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The Sun Pharmaceutical Industries Limited has received positive verdict from the Department of Pharmaceuticals (DoP) on revision of ceiling prices of nitrofurantoin 100 mg capsule as the DoP has directed the NPPA to re-fix and re-notify the price of nitrofurantoin 100 mg capsule under Para 4, taking into account Para 9(5) of DPCO, 2013, and without applying WPI change in ascertaining the ceiling price.
The DoP further directed the NPPA that the same principles should be applied to all other such cases by the NPPA. NPPA was also directed to exclude the product pack of U FREE 100mg capsule 14x10 of Zydus Cadilla in the price calculation of nitrofurantoin 100 mg, verify the data of Urifist CP100 mg capsule of Cipla and to re-fix the ceiling price of nitrofurantoin 100mg capsule, on merit.
In the review petition, the petitioner contended to exclude Niftran 100 mg capsule 30, Niftran 100 mg capsule 10 from the ceiling price calculation of nitrofurantoin 100 mg capsule as these two packs are not conventional formulations but are therapeutically advanced formulation. These should have been considered as per DOP notification S.O 701(E) dated 10/3/16.
In reply, the NPPA commented that it has notified the ceiling price of Rs. 6.51/ nitrofurantoin 100mg capsule vide S. O. 3180(E) dated 07.10.2016 as per para 4, 10, 11, 14, 16, 17, & 18 of DPCO, 2013 based on the data provided by pharmatrac for the month of August 2015 as per existing practice. It has rightly included Niftran 100mg capsule 30’s and Niftran 100mg capsule 10’s while fixing the ceiling price for nitrofurantoin 100mg capsule.
During examination, the DoP noted that as regards the issue of exclusion of Niftran 100 mg capsule 30 and Niftran 100 mg capsule 10 from the ceiling price calculation on the ground that these two packs are not conventional formulations but are therapeutically advanced formulation, the underlying principle is that of the “essentiality” of a Drug, which is measured from therapeutic and intended use angle and hence, no drug can fall out of price control merely because it involves a New Drug Delivery System. Hence, merely because a capsule is conventional or non-conventional does not make it cease to be capsule.
Regarding the grievance of the company about WPI impact, in this case, there is no ceiling price of the product on 1.4.2016. Ceiling price is fixed for the first time on 7.10.2016. So, when there is no ceiling price on 1.4.2016, there cannot be any revision of ceiling price due to WPI. Hence, applying WPI without the ceiling price having been fixed is not in accordance with the provisions of DPCO. In view of this, NPPA should fix the ceiling price of the product taking into account the data available for the month ending immediately before six months of the Notification of revision in the first schedule i.e. 10.03.2016 in the instant case in terms of Para 9(5) of the DPCO, 2013, the DoP noted.
It further noted that the NPPA has erred in applying WPI in this case where it is not applicable. It is observed that the product pack of U FREE 100mg capsule 14x10 of Zydus Cadilla has not been rightfully included in the price calculation of nitrofurantoin 100 mg capsule by NPPA, as DPCO does not recognize a company for average PTR but only medicines/formulations. The issue of inclusion of product pack URIFIST CP100 MG capsule of Cipla has not been considered by NPPA. NPPA may be directed to look into the matter.
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