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The National Pharmaceutical Pricing Authority (NPPA) will be exploring sources other than the Pharmatrac database, which it relies on price fixation, while fixing the ceiling prices for some of the scheduled formulations for which further data would be helpful.
The decision is following an observation that there is data outside the purview of Pharmatrac, including other manufacturers whose supply chain differs from the typical retail distribution channels for pharmaceuticals.
So far, the pricing authority has been fixing the prices based on Pharmatrac data only, without considering data from other sources like Integrated Pharmaceutical Database Management System (IPDMS), web sources or the information submitted by the companies in their representations.
However, in a latest meeting, the Authority observed that Pharmatrac data captures limited hospital supply products.
Recently, the Department of Pharmaceuticals (DoP) has asked the authority to review ceiling price it fixed for Iohexol injection 300 mg iodine/ml, a contrast media in clinics and diagnostic centres for procedures like angiograms, as a special case accepting the claim of J B Chemicals and Pharmaceuticals and Unijules Lifesciences that Pharmatrac is not equipped to track secondary sales of medical devices or contrast media.
The Authority, after detailed discussion on the matter, decided that in the remaining cases of ceiling price fixation, in case the qualifying items as per Pharmatrac database are less than five, data from other sources such as Form II of the IPDMS, web sources, market survey or any other source "may be explored for identification of other manufacturers in line with Para 9(1) of DPCO, 2013".
The Para 9 of the Drug Prices Control Order (DPCO), 2013 details the reference data and source of market based data, which stipulates that the source of market based data shall be the data available with the pharmaceutical market data specializing company as decided by the government and if the government deems it necessary, it may validate such data by appropriate survey or evaluation.
As reported earlier, JB Chemicals and Pharmaceuticals and Unijules Lifesciences in its review petition to the DoP regarding price fixation of Iohexol injection claimed that as such, the supply chain for the product differs from the retail sale channels typically used for pharmaceuticals. While Pharmatrac, the agency which provides data to the NPPA related to pricing, is designed to capture secondary sales data for the retail sale of pharmaceuticals, it is not equipped to track secondary sales of medical devices or contrast media.
They alleged that the authority has fixed the ceiling price for the product based on only one company - Contrapaque brand f JB Chemicals - as appearing in the Pharmatrac database, while there are products from Ocean Pharmaceuticals, Arco Lifesciences, Genetek Life Sciences, GE Healthcare and Unijules Life Sciences, which are not considered by NPPA for price fixation.
Following this, the NPPA has sought manufacturers and marketing companies of iohexol injection 300 mg iodine per ML to submit price and market data on the product for fixation of its ceiling price.
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