The Department of Pharmaceuticals (DoP) has rejected the review petition filed by Boehringer Ingelheim against ceiling price fixation of “Hyoscine butyl bromide iInjection 20 mg/ml” by the National Pharmaceutical Pricing Authority (NPPA).
The NPPA had fixed the ceiling price of “Hyoscine butyl bromide injection 20 mg/ml” vide its order No. S.O. 4128(E), dated 22.12.2016. Aggrieved by the order, Boehringer Ingelheim filed a review application asking the reviewing authority DoP to examine the matter.
In the review petition, the petitioner contended that the PTR mentioned for some brands has been rightly considered for the calculation, like for Buscogast injection which is with Boehringer Ingelheim, the price considered is rightly taken however, for another product hyocimax injection 20mg/ml from Zydus Cadila has been wrongly considered. This is impacting the overall calculation of proposed ceiling price for hyoscine butyl bromide injection 20mgl ml and hence affecting the price for their brand Buscogast injection as well.
In view of above, they requested the DoP to request NPPA to revalidate correct price for hyocimax injection (Zydus Cadila) from Zydus Cadila to calculate the correct ceiling price and offer them relief on the right ceiling price.
In reply, the NPPA commented that the points raised by the company are not relevant. Price fixation has been done strictly in accordance with the provisions of DPCO, 2013 and as per the decisions of 27th Authority meeting held on 29.3.2016.
During examination of the issue, the DoP noted that the petitioner company has challenged the NPPA Order S.O. 4128(E), dated 22.12.2016 for price fixation of their formulation hyoscine butyl bromide injection 20 mg/ml on the ground that correct methodology was not followed in arriving at the ceiling price of hyoscine butyl bromide 20 mg/ml injection and the price of hyocimax injection 20 mg/ml from Zydus Cadila has been wrongly considered. The company has not submitted any documentary proof in support of their claim that NPPA has wrongly taken the data of hyocimax injection 20 mg/ml. NPPA has fixed the ceiling price based on the data provided by Pharmatrac for the month of August, 2015 and strictly in accordance with the provisions of DPCO 2013. Therefore, the grievance of the company has got no merit and the review petition may be rejected.
“The grievance raised by Boehringer Ingelheim India Pvt. Ltd. in their review petition has got no merit and hence the petition stands rejected,” the DoP ordered.