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

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-03-23T18:00:08+05:30 | Updated On 23 March 2024 6:00 PM IST

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.

Also Read: Modify Clinical study protocol of Iptacopan study in aHUS: CDSCO Panel Tell Novartis

emcure pharmaceuticalscdscoFerric Maltoliron supplementIron deficiency

Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751