The Department of Pharmaceuticals (DoP) has directed the National Pharmaceutical Pricing Authority (NPPA) to revise the ceiling price of nitrofurantoin 100mg capsule over a review petition filed by Sun Pharmaceuticals, the manufacturer of the formulation.

However, in a setback for the drug maker, the department rejected its argument that the price regulator had ignored an earlier review order and applied the wholesale price index (WPI) factor in ceiling price calculation.

This is the second time within a month that Sun Pharmaceuticals has obtained a favourable decision from the DoP over ceiling price of its products. Two weeks back, the NPPA was ordered to revise the ceiling price of the company’s products --  ciprofloxacin 250mg and ciprofloxacin 500mg tablets.

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.

In its review petition, the drug maker contended that a price notification issued in 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.”

“Despite having explicitly mentioned in the review order, the WPI factor of -2.7105 per cent was applied in ceiling price application. It is against the review order,” the company pointed out.

Countering the drug manufacturer’s view, the price regulator said the price was fixed according to the policy being consistently followed by the Authority. “The Authority discussed the matter with the DoP and decided that the same cannot be changed retrospectively. Accordingly, WPI effect was given in price calculation,” the NPPA said during the proceedings. The government endorsed the stance taken by the regulator in this issue saying that the base price considered for fixing the ceiling price is of August 2015.

At the same time 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.

In fact, the drug regulator had sent Urifast to Pharmatrac for verification. But due to a typographical error, Urifast was mentioned as Urifist. Pharmatrac, in its reply, rightly stated that there was no product in their data base as Urifist CP 100mg capsule. The company has brought this issue to the attention of the government during the review petition hearing.

Accepting this argument put forward by the company, the DoP ruled: “NPPA is 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 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. The NPPA would decide the case within a period of 30 days from the date of receipt of representation/evidences from the petitioner and intimate the government.”