Brand check
Is Coldact banned in India?
Last checked 19 September 2026. A few details are still being checked against the original document.
Coldact is not banned in India as of 19 Sep 2026; its current chlorpheniramine + phenylephrine formula is restricted from use in children below four years under S.O. 1717(E) of 15 Apr 2025 and S.O. 4595(E) of 18 Aug 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; historical PPA ban GSR 82(E), 10 Feb 2011 (stay status:, being verified
- Latest action
- 19 September 2026
- Last checked
- 19 September 2026details being verified
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CDSCO: List of prohibited FDC drugs, 156 FDCs dated 02.08.2024
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 Always check the linked government document for the current position, and tell us if something is out of date.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 organise and explain what the document says. The document above is the authority.
Key facts
- Governing authority
- CDSCO, Ministry of Health and Family Welfare
- Current formula
- Chlorpheniramine + phenylephrine sustained-release capsule (being verified)
- Restriction
- S.O. 1717(E), 15 Apr 2025; S.O. 4595(E), 18 Aug 2026
- Old formula
- Phenylpropanolamine (PPA) + chlorpheniramine: PPA banned GSR 82(E), 10 Feb 2011; brand reformulated
- Manufacturer
- Sun Pharma (formerly Ranbaxy)
Coldact is a sustained-release cold capsule whose ingredients have changed once already because of a ban, which is why its status needs a short history.
The original Coldact combined phenylpropanolamine (PPA), a decongestant, with chlorpheniramine. PPA was linked to haemorrhagic stroke in a US study, and on 10 February 2011 the Health Ministry prohibited it under GSR 82(E), in the same notification that banned nimesulide for children. Vibcare's status table notes that the single-ingredient PPA ban was stayed by the Madras High Court; whether that stay is still operative is flagged for verification. In practice the market moved on: Ranbaxy, and later Sun Pharma, reformulated Coldact with phenylephrine in place of PPA. The paracetamol + chlorpheniramine + PPA combination was in any case prohibited in the August 2024 FDC list.
Today's Coldact, chlorpheniramine + phenylephrine, is not banned. It falls under the 2025 to 2026 restriction on that pairing: S.O. 1717(E) of 15 April 2025 required an under-four warning on drops and syrups, and S.O. 4595(E) of 18 August 2026 extended the condition to all chlorpheniramine + phenylephrine FDCs. For an adult capsule the practical effect is a label statement.
Adults can use Coldact as directed. Anyone giving cold remedies to a child under four should ask a doctor instead.
What this means for you
Adults can use the capsule as labelled
The current formula is legal; the under-4 rule is irrelevant to an adult capsule but appears on the label.
Old PPA-era stock is long gone
Any Coldact made after 2011 uses phenylephrine, not phenylpropanolamine.
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
- News
- CDSCO: List of prohibited FDC drugs, 156 FDCs dated 02.08.2024RegulatorCDSCO · 2 August 2024