Regulatory status record
Is Loperamide (Imodium) banned in India?
Last checked 19 September 2026. A few details are still being checked against the original document.
Loperamide is not banned in India as of 19 Sep 2026; it is sold on prescription for adults, and a reported restriction on its use in young children is being verified against the Gazette.
- Classification
- No ban or recall found in official records
- Decided by
- CDSCO / Ministry of Health and Family Welfare
- Reference
- No Section 26A notification found for adult use; paediatric restriction (being verified)
- Latest action
- 2 August 2024
- Last checked
- 19 September 2026details being verified
Photo: Tablets Pills by khunkorn laowisit (CC0). 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 Always check the linked government document for the current position, and tell us if something is out of date.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
- Adult use
- Not banned; Schedule H prescription drug
- Children
- Label contraindication in young children; a regulatory restriction is reported (being verified)
- Common brands
- Imodium, Lopamide, Eldoper, Diarlop
- Clinical note
- Not for diarrhoea with fever or blood; oral rehydration is first-line for children
Where the claim comes from
Loperamide is restricted in children in many countries because it can cause paralytic ileus and severe drowsiness in infants, and India's antidiarrhoeal bans of the 1980s and 1990s, kaolin-pectin products and furazolidone combinations, sit on the same lists people search. 'Is Imodium banned in India' seems to combine the two. We have not found a notification banning loperamide for adults.
Loperamide slows the gut and is the standard over-the-counter antidiarrhoeal in most countries; in India it is a Schedule H prescription drug sold as Imodium, Lopamide, Eldoper and generics. It is not banned for adults.
We have found no Section 26A notification against loperamide. It is not on the CDSCO's list of banned drugs, which does include some older antidiarrhoeal products such as kaolin-pectin combinations and furazolidone combinations, and it is not in any of the FDC ban waves. The question that remains open, and that our plan flags for verification, is whether India has issued a specific restriction on loperamide in children. Several countries prohibit it under two, four or six years because it can cause paralytic ileus, severe drowsiness and breathing problems in infants, and Indian labels carry a similar contraindication. Whether that contraindication rests on a Gazette notification or only on the product label should be confirmed before this page is treated as final.
For practical purposes the answer is the same either way. Adults with simple diarrhoea can use loperamide for a short course as prescribed, and should not use it when there is fever or blood in the stool. Children with diarrhoea should be given oral rehydration solution and zinc, and seen by a doctor; loperamide is not part of paediatric treatment in India regardless of the regulatory paperwork.
What this means for you
Adults can use it as prescribed
Short courses for travellers' or simple diarrhoea are the labelled use.
Not for young children
Whatever the regulatory position turns out to be, the label and paediatric guidance say the same: give oral rehydration solution and see a doctor.
This is a record of official orders, not medical advice. Do not stop a prescribed medicine without asking your doctor or pharmacist.
Entries on the banned drugs list
| Drug / combination | Action | Notification | Date | Status note |
|---|---|---|---|---|
| Norfloxacin + Tinidazole + Loperamide | Banned | S.O. 201(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. |
| Furazolidone + Metronidazole + Loperamide | Banned | S.O. 4507(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Furazolidone + Metronidazole + Loperamide | Quashed | S.O. 844(E) | 10 March 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Loperamide Hydrochloride with Furazolidone | Banned | GSR 170(E) | 12 March 2001 | In force per CDSCO consumer list (1983-2017) |
| Liquid Oral Antidiarrhoeals or any other Dosage Form for Pediatric Use containing Diphenoxylatelorloperamide or Atropine or Belladonna Including Their Salts or Esters or Metaboliteshyoscyamine or Their Extracts or Their Alkaloids | Banned | GSR 731(E) | 30 September 1994 | In force per CDSCO consumer list (1983-2017) |
Batches declared Not of Standard Quality
Batches of products containing Loperamide 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 |
|---|---|---|---|---|---|
| Loperamide Hydrochloride Tablets IP 2mg | 2402Mfg 2025-03 · Exp 2027-02 | Abil Healthcare 311Madhya Pradesh | Failed AssayAssay | DTL, PuducherryState lab | Jun 2026 |
| Ofloxacin 100mg, Ornidazole 2500mg & Loperamide 7.5mg Bolus IP | DF-1677Mfg 2025-09 · Exp 2027-08 | DUTCH FORMULATIONS 32Himachal Pradesh | Assay of Ofloxacin, Ornidazole & LoperamideAssay | CFDL JammuState lab | Apr 2026 |
| Loperamide Hydrochloride Tablets IP 2mg | GTE1588Mfg 2025-05 · Exp 2027-04 | Gidsha PharmaceuticalsGujarat | Misbranded-Incorrect LabellingMisbranded | DTL, PuducherryState lab | Apr 2026 |
| Loperamide Hydrochloride Capsules I.P | C-2127Mfg 2024-12 · Exp 2026-11 | Supercure Biotech Pvt. LtdHaryana | Dissolution TestDissolution | DTL, Bengaluru, KarnatakaState lab | Apr 2026 |
| Loperamide Hydrochloride Tablets IP 2 mg | T50022Mfg 2025-01 · Exp 2026-12 | Zenith Drugs Ltd.72/5 and 72/3Madhya Pradesh | The sample does not comply as per I.P. 2022 with respect to the test for Dissolution of Loperamide Hydrochloride.Dissolution | RDTL, GuwahatiCDSCO lab | Feb 2026 |
| Loperamide Hydrochloride Tablets IP 2 MG (Lomorex Tablets) | CT-7350Mfg 2024-04 · Exp 2027-03 | Chemetac Pharmaceuticals 42 Maina PurUttar Pradesh | The sample does not comply as per I.P. 2022 with respect to the test for "Dissolution" of Loperamide Hydrochloride.Dissolution | RDTL, GuwahatiCDSCO lab | Oct 2025 |
| Loperamide HCI Tablet IP (KARLOP) | T-17075Mfg 2025-04 · Exp 2027-03 | Karnani Pharmaceuticals(P) Ltd. 38Uttarakhand | The sample does not conform to the IP with respect to AssayAssay | DTL, JaipurState lab | Oct 2025 |
| Loperamide Hydrochloride Capsules IP 2 mg | 7645Mfg 2025-03 · Exp 2027-02 | R.P. Biotech Pvt. Ltd. 61Punjab | sample does not conform to claim as per IP 2022 in respect to the Test of DissolutionDissolution | RDTL, ChandigarhCDSCO lab | Sep 2025 |
| Loperamide Hydrochloride Tablets IP (JKMSCL Hospital Supply) | T-16201Mfg 2024-05 · Exp 2026-04 | Karnani Pharmaceuticals Pvt. LtdUttarakhand | The sample does not conform to IP with respect to the test for Dissolution & AssayAssay | Drug Testing Laboratory Srinagar (J&K) vide report on Form 13 bearing No. L/DA/2024-25/1311 Dated: 27.09.2024. (Report attached as Annexure C)State lab | Sep 2024 |
| Loperamide Hydrochloride Tablets I.P. 2 mg (LOMJAN) | L-2401Mfg 2024-01 · Exp 2025-12 | Arya PharmaceuticalsMadhya Pradesh | Dissolution and Assay/ Content of Loperamide Hydrochloride and DescriptionAssay | RDTL GuwahatiCDSCO lab | Sep 2024 |
| Loperamide Hydrochloride Tablets IP (DYRIA STOP TABLETS) | DY?2214Mfg 2023-02 · Exp 2025-01 | Cyper PharmaHimachal Pradesh | Dissolution of Loperamide HydrochlorideDissolution | RDTL ChandigarhState lab | May 2023 |
| Lomolok (Loperamide Hydrochloride Tablets I.P.) | T8842Mfg 2021-07 · Exp 2024-06 | Quest Laboratories Pvt. LtdMadhya Pradesh | AssayAssay | RDTL GuwahatiState lab | Dec 2022 |
| Loperamide Hydrochloride Tablets IP 2 mg. (LOMOCARE) | LCT-2009Mfg 2020-09 · Exp 2022-04 | Suprex LaboratoriesMadhya Pradesh | DissolutionDissolution | RDTL GuwahatiState lab | Sep 2021 |
| SESTIL - AD (Loperamide Hydrochloride Dispersible Tablets) | CST-75Mfg 2020-07 · Exp 2023-06 | Coastal Medicare Pvt. LtdAndhra Pradesh | AssayAssay | CDL KolkataCDSCO lab | Jun 2021 |
| Loperamide Hydrochloride Tablets IP (LOPSOL TABLETS) | BT-391Mfg 2018-08 · Exp 2020-07 | Boffin Biotech Pvt. LtdHimachal Pradesh | DissolutionDissolution | RDTL ChandigarhState lab | May 2019 |
Official sources and primary records
- Regulator
- CDSCO: List of prohibited FDC drugs, 156 FDCs dated 02.08.2024RegulatorCDSCO · 2 August 2024
- Regulator