Regulatory status record
Is Ranitidine banned in India?
Last checked 19 September 2026. A few details are still being checked against the original document.
Ranitidine is not banned in India as of 19 Sep 2026; it was dropped from the National List of Essential Medicines in 2022, and the Drugs Technical Advisory Board deferred a ban in April 2025 pending an ICMR study.
- Who decided: CDSCO / Ministry of Health and Family Welfare; Drugs Technical Advisory Board
- Reference: No Section 26A notification; DTAB meeting, Apr 2025 (deferred, ICMR study requested)
- Status as of: 19 September 2026
Photo: Tablets Pills by khunkorn laowisit (CC0). All photo credits.
Key facts
- Governing authority
- CDSCO, MoHFW; Drugs Technical Advisory Board
- Ban notification
- None
- NLEM
- Removed from the National List of Essential Medicines, 2022
- Testing
- CDL Kolkata found 21 of 42 samples above 0.32 ppm NDMA (acceptable intake limit)
- DTAB
- Apr 2025: deferred a ban; asked ICMR to study NDMA formation and safety
- Abroad
- Withdrawn in the US (Apr 2020) and EU (2020) over NDMA
Where the claim comes from
Ranitidine was withdrawn in the United States in April 2020 and across the European Union the same year because the molecule can form N-nitrosodimethylamine (NDMA), a probable carcinogen, over time. Indian coverage of those withdrawals, the drug's removal from NLEM 2022, and the April 2025 DTAB discussion of a ban all produced 'ranitidine banned in India' headlines. None has been followed by a notification.
Ranitidine is the acid-reducing drug behind Rantac, Aciloc and Zinetac, and it is the clearest case in India of a medicine that is widely believed to be banned but is not.
The concern is a contaminant. In 2019 regulators found that ranitidine can degrade into N-nitrosodimethylamine (NDMA), a probable human carcinogen, and that the amount rises with storage time and temperature. The United States withdrew all ranitidine products in April 2020; the European Union suspended them the same year. India instead ordered testing. The Central Drugs Laboratory in Kolkata found that 21 of 42 samples exceeded 0.32 parts per million of NDMA, the acceptable-intake threshold, and the drug was dropped from the National List of Essential Medicines in 2022.
A ban was placed before the Drugs Technical Advisory Board in April 2025. The Board deferred it and asked the Indian Council of Medical Research to study NDMA formation in Indian conditions and the associated risk. Business Standard reported the deferral on 1 May 2025. No Section 26A notification has followed, so ranitidine remains licensed and on sale. A ranitidine oral solution batch appeared in the June 2026 quality alert, which is a batch-specific finding.
Patients on ranitidine have a real question to ask their doctor: whether famotidine or a proton-pump inhibitor would be a better choice. That is a clinical decision, not a regulatory one.
What this means for you
It can still be prescribed and sold
Rantac, Aciloc and generics are licensed as of today.
There are alternatives if you are concerned
Famotidine and proton-pump inhibitors do the same job; ask your doctor rather than switching on your own.
Expect a decision eventually
The ICMR study will inform the DTAB; this page will change if a notification follows.
This is a record of official orders, not medical advice. Do not stop a prescribed medicine without asking your doctor or pharmacist.
Common questions
Why is ranitidine banned in other countries?
Because it can form NDMA, a probable carcinogen, during storage. India has not banned it; a DTAB decision awaits an ICMR study.
Entries on the banned drugs list
| Drug / combination | Action | Notification | Date | Status note |
|---|---|---|---|---|
| Ranitidine + Dicyclomine + Clidinium Bromide | Banned | S.O. 207(E) | 11 January 2019 | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Ranitidine + Omeprazole | Banned | S.O. 208(E) | 11 January 2019 | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Ranitidine + Dicyclomine + Nimesulide | Banned | S.O. 249(E) | 11 January 2019 | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Ranitidine + Dicycloverine + Simethicone | Banned | S.O. 250(E) | 11 January 2019 | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Ranitidine + Drotaverine | Banned | S.O. 251(E) | 11 January 2019 | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Paracetamol + Mefenamic Acid + Ranitidine + Dicyclomine | Banned | S.O. 4401(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 |
| Ranitidine + Magaldrate + Simethicone | Banned | S.O. 4500(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 |
| Ranitidine + Magaldrate | Banned | S.O. 4509(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Levocetirizine + Ranitidine | Banned | S.O. 4547(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Paracetamol + Mefenamic Acid + Ranitidine + Dicyclomine | Quashed | S.O. 729(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 Ranitidine 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 |
|---|---|---|---|---|---|
| Ranitidine Oral Solution IP | RAN191Mfg 2025-07 · Exp 2027-06 | Revive Formulation India PvtTamil Nadu | ContentOther | DTL, Madurai-19State lab | Jun 2026 |
| Ranitidine Oral Solution IP | L5E068Mfg 2025-05 · Exp 2027-04 | Samyan Health Care Pvt. LtdHimachal Pradesh | Sample does not conform to IP standards with respect to AssayAssay | DTL, ThrissurState lab | Jun 2026 |
| Ranitidine HCL I.P. 150 mg). | 25S007B01Mfg 2025-10 · Exp 2027-09 | Daundi Biological Pvt. LtdUttarakhand | Storage - Does not comply with I.P.Other | SDFTL US Nagar,UKState lab | Jun 2026 |
| Ranitidine Hydrochloride Tablets IP 150mg | RDT24029Mfg 2024-06 · Exp 2026-05 | Vivek Pharmachem (India) LimitedRajasthan | DescriptionDescription | DTL, KonniState lab | Mar 2026 |
| Ranitidine Hydrochloride Tablets IP 150 mg | TMG-240616Mfg 2024-03 · Exp 2026-02 | Prochem Pharmaceuticals Pvt. LtdUttarakhand | The sample does not conform to I.P. with respect to DescriptionDescription | CDL, KolkataCDSCO lab | Mar 2026 |
| Ranitidine Oral Solution IP ZALTAC Syrup | MDL-C490Mfg 2025-08 · Exp 2027-07 | Marvellon Pharmaceuticals Pvt. Ltd. Kh. No. 114Himachal Pradesh | The sample does not conform to claim as per IP 2022 in respect to The test pH and Assay of Ranitidine Hydrochloride calculated as Ranitidine.Assay | RDTL, ChandigarhCDSCO lab | Dec 2025 |
| Ondansetron and Ranitidine HCI Injection Vomibac R Injection | 110525Mfg 2025-05 · Exp 2027-04 | Pharma Chemico Laboratories DevghatHimachal Pradesh | The sample received does not conform to manufacturer specification with respect to The test for pH only.pH | CDTL-HyderabadCDSCO lab | Dec 2025 |
| Ranitidine Oral Solution IP | SR-017Mfg 2024-06 · Exp 2026-05 | Sresan Pharmaceutical ManufacturerKarnataka | This particular batch of sample fails the test Assay of Ranitidine.Assay | RDTL ErnakulamState lab | Nov 2025 |
| Ranitidine Oral Solution IP | AL24011221DMfg 2024-01 · Exp 2025-12 | Accura Care Pharmaceuticals Pvt. LtdHimachal Pradesh | Content of RanitidineOther | SDT&RL, BhubaneswarState lab | Nov 2025 |
| Ranitidine Hydrochloride Tablets IP 150mg | AZCT-2505Mfg 2025-05 · Exp 2027-04 | SELDOM PHARMA PVT.LTD #6-8-122Puducherry | Circular orange colored, biconvex plain on both sides. Two types of colored tablets observed while opening from the strips. Some tablets are light brown colored and some tablets are orange colored, hence Description (Appearance) test parameter does not complies as per IP specification.Description | DCL TelanganaState lab | Nov 2025 |
| Rantac RD (Rabeprazole and Domperidone Capsule) | YCRE23010Mfg 2023-10 · Exp 2025-09 | Innova Captab LtdHimachal Pradesh | The sample does not conform to claim with respect of 'Assay' test.Assay | State Drugs Testing Laboratory, Kolkata, West BengalState lab | Jul 2025 |
| Ranitidine Injection IP-2ML | HLI352CMfg 2024-03 · Exp 2026-02 | Himalaya Meditek Pvt LtdUttarakhand | Sample does not conform to requirement for AssayAssay | King Institute of Preventive Medicine & Research, Guindy, Chennai-32State lab | May 2025 |
| Ranitidine Hydrochloride Tablets IP 150mg (Zeptiloc-150 tablets) | ZCI24003Mfg 2024-04 · Exp 2026-03 | Danish Healthcare (P) Ltd. 76/27-28 | DescriptionDescription | State Drugs Laboratory, PunjabState lab | May 2025 |
| Ranitidine Hydrochloride Injection I.P | AV3082Mfg 2023-02 · Exp 2025-01 | Alpa Laboratories LtdMadhya Pradesh | Test for SterilitySterility | State Lab KarnatakaState lab | Dec 2024 |
| Ranitidine Hydrochloride Tablets (Ranylaj-150) | GTDE3019Mfg 2023-05 · Exp 2025-04 | Francis Remdies (India) Pvt.LtdUttarakhand | DescriptionDescription | CDL KolkataCDSCO lab | Jun 2024 |
Official sources and primary records
- Business Standard: Ranitidine ban in India: NDMA cancer risk and regulatory statusNewsBusiness Standard · 1 May 2025
- ETV Bharat: CDSCO flags 159 substandard drugs in June; over 3,500 prosecution cases filed over five yearsNewsETV Bharat · 23 July 2026
- Regulator