The Department of Pharmaceuticals (DoP) has rejected the two review petitions including the one by Lupin against fixation of price of Levo-salbutamol by the National Pharmaceutical Pricing Authority (NPPA).
The other review petition was filed before the Department by Puducherry-based Tristar Formulations against the NPPA order dated March 23, 2007 fixing price of formulation of aspirin+atorvastatin capsules.
Lupin has filed the review of the price against the price fixation order dated April 1, 2013. The department held hearing of both the sides, in the presence of pharma technical expert, before rejecting the petition.
“The issues involved in the review application have been examined based on the record of note of discussions of the personal hearing and other documents on record. As the salbutamol is a scheduled drug and it is possible to derive levosalbutamol from salbutamol through resolution and also that levosalbutamol and dextro salbutamol are two stereoisomers of salbutamol, a scheduled drug, levosalbutamol is thus a scheduled drug and therefore action of NPPA in fixing the bulk price under para 3 of DPCO, 1995 is in order. The review application of the Petitioners is, therefore, rejected,” said the order by the Department dated July 15.
Tristar Formulations had represented to the reviewing authority in December 2011and to Madras High Court order in November 2011. The department held hearing of the petitioner and the NPPA following this and rejected the complaint now.
“From the composition of the Ecosprin AV 75, it is quite evident that the formulation is covered within the purview of price fixation under DPCO, 1995. The SO No. 440(E) dated 23.3.2007 clearly provided sufficient opportunity to the petitioners to approach NPPA for any special feature, to be priced separately. The petitioners have not approached NPPA and did not submit any information to claim any special pricing,” the order said.
“The review application is, therefore, not maintainable and accordingly rejected,” said the order by the Department dated July 17, 2013.