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The Department of Pharmaceuticals (DoP) has directed the NPPA to adopt the correct methodology in all such cases of calculating the ceiling price of scheduled formulations like ciprofloxacin 500 mg and ciprofloxacin 250 mg tablets as per para 4(i) of DPCO, 2013 and provisions of existing Schedule-I by including market shares of only generic/brands and not company-wise MAT percentage.
Delivering its order on a review petition filed by Sun Pharmaceuticals Industries Ltd, the DoP also directed the NPPA to re-fix the ceiling prices of the ciprofloxacin 500 mg. and ciprofloxacin 250 mg. tablets, on merit, after due verification of all data. The Sun Pharmaceuticals had earlier filed a review application against the fixation of ceiling price of “ciprofloxacin 500 mg tablet” and “ciprofloxacin 250 mg tablet” by the NPPA through its notification S.O. No. 1686(E) dated 09.05.2016 issued under DPCO, 2013.
During the examination of the matter, the DoP noted that in the personal hearing on 15.7.2016, the company representative agreed to submit Form IV for discontinuation of the captioned formulations. However, after repeated reminders, NPPA confirmed on 23.9.2016, that the petitioner company has not submitted Form IV. Therefore, the contention of the petitioner company that NPPA has taken the data of prices of drugs discontinued/seems to be discontinued while calculating the ceiling prices of the subject formulations, has got not merit.
The other point of taking price data of six months prior to the date of notification, which in this case appears November, 2015, but NPPA has taken MAT of August, 2015, NPPA has taken August 2015 data since it is six months prior to the date of notification of the amended DPCO 2013 based on NLEM 2015 and thus it is as per the provisions of DPCO 2013. Regarding the contentions of the petitioner company regarding wrongly capturing data of Cifran 250 and Cifran 500, there is a basic flaw in calculating the ceiling prices in the case of both ciprofloxacin 250 mg and ciprofloxacin 500 mg. In the computation sheet, NPPA has erred in taking the company-wise percentage of MAT instead of SKU-wise MAT, the DoP noted.
This is in gross violation of para 4(i) of the DPCO, 2013, which gives the methodology of calculating the ceiling prices of Scheduled formulations. It does not provide for calculating the ceiling prices of company-wise MAT percentages, but on individual brand and generic versions having market share of more than 1%. If the revised computation is done, only 8 versions would be used for computation of ceiling prices of ciprofloxacin 250 mg and 8 versions also for ciprofloxacin 500 mg., instead of 13 and 15 versions respectively considered by NPPA in their computation.
Also, the existing data used for computation needs to be verified. The existing Schedule-I of DPCO, 2013 is very clear that “the formulations developed through incremental innovation or novel drug delivery systems like lipid/liposomal formulations, sustained release/controlled release etc. should be considered as included only if specified in the list against any medicine”. NPPA may also be directed to comply with these provisions of Schedule-I and to use the correct methodology for computation of ceiling by including market shares of only generic/brands and not company-wise MAT percentage, the DoP further stated.
After due examination of the case, the DoP ordered, “NPPA is directed to adopt the correct methodology in all such cases of calculating the ceiling price of scheduled formulations as per para 4(i) of DPCO, 2013 and provisions of existing Schedule-I by including market shares of only generic / brands and not company-wise MAT percentage and to re-fix the ceiling prices of the ciprofloxacin 500 mg. and ciprofloxacin 250 mg. tablets, on merit, after due verification of all data within a period of one month from the date of issue of this Order”.
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