Maharashtra FDA Finds Iron-Folic Acid Tablet With Just 62.36 Per Cent Folic Acid In Quality Test

Mumbai, October 8, 2026: Not all patients taking iron and folic acid tablets for anaemia or to maintain adequate iron levels during pregnancy may be getting the required amount of folic acid. Maharashtra FDA testing found one Palghar-made batch contained far less folic acid than required, potentially reducing the medicine’s intended benefit.

The Food and Drug Administration (FDA), Maharashtra, found that a batch of Iron and Folic Acid tablets manufactured in Palghar contained only 62.36% of the stated folic acid content, against the minimum 90% required under Indian Pharmacopoeia (IP) standards.

Batch Fails Quality Test

The finding is part of the Central Drugs Standard Control Organisation’s (CDSCO) August 2026 list of 220 drugs declared Not of Standard Quality (NSQ) during routine quality surveillance.

The affected Iron and Folic Acid IP (Large), batch TCW25029AL, was manufactured by Hindustan Laboratories Ltd, Palghar, and tested by the Maharashtra FDA’s state laboratory in Mumbai.

The drug was manufactured in November 2025 with expiry in October 2027. The finding applies to the tested batch and does not automatically mean that all batches of the medicine are substandard.

Dr Gandhali Deorukhkar, Consultant, Obstetrics and Gynaecology, Wockhardt Hospitals, Mumbai Central, said folic acid is particularly important during pregnancy, especially in the early stages, when adequate levels are essential for fetal development.

“If a tablet contains only 62.36% of its stated folic acid content, against the required minimum of 90%, the patient may not be receiving the intended dose. While the clinical impact would depend on the individual’s overall folate status and duration of use, such a significant shortfall is concerning. It highlights the need for strict quality control and compliance with pharmacopoeial standards, particularly for medicines prescribed to pregnant women and children,” said Dr Deorukhkar.

Similarly, in children, folate is needed for normal growth and healthy blood formation, and deficiency can cause anaemia, weakness and tiredness.

Manufacturer Challenges FDA Report

Responding to the Free Press Journal query, Hindustan Laboratories Ltd, Palghar, said it had “challenged the report of Government Analyst as per Drugs and Cosmetic Act and rules thereunder.”

In addition, the Maharashtra FDA findings also flagged specific batches of several commonly used medicines from pharmaceutical companies in Maharashtra and other states, including drugs used for infections, acidity, nausea, fungal infections and cholesterol.

Among the 12 Maharashtra-linked samples in the August list, one was tested at CDSCO’s Central Drugs Testing Laboratory (CDTL), Mumbai, and 11 by the Maharashtra FDA laboratory.

Across the country, CDSCO’s August surveillance identified 220 NSQ samples — 29 detected by central drug laboratories and 191 by state drug-testing laboratories.

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After Declaring Drug NSQ

Once a drug is declared Not of Standard Quality (NSQ), its sale is stopped and the affected batch is recalled from the market. The manufacturer has to provide details of the batch’s production, stock and distribution and explain why it failed the quality test.

Regulators then investigate and, depending on the seriousness of the defect, can issue a show-cause notice, suspend or cancel the licence and order further corrective action. Prosecution can also be initiated in serious, repeated or deliberate violations.

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