Price Control Alert: NPPA Seeks Data on Iohexol, IV Fluids for Pricing Review

The National Pharmaceutical Pricing Authority (NPPA) has requested data from drug manufacturers and marketing companies to set ceiling prices for several key intravenous (I.V.) fluids, including glucose, Ringer Lactate, sodium chloride injections, and lohexol injections. This is part of the implementation of the Revised Schedule-I of the National List of Essential Medicines (NLEM) 2022, under the guidelines of the Drug Price Control Order (DPCO) 2013.

In a recent directive issued on January 21, 2025, the NPPA has asked pharmaceutical companies to submit important data needed for determining the ceiling prices of various I.V. fluids. These fluids include glucose injections in concentrations of 5%, 10%, and 50%; glucose-sodium chloride injections (5% glucose with 0.9% sodium chloride); sodium chloride injections (0.9% and 3%); and Ringer lactate injections.

To assist in this process, the NPPA has requested companies to provide information such as Price to Retailer (PTR), Moving Annual Turnover (MAT), pack size, and type of packaging (whether glass or non-glass) for the month of October 2023. The NPPA stressed the importance of submitting this information within 10 days of the issuance of the Office Memorandum (O.M.) to ensure transparency. Additionally, companies are required to submit product samples and the necessary verification forms (Form-II/V).

In a separate notification, the NPPA has also asked for PTR and MAT data for lohexol injections (300 mg iodine/ml), which are included under the Revised Schedule-I of DPCO 2013. Pharmaceutical companies are expected to provide sales data for July 2022, along with relevant forms, within 7 days of the notification. The requested information includes brand composition, strength, dosage details, PTR for July 2022, and MAT sales data from August 2021 to July 2022. The NPPA has highlighted the importance of submitting the data on time to maintain a transparent price-setting process for these important formulations.

To ensure compliance across the industry, the NPPA has circulated the notifications to several prominent pharmaceutical associations, such as the Indian Drug Manufacturers' Association (IDMA), Indian Pharmaceutical Alliance (IPA), Organisation of Pharmaceutical Producers of India (OPPI), Federation of Pharmaceutical Entrepreneurs (FOPE), Federation of Indian Chambers of Commerce and Industry (FICCI), and the Associated Chambers of Commerce and Industry of India (ASSOCHAM).

Furthermore, the NPPA has been asked to review the ceiling price for iohexol injection 300 mg iodine/ml, a diagnostic agent, following a request from the Department of Pharmaceuticals (DoP). The DoP's directive stems from a review application submitted by Mumbai-based JB Chemicals and Pharmaceuticals and Unijules Life Sciences, challenging the NPPA's decision regarding the price fixation for this formulation.

JB Chemicals filed a review application in April 2023, arguing that the NPPA had incorrectly set the ceiling price for the Contrapaque 300 mg infusion 100 ml and Contrapaque 30 mg injection 20 ml, which both contain iohexol injection 300 mg iodine/ml. The company claimed that the NPPA's price determination was based on data from just one manufacturer, Contrapaque by JB Chemicals, and did not account for other products from manufacturers like Ocean Pharmaceuticals, Arco Lifesciences, Genetek Life Sciences, GE Healthcare, and Unijules Life Sciences.

Unijules, which produces Nioscan 300 and Nioscan 350 brands, also filed a review application, asserting that several companies manufacture the iohexol formulation in different brand names, and that price reduction based on a monopoly assumption was beyond the scope of the DPCO 2013.

In response to these concerns, the NPPA clarified that iohexol injection was included in the National List of Essential Medicines (NLEM) as far back as 2015, with the ceiling price set at Rs. 15.08 per ml for iohexol injection 300 mg iodine/ml. This price was revised annually based on the Wholesale Price Index (WPI), and by April 2022, the ceiling price had risen to Rs. 18.46 per ml. The ceiling prices for 2022 remained the same, with iohexol injection available in two strengths—300 mg iodine/ml and 350 mg iodine/ml.

Following this, in February 2023, draft worksheets for the formulations were published, and no company filed objections. Consequently, the ceiling prices were finalized in March 2023, with the price for 300 mg iodine/ml set at Rs. 15.07 and Rs. 12.70 for 350 mg iodine/ml. After WPI adjustments, the prices were revised to Rs. 16.89 for 300 mg and Rs. 14.23 for 350 mg, effective from April 1, 2023.

However, the review authority found that the Pharmatrac database underrepresented total sales volume for the iohexol formulation, as it did not include secondary sales from diagnostic centers. The review authority also acknowledged that multiple manufacturers were selling iohexol-based diagnostic products, and as such, the market data used by the NPPA was incomplete.

Given these factors, the review authority suggested that the NPPA consider using other data sources to better reflect the market for iohexol in diagnostic centers and hospitals. As a result, the case was referred back to the NPPA for further investigation, allowing the authority to explore additional databases to set a more accurate and representative ceiling price in line with the provisions of the DPCO 2013.

(Input from various sources)

(Rehash/Sai Sindhuja K/MSM)