NPPA Seeks Pricing Details Of Sodium Chloride 0.45% Injection From Manufacturers And Marketers


New Delhi : The National Pharmaceutical Pricing Authority (NPPA) has called for the price related details of sodium chloride 0.45 percent injection from all the concerned manufacturers and marketers, as part of fixation of ceiling price for the product.

The Authority has asked the manufacturers and markets to furnish the information relating to Price to Retailer (PTR), Moving Annual Turnover (MAT) and relevant details, together with a copy of invoices for the month of April, 2022, latest by September 5, through email.

The details which are to be submitted include the brand name, the type of packaging – whether it is glass or non glass, pack size, along with the PTR and MAT.

Sodium chloride 0.45% injection is a sterile parenteral solution containing sodium chloride in water for injection intended for intravenous administration. Each 100 mL of the injection contains 450 mg of sodium chloride in water, and is an electrolyte replenisher.

According to the US Food and Drug Administration documents, when administered intravenously, these solutions provide a source of water and electrolytes, providing combinations of hypotonic or isotonic concentrations of sodium chloride suitable for parenteral maintenance or replacement of water and electrolyte requirements.

“Isotonic concentrations of sodium chloride are suitable for parenteral replacement of chloride losses that exceed or equal the sodium loss. Hypotonic concentrations of sodium chloride are suited for parenteral maintenance of water requirements when only small quantities of salt are desired. A hypertonic concentration of sodium chloride may be used to repair severe salt depletion syndrome,” it says.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirements range from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).

Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiological equilibrium, it added.


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