Regulatory status record
Is Domperidone banned in India?
Last checked 1 October 2026
Domperidone is not banned in India as of 1 Oct 2026; the 2 Aug 2024 notification prohibited sucralfate + domperidone and tramadol + dicyclomine + domperidone, and three-drug pantoprazole + domperidone products were halted in April 2025.
- Classification
- No ban or recall found in official records
- Decided by
- CDSCO / Ministry of Health and Family Welfare
- Reference
- No Section 26A notification for domperidone; S.O. 3437(E) and S.O. 3439(E), 2 Aug 2024, cover listed combinations
- Evidence
- Government document
- Latest action
- 11 April 2025
- Last checked
- 1 October 2026
Domperidone 5 mg tablets in a blister pack. Photo: Domperidone nauzelin 5mg.JPG by Tama998 (CC0). Brand names and logos belong to their owners and are used here to identify the product this entry is about. All photo credits.
CDSCO: Drugs banned in India (consumer section)
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 Always check the linked government document for the current position, and tell us if something is out of date.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
- Domperidone alone
- Not banned
- Banned 2 Aug 2024
- Sucralfate + domperidone + simethicone (S.O. 3437(E)); sucralfate + domperidone; tramadol + dicyclomine + domperidone (S.O. 3439(E))
- Halted 11 Apr 2025
- Pantoprazole + domperidone + levosulpiride; pantoprazole + domperidone + simethicone
- Still legal
- Pan-D, Omez-D, Rantac-D and other two-drug PPI/H2 + domperidone products
- Abroad
- Restricted in the EU (2014) and unapproved in the US over heart-rhythm risk, not banned in India
Where the claim comes from
Domperidone was restricted in the European Union in 2014 and has never been approved in the United States because of a heart-rhythm risk, and Indian articles about those decisions often ask whether India will follow. The August 2024 ban list then included two domperidone combinations and the April 2025 halt two more, which produced 'domperidone banned' headlines.
Domperidone is an anti-nausea and prokinetic drug used on its own (Vomistop, Domstal) and in dozens of combinations with acid reducers such as Pan-D and Omez-D. It is not banned in India.
The molecule has never been the subject of a Section 26A notification. Its regulatory history abroad is the first source of the question: the European Medicines Agency restricted domperidone in 2014 to short courses at low doses because of a small risk of serious heart-rhythm effects, and the United States has never approved it. India's response was a label caution rather than a withdrawal.
The second source is the combination bans. The 156-FDC notification of 2 August 2024 prohibited sucralfate + domperidone with and without simethicone (S.O. 3437(E) for the simethicone version) and tramadol + dicyclomine + domperidone (S.O. 3439(E)). On 11 April 2025 the CDSCO halted three-drug pantoprazole + domperidone products with levosulpiride or simethicone among 35 combinations licensed without central approval. In each case the target was the specific combination, not domperidone.
The two-drug combinations that most patients use, pantoprazole + domperidone, omeprazole + domperidone, ranitidine + domperidone, were not in any of these actions and remain licensed.
Patients should use domperidone as prescribed, at the lowest dose that works, and check any pack with three actives against the halted list.
What this means for you
Plain domperidone and Pan-D-type products continue
The molecule and its two-drug combinations with acid reducers are licensed.
Sucralfate + domperidone packs are gone
If your reflux medicine lists sucralfate with domperidone, ask your pharmacist for a replacement.
Heart-rhythm caution is on the label
Domperidone is used at the lowest dose for the shortest time; that is prescribing advice, not a ban.
This is a record of official orders, not medical advice. Do not stop a prescribed medicine without asking your doctor or pharmacist.
Common questions
Is Vomistop banned in India?
No. Vomistop is single-ingredient domperidone and is not subject to any ban.
Entries on the banned drugs list
| Drug / combination | Action | Notification | Date | Status note |
|---|---|---|---|---|
| Sucralfate + Domperidone + Dimethicone | Banned | S.O. 3301(E) | 2 August 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Sucralfate + Domperidone | Banned | S.O. 3302(E) | 2 August 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Sucralfate + Domperidone + Simethicone | Banned | S.O. 3437(E) | 2 August 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Tramadol HCl + Dicyclomine HCl + Domperidone | Banned | S.O. 3439(E) | 2 August 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Dicyclomine + Paracetamol + Domperidone | Banned | S.O. 4385(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Domperidone + Caffeine | Banned | S.O. 4410(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Flunarizine + Paracetamol + Domperidone | Banned | S.O. 4495(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Magaldrate + Ranitidine + Pancreatin + Domperidone | Banned | S.O. 4499(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Rabeprazole + Zinc + Domperidone | Banned | S.O. 4502(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Ranitidine + Domperidone + Simethicone | Banned | S.O. 4504(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Dicyclomine + Paracetamol + Domperidone | Quashed | S.O. 711(E) | 10 March 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Paracetamol + Domperidone + Caffeine | Quashed | S.O. 739(E) | 10 March 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
Ingredient records
Every banned combination and failed batch containing each ingredient.
Batches declared Not of Standard Quality
Batches of products containing Domperidone flagged in CDSCO monthly alerts. An NSQ result concerns one batch, not the molecule or the brand.
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Rabeprazole Sodium Enteric coated & Domperidone Sustained Release Capsules | Batch CF10008AMfg Oct 2025 · Exp Sep 2027 | Hetvi Lifesciences Pvt. LtdGujarat | The sample does not conform to claim with respect to the Assay of Rabeprazole Sodium.Assay | CDL, KolkataCDSCO lab | Sep 2026 |
| Rabeprazole Sodium (Enteric Coated) & Domperidone (Sustained Release) Capsules | Batch BCD-B0204GMfg Jan 2026 · Exp Dec 2027 | Broad Tab Pvt. LtdHaryana | The sample does not conforms to the claim with respect to Assay of Rabeprazole Sodium and Domperidone.Assay | DTL, JaipurState lab | Sep 2026 |
| Rabeprazole Sodium (EC) & Domperidone (SR) Capsules | Batch CE-25022Mfg May 2025 · Exp Apr 2027 | Horizon Bioceuticals Pvt. LtdHimachal Pradesh | The sample does not conform to declared formula, in respect of content of Rabeprazole sodiumOther | LUCKNOW, Uttar PradeshState lab | Sep 2026 |
| Rabeprazole Sodium (EC) & Domperidone (SR) Capsules | Batch LGQ01/199/01Mfg Jan 2026 · Exp Jun 2027 | Logos PharmaHimachal Pradesh | The sample does not conform to declared formula in respect of content of Rabeprazole and Domperidone.Other | VARANASI, Uttar PradeshState lab | Sep 2026 |
| Pantoprazole & Domperidone Tablets | Batch SRGT-25971Mfg Nov 2025 · Exp Oct 2027 | Spas RemediseHimachal Pradesh | Test for DisintegrationDisintegration | RDTL, Bellary, KarnatakaState lab | Sep 2026 |
| Omeprazole & Domperidone Capsules IP | Batch C-2873Mfg Oct 2025 · Exp Sep 2027 | Supercure Biotech Pvt. LtdHaryana | The sample does not conform to IP in respect of Uniformity of Content.Uniformity of weight/content | LUCKNOW, Uttar PradeshState lab | Sep 2026 |
| Rabeprazole Sodium Gastro Resistant and Domperidone Prolonged Release Capsules | Batch 2604209Mfg Apr 2026 · Exp Mar 2028 | Sai sarvaa Biotech Pvt. Ltd | The sample does not conform to claim as per Patent and Proprietary in respect to the Test of Dissolution of Domperidone (12th hours), Dissolution of Rabeprazole Sodium (buffer stage).Dissolution | RDTL, ChandigarhCDSCO lab | Aug 2026 |
| Rabeprazole Sodium (EC) & Domperidone (SR) Capsules | Batch PGC25-377EMfg Nov 2025 · Exp Oct 2027 | Plena RemediesHimachal Pradesh | The sample does not conform to declared formula in respect of content of Rabeprazole SodiumOther | GORAKHPUR LABState lab | Aug 2026 |
| Rabeprazole Sodium (EC) & Domperidone (SR) Capsules | Batch DC-10856Mfg Nov 2025 · Exp Oct 2027 | Dual HealthcareHimachal Pradesh | The sample does not conform to declared formula in respect of Identity test for Rabeprazole sodium & Domeperidone, Hence spurious.Spurious | LUCKNOW LABState lab | Aug 2026 |
| Rabeprazole Sodium & Domperidone Tablets | Batch SPT-41856Mfg Jan 2026 · Exp Dec 2027 | Shervotec PharmaceuticalsHimachal Pradesh | The sample does not comply with IP requirements fo the Disintegrarion Test for Enteric Coated TabletsOther | FDAL, MumbaiState lab | Aug 2026 |
| Pantoprazole Sodium & Domperidone Capsules | Batch SC-2085Mfg Mar 2026 · Exp Feb 2028 | Sidhdeep Biotech (P) Ltd | Assay of Pantoprazole Sodium I.P. and Domperidone I.P.Assay | SFDTL, UttarakhandState lab | Aug 2026 |
| Esomeprazole Magnesium (EC) & Domperidone (SR) Capsules | Batch AC26-0089AMfg Mar 2026 · Exp Feb 2028 | Algen Healthcare Ltd 134/2Himachal Pradesh | The sample does not conform to declared formula, in respect of content of EsomeprazolOther | LUCKNOW LABState lab | Aug 2026 |
| Enteric Coateed Rabeprazoel Sodium & Domperidone Sustained Release Capsules (20mg+30mg) | Batch RBZ25065Mfg Aug 2025 · Exp Jul 2027 | Tirupati Medicare Ltd. Nahan RoadHimachal Pradesh | The Content of Rabeprazole Sodium in the Sample is less (i.e. 57.65% of Stated Amount) than Schedule V Limit.Other | FDAL, MumbaiState lab | Aug 2026 |
| Domperidone Tablets IP 10mg | Batch IT14501Mfg Sep 2025 · Exp Aug 2028 | Inducare Pharmaceutical and Research FoundatiionMaharashtra | The Sample Does Not Comply With IP requirements for the Dissolution test. The Sample is Declared As Misbranded Vide Rule 96 Section 17(b) and (c), of Drugs And Cosmetics Act, 1940 And Rules 1945, as the Manufacturing details about Mfg. Date and Exp. Date mentioned on Sample Carton and Sample Strips are different. Also Manufacturer mentioned name of Active Ingredients as Domperidone instead of Domperidone Maleate Equivalent to Domperidone.Dissolution | FDAL, MumbaiState lab | Aug 2026 |
| Rabeprazole Sodium (EC) & Domperidone (SR) Capsules | Batch CG24-0548MMfg Oct 2024 · Exp Sep 2026 | Humankind Pharmaceuticals Lunia MohallaUttarakhand | Content of Rabeprazole SodiumOther | GORAKHPUR LAB, UPState lab | Jul 2026 |
Sources
Government documents
- CDSCO: List of prohibited FDC drugs, 156 FDCs dated 02.08.2024RegulatorCDSCO · 2 August 2024
- Regulator
News reports
- Business Today: India halts 35 drug combinations over health risks, full listNewsBusiness Today · 17 April 2025