Conduct bioequivalence study: CDSCO Panel Tells Emcure Pharmaceutical on Ferric Maltol Capsules

New Delhi: Citing there is an unmet medical need, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined Emcure Pharmaceutical to conduct the bioequivalence study (BE) of the Ferric Maltol Capsules 30mg, a complexed iron supplement used to treat iron deficiency in adults.

This came after Emcure Pharmaceutical presented its proposal for a grant of permission to manufacture and market the drug along with BE study protocol vide no. VRL-24-001, Version no. 2.0, dated 09.01.2024, along with a request for Phase III Clinical trial waiver before the committee.

Ferric maltol is an iron(III) atom complexed with 3 maltol molecules to increase the bioavailability compared to iron(II), without depositing it in the duodenum as insoluble ferric hydroxide and phosphate.

Ferric maltol dissociates as the iron atom is donated to unknown iron uptake mechanisms, possibly beta 3 integrin or divalent metal transporter 1,6 in the ileum and duodenum. Once the iron is in circulation, it then associates with transferrin and ferritin. Ferric maltol is used to treat iron deficiency (not enough iron in the blood).

At the recent SEC meeting Haematology held on 5th March 2024, the expert panel reviewed the proposal for the grant of permission to manufacture and market the drug along with BE study protocol vide no. VRL-24-001, Version no. 2.0, dated 09.01.2024, presented by Emcure Pharmaceutical.

After detailed deliberation, the committee opined that there was an unmet medical need. Therefore, it is advised that authorization be granted to carry out the bioequivalency study in accordance with the described protocol

Accordingly, the expert panel suggested that the firm should submit the bioequivalence study results before the committee for further consideration.

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