DoP Dismisses Aristo Pharma's Plea to Reassess Multivitamin Tablet Pricing Set by NPPA

Aristo filed a review application on March 23, 2023, challenging NPPA’s price fixation order for its multivitamin tablets with minerals and trace elements. The application, under Paragraph 31 of the Drugs (Prices Control) Order (DPCO) 2013, was filed after NPPA set a retail price on February 24, 2023. Aristo claimed NPPA had made an error in setting this price and should reassess it based on their status as an "existing manufacturer" of Cholecalciferol-based drugs. They provided a detailed breakdown of their product’s composition, highlighting its unique formulation.

Each sugar coated tablet contains:

Vitamin A (As Acetate) 10000 IU + Cholecalciferol 1000 IU (In stabilized form) + Thiamine Mononitrate 10 mg + Riboflavin 10 mg + Pyridoxine Hydrochloride 3mg +

Cyanocobalamin 15 mcg + Nicotinamide 100 mg + Calcium Pantothenate 16.30 mg + Ascorbic Acid 150 mg + a Tocopheryl Acetate 25 mg + Biotin 0.25 mg + Tribasic Calcium Phosphate 129 mg + Light Magnesium Oxide 60 mg + Dried Ferrous Sulphate 32.04 mg + Manganese Sulfate Monohydrate 2.03 mg + Total Phosphorus in the preparation 25.80 mg + Copper Sulfate Pentahydrate 3.39 mg + Zinc Sulphate 2.20mg + Sodium Molybdate Dihydrate 0.25 mg + Sodium Borate 0.88 mg.

In calculating the price, NPPA had used Supradyn, a tablet produced by Piramal and marketed by Bayer, as a reference, uploading a draft calculation sheet in January 2023. Aristo argued that their product’s composition was significantly different from Supradyn, making it an unsuitable comparison.

The composition of Supradyn tablet is as below:

Vitamin A (As Acetate) 5000 IU + Cholecalciferol (Vitamin 03) 400 IU + Vitamin

Bl (as Thiamine Mononitrate) 5mg + Riboflavin (Vitamin B2) 5mg + Vitamin B6 (as Pyridoxine Hydrochloride) I .5mg + Nicotinamide ( Vitamin B3) 50mg + Calcium-D Pantothenate 10mg + Ascorbic Acid 75mg + Tocopheryl Acetate 25mg+ D-Biotin 150mcg + Magnesium Oxide Light 10mg +Manganese Sulphate Monohydrate 5mg+ Copper Sulphate (as Copper Sulphate Pentahydrate) 2mg+ Zinc Sulphate 55mg + Sodium Molybdate (as Sodium Molybdate Dihydrate) 25mcg+Methylcobalamine 500mcg + Folic Acid 1.5mg + Chromium Picolinate 250mcg+ Selenium (as Sodium Selenite Pentahydrate) 70 mcg + L- Glutamic Acid 50mg.

Representations filed by Aristo in January 2023 to address these perceived anomalies went allegedly unheeded by NPPA, which later fixed a retail price of INR 1.88 per tablet—an amount Aristo argued was arbitrary and inaccurate.

Aristo further opposed NPPA's decision to benchmark their formulation against Supradyn, claiming theirs was a "new drug" in the Indian market with no similar alternatives. They argued that the pricing approach should have aligned with Paragraphs 5(2) and 15(3) of DPCO. Additionally, Aristo noted NPPA’s prior ceiling price for Cholecalciferol tablets at INR 4.16 each, making their product’s fixed price of INR 1.88 per tablet disproportionate.

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In response to Aristo’s review application, NPPA contended that the application was unfounded due to several reasons. NPPA noted that Aristo had filed a Form-I application in November 2022 to fix the retail price of the formulation. As Supradyn Tablet was the only similar product in the Pharmatrac database for that month, NPPA based the price calculation on it, as confirmed by Pharmatrac on December 2, 2022. Aristo later suggested that the price of its product be compared to Surbex XT, a product marketed by Abbott India Ltd. However, NPPA argued that Surbex XT had a different composition, making it unsuitable as a price comparison. Pharmatrac verified on January 18, 2023, that Supradyn’s composition closely matched Aristo's formulation, which justified its use as the basis for pricing.

NPPA defended its decision in the 109th meeting on February 21, 2023, concluding that the pricing conformed with DPCO, 2013, provisions, regardless of Aristo’s objections about the single-component cholecalciferol's price. In a follow-up email dated September 23, 2023, Pharmatrac reaffirmed that while Supradyn had been discontinued in May 2021, it had significant sales from May 2021 to April 2022. This further justified using Supradyn’s data for price fixation as per DPCO norms. Therefore, NPPA argued the established price was appropriate and based on reliable data.

Upon reviewing Aristo's application, DoP noted that;

“Para 9(4) of DPCO 2013 states that, "The market-based datafor fixing the retail price of new drugs available in the market, shall be the data available for the month ending immediately before six months ofreceipt of application forfixing the price of the new drug". It nowhere differentiates between continuing and discontinued products.”

It further observed;

“A comparison of Surbex-XT and the applied formulation submitted by the Applicant in its representation dated 06.01.2023 shows that both the tablets have different composition except few common ingredients. Since the data for the exact formulation is available in Pharmatrac database, the matter was not referred to MDC as per provisions of DPCO, 2013.”

Subsequently, NPPA’s price fixation decision was upheld, and Aristo’s review application was dismissed. The Department pronounced;

“In the backdrop of these facts, the action of NPPA fixing the Retail prices of the formulation Multivitamin tablets with Mineral & Trace elements (Non Schedule) of Aristo Pharmaceuticals Private Limited vide S.O. No. 878(E) dated 23.03.2023 is upheld and the Review Application under consideration is accordingly rejected.”