Ingredient record · Bronchodilator
Etofylline: 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
11 entries containing Etofylline are on India's banned-drugs list, and 6 are banned today. 2 batches of medicines containing Etofylline failed a government lab test between December 2019 and March 2020, from 2 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
On the banned-drugs list
Etofylline 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 |
|---|---|---|---|---|---|
| Etofylline + Theophylline Anhydrous eq. to Theophylline Hydrate + Ambroxol HClFixed-dose combination · cough-cold | Banned | S.O. 3396(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Etofylline + Theophylline Anhydrous eq. to Theophylline Hydrate + MontelukastFixed-dose combination · cough-cold | Banned | S.O. 3397(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Salbutamol + Hydroxyethyltheophylline (Etofylline) + BromhexineFixed-dose combination · cough-cold | Banned | S.O. 2407(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). |
| Salbutamol + Hydroxyethyl Theophylline (Etofylline) + BromhexineFixed-dose combination · cough-cold | Under examination | S.O. 4687(E) | 7 September 2018 | 328 FDCs · Sep 2018 | SC order 14.02.2019: claimed pre-1988 FDC; under examination with Expert Committee per CDSCO list as on 22.11.2021 (note 4#). Legally on sale pending examination. |
| Terbutaline + Bromhexine + EtofyllineFixed-dose combination · cough-cold | Banned | S.O. 4598(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Terbutaline Sulphate + Etofylline + AmbroxolFixed-dose combination · cough-cold | Banned | S.O. 4624(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Albuterol + Etofylline + Bromhexine + MentholFixed-dose combination · cough-cold | Banned | S.O. 4685(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Terbutaline + Bromhexine + EtofyllineFixed-dose combination · cough-cold | Quashed | S.O. 940(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Terbutalinesulphate + Etofylline + AmbroxolFixed-dose combination · cough-cold | Quashed | S.O. 967(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Albuterol + Etofylline + Bromhexine + MentholFixed-dose combination · cough-cold | Quashed | S.O. 1032(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Salbutamol + Hydroxyethyltheophylline (Etofylline) + BromhexineFixed-dose combination · cough-cold | Quashed | S.O. 1034(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
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 |
|---|---|---|---|
| H E T | 1 | 1 | Mar 2020 |
| Etofylline Theophylline | 1 | 1 | Dec 2019 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| H-E-T ? 2 ml (Etofylline & Theophylline Injection) | 051904Mfg 2019-05 · Exp 2021-04 | Bhavani Pharmaceuticals (P) LtdUttar Pradesh | Description and Particulate MatterDescription | CDL KolkataCDSCO lab | Mar 2020 |
| Etofylline & Theophylline Tablets IP | BN9002Mfg 2019-04 · Exp 2022-03 | Halewood Laboratories Pvt. LtdGujarat | DisintegrationDisintegration | CDTL MumbaiCDSCO lab | Dec 2019 |
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.