Folic Acid Dosage Mislabeling: CDSCO Panel Proposes Urgent Correction in Drug Rules
New Delhi: The Drugs Consultative Committee (DCC) has moved to enhance accuracy in drug labeling by recommending a correction in the unit of measurement for Folic Acid under Schedule V of the Drugs Rules, 1945. This revision seeks to prevent dosage misinterpretation, improve patient safety, and align pharmaceutical labeling with established medical standards.
During its 65th meeting, the DCC, the statutory committee under the Central Drugs Standard Control Organization(CDSCO) acknowledged that Folic Acid is currently listed in milligrams (mg) under Schedule V, whereas it should be measured in micrograms (mcg). The Committee was apprised that, "the unit of measurement of Folic Acid under the Schedule V of Drugs Rules, 1945 mentioned as milligram (mg) which needs to be corrected to microgram (mcg)."
Accordingly, it was proposed to correct the unit of Folic Acid to microgram (mcg) from milligram (mg).
This discrepancy, if left uncorrected, could lead to misinterpretation of doses, incorrect prescriptions, and possible health risks. Recognizing the importance of precise dosage information, the committee proposed amending the Drugs Rules to reflect the correct unit of measurement.
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After detailed deliberations, the DCC agreed with the proposal, stating:
“DCC deliberated the matter and agreed with the proposal for appropriate amendment in the Drugs Rules.”
Folic Acid is a crucial vitamin (Vitamin B9) widely used in nutritional supplements, prenatal vitamins, and anemia treatments. Proper dosage is especially vital for pregnant women and individuals with folic acid deficiency, as even minor miscalculations can affect health outcomes. By recommending this correction, the DCC aims to standardize dosage labeling, enhance transparency in drug formulations, and align India’s pharmaceutical regulations with global standards.
The recommendation will now be forwarded to the Drugs Technical Advisory Board (DTAB) for further review and approval. If implemented, drug manufacturers will be required to update their packaging and labeling to reflect the correct unit of measurement for Folic Acid.
