomplete as full data has not been considered while arriving at the price. Specifically, the some formulations, that should have been considered in the first place have been totally missed in the working sheet. The company procured and handed over physical pack/carton of some of them during the hearing.

After hearing both the petitioner and the NPPA, the reviewing authority DoP ordered, “NPPA is directed to re-fix the ceiling price of “Clotrimazole Cream 1%” after taking into consideration data furnished by the petitioner company on merit within a period of one month from the date of issue of this Order. Issued on this date of 08th of July, 2016”.