Sun Pharma plea to refix price of Ciprofloxacin Hydrochloride Injection rejected

New Delhi: In a major setback to Ranbaxy Laboratories Limited (now Sun Pharmaceutical Industries Ltd.), the Department of Pharmaceuticals (DoP) has found its review petition against the National Pharmaceutical Pricing Authority (NPPA) fixing the ceiling price of Ciprofloxacin Hydrochloride Injection 200mg/100ml devoid of merit and rejected the plea.

Sun Pharma had moved a submission with DoP in 2015 against the price notification by NPPA for the said formulation. However, the application was disposed of by the authority. Thereafter, the drugmaker approached the Bombay High Court and had filed a writ petition.

The court found substance in the contention of Sun Pharma and stated that the basic principles of natural justice were violated as the authority who heard the matter had not passed the impugned order and set aside the said review order. Consequently, the court directed that the review application be decided afresh after giving a fresh hearing and directed the drugmaker to appear before DoP on January 8, 2019.

Accordingly, the drugmaker was granted a personal hearing on 08.01.2019. During the hearing, the firm requested for some more time to make further submissions pertaining to queries raised to them. The hearing was again held on 05.02.2019.

In its submission, the firm sought the department to direct NPPA to review, recalculate and revise the Ceiling Price of the drug Ciprofloxacin Infusion 200mg/100ml in accordance with the provisions of Paragraph 4 of DPCO after taking into consideration the prevailing price of the firm's product Cifran Infusion 200mg per 100ml and all other omitted formulations from the initial calculation of Ceiling Price dated 28.04.2014.

The drugmaker contended that by a notification dated 28.04.2014, the NPPA erroneously superseded the notification dated 10.06.1997 instead of notification 25.11.2003, which was effective as on the date of the notification 28.04.2014. As per notification dated 25.11.2003, the ceiling price of Ciprofloxacin Hydrochloric injection was Rs 0.1776 per ml pack. However, the NPPA considered the ceiling price of notification 10.06.1997 instead of considering the ceiling price notified under the notification, dated 25.11.2003.

"Under the notification dated 28.04.2014, PTR of brands were restricted superseding the notification dated 10.06.1997 at Rs 0.15 per ml, whereas as per notification dated 25.11.2003 the ceiling price was Rs 0.1776 per ml. The notification dated 28.04.2014 for Ciprofloxacin Hydrochloric Injection did not consider the PTR of the firm's product Cifran infusion in spite of having a market share of more than 1%," the firm added.

It further contended;

"NPPA issued a notification dated 10.07.2014, which superseded the notification dated 28.04.2014 and revised the ceiling price of Ciprofloxacin Hydrochloric injection 200mg/100 ml. at Rs 0.27 (from of Rs 0.16 per 1 ml.). However, on the very next day i.e. on 11.07.2014, NPPA withdrew the notification dated 10.07.2014. "

In response to this, NPPA contended that the Authority considered the ceiling price of the notification dated 10.06.1997 for restriction purpose as DoP vide notice dated 10.06.1997 fixed the price of "ciprofloxacin hydrochloride injection 200mg/100ml" under DPCO, 1995. Further, NPPA vide notice dated 25.11.2003 fixed the price of formulations "ciprofloxacin-2mg per ml + sodium chloride 0.9%" and "ciprofloxacin-2mg per ml + Dextrose 5%" under DPCO, 1995.

Subsequently, under DPCO, 2013 NPPA vide notification dated 28.04.2014 fixed the price of same formulation i.e. "ciprofloxacin hydrochloride injection 200mg/100ml" at Rs 0.16 per ml, by correctly superseding the notice dated 10.06.1997 since both formulations are same.

"The NPPA has considered PTR of their product Cifran Infusion while notifying the ceiling price at Rs 0.16 per ml vide notice dated 28.04.2014. Further, the order dated 25.11.2003 was issued under the DPCO, 1995 where the exemption was granted to Ranbaxy. However, the notice dated 28.04.2014 was issued under the DPCO, 2013 where no exemption was granted to Ranbaxy Laboratories. Accordingly, the petitioner was required to follow the notified price, " the Authority added.

After hearing both the parties, the Department noted;

"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 the issue of the notification 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."

It was further observed that the NPPA also clarified that the DoP via notice dated 10.06.1997 fixed the price of "ciprofloxacin hydrochloride injection 200mg/100ml" under the DPCO, 1995. Further, the NPPA vide notice dated 25.11.2003 fixed the price of formulations "ciprofloxacin-2mg per ml + sodium chloride 0.9%" and "ciprofloxacin-2mg per ml+Dextrose 5%" under the DPCO, 1995. Subsequently, under the DPCO, 2013 the NPPA vide notice dated 28.04.2014 fixed the price of same formulation i.e. "ciprofloxacin Hydrochloride injection 200mg/100ml", by correctly superseding SO 438(E) dated 10.06.1997 since both formulations were same. Hence, the NPPA has rightly considered the ceiling price notified under the DPCO 1995 vide 438(E), dated 10.06.1997, while notifying the ceiling price of Ciprofloxacin Hydrochloride Injection under the DPCO 2013 vide SO 1157(E), dated 28.04.2014.

Upholding NPPA's decision, the court finally rejected the review application submitted by Sun Pharma and held;

"The review application of Ranbaxy Laboratories Limited (now M/s Sun Pharmaceutical Industries Ltd.) is devoid of merit and is therefore rejected."