Brand check
Is Wikoryl banned in India?
Last checked 21 September 2026
Wikoryl is not banned in India as of 19 Sep 2026; as a chlorpheniramine + phenylephrine FDC it is restricted from use in children below four years by S.O. 1717(E) of 15 Apr 2025 and S.O. 4595(E) of 2026.
- Classification
- Restricted under Section 26A, Drugs and Cosmetics Act, 1940
- Decided by
- CDSCO / Ministry of Health and Family Welfare
- Reference
- S.O. 1717(E), 15 Apr 2025; S.O. 4595(E), 18 Aug 2026
- Latest action
- 19 September 2026
- Last checked
- 21 September 2026
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Medical Dialogues: Health ministry restricts chlorpheniramine + phenylephrine FDCs for children below 4, mandates warning labels
Our team has checked this record against the published reports, last on 21 September 2026. The government order itself is not published online, or we have not found it yet, so we link the best public report. If you have the order, send it to us and we will link it instead.
Scope. A record here does not by itself mean a product or company is unsafe or banned today. Regulatory actions can apply to one batch, one formulation, one period or one state. Always check the linked government document for the current position, and tell us if something is out of date. How we label records.
Below: Blacklisted's explanationWe explain what has been reported. The report above is the best source we hold.
Key facts
- Governing authority
- CDSCO, Ministry of Health and Family Welfare
- Restriction
- S.O. 1717(E), 15 Apr 2025; S.O. 4595(E), 18 Aug 2026
- Composition
- Paracetamol + chlorpheniramine + phenylephrine
- Manufacturer
- Alembic Pharmaceuticals
- Pending
- Red under-4 warning proposal before the DCC, 19 Sep 2026
Wikoryl is Alembic's cold and flu product, sold as syrup, paediatric drops and tablets, combining paracetamol with chlorpheniramine maleate and phenylephrine. It is not banned. It is one of the many brands affected by the Health Ministry's restriction on chlorpheniramine + phenylephrine combinations in young children.
The first notification, S.O. 1717(E) of 15 April 2025, required drops and syrups containing the two drugs to state that they "shall not be used in children below four years" and barred their promotion for that age. The second, S.O. 4595(E) of 18 August 2026, extended the condition to every fixed-dose combination containing chlorpheniramine and phenylephrine, regardless of dosage form or additional ingredients. The reasoning, set out in the CDSCO's 2023 correspondence with manufacturers, is that decongestant-antihistamine combinations have no proven benefit in small children and carry a risk of serious adverse events.
A separate DGHS proposal, discussed by the Drugs Consultative Committee on 19 September 2026, would add a red "not below four years" warning to all cough syrups. That would change the packaging, not the legal status.
Wikoryl was not named in the August 2024 ban list, which prohibited the cetirizine-based cold tablet rather than the chlorpheniramine one. For adults and children over four the product can be used as labelled; for younger children, ask a doctor.
What this means for you
Older children and adults: unchanged
Wikoryl syrup and tablets remain licensed for the ages on the label.
Under four: no
Drops and syrup cannot be used for children below four. A doctor can suggest alternatives.
This is a record of official orders, not medical advice. Do not stop a prescribed medicine without asking your doctor or pharmacist.
Batches flagged in CDSCO alerts
No NSQ batch on record. No product matching this name appears in CDSCO or state-lab NSQ alerts from Jan 2019 to July 2026. Absence from the alerts is not proof of quality, check your batch number.
Official sources and primary records
- Medical Dialogues: Health ministry restricts chlorpheniramine + phenylephrine FDCs for children below 4, mandates warning labelsNewsMedical Dialogues
- Business Standard: Cough syrups may soon get a red warning against use for children under 4NewsBusiness Standard · 19 September 2026
- AIR: Health ministry advises cough syrups should not be prescribed or dispensed to children below two yearsNewsAll India Radio · 4 October 2025