NPPA panel fixes retail price of Intas Pharma Normal Human Immunoglobulin 5% solution

The retail price of each vial of Normal Human Immunoglobulin 5% infusion , containing Total protein 50g/L, Immunoglobulin M 6g/L, Immunoglobulin A 6g/L, Immunoglobulin G 38g/L, Glucose Monohydrate 27.5 g/L, Sodium Chloride 4.56 g/L, and water for injection,where the distribution of Immunoglobulin G subclass is approximately, 62% Ig G1,27% IgG2,,1% IgG3,10% IgG4 , of Intas Pharmaceuticals Limited has been set at Rs. 177.85 per ml, excluding GST.

This recommendation came during the 39 th meeting of the Multidisciplinary Committee of Experts held on February 25,2022, under the convenorship of Shri Manmohan Sachdeva, Advisor (Cost), through video-conferencing.

The Normal Human Immunoglobulin 5% infusion is used to treat immunoglobulin deficiency in people with primary immunodeficiency's or PID (present from birth) and secondary immunodeficiency or SID (developed in the later stages of life).

In the subsidiary representation by the Intas Pharmaceuticals Limited held on February 16,2022,the Committee observed that the presentation made by Intas Pharmaceuticals Limited was with regard to the subject formulation.

The Committee also noted that the Human Normal Immunoglobulin Solution for Infusion 5 % is a scheduled formulation under DPCO 2013 and the present applicable ceiling price is Rs. 154.65 per ml excluding GST.

In addition, the Committee observed that the subject formulation is an incremental innovation and have advantage without any increased side effect over normal human immunoglobulin 5 % infusion.

After detailed deliberation, the committee decided that an additional 15 % increase over the present applicable ceiling price of Normal human lmmunoglobulin 5% infusion be allowed to the subject formulation of lntas Pharmaceuticals for incremental innovation.

Accordingly, the Committee recommended the retail price of each vial of Human Normal Immunoglobulin 5% solution (lg M enriched) which contains Total Protein S0g/L plus lmmunoglobulin M 6g/L plus lmmunoglobulin A 6g/L plus lmmunoglobulin G 38g/L plus Glucose Monohydrate (as stabilizer) 27.5 g/L plus Sodium Chloride 4.56 g/L plus Water for injection, Distribution of lg G subclass is approx. 62% lgGl , 27% lgG2, 1% lg G3, 10% lg G4 for M/s lntas Pharmaceuticals (manufacturer and marketer) at Rs. 177.85 per ml (R s. 154.65 per+ additional 15% increment) excluding GST.