The Indian pharma major Sun Pharmaceuticals has received a favourable ruling from the reviewing authority department of pharmaceuticals (DoP) on its review petition on Histec EVT tablets and Fucibet cream 15 mg aluminium tube as the DoP has directed the National Pharmaceutical Pricing Authority (NPPA) to revise the prices of these drugs.
Earlier, Ranbaxy Laboratories (now Sun Pharmaceuticals) had filed an application with the NPPA for fixation/revision of ceiling prices of Histec EVT tablets and Fucibet cream in 15 gm aluminium tube under DPCO, 1995. And the NPPA vide letter No. 8(37)/2012/DP/Div.II/NPPA dated 10.1.2013 closed the petitioner’s form III applications in respect of these formulations.
Aggrieved by the NPPA letter, Ranbaxy submitted a review application dated 20.2.2013 under para 22 of DPCO, 1995 for the review of NPPA’s decision to close the petitioner’s form III applications.
Subsequent to the passing of review order by the DoP, the petitioner challenged the review order in the Delhi High Court. The Delhi High Court vide its order dated 15.04.2015 set aside the impugned order and the matter was remanded to the reviewing authority to take a fresh decision in the matter.
In the hearing, the petitioner mentioned that they had filed an application in form III for price fixation on 24.4.12 pertaining to Histec EVT tablets on the ground that the prices of bulk drugs were revised by NPPA on 11.10.2010. In the said application in form III the company had also contended that the prices of the said formulation should be revised in view of the increase in the excise duty levied by the central government.
The petitioner mentioned that they had also filed another application in form III dated 18.10.2012 for price revision of price fixation Order SO No. 1937(E) dt. 3.8.2009 pertaining to Fucibet cream 15 gm aluminium tube. The petitioner further mentioned that despite the application was pending with NPPA they did not revise the prices on the basis of their request. However, they received a letter dt. 10.1.13 that their form III application was considered as closed in the light of National Pharmaceutical Pricing Policy (NPPP) 2012.
Then the NPPA stated that as per para 8(4) two months time from the date of receipt of complete information is permitted. NPPA has not received complete information from Ranbaxy till date in respect of Histac tablet. Further in respect of the application dt. 18.10.12 for Fucibet cream, NPPP 2012 was notified prior to the expiry of two months from the date of application.
After hearing both the parties, the DoP recommended, “In respect of Histec EVT tablet the company did not provide the information to NPPA. NPPA may seek relevant information pertaining to form III from the company within 3 weeks from the issue of Order and the company will provide necessary details within another 3 weeks from the date of receipt of order. After receipt of complete information from the company NPPA will revise the prices as per provisions of DPCO, 1995.
“In the case of Fucibet cream 15 mg aluminium tube, NPPA to consider the information filed by the company in form III and fix the price within 45 days from the date of issue of this order. In respect of revision of ranitidine downward by NPPA on 11.10.2010 from Rs.691 to Rs.660/- NPPA may take action as per extant rules and procedures.”