Brand check

Is Phensedyl banned in India?

Last checked 3 November 2026

Phensedyl. Status: CPM + codeine formula banned (2023).

The chlorpheniramine + codeine syrup sold as Phensedyl has been prohibited in India since the 14-FDC notification of 2 Jun 2023; the 2016 ban was set aside in court (Delhi High Court, 1 Dec 2016; Supreme Court, 15 Dec 2017).

Classification
Prohibited under Section 26A, Drugs and Cosmetics Act, 1940
Decided by
CDSCO / Ministry of Health and Family Welfare
Reference
S.O. 2398(E), 2 Jun 2023 (chlorpheniramine maleate + codeine syrup), 14-FDC list; earlier 2016 notification set aside in court
Evidence
Government document
Latest action
21 October 2026
Last checked
3 November 2026

Photo: syrup-bottle-pills by rawpixel (cc0). All photo credits.

Primary government sourceTier 1: government primary source

List of Prohibited FDC drugs (14 FDCs) dated 02.06.2023

CDSCO / Ministry of Health and Family Welfare · S.O. 2398(E), 2 Jun 2023 (chlorpheniramine maleate + codeine syrup), 14-FDC list; earlier 2016 notification set aside in court · 2 June 2023

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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 Always check the linked government document for the current position, and tell us if something is out of date.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 notification
S.O. 2398(E), 2 Jun 2023, Section 26A, one of 14 FDCs
Earlier notification
10 Mar 2016 (344-FDC wave), quashed
Original maker
Abbott India
Variant
Phensedyl DX: chlorpheniramine maleate 2 mg + dextromethorphan hydrobromide 10 mg (Apollo listing), Abbott India; no codeine, so not covered by S.O. 2398(E)
Enforcement
Phensedyl is the most seized codeine syrup on the Bangladesh border; raids continue in 2026

Phensedyl, Abbott's chlorpheniramine + codeine cough syrup, shares its regulatory history with Corex and has an added reputation as India's most smuggled medicine.

The combination was banned on 10 March 2016 as part of the 344-FDC wave. Manufacturers went to the Delhi High Court, which quashed the notifications on 1 December 2016. On 15 December 2017 the Supreme Court sent the list back to the Drugs Technical Advisory Board but excluded FDCs licensed before 1988, a group that included the codeine syrups. So Phensedyl stayed on sale, under Schedule H1 prescription rules, while a sub-committee examined it.

On 2 June 2023 the Health Ministry prohibited 14 of those older combinations, and CDSCO's list of those 14 shows chlorpheniramine maleate + codeine syrup at S.O. 2398(E). The notification names the formulation, not the brand, so the link to Phensedyl rests on its composition.

Phensedyl's other story is enforcement. Because codeine is an opioid, the syrup has been trafficked across the Bangladesh border for years, and state drug authorities in Tripura, Uttar Pradesh, Madhya Pradesh and Chhattisgarh reported seizures throughout 2026. Bottles sold informally are as likely to be counterfeit as diverted.

Two High Courts have recently differed in emphasis on codeine syrup cases. On 1 September 2026 the Allahabad High Court held that codeine syrup held for non-medicinal use counts as a narcotic under the NDPS Act. In Bharat Kumar v. State of Bihar, reported on 21 October 2026, a single judge of the Patna High Court held that cough syrups with codeine "within the permissible limits should be dealt with under the Drugs and Cosmetics Act", criticised police for "routinely registering cases" under NDPS, and granted bail. These are bail and interpretation rulings; neither changes the 2023 ban.

Phensedyl DX is a separate product. Apollo Pharmacy lists it as chlorpheniramine maleate 2 mg + dextromethorphan hydrobromide 10 mg, from Abbott India. It contains no codeine, so the 2023 order on chlorpheniramine + codeine does not cover it.

What this means for you

Old bottles should not be dispensed

The two-drug codeine formula is prohibited. Ask your pharmacist about disposal of leftover stock.

Any legal codeine syrup needs a prescription

Codeine products are Schedule H1 and must be sold against a recorded prescription.

Do not buy from informal sellers

Seized Phensedyl stock is frequently counterfeit or diverted; there is no safe way to check it.

This is a record of official orders, not medical advice. Do not stop a prescribed medicine without asking your doctor or pharmacist.

If you have this at home

  1. Check that the product name, strength, batch number and maker on your pack match this record. Only the batches or the formula named here are affected.
  2. Do not stop a medicine your doctor prescribed without talking to your doctor or pharmacist first.
  3. Keep the pack and the bill. Ask the shop that sold it to take it back.
  4. Report it to your state drug controller, or through CDSCO's consumer page. You can also check a batch number.

Common questions

Is Phensedyl DX banned?

It is not covered by the 2023 codeine order. Phensedyl DX is chlorpheniramine + dextromethorphan, with no codeine.

Is Phensedyl cough syrup banned in India?

Yes. The chlorpheniramine + codeine syrup has been prohibited since 2 Jun 2023 under S.O. 2398(E).

Why was Phensedyl syrup banned?

An expert review of older FDCs led to the 2 Jun 2023 ban on chlorpheniramine + codeine syrup, after an earlier 2016 ban was quashed.

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 September 2026. Absence from the alerts is not proof of quality, check your batch number.

Sources

Government documents

News reports

Other sources