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DoP refers ceiling price fixation of antibiotic cefuroxime back to NPPA for recalculation
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Gireesh Babu, New Delhi
February 19 , 2024
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The Department of Pharmaceuticals (DoP) has referred back the calculation of ceiling price of a particular strength of antibiotic cefuroxime to the National Pharmaceutical Pricing Authority (NPPA) for recalculation, owing to a mistake that took place in calculation during the notification of the price in December, 2022.
The order was based on a review application filed by Mumbai-based Glenmark Pharmaceuticals in January, 2013, against NPPA's price fixation order on December 19, 2022, fixing the ceiling price of cefuroxime oral liquid 125 mg/5ml.
The company argued that the NPPA has erred in determining ceiling price of the drug and hence may be directed to revise the ceiling price of their formulation by considering the actual Price To Retailer (PTR).
It added that incorrect PTR data of brands Cefakind 125 mg syrup 30 ml from Mankind Pharmaceuticals, Cetil 125 mg dry syrup 60 m from Lupin Ltd and Xoxe 125 mg dry syrup 30 m from Corona Remedies was considered for the purpose of fixing the ceiling price of the drug.
The company also conveyed this to the NPPA through a representation on December 7, 2022, which is within the prescribed timeline of 10 working days.
The company said that the ceiling price fixation should have been considered revised PTR of Cefakind 125 mg syrup 30 ml at Rs. 117.86 and not Rs. 107.14, for Cetil 125 mg dry syrup 60 m at Rs. 240.89 and not Rs. 219.11 and Xoxe 125 mg dry syrup 30 m at Rs. 120.21 and not Rs. 109.29.
Responding to the review application, the NPPA informed the review authority that the drug was added in NLEM, 2022 for the first time. Lupin Ltd and Corona Remedies did not file Form V with NPPA and the price revision of these drugs were not considered due to this. However, Mankind Pharmaceuticals submitted its Form V on July 22, 2022 and for the newly added formulations, Form V filed till July 31, 2022 were considered. However, Form V of Mankind Pharma has inadvertently not been considered, it agreed.
The review authority, hearing both the sides, observed that NPPA acknowledged that inadvertently, Form-V of Mankind Pharmaceuticals was not considered and that, prima facie, if the same had been considered, it would have resulted in a higher ceiling price of cefuroxime oral liquid 125 mg/5ml at Rs. 4.74 instead of Rs. 4.71 per ml.
"NPPA may once again look out for all such possible errors in calculation of ceiling price," said the authority.
In the backdrop of these facts, the case was referred back to NPPA for recalculation of the ceiling price based on the provisions of the DPCO, 2013, it said.
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