NPPA Directs Drug Makers to Submit Data for Ceiling Prices of Lohexol, IV Fluids
New Delhi: The National Pharmaceuticals Pricing Authority (NPPA) has sought certain data from concerned drug manufacturers and marketing companies for fixation of ceiling prices for essential intravenous (I.V.) fluids, including glucose, Ringer Lactate and sodium chloride injections, as well as lohexol injections, under the Revised Schedule-I of the National List of Essential Medicines (NLEM) 2022, as per the Drug Price Control Order (DPCO), 2013.
In its latest notification, dated January 21, 2025, the NPPA directed pharmaceutical manufacturers and marketing companies to submit essential data for determining ceiling prices for 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 facilitate this process, companies have been asked to provide details such as the Price to Retailer (PTR), Moving Annual Turnover (MAT), pack size, and type of packaging (glass or non-glass) for the month of October 2023. The NPPA has emphasized the importance of submitting this information within 10 days from the issuance of the Office Memorandum (O.M.) to ensure transparency in the price fixation process. Companies are also required to submit product samples and the necessary forms (Form-II/V) for verification.
In a separate notification, the NPPA has sought PTR and MAT data for lohexol injections (300 mg iodine/ml), which is a scheduled formulation under the Revised Schedule-I of the DPCO 2013. Pharmaceutical companies are required to provide data pertaining to July 2022 sales along with relevant forms within 7 days of the notification. The requested data includes the brand composition and strength, dosage specifications, PTR for July 2022, and MAT sales values from August 2021 to July 2022. The NPPA has underscored the need for timely submission of this data to ensure a transparent price fixation process for these critical formulations.
To ensure industry-wide compliance, the NPPA has circulated the notifications to major pharmaceutical associations, including 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 Associated Chambers of Commerce and Industry of India (ASSOCHAM).
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