Ingredient record · Opioid cough suppressant and painkiller
Codeine: bans, restrictions and failed batches in India
Last checked 20 September 2026. Sources: CDSCO banned-drugs notifications and monthly NSQ alerts, Jan 2019 to Jul 2026
15 entries containing Codeine are on India's banned-drugs list, and 7 are banned today. 6 batches of medicines containing Codeine failed a government lab test between June 2023 and July 2026, from 6 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
7
Banned combinations in force
8
Other listed orders (stayed, restricted, quashed)
6
Batches failed a lab test
Jul 2026
Latest lab alert
Is it banned? Our answer pages
CPM + codeine formula banned (2023)
CPM + codeine formula banned (2023)
On the banned-drugs list
Codeine on its own is not on CDSCO's banned list. The entries below are specific combinations that contain it. Status follows CDSCO's own notes on each entry.
| Drug / combination | Action | Notification | Date | Order | Status note |
|---|---|---|---|---|---|
| Chlorpheniramine Maleate 4mg + Codeine Phosphate 10mg + Sodium Citrate 75mg SyrupFixed-dose combination · cough-cold | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 23 | 11 April 2025 | 35 FDCs · Apr 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Chlorpheniramine Maleate + Codeine SyrupFixed-dose combination · cough-cold | Banned | S.O. 2398(E) | 2 June 2023 | 14 FDCs · Jun 2023 | Prohibited under s.26A on DTAB/Expert Committee advice; these are 14 of the 15 'pre-1988' FDCs excluded from the 2018 re-ban (Imipramine + Diazepam not included). |
| Chlorpheniramine + Codeine Phosphate + Menthol SyrupFixed-dose combination · cough-cold | Banned | S.O. 2404(E) | 2 June 2023 | 14 FDCs · Jun 2023 | Prohibited under s.26A on DTAB/Expert Committee advice; these are 14 of the 15 'pre-1988' FDCs excluded from the 2018 re-ban (Imipramine + Diazepam not included). |
| Paracetamol + Caffeine + Codeine PhosphateFixed-dose combination · painkillers | Banned | S.O. 4419(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Chlorpheniramine + Codeine + Sodium Citrate + Menthol SyrupFixed-dose combination · cough-cold | Banned | S.O. 4543(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Codeine + Levocetirizine + MentholFixed-dose combination · cough-cold | Banned | S.O. 4563(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Codeine + Chlorpheniramine + Alcohol SyrupFixed-dose combination · cough-cold | Banned | S.O. 4581(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Codeine + ChlorpheniramineFixed-dose combination · cough-cold | Banned | S.O. 4625(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Caffeine + Codeine PhosphateFixed-dose combination · painkillers | Quashed | S.O. 749(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Chlorpheniramine + Codeine + Sodium Citarte + Menthol SyrupFixed-dose combination · cough-cold | Quashed | S.O. 881(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Codeine + Levocetirizine + MentholFixed-dose combination · cough-cold | Quashed | S.O. 901(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Chlorpheniramine Maleate + Codeine SyrupFixed-dose combination · cough-cold | Under examination | S.O. 909(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; SC order 15.12.2017 treated it as a pre-1988 FDC, under examination with Expert Committee per CDSCO list as on 22.11.2021 (note 3#). 14 of these 15 were re-prohibited on 02.06.2023 (wave 2023-14). |
| Codeine + Chlorpheniramine + Alcohol SyrupFixed-dose combination · cough-cold | Quashed | S.O. 920(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Paracetamol + Codeine + ChlorpheniramineFixed-dose combination · cough-cold | Quashed | S.O. 968(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Chlorpheniramine + Codeine Phosphate + Menthol SyrupFixed-dose combination · cough-cold | Under examination | S.O. 983(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; SC order 15.12.2017 treated it as a pre-1988 FDC, under examination with Expert Committee per CDSCO list as on 22.11.2021 (note 3#). 14 of these 15 were re-prohibited on 02.06.2023 (wave 2023-14). |
Products that failed lab tests
Product names as printed by the testing labs, grouped. Open a product to see every batch number.
| Product | Batches | Makers | Latest |
|---|---|---|---|
| Triprolidine Hydrochloride Codeine Phosphate | 2 | 2 | Jul 2026 |
| Anrex Cough Codeine Phosphate Triprolidine Hci | 1 | 1 | Mar 2026 |
| Codeine Phosphate / | 1 | 1 | Aug 2025 |
| Codeine Phosphate Chlorpheniramine Maleate Sodium Citrate Cough Linctus | 1 | 1 | May 2025 |
| Chlorpheniramine Maleate Codeine Phosphate Onerex Cough | 1 | 1 | Jun 2023 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Triprolidine Hydrochloride & Codeine Phosphate Syrup, 100 ml | L-221226Mfg 2025-11 · Exp 2027-10 | BDC Pharmaceuticals 272 | Content of Triprolidine Hydrochloride & Codeine PhosphateOther | Lucknow LabState lab | Jul 2026 |
| Triprolidine Hydrochloride & Codeine Phosphate Syrup | TBHX0972Mfg 2025-02 · Exp 2027-01 | Three B Healthcare LtdHimachal Pradesh | ContentOther | DTL,MaduraiState lab | Mar 2026 |
| Anrex Cough Syrup Codeine Phosphate & Triprolidine HCI Syrup | AN-1629Mfg 2024-10 · Exp 2026-09 | Pharma Chemico Laboratories. DeonghatHimachal Pradesh | The content fo triprolidine hydrochloride is less than the schedule V limit.Other | FDAL, MumbaiState lab | Mar 2026 |
| Codeine Phosphate Syrup IP 15 mg/5ml | LE24-57Mfg 2024-05 · Exp 2026-04 | Om Biomedic Pvt. LtdUttarakhand | Assay of Codeine PhosphateAssay | Drugs Testing Laboratory,Shillong,MeghalayaState lab | Aug 2025 |
| Codeine Phosphate, Chlorpheniramine Maleate and Sodium Citrate Cough Linctus (WYKAREX-CD Cough Linctus) | AL-5770Mfg 2023-11 · Exp 2025-10 | Acron PharmaceuticalsGujarat | The Content of Codeine Phosphate in the sample less (i.e 32.50% of the labelled amount)Labelling | B.D. Marewad, FDA Lab, M.S. Chhatrapati Sambhajinagar . Maharashtra StateState lab | May 2025 |
| Chlorpheniramine Maleate & Codeine Phosphate Syrup ONEREX? COUGH SYRUP | ONCS 1713Mfg 2022-03 · Exp 2024-02 | Wings biotech LLP 43 & 44Himachal Pradesh | Identification and Assay of Codeine phosphateAssay | RDTL GuwahatiState lab | Jun 2023 |
Holding a strip or bottle? The batch number is printed after "B. No." Check it against every alert. If it matches, return it to the pharmacy. What the labels mean: status guide.