Regulatory status record
Is Domperidone banned in India?
Last checked 19 September 2026. A few details are still being checked against the original document.
Domperidone is not banned in India as of 19 Sep 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
- Latest action
- 11 April 2025
- Last checked
- 19 September 2026details being verified
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 Always check the linked government document for the current position, and tell us if something is out of date.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 |
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 (EC) & Domperidone (SR) Capsules | CG24-0548MMfg 2024-10 · Exp 2026-09 | Humankind Pharmaceuticals Lunia MohallaUttarakhand | Content of Rabeprazole SodiumOther | GORAKHPUR LAB, UPState lab | Jul 2026 |
| Pantoprazole and Domperidone Tablets | T-241215Mfg 2024-12 · Exp 2026-11 | Medirose Drugs And Pharmaceuticals | The sample does not conform to claim with respect to above tests and The sample is not of standard quality for the reason stated under Description.Description | CDL, KolkataCDSCO lab | Jul 2026 |
| Pantoprazole and Domperidone Tablets | AN-06-25Mfg 2025-10 · Exp 2027-09 | Anchor Pharma Pvt. LtdDaman & Diu | TEST FOR DISINTEGRATION TIMEDisintegration | DTL, DelhiState lab | Jul 2026 |
| Pantoprazole Gastro-resistant and Domperidone Prolonged- released Capsules IP | 25441645Mfg 2025-05 · Exp 2027-04 | Alkem Health ScienceSikkim | TESTS FOR ASSAY (CONTENT) OF PANTOPRAZOLE & UNIFORMITY OF WEIGHTAssay | DTL, DelhiState lab | Jul 2026 |
| Pantoprazole Gastro- Resistant & Domperidone Prologed Release Capsules I.P. | CG26-0049RMfg 2026-03 · Exp 2028-02 | Athens Life Sciences Mauza Rampur JattanHimachal Pradesh | 01. ASSAY OF PANTOPRAZOLE SODIUM I.P. & DOMPERIDONE I.P. ? Less than prescribed limit.Assay | SFDTL UttarakhandState lab | Jul 2026 |
| Omeprazole & Domperidone Capsules | AC25/211Mfg 2026-01 · Exp 2027-12 | Accuwell Medics Private Ltd. Suvery No.-414Gujarat | Content of Omeprazole & DomperidoneOther | Lucknow LabState lab | Jul 2026 |
| Enteric Coated Rabeprazole Sodium & Domperidone Sustained Release Capsules | RDAA24009Mfg 2024-10 · Exp 2026-09 | Signova Healthcare Pvt LtdAssam | The sample does not conform to I.P. w.r.to the tests for Dissolution & AssayAssay | SDTL, GuwahatiState lab | Jun 2026 |
| Enteric Coated Rabeprazole Sodium & Domperidone (SR) Capsules | VDR24002Mfg 2024-09 · Exp 2026-08 | Windlas Biotech Limited Plain-2Uttarakhand | Uniformity of WeightUniformity of weight/content | SDTL, PunjabState lab | Jun 2026 |
| Rabeprazole Sodium (Enteric-Coated) & Domperidone (SR) Capsules. | IGC-0044Mfg 2025-01 · Exp 2027-10 | I.G. Pharma LtdUttarakhand | The content of Rabeprazole Sodium found to be 16.22mg/Capsule against labelled claim of 20.0mg/CapsuleLabelling | SDTL, PunjabState lab | May 2026 |
| Rabeprazole Sodium & Domperidone Capsules | HPC-5116Mfg 2025-09 · Exp 2027-08 | Helpzyn PharmaceuticalsHimachal Pradesh | Assay of Rabeprazole and DomperidoneAssay | SDTL, Andhra Pradesh, VijayawadaState lab | May 2026 |
| Paracetamol and Domperidone Tablets (Dompar) | 4C11469Mfg 2024-12 · Exp 2027-11 | Cipla LtdHimachal Pradesh | DisintegrationDisintegration | DTL KonniState lab | May 2026 |
| Pantoprazole sodium (EC) & Domperidone (SR) Capsules | MT-25025Mfg 2025-03 · Exp 2027-02 | Shri sai Pharmatech Pvt. Ltd.20Himachal Pradesh | Assay of Domperidone IP- less than prescribed limit.Assay | SDTL, UttarakhandState lab | May 2026 |
| Pantoprazole & Domperidone Tablet | BCV4001DZMfg 2024-07 · Exp 2026-06 | VPAM Healthcare Pvt. Ltd. Plot No. 16&17Himachal Pradesh | Test for Disintegration OnlyDisintegration | RDTL, Bellary, KarnatakaState lab | May 2026 |
| Pantoprazole Gastro-resistant & Domperidone Prolonged-release Capsules IP | AGC240287Mfg 2025-01 · Exp 2026-12 | Asterisk Healthcare | The sample does not conform to IP and Manufacturer's Specification with repect to the test of Dissolution of Domperidone.Dissolution | CDL, KolkataCDSCO lab | Apr 2026 |
| Pantoprazole Gastro ? Resistant & Domperidone Prolonged ? Release Capsules IP | KC25G002Mfg 2025-07 · Exp 2027-06 | Keylink Global Exim Pvt. LtdHimachal Pradesh | The sample does not conform to Standard Quality in respect of the tests for Dissolution in Buffer stage performed.Dissolution | SDTL, TripuraState lab | Apr 2026 |
Official sources and primary records
- CDSCO: List of prohibited FDC drugs, 156 FDCs dated 02.08.2024RegulatorCDSCO · 2 August 2024
- Business Today: India halts 35 drug combinations over health risks, full listNewsBusiness Today · 17 April 2025
- Regulator