NPPA Calls For Data On Essential IV Fluids In India

The National Pharmaceutical Pricing Authority (NPPA) has issued a revised directive regarding data submission for fixing ceiling prices of essential intravenous (IV) fluids.

NPPA had previously issued a directive dated February 1st, 2023 requesting price and sales data for July 2022. Following a recent decision taking in a meeting dated January 24, 2024, the NPPA is now requiring manufacturers and marketing companies to submit data for October 2023.

What Data is Needed?

Companies must provide the following information for each specified IV fluid formulation for October 2023:

  1. Pack size for each type of pack
  2. Type of packaging: Details for glass or non-glass packaging with special features.
  3. Price to Retailer (PTR)
  4. Moving Annual Turnover (MAT) Sales Value
  5. Form II/ Form V
  6. Licenses indicating pack size and packaging type
  7. Product Samples

Notably, MAT sales for October 2023 means total sales from November 2022 to October 2023, excluding taxes.

The information is sought for the following formulations

FormulationsDosage form and Strength
GlucoseInjection 5%
GlucoseInjection 10%
GlucoseInjection 50%
Glucose (A) + Sodium Chloride (B)Injection 5% (A) + 0.9% (B)
Sodium ChlorideInjection 0.9% & 3%
Ringer LactateInjection (as per IP)
Specified Formulations

    Furthermore, the information must be submitted by June 15, 2024.

    This data is crucial for the NPPA to set fair and transparent ceiling prices for essential IV fluids under the revised Schedule I of the Drugs (Prices Control) Order, 2013 (DPCO).