NPPA fixes ceiling price of Amphotericin B Emulsion Injection to treat Black Fungus

New Delhi: Through a recent Office Memorandum, the National Pharmaceutical Pricing Authority (NPPA) has confirmed the ceiling price of antifungal drug Amphotericin B (emulsion) injection 50mg per pack, as Rs 3,136.81 excluding GST.

The decision was taken during the 89th Authority meeting under DPCO 2013, held on June 28, 2021, where the subject of issues relating to pricing of Amphotericin B (Emulsion) 50mg /10 ml injection was thoroughly examined.

Amphotericin B is a polyene antifungal antibiotic produced by Streptomyces nodosus, with antifungal activity, used to treat a rare infection known as black fungus (mucormycosis). It acts by binding to ergosterol, an essential component of the fungal cell membrane, thereby causing depolarization of the membrane and altering cell membrane permeability, which leads to leakage of important intracellular components, cell rupture, and eventually cell death. 

Amphotericin B is currently sold by Abbott, Bharat Serums, Cipla, Sun Pharma and Viatris. Five drug makers including Alembic, Emcure and Natco received approval from the Drugs Controller General of India (DCGI) to manufacture the antifungal drug.

In addition to this, the authority also noted that Lyka Labs Ltd had filed an application for retail price fixation of the formulation Amphotericin B (Emulsion) 50mg /10 ml injection.

The matter was placed before the Multidisciplinary Committee of Experts in its 33rd meeting dated 21.06.2021 in which the Committee recommended and decided that "...clarification be obtained from Central Drug s Standard Control Organisation (CDSCO) as to whether Emulsion form of Amphotericin B has major difference from Lipid form to consider a separate price for it or ceiling price notified for Amphotericin B (Lipid) may also be extended to Amphotericin B Emulsion)."

Accordingly, clarification was sought from CDSCO.

CDSCO vide its e-mail dated 23.06.2021 stated that "....Drugs Delivery system of Amphotericin-B includes liposomal encapsulation of Amphotericin-B or incorporation of the drug in lipid complex/emulsion. Liposomal or Lipid incorporated formulations of Amphotericin B may vary from one another in the chemical composition and physical form of the lipid components. However, broadly, the Amphotericin-B lipid complex/ emulsion may be considered as one group which is different from liposomal Amphotericin-B & Conventional Amphotericin-B. "

The Drug Controller General of India (DCGI), also the Authority member, clarified that the emulsion version of Amphotericin B is a subcategory of a broader category of lipid variants. DCGI further mentioned that the emulsion and other lipid variants of Amphotericin B injection have the same/similar level of efficacy and toxicity.

After detailed deliberation, NPPA decided that the ceiling price as applicable for Amphotericin B ( Lipid) Powder for Injection 50 mg is also applicable for Amphotericin B (Emulsion) injection having the same dosage form and strength. The Authority further decided to issue a clarification in this regard. The Authority also decided to close the retail price application of Lyka Labs Ltd.

Medical Dialogues Team had earlier reported that the NPPA had set a ceiling price of Rs 3136.81 for Amphotericin B (Lipid) Per Pack.

" The ceiling price and provisions of DPCO 2013 as extended for Amphotericin B (Lipid) Powder for Injection 50 mg would also be applicable for the formulation Amphotericin B (Emulsion) injection having the same dosage form and strength."

As a result, the ceiling price for the formulation Amphotericin B (Emulsion) injectable 50mg,  would be Rs.3,136.81 per pack, excluding GST.