The Department of Pharmaceuticals (DoP) directive to the NPPA comes following complaints from several manufacturers that the NPPA is adopting a practice that even when some brands/generic versions of a medicine of a company have less than 1% market share, the market share of all such versions of that medicine of that company is clubbed together.
It has been noticed by the DoP that while fixing the prices of Scheduled formulations/medicines, NPPA has adopted a practice that even when some brands/generic versions of a medicine of a company have less than 1% market share, the market share of all such versions of that medicine of that company is clubbed for the purpose of determining whether the company's market share (in place of a given brand's market share) is equal to or more than 1%.
DoP stated that DPCO, 2013 does not recognize a company for average PTR but recognizes only medicines/formulations. This has also been stated in different Review Orders passed by the government in its capacity as reviewing authority and NPPA has been directed to refix the ceiling price by considering the PTR (Price to Retailer) of only such formulations/brands that have more than 1% market share.
Now therefore, the government hereby clarifies that while fixing the ceiling prices of scheduled formulations, MAT value and PTR of only those medicines/formulations shall be considered which are having 1% or more market share
