Revise ceiling price of Sun Pharmas nitrofurantoin 100mg capsule: DoP tells NPPA

New Delhi: The drug pricing regulator has been directed by the Department of Pharmaceuticals (DoP) to revise the ceiling price of Nitrofurantoin 100mg capsule of Sun Pharmaceuticals. On the other hand, the department has rejected the grievance of Sun pharma about not considering negative WPI for 2015.

Nitrofurantoin is an antibacterial agent used commonly in the treatment of acute or recurrent, uncomplicated lower urinary tract infections or inflammation of the renal pelvis, either spontaneous or following surgical procedures.

Sun Pharma had filed a petition under paragraph 31 of the Drugs (Prices Control) Order, 2013 against notification S.O. No.2401(E), dated 28.07.2017 issued by the National Pharmaceutical Pricing Authority (NPPA) fixing the ceiling price of Nitrofurantoin Capsule 100mg.

In the petition Sun Pharma contended that a price notification issued on 28 July 2017 over an earlier review order was not implemented in totality. In the earlier order, the NPPA was directed to “re-fix and re-notify the price of the product without applying WPI change in ascertaining the ceiling price.”

The Review Order No. 31015/91/2016-PI.I dated 06.03.2017 reads as:-

“NPPA is hereby directed to re-fix and re-notify the price of the products of the petitioner company under Para 4, taking into account Para 9(5) of DPCO 2013 and without applying WPI change in ascertaining the ceiling price. The same principle should be applied to all other such cases also by NPPA. NPPA is further directed to exclude the product pack of U FREE 100 mg capsule 14X10 of M/S Zydus Cadila in the price calculation of Nitrofurantoin 100 mg, verify the data of URIFIST CP 100 MG Capsule of M/s Cipla and to re-fix the ceiling price of Nitrofurantoin 100 mg Capsule, on merit.”

The company further contended that despite having explicitly mentioned in the review order, the WPI factor of -2.7105 percent was applied in ceiling price application. It was against the review order.

However, during the proceedings, NPPA stated that ceiling price of Nitrofurantoin Capsule 100mg had been fixed as Rs. 7.13/Capsule as per direction given by DOP vide review order no. 31015/91/2016-PI-I dated 06.03.2016. As per as the applicability of WPI is concerned, the same was done based on the policy being consistently followed by the Authority. The competent Authority discussed the matter with Department of Pharmaceutical and decided that the same cannot be changed retrospectively. Accordingly, WPI effect was given in CP calculation. As directed in the stated review order the data related to the product Urifist CP 100mg capsule was sent to Pharmatrac for verification. Pharmatrac in its reply stated that there is no product in their database as URIFIST CP 100mg capsule. Accordingly, Urifist CP 100mg capsule was not included in calculation sheet.

At the time of examination, the DoP found merit in the company’s contention that Urifast CP 100 mg capsule of Cipla was not included in ceiling price calculation despite the product having composition as nitrofurantoin 100 mg.

Giving the decision, DoP stated

“The grievance raised by M/s Sun Pharmaceutical Industries Ltd. about not considering negative WPI for 2015 cannot be considered as the base price considered for fixing the ceiling price as of August 2015.”

“NPPA is, however, directed to consider the petitioner’s representation and examine and verify the documents claimed by the petitioner, i.e. scanned copy of show box of URIFAST CP 100mg Capsule of M/s Cipla, and after verification, refix the price of formulation Nitrofurantoin capsule 100mg, on merit. The petitioner should submit his/her case/representation along with all documents/evidences at the earliest. NPPA would decide the case within a period of thirty days from the date of receipt of representation/evidences from the petitioner and intimate the Government.”

Below is the attached DoP order.