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 The National Pharmaceutical Pricing Authority (NPPA) has released draft version of calculation of ceiling price for six formulations under the revised Schedule I of Drugs Prices Control Order (DPCO), 2013, including three strengths of human immunoglobulin, denatured ethyl alcohol, peritoneal dialysis solution, and vitamin tablet riboflavin.
The ceiling price of human normal immunoglobulin 5% solution for infusion, has been proposed for a 23.95% reduction to Rs. 148.60 per ml, as compared to the current ceiling price of Rs. 195.41 per ml, as fixed in the end of March, 2025. The formulation, with a Moving Annual Turnover (MAT) of Rs. 39.25 crore, has six companies with a market share of one per cent or above and the Authority has considered MAT Value of Rs. 39.05 crore for the calculation.
For the human normal immunoglobulin 10% solution for infusion, NPPA has proposed a ceiling price of Rs. 206.53 per ml, with a 21.94% reduction from the current ceiling price of Rs. 264.57, fixed in the end of March, 2025. The formulation has a MAT of Rs. 32.25 crore, with two companies having a market share of one per cent or above. The Price to Retailer (PTR) of some of the packs considered for the calculation of these two formulations are based on Form V or II filed by the company.
The ceiling price of human normal immunoglobulin 16.5% solution for infusion has been calculated at Rs. 478.57 per ml, with a 4.88% reduction compared to the current ceiling price of Rs. 503.13 per ml, which was fixed in the end of March, 2025. The formulation has a MAT of Rs. 33.7 crore, with two companies having market share of one percent and above.
The Authority proposed the ceiling price of ethyl alcohol (denatured) 70% solution at 0.40 per ml, which is 26.52% lower compared to the current ceiling price of Rs. 0.54 per ml.
The ceiling price of peritoneal dialysis solution, used for the treatment of kidney failure, has been fixed at Rs. 0.22 per ml. The formulation, with a MAT value of Rs. 99.79 crore has only one company with one per cent and above market share. Prices of six packs, from Baxter India were considered for calculation of the price.
The ceiling price of vitamin formulation riboflavin 10 mg tablet, has been fixed at Rs. 1.11 per tablet through the draft calculation sheet. Only one company has one per cent and above market share for the product and the price regulator considered one pack of Shreya Life Sciences' brand for calculation of the price.
It may be noted that in March, this year, the Authority has said that it 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 was 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.
It decided to consider data from sources such as company filing in IPDMS Form II and V, web sources, market survey or any other source, since the qualifying items as per the Pharmatrack database on some of these formulations are less than five.
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