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DoP rejects Aristo Pharma’s review application for its multivitamin tablets
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Gireesh Babu, New Delhi
November 08 , 2024
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The Department of Pharmaceuticals (DoP) has upheld the retail price fixation of National Pharmaceutical Pricing Authority (NPPA) for Mumbai-based Aristo Pharmaceuticals for its multivitamin tablets with mineral and trace elements, rejecting the company's review application.
The NPPA has fixed the retail price of the non scheduled formulation containing vitamin A (as acetate) 10,000 IU, cholecalciferol IP 1,000 IU (in stabilized form), thiamine mononitrate 10mg, among several other ingredients, through an order on February 24, 2023, at Rs. 1.88 per tablet.
The company informed the review authority that the NPPA has erred in determining retail price of the drug and hence may be directed to revise the same on various grounds.
The company applied for the price under the provisions of Drugs Prices Control Order, 2013 since they are an existing manufacturer of cholecalciferol tablets and capsules 60000 IU, which is a scheduled formulation under the National List of Essential Medicines (NLEM).
NPPA released the draft version of the proposed price calculation sheet for the retail price fixation of this formulation on January 4, 2023, based on the market price of Supradyn tablets manufactured by Piramal Healthcare and marketed by Bayer Pharmaceuticals.
The company said that its multivitamin daily tablet product is not similar to Supradyn tablet, comparing its composition. It claimed that its product is a new drug in the domestic market and there is no similar drug available in the market. Decision to derive the price of their formulation based on the product Supradyn tablet is erroneous and arbitrary, it said.
Aristo Pharma in representations on January 6 and 16, 2023, requested NPPA consider the anomaly in the price fixation in the draft sheet, but the Authority did not consider the request while fixing the price, it alleged.
Besides, NPPA has in the past fixed the ceiling price of single ingredient cholecalciferol 1000 IU at Rs. 4.16 per tablet through notification on March 30, 2022 and also at Rs. 3.84 per tablet through notification on November 19, 2022. In the present case, the price was recommended at Rs. 1.88 per table, which is much below the ceiling price of a single ingredient, it added.
NPPA said that the company filed Form I application for retail price fixation in November, 2022 and only a single line item of Supradyn tablet appeared in the Pharmatrac database during the period and it has considered the price of this drug while fixing the price.
The company requested NPPA for either considering the price of Surbex XT tablet of Abbott India (priced at Rs. 144.05 for a pack of 15 tablets) or referring the matter to the Multidisciplinary Committee of Experts.
NPPA observed that the composition of Abbott's drug is different from that of Aristo Pharma's formulation and both cannot be compared. Since the data for exact formulation is available in Pharmatrac database, the matter was not referred to MDC. Pharmatrac confirmed that the Supradyn tablet is the only available item in database and have the same composition as applied by the company.
It also refuted the company's contention that the single component cholecalciferol 1000 IU is higher than the multivitamin formulation, stating that it is not tenable as the Pharmatrac database has been considered for price fixation in line with the DPCO provisions. Though the brand Supradyn tablet was discontinued form May, 2021, it was being sold in the market during May, 2021 to April, 2022 and the MAT value was Rs. 22.39 crore.
The review authority accepted the arguments given by NPPA and upheld the price fixation, rejecting the review application of Aristo Pharmaceuticals.
It may be noted that the DoP has issued orders on several review applications submitted by individual firms, including Pfizer, AstraZeneca, Abbott Healthcare, Cipla, Lupin and others during the month of October.
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