DoP accepts Sun Pharma's review petition on Fucibet cream 15 gm AI tube while rejecting Histac EVT 2’s AI strip

The Department of Pharmaceuticals (DoP) has accepted Sun Pharmaceutical's review petition against price fixation of “Fucibet cream 15 gm AI tube” and has directed the NPPA to fix the price of Fucibet cream 15 mg AI tube as per provisions applicable for nonscheduled formulations in DPCO, 2013. On the other hand DoP has rejected review petition against price fixation on “Histac EVT 2’s AI strip” saying that it has no merit.

Sun Pharmaceutical Industries Limited had filed a review petition under paragraph 22 of the Drugs (Prices Control) Order, 1995 against notification S.O. No.579(E) dated 24.02.2016 issued by the National Pharmaceutical Pricing Authority (NPPA) regarding fixing the ceiling price of Histac EVT 2’s AI Strip and Fucibet Cream 15 gm AI Tube based on review order No.31015/7/2013-PI.I, dated 7.10.2015.

NPPA had fixed revise price of Histac EVT 2’s Al Strip pack at Rs.3.68 and Fucibet Cream 15 gm Al Tube pack at Rs.46.22 excluding excise duty and local taxes under DPCO, 1995 which was challenged by the petitioner contending that the production of Histac EVT tablets involves a special process and requires dedicated facilities and this aspect have been totally ignored.

Sun pharma sought a price of Rs. 5.16 for Histac EVT Al strip of 2 tablets which being Hygroscopic require such packaging material and raw material cost based on actuals; and Rs. 69.08 for Fucibet cream which is sterile and packed in lacquered Al tube based on actual cost as submitted by them and the relevant norms for conversion cost and packing charges.

At the time of examination of the case, the DoP noted that the case has already been examined in detail in the last review of the application filed by the company. In the case of Histac EVT, the bulk drug ranitidine 150 mg is a scheduled formulation as per NLEM 2015. Therefore, the price fixed by the NPPA vide S.O. 1253(E) dated 01.4.2016 is applicable for Histac EVT and is valid until some ambiguity is pointed out in the method of calculation included in the working sheet. As such, the grievance of the company has got no merit and deserves to be rejected.

As regards, Fucibet cream, as it contains Fusidic Acid as API and it was not included either in NLEM 2011 or NLEM 2015, the provisions applicable for nonscheduled formulations as per DPCO needs to be applied. Therefore the request of the applicant in this case deserves consideration noted the DOP.

Giving the decision, DoP stated

“The grievance of the petitioner company in respect of Histac EVT 2’s AI strip has no merit and deserves to be rejected. However, in case of Fucibet cream 15 mg AI tube, as it was not included either in NLEM 2011 or NLEM 2015, the provisions applicable for non-scheduled formulations as per DPCO needs to be applied. Therefore, NPPA is directed to fix the price of Fucibet cream 15 mg AI tube as per provisions applicable for nonscheduled formulations in DPCO, 2013, within 30 days from the date of issue of this order.”

To read the DoP order, click on the following link

http://pharmaceuticals.gov.in/sites/default/files/Speaking Order - Sun Pharma 579-7.pdf