The Department of Pharmaceuticals (DoP) has directed the National Pharmaceutical Pricing Authority (NPPA) to re-fix the ceiling price of Furosemide injection (Furosemide-10mg/ml).

Earlier, Sanofi India had filed a review petition against price fixation of “Furosemide injection (Furosemide-10mg/ml)” by  NPPA via its order No. S.O. 788(E), dated 10.03.2017 issued under DPCO 2013.

In the review petition, the petitioner contended that considering that there was an apparent error in the draft version of proposed price calculation sheet for proposed ceiling price of Rs. 1.01 per ml. in respect of Furosemide injection (Furosemide-10mg/ml displayed on NPPA website which was uploaded on 21st February, 2017, they made a detailed representation to NPPA vide their letter dated 3-3-2017 pointing out errors in working out the proposed ceiling price by including prices of non-existent products.

During the examination of the matter, the DoP noted that the petitioner company has challenged the NPPA Order S.O. 788(E), dated 10.03.2017 for price fixation of their formulation Furosemide injection (Furosemide-10mg/ml) on the ground that NPPA has erred by considering their four formulations, namely Lasix 10mg injection 2ml, Lasix HD 10mg Injection 5ml, Lasix 20mg Injection 2ml & Lasix 250mg injection 25ml to derive the average PTR for this formulation while company has been manufacturing and marketing only one pack of Furosemide injection 10mg/ml namely Lasix 2ml (containing Furosemide 10mg/ml).

In this connection, NPPA has stated that the ceiling price of the formulation has been fixed based on the data provided by Pharmatrac for the month of August 2015. Further, earlier representation of the company was not considered by NPPA as the company had not complied with IPDMS up to 100% (at that time).

On examination, it is found that the company has filed documentary proof in support of their claim that the company is manufacturing only Lasix 20 mg injection 2 ml and the other three products are not in production. The company has also submitted necessary information/documents in proper forms vide their letter, dated 22.3.2017 to NPPA.

In view of the above, it is decided that NPPA may be directed to examine all the relevant documents/information furnished by the petitioner company, get confirmation from Pharmatrac about the authenticity of the claim of the petitioner company and re-fix the ceiling price of Furosemide injection (Furosemide-10mg/ml), on merit.

“NPPA is hereby directed to examine all the relevant documents/ information furnished by the petitioner company and re-fix the ceiling price of Furosemide injection (Furosemide-10mg/ml), on merit, within 30 days of this Order and to send the compliance report to the Department”, the DoP order said.