1 hr ago
Maharashtra FDA Finds Folic Acid Tablet Below Required Standard
A medicine batch made in Palghar was tested by Maharashtra’s drug regulator.
The tablets had less folic acid than the amount written on the label.
The test found 62.36% of the stated amount, while the required minimum is 90%.
This may mean people taking tablets from this batch get less folic acid than intended.
A doctor said folic acid is important during pregnancy and for children’s growth and blood health.
The finding concerns this batch only, not every batch of the medicine.
The company says it has challenged the test report.
Drug regulators may investigate and take steps such as stopping sales or recalling an affected batch.
Maharashtra FDA testing found batch TCW25029AL contained 62.36% of its stated folic acid content, below the 90% minimum under Indian Pharmacopoeia standards.
The Iron and Folic Acid IP (Large) tablets were made by Hindustan Laboratories Ltd in Palghar and tested at the Maharashtra FDA laboratory in Mumbai.
The batch was manufactured in November 2025 and is due to expire in October 2027; the finding applies to this batch, not necessarily others.
The batch appeared in the Central Drugs Standard Control Organisation’s August 2026 list of 220 medicines declared Not of Standard Quality.
Hindustan Laboratories said it has challenged the Government Analyst’s report under the Drugs and Cosmetics Act and rules.
- Who
- Maharashtra FDA tested a batch made by Hindustan Laboratories Ltd.
- What
- The batch contained 62.36% of its stated folic acid content, below the 90% minimum standard.
- Where
- The tablets were manufactured in Palghar, Maharashtra, and tested at the Maharashtra FDA laboratory in Mumbai.
- When
- The finding was included in CDSCO’s August 2026 surveillance list; the batch was made in November 2025.
- Why
- Routine drug-quality surveillance identified the shortfall against Indian Pharmacopoeia standards.
Regulatory finding
Manufacturer response
Test result
Regulatory finding
Maharashtra FDA found the tested batch contained 62.36% of its stated folic acid content, below the 90% minimum.
Manufacturer response
Hindustan Laboratories said it has challenged the Government Analyst’s report under the Drugs and Cosmetics Act and rules.
Key facts
- Medicine
- Iron and Folic Acid IP (Large)
- Batch
- TCW25029AL
- Folic acid measured
- 62.36% of the stated content
- Required minimum
- 90% under Indian Pharmacopoeia standards
- Manufacturer
- Hindustan Laboratories Ltd, Palghar
- Manufacture and expiry
- Manufactured November 2025; expiry October 2027
- CDSCO August 2026 list
- 220 Not of Standard Quality samples: 29 detected by central laboratories and 191 by state laboratories
Quotes
Dr Gandhali Deorukhkar
Consultant in obstetrics and gynaecology at Wockhardt Hospitals, Mumbai Central
“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.”
freepressjournal.in
Hindustan Laboratories Ltd, Palghar
Manufacturer of the affected tablet batch
“challenged the report of Government Analyst as per Drugs and Cosmetic Act and rules thereunder.”
freepressjournal.in
Sources
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