Regulatory status record
Is Loperamide (Imodium) banned in India?
Last checked 1 October 2026
Loperamide is not banned in India as of 1 Oct 2026; it is sold on prescription for adults, and labels contraindicate it in young children.
- 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; label contraindication in young children
- Evidence
- Government document
- Latest action
- 2 August 2024
- Last checked
- 1 October 2026
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 Always check the linked government document for the current position, and tell us if something is out of date.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; no Gazette restriction found
- 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. India has not issued a specific Gazette restriction on loperamide in children that we can find. 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. That contraindication rests on the product label rather than on a Gazette notification.
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
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) |
Ingredient records
Every banned combination and failed batch containing each ingredient.
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 |
|---|---|---|---|---|---|
| Metronidazole, Furazolidone & Loperamide HCL Bolus (Vet) | Batch WT-002Mfg Mar 2025 · Exp Feb 2027 | Therawin FormulationsHaryana | Test for Disintegration onlyDisintegration | RDTL, Hubli, KarnatakaState lab | Sep 2026 |
| Loperamide Hydrochloride Tablets IP 2 mg- | Batch SBT-3269Mfg Jul 2025 · Exp Jun 2027 | Supercure Biotech Pvt. LtdHaryana | Sample does not conform to IP standards. This particular batch of sample fails in the tests'dissolution and assay of Loperamide Hydrochloride.Assay | RDTL , ErnakulamState lab | Sep 2026 |
| Loperamide Hydrochloride Tablets IP 2 mg | Batch LOF-26002Mfg Apr 2026 · Exp Mar 2029 | Okvik Pharma Pvt. LtdHaryana | The sample does not conform to IP in respect of Assay & DissolutionAssay | LUCKNOW, Uttar PradeshState lab | Sep 2026 |
| Loperamide Hydrochloride Tablets IP 2 mg | Batch LOP-25014Mfg Feb 2026 · Exp Jan 2029 | Okvik Pharma Pvt. LtdHaryana | The sample does not conform to I. P. in respect of Assay. (Content of Loperamide Hydrochloride)Assay | Gorakhpur, Uttar PradeshState lab | Sep 2026 |
| Loperamide Hydrochloride Tablets IP 2 mg | Batch SBT3269Mfg Jul 2025 · Exp Jun 2027 | Supercure Biotech Pvt. LtdHaryana | Dissolution and Assay of Loperamide HydrochlorideAssay | RDTL, EKMState lab | Aug 2026 |
| Loperamide Hydrochloride Tablets I.P | Batch IGT-0484Mfg Nov 2024 · Exp Oct 2027 | IG Pharma LtdUttarakhand | DescriptionDescription | RDTL, Hubli, KarnatakaState lab | Aug 2026 |
| Loperamide Hydrochloride Tablets IP 2mg | Batch 2402Mfg Mar 2025 · Exp Feb 2027 | Abil Healthcare 311Madhya Pradesh | Failed AssayAssay | DTL, PuducherryState lab | Jun 2026 |
| Ofloxacin 100mg, Ornidazole 2500mg & Loperamide 7.5mg Bolus IP | Batch DF-1677Mfg Sep 2025 · Exp Aug 2027 | Dutch Formulations 32Himachal Pradesh | Assay of Ofloxacin, Ornidazole & LoperamideAssay | CFDL JammuState lab | Apr 2026 |
| Loperamide Hydrochloride Tablets IP 2mg | Batch GTE1588Mfg May 2025 · Exp Apr 2027 | Gidsha PharmaceuticalsGujarat | Misbranded-Incorrect LabellingMisbranded | DTL, PuducherryState lab | Apr 2026 |
| Loperamide Hydrochloride Capsules I.P | Batch C-2127Mfg Dec 2024 · Exp Nov 2026 | Supercure Biotech Pvt. LtdHaryana | Dissolution TestDissolution | DTL, Bengaluru, KarnatakaState lab | Apr 2026 |
| Loperamide Hydrochloride Tablets IP 2 mg | Batch T50022Mfg Jan 2025 · Exp Dec 2026 | Zenith Drugs Ltd. 72/5 & 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) | Batch CT-7350Mfg Apr 2024 · Exp Mar 2027 | 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) | Batch T-17075Mfg Apr 2025 · Exp Mar 2027 | 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 | Batch 7645Mfg Mar 2025 · Exp Feb 2027 | 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) | Batch T-16201Mfg May 2024 · Exp Apr 2026 | 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 |
Sources
- Regulator
- CDSCO: List of prohibited FDC drugs, 156 FDCs dated 02.08.2024RegulatorCDSCO · 2 August 2024
- Regulator