Date: 20-Jan-2020

DoP rejects Sun Pharma’s review petition on ciprofloxacin hydrochloride injection

The Department of Pharmaceutical (DoP) has rejected the review application filed by Ranbaxy Laboratories Ltd (Now Sun Pharmaceutical Industries Limited) against the notification S.O. No. 2095(E), dated 20.08.2014 issued by the NPPA fixing the ceiling price of ciprofloxacin hydrochloride injection 200mg/100ml. The applicant Ranbaxy had filed a review application, dated 18.09.2014 under paragraph 31 of DPCO, 2013 against the notification. But, the review application was disposed of by the DoP in its review order no. 31015/53/2015-PI.I, dated 14.05.2015. Dissatisfied over the DoP’ rejection of its review application, the applicant moved Bombay High Court. The Bombay High Court vide its order dated 30.11.2018 in W.P. No.2380/2015 found substance in the contention of the petitioner and stated that the basic principles of natural justice have been violated as the authority who heard the matter has not passed the impugned order dated 14.05.2015 and set aside the above said review order. The Bombay High Court further directed that the review application be decided afresh after giving a fresh hearing and directed the petitioner company to appear before the concerned authority (DoP) on January 08, 2019. In its review petition, Sun argued that under the said notification dated 20.08.2014, the Ministry/NPPA could not seek to revise the price of ciprofloxacin hydrochloric injection 200mg./100 ml. since, there was no price fixation under DPCO 2013. This was in view of the supersession of notification dated 28.04.2014 by revising ceiling price vide notification dated 10.07.2014 and then on 11.07.2014 withdrawing of the then notification dated 10.07.2014. It further contended that the working sheet showing calculation of fixation of price on the website of NPPA and the MAT%, PTR and price of their product was incorrect; in view of the stay order granted to the applicant for and in respect of ciprofloxacin and its formulations (qua DPCO 1995), the same would cover and protect the applicant qua notification dated 20.08.2014; and as such, the notified price was ex-facie illegal. During the examination of the case, the DoP noted that the DPCO 2013 came into existence with effect from 15.05.2013 in supersession of the DPCO, 1995. The formulation ciprofloxacin hydrochloride injection was included as a scheduled drug in NLEM, 2011 at section 6.2.2. Accordingly, the NPPA fixed the retail price of ciprofloxacin hydrochloride Injection vide SO 1157(E) dated 28.04.2014. The said notification SO 1157(E) dated 28.04.2014 was superseded by SO 1784(E) dated 10.07.2014. However, SO 1784(E) dated 10.07.2014 was withdrawn on 11.07.2014 vide SO 1823(E). The NPPA observed that SO 1784(E), dated 10.07.2014 was issued inadvertently as it is a ceiling price case and Ranbaxy Laboratories Ltd. had gone to court against ciprofloxacin bulk drugs and the case was subjudiced at that time. Accordingly, the NPPA decided to withdraw the notification on 11.07.2014. It further noted that the sequence of events clearly shows that on 11.07.2014, the notification dated 10.07.2014 was withdrawn and therefore the notification dated 28.4.2014 continued to remain operational. Therefore, the notification dated 28.4.2014 was in existence till issue of notification SO 2095(E), dated 20.08.2014 revising the ceiling price of the subject formulation from Rs.0.16 to Rs.0.17 per ml. Therefore, there is no merit in the contention of the applicant that the NPPA could not revise the ceiling price of the subject formulation as the ceiling price was non-existent on the date of revision i.e. 20.08.2014. The NPPA has considered PTR of applicant’s product CIFRAN Infusion, while notifying the ceiling price vide SO 1157(E) dated 28.04.2014. The PTR was restricted as per ceiling price notification SO 438(E) dated 10.06.1997. The stand taken by the NPPA of restricting the PTR of applicant’s product CIFRAN as per ceiling price notification SO 438(E), dated 10.06.1997 while notifying the ceiling price of ciprofloxacin isnjection vide SO 1157(E), dated 28.4.2014 is in order. Therefore, the contention of the applicant has got no merit, the DoP noted. The DoP also noted that the review application dated 26th May 2014 against SO 1157(E), dated 28.4.2014 was filed on the similar grounds which were raised in subsequent review application dated 18.09.2014 against SO 2095(E), dated 20.08.2014. The issues raised in the review application, dated 26th May 2014 have already been covered while examining the review application dated 18.09.2014. “The review application of Ranbaxy Laboratories Limited (now M/s Sun Pharmaceutical Industries Ltd.) is devoid of merit and is therefore rejected”, the DoP in its order dated January 2, 2020 said.