|
NPPA notifies revised ceiling price of six scheduled formulations
|
|
Gireesh Babu, New Delhi
November 07 , 2025
|
|
|
The National Pharmaceutical Pricing Authority has fixed the ceiling price of 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 Authority considered company representations regarding fixation of revised prices for four formulations, and rejected during the process of finalising the ceiling prices.
The ceiling price of human normal immunoglobulin 5 per cent solution for infusion has seen a 23.95 per cent reduction to Rs. 148.60 per ml, as compared to the previous 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 per cent solution for infusion, NPPA has fixed a ceiling price of Rs. 206.53 per ml, with a 21.94 per cent reduction from the 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 per cent solution for infusion has been fixed at Rs. 478.57 per ml, with a 4.88 per cent 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 announced the ceiling price of ethyl alcohol (denatured) 70% solution at 0.40 per ml, which is 26.52 per cent 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 percent and above market share. Prices of six packs, from Baxter India were listed by the authority while calculating 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.
The Authority fixed and notified the revised prices in tune with the draft calculation sheets it published on September 18, after rejecting representations from Stedman Pharmaceuticals, and Zydus Group regarding the proposed prices for four formulations.
Stedman Pharmaceuticals represented the Authority that the draft calculation for ethyl alcohol (denatured) solution 70% is incorrect and that the form V submitted by the company on January 28, 2025 at Rs. 0.42 per ml should be considered for fixing the price. The Authority said that the PTR of Rs. 0.42per ml is effective from May, 2024 and the company did not file Form V or Form II before this date.
"Since, the revision in PTR is considered only for the cases where Form II/V is filed within the timelines mentioned in Para 16 of DPCO, 2013, the company's representation was not considered," said the Authority in its meeting.
Zydus Lifesciences informed the Authority that the price increase of ethyl alcohol (denatured) solution 70% has increased only 10.2% in last 12 years and refixation of the price with 26% reduction may destabilise the availability and accessibility of the sanitizers. The Authority examined the representation and said that it is not found tenable as draft working sheet was in compliance with provisions of DPCO, 2013.
Zydus Healthcare filed a representation against proposals to revise the prices of human normal immunoglobulin solutions for infusion, giving reference to pending court cases and stating that the price fixation under National List of Essential Medicines (NLEM), 2022 may trigger non availability of the formulation. It added that the Wholesale Price Index (WPI) increase over existing ceiling price would ensure reasonable and transparent ceiling price.
The Authority said that it has examined the representation and found that it is not tenable, as revision is as per the provisions of the DPCO. The court cases mentioned by the company is related to another formulation and do not have any implication on the ceiling price fixation.
Zydus has also mentioned that the ceiling price of human immunoglobulin 16.5% fixed under NLEM, 2015 is sub-judice. The authority noted that although the matter is sub-judice, no stay has been imposed for implementation of ceiling price.
"Accordingly, the ceiling price as fixed under NLEM 2015 and as revised based on WPI from year to year are effective. Hence, the representation was not found tenable," it added.
|
|
|
|
|
|
|
|
TOPICS
|
The Food and Drug Administration (FDA), Maharashtra, has issued a public advisory urging citizens to report any misleadi ...
|
|
|
|
|