The Department of Pharmaceuticals (DoP) has directed the national drug regulator National Pharmaceutical Pricing Authority (NPPA) to revalidate data on ciprofloxacin HCl tablet 250mg for reviewing the ceiling prices of the same. The DoP's order in this regard came on a review petition filed by Zydus Healthcare Ltd against fixation/revision of ceiling prices of ciprofloxacin HCl tablet 250mg by the NPPA.
Earlier the NPPA vide price fixation Order S.O. No.2352(E) dated 15/9/2014 had fixed/revised ceiling price of ciprofloxacin HCl tablet 250mg under DPCO, 2013 included at section 8.2.2.3 in Schedule-I of the order.
Aggrieved by the NPPA notification, Zydus Healthcare Ltd submitted a review application with the reviewing authority DoP dated 7.10.2014 under para.31 of DPCO, 2013 for the review of NPPA Price fixation Order S.O.No.2352 (E) Dated 15.9.2014 fixing ceiling price of Rs.2.02 per tablet of ciprofloxacin HCl tablet 250mg under DPCO, 2013.
In the review petition, the petitioner mentioned that their brand Ciprobid 250mg tablet with PTR (price to retailer) of Rs.2.71 per tablet has not been considered by NPPA. The company, therefore, requested that the price fixation may be reconsidered by NPPA by considering their brand Ciprobid 250mg tablet having PTR of Rs.2.71 per tablet which has a market share of 23 per cent as per AWACS.
The petitioner representative provided a photocopy of strip of Ciprobid 250 mg tablet manufactured in July 2013 (batch No.ZHN 2943) substantiating that Ciprobid 250 mg tablet was/is existing in the market.
Responding to petitioner's plea, the NPPA stated that data as provided by IMS Health has been considered in price fixation which did not include data of Ciprobid 250mg tablet of Zydus Healthcare.
After hearing both the parties, the reviewing authority DoP ordered, “Para 9(1) of DPCO 2013 empowers NPPA to revalidate data by appropriate survey or evaluation. NPPA is directed to revalidate the data.”