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DoP asks NPPA to recalculate ceiling price of vitamin product Thiamin 100 mg
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Gireesh Babu, New Delhi
October 18 , 2024
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The Department of Pharmaceuticals (DoP) has referred the ceiling price fixation of vitamin product Thiamin 100 mg injection 2 ml containing thiamine 100 mg per ml from Ordain Health Care Global, back to the price regulator for recalculation after identifying that a fixed dose combination of another company was considered in the previous calculation.
The company, with its facility in Tamil Nadu, approached the review authority with a review application in March, 2023, after the National Pharmaceutical Pricing Authority (NPPA) notified the ceiling price of the product in February, 2023.
The company argued that it has implemented the Wholesale Price Index (WPI) based increase in Maximum Retail Price in the month of April, 2022 and submitted the Form V with the updated details in July, 2022.
A delay in implementation of revised MRP or Price to Retailer based on WPI impact should not be construed as non-implementation of WPI based revision and does not limit the implementation of the revision in case of an increase in ceiling price of the formulation. Hence, the ceiling price of the said formulation should have included the revised PTR for Thiamin 100 mg injection 2 ml at Rs. 46.01 and not Rs. 41.75, it argued.
Besides, based on the market information, the company has confirmed that the formulation Vitneurin AQ 100 mg injection 2 ml as marketed by Corona Remedies Pvt Ltd is not a thiamine 100 mg per ml injection, but a fixed dose combination of Vitamin B1-100 mg, Vitamin B6-50 mg, Vitamin B12-1000 mg, and D Panthenol 50 mg. The company said that this brand should be removed from the calculation.
NPPA, in response to the company's arguments, contended that the company did not file the Form II and Form V of the subject formulation within the prescribed time as per the Drugs Prices Control Order, 2013. The information about the revision should have been forwarded to the government in Form II within a period of 15 days of such revision, which implies the Form should have been submitted latest by May 15.
Delay in implementation of WPI beyond April and the non-receipt of information about the revision within 15 days of such revision shall be construed as non-revision of MRP, it said. No representation was received related to the draft worksheet of the ceiling price of the drug within the prescribed time, it added.
However, it accepted the contention that the brand Vitneurin AQ 100 mg Injection 2 ml should have been excluded as the brand does not have composition as mentioned in the Schedule.
The review authority observed that the applicant company had not fulfilled the requisite formalities of submission of Form II and Form V within the prescribed time limit and decided that the PTR of Thiamin 100 mg Injection 2 ml considered by the NPPA in fixation of ceiling price of the schedule formulation is as per the provisions of DPCO, 2013 and suffers no infirmity.
However, price of the brand Vitneurin AQ 100 mg injection 2ml should not be considered for ceiling price calculation of the present formulation and the failure to represent within ten days against the ceiling price fixed by NPPA may not deprive the company of the legitimate prices of drugs manufactured by them, observed Awadhesh Kumar Choudhary, senior economic advisor to the Government of India.
Accordingly, the case was referred back to NPPA for re-examination and re-calculation of the prices of the subject formulation as per the provisions of DPCO, 2013, said the review order issued earlier this month.
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