1. Clinical & Scientific Overview
Elemental Iron (Ferrous Bisglycinate Chelate Nutraceutical) (TIP-MED-000628, Reference Code [SUP-04]) is classified under
Dietary Supplements & Nutraceuticals (FSSAI / ICMR-NIN) as a Clinical Nutrition & Nutraceutical Science • Amino Acid Chelated Divalent Iron Micronutrient.
Within the Indian regulatory and compendial framework, it is governed under FSSAI Health Supplement / Nutraceutical Ingredient (Ferrous Bisglycinate within RDA)..
FSSAI Licensed Health Supplement / Nutraceutical Formulations (RDA Compliant)
ICMR-NIN 2024 RDA: 19 mg/day (adult men), 29 mg/day (adult women), 27 mg/day (pregnancy), 23 mg/day (lactation); Tolerable Upper Limit (UL): 45 mg/day elemental iron (therapeutic IDA dosing of 60–100 mg elemental iron is a drug regimen under Anemia Mukt Bharat).
Clinical Nutrition, ICMR-NIN RDA & FSSAI Nutraceutical Profile
Ferrous Bisglycinate
Amino Acid Chelated Divalent Iron Micronutrient
Haem iron (meat, fish, poultry — 15–35% absorbed) and Non-haem iron (bajra/pearl millet, ragi, legumes, jaggery, green leafy vegetables — 2–10% absorbed due to dietary phytates)
ICMR-NIN 2024 Recommended Dietary Allowance (RDA) & Tolerable Upper Intake Limit (UL): ICMR-NIN 2024 RDA: 19 mg/day (adult men), 29 mg/day (adult women), 27 mg/day (pregnancy), 23 mg/day (lactation); Tolerable Upper Limit (UL): 45 mg/day elemental iron (therapeutic IDA dosing of 60–100 mg elemental iron is a drug regimen under Anemia Mukt Bharat).
Deficiency Clinical Syndromes vs Chronic Excess / Hypervitaminosis Risks: Deficiency: Microcytic hypochromic Iron Deficiency Anaemia (IDA), koilonychia, pica, and fatigue. Excess / Acute Paediatric Overdose: Corrosive haemorrhagic gastroenteritis, metabolic acidosis, shock, and hepatic necrosis (keep strictly out of reach of children!).
Drug–Nutrient Chelation & Timing Interactions: CHELATION INTERACTIONS: Chelates and reduces oral absorption of Levothyroxine, Fluoroquinolones (ciprofloxacin, levofloxacin), Tetracyclines (doxycycline), Levodopa, and Integrase Inhibitors (dolutegravir, bictegravir) by 50–80% — separate by at least 2 to 4 hours! Tea/coffee tannins and calcium supplements inhibit absorption; Vitamin C (ascorbic acid) enhances absorption.
FSSAI Health Supplement vs Therapeutic Drug Distinction: FSSAI Health Supplement / Nutraceutical Ingredient (Ferrous Bisglycinate within RDA).
3. Mechanism of Action & Pharmacodynamics
Ferrous iron (Fe2+) chelated with two glycine molecules is absorbed intact via intestinal peptide transporters (PepT1) and DMT1, reducing lumenal precipitation by dietary phytates and polyphenols and incorporated into haemoglobin, myoglobin, and cytochromes.
4. Therapeutic Indications & Evidence-Supported Uses
- Physiological & Biochemical Role: Ferrous iron (Fe2+) chelated with two glycine molecules is absorbed intact via intestinal peptide transporters (PepT1) and DMT1, reducing lumenal precipitation by dietary phytates and polyphenols and incorporated into haemoglobin, myoglobin, and cytochromes.
- Dietary Sources: Haem iron (meat, fish, poultry — 15–35% absorbed) and Non-haem iron (bajra/pearl millet, ragi, legumes, jaggery, green leafy vegetables — 2–10% absorbed due to dietary phytates)
- ICMR-NIN RDA & Upper Limits: ICMR-NIN 2024 RDA: 19 mg/day (adult men), 29 mg/day (adult women), 27 mg/day (pregnancy), 23 mg/day (lactation); Tolerable Upper Limit (UL): 45 mg/day elemental iron (therapeutic IDA dosing of 60–100 mg elemental iron is a drug regimen under Anemia Mukt Bharat).
5. Educational Dosage Context, Formulations & Administration
Educational Dosing & Regimen Summary: ICMR-NIN 2024 RDA: 19 mg/day (adult men), 29 mg/day (adult women), 27 mg/day (pregnancy), 23 mg/day (lactation); Tolerable Upper Limit (UL): 45 mg/day elemental iron (therapeutic IDA dosing of 60–100 mg elemental iron is a drug regimen under Anemia Mukt Bharat).
Administration & Meal Timing: CHELATION INTERACTIONS: Chelates and reduces oral absorption of Levothyroxine, Fluoroquinolones (ciprofloxacin, levofloxacin), Tetracyclines (doxycycline), Levodopa, and Integrase Inhibitors (dolutegravir, bictegravir) by 50–80% — separate by at least 2 to 4 hours! Tea/coffee tannins and calcium supplements inhibit absorption; Vitamin C (ascorbic acid) enhances absorption.
6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment
Salt-form and meal-timing dependent gastrointestinal absorption; see bioavailability and drug-nutrient chelation notes (CHELATION INTERACTIONS: Chelates and reduces oral absorption of Levothyroxine, Fluoroquinolones (ciprofloxacin, levofloxacin), Tetracyclines (doxycycline), Levodopa, and Integrase Inhibitors (dolutegravir, bictegravir) by 50–80% — separate by at least 2 to 4 hours! Tea/coffee tannins and calcium supplements inhibit absorption; Vitamin C (ascorbic acid) enhances absorption.).
Incorporated into cellular coenzyme pools, metalloproteins, or membrane phospholipids.
Caution with magnesium, potassium, calcium, vitamin D, and high-dose vitamin C/collagen (oxalate) in Chronic Kidney Disease.
Caution with fat-soluble vitamins and concentrated lipophilic extracts in hepatobiliary disease.
7. Contraindications, Precautions & High-Risk Warnings
- Supratherapeutic megadosing above the ICMR-NIN Tolerable Upper Intake Level (UL) without medical indication
- Deficiency: Microcytic hypochromic Iron Deficiency Anaemia (IDA), koilonychia, pica, and fatigue. Excess / Acute Paediatric Overdose: Corrosive haemorrhagic gastroenteritis, metabolic acidosis, shock, and hepatic necrosis (keep strictly out of reach of children!).
Key Clinical Precautions: Deficiency: Microcytic hypochromic Iron Deficiency Anaemia (IDA), koilonychia, pica, and fatigue. Excess / Acute Paediatric Overdose: Corrosive haemorrhagic gastroenteritis, metabolic acidosis, shock, and hepatic necrosis (keep strictly out of reach of children!).
8. Adverse Effects Profile
- Deficiency: Microcytic hypochromic Iron Deficiency Anaemia (IDA), koilonychia, pica, and fatigue. Excess / Acute Paediatric Overdose: Corrosive haemorrhagic gastroenteritis, metabolic acidosis, shock, and hepatic necrosis (keep strictly out of reach of children!).
- Deficiency: Microcytic hypochromic Iron Deficiency Anaemia (IDA), koilonychia, pica, and fatigue. Excess / Acute Paediatric Overdose: Corrosive haemorrhagic gastroenteritis, metabolic acidosis, shock, and hepatic necrosis (keep strictly out of reach of children!).
9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions
- CHELATION INTERACTIONS: Chelates and reduces oral absorption of Levothyroxine, Fluoroquinolones (ciprofloxacin, levofloxacin), Tetracyclines (doxycycline), Levodopa, and Integrase Inhibitors (dolutegravir, bictegravir) by 50–80% — separate by at least 2 to 4 hours! Tea/coffee tannins and calcium supplements inhibit absorption; Vitamin C (ascorbic acid) enhances absorption.
10. Clinical Monitoring, Patient Counselling & Storage
Clinical & Laboratory Monitoring: Verify whether the patient requires physiological nutritional maintenance (<=1 RDA under FSSAI) or high-dose therapeutic deficiency correction (Schedule H/medical supervision), and check for multi-supplement stacking.
Pharmacist Patient Counselling Points:
- CHELATION INTERACTIONS: Chelates and reduces oral absorption of Levothyroxine, Fluoroquinolones (ciprofloxacin, levofloxacin), Tetracyclines (doxycycline), Levodopa, and Integrase Inhibitors (dolutegravir, bictegravir) by 50–80% — separate by at least 2 to 4 hours! Tea/coffee tannins and calcium supplements inhibit absorption; Vitamin C (ascorbic acid) enhances absorption.
- Check all multivitamin and wellness labels to avoid accidentally doubling up on fat-soluble vitamins (A, D, E, K), iron, or zinc.
- Health supplements support normal physiological nutrition and are NOT intended to diagnose, treat, cure, or prevent disease under Section 22 of the FSS Act, 2006.
Storage, Stability & Dispensing Safeguards: Store in a cool, dry place below 25°C away from moisture and direct sunlight; verify FSSAI License Number and Veg/Non-Veg symbol on packaging.
11. Visual Pharmacology & Mechanism Diagram (svg-v339-01-adme-12-step-journey)
12. Authoritative References, Regulatory Sources & Editorial Disclaimer
Primary Compendial & Guideline Reference: ICMR-NIN (National Institute of Nutrition) Nutrient Requirements and Recommended Dietary Allowances (RDA) for Indians (2020/2024); FSSAI (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2022.
Official Verification Portals: ICMR-National Institute of Nutrition (NIN) — Dietary Guidelines & Nutrient Requirements for Indians • FSSAI — Food Safety and Standards (Health Supplements and Nutraceuticals) Regulations
Last Medically & Pharmaceutically Reviewed: 2026-11-10 • Verification Status: VERIFIED_EDUCATIONAL_CONTENT
Educational & Clinical Disclaimer: This reference profile is published solely for pharmacy education, academic study, and professional clinical reference. It does not substitute for patient-specific clinical judgement, qualified specialist oncology/medical supervision, or official CDSCO/IP prescribing information. Never self-medicate with prescription, Schedule H/H1/X, NDPS, or oncology medicines.