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National Pharmaceutical Pricing Authority fixes price for Intas Pharma's incremental immunoglobulin solution

National Pharmaceutical Pricing Authority fixes price for Intas Pharma's incremental immunoglobulin solution

The National Pharmaceutical Pricing Authority (NPPA) has fixed the retail price of Intas Pharmaceuticals’ immunising agent immunoglobulin combination at 15 per cent higher than the existing human normal immunoglobulin solution for infusion 5%, since it is an incremental innovation having advantage without any increased side effect over the existing product.

Intas Pharmaceuticals has requested the price regulator to fix the retail price of Total Protein 50g/L+Immunoglobulin M 6g/L+Immunoglobulin A 6g/L+Immunoglobulin G 38g/L+Glucose Monohydrate (as stabiliser) 27.5 g/L+Sodium Chloride 4.56 g/L+water for injection. It has also submitted an additional representation through a letter on February 16, 2022, for the same.

The panel noted that the Human Normal Immunoglobulin Solution for Infusion 5% is a scheduled formulation under the Drugs (Price Control) Order, 2013, and the current applicable ceiling price for the drug is Rs 154.65 per ml excluding Goods and Services Tax (GST).

“The Committee observed that the subject formulation is an incremental innovation and has an advantage without any increased side effect over normal human immunoglobulin 5% infusion,” said NPPA.

The Committee deliberated upon the matter in detail and decided that an additional 15% increase over the present applicable ceiling price of Normal Human Immunoglobulin 5% infusion be allowed to the subject formulation for incremental innovation. Human Normal Immunoglobulin is used to treat immunoglobulin deficiency and some of the inflammatory disorders.

The price for each vial of human normal immunoglobulin 5% solution with incremental innovation has been fixed at Rs 177.85 per ml, which is 15 per cent higher, excluding GST.

The Committee, in its latest meeting, also decided to seek clarification from the Central Drugs Standard Control Organisation (CDSCO) on the approval status of the Tacrolimus Prolonged Release, in line with the New Drugs and Clinical Trial Rules, 2019. Cadila Healthcare, now Zydus Healthcare, requested the Authority for price fixation of Tacrolimus prolonged release capsules 3 mg.

More news about: safety | Published by Darshana | March - 08 - 2022 | 296

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