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The Department of Pharmaceuticals (DoP) has rejected pharma major Sun Pharmaceuticals' review petition against price fixation of “Histac EVT 2’s AI strip”. However, the DoP has found merit in the company's review petition against the price fixation of “Fucibet cream 15 gm AI tube” 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.
In the review petition, the petitioner referred to DoP's review order no. 31015/7/2013-PI.I dated 07.10.2015 and subsequently NPPA notification S.O.No.579(E) dated 24.02.2016 revising the price of Histac EVT 2’s Al strip pack from Rs. 2.96 to Rs. 3.68 and Fucibet cream 15 gm Al tube pack from Rs. 30.52 to Rs. 46.22 excluding excise duty and local taxes under DPCO, 1995 based on the review order of the Ministry. Aggrieved by the inadequate revision, the company sought review of the same under Paragraph 22 of DPCO, 1995.
In the petition, the petitioner contended that the production of Histac EVT tablets involves a special process and requires dedicated facilities and this aspect have been totally ignored. They 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 us and the relevant norms for conversion cost and packing charges.
The petitioner further contended that norms of conversion cost, packing charges and packing materials have not been revised based on established procedure of costing after the year 2006 and as such norms for conversion cost are not correct. Histac EVT tablets and Fucibet 15 gm cream have become nonscheduled formulation under DPCO, 2013 and although inadequate price have been fixed but its base year is April 2012 and Oct 2012 respectively when they submitted their price application.
During the 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.
“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,” the DoP ordered.
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