Ingredient record · Antispasmodic for stomach cramps
Drotaverine: bans, restrictions and failed batches in India
Last checked 20 September 2026. Sources: CDSCO banned-drugs notifications and monthly NSQ alerts, Jan 2019 to Jul 2026
4 entries containing Drotaverine are on India's banned-drugs list, and 3 are banned today. 11 batches of medicines containing Drotaverine failed a government lab test between June 2019 and July 2026, from 11 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
3
Banned combinations in force
1
Other listed orders (stayed, restricted, quashed)
11
Batches failed a lab test
Jul 2026
Latest lab alert
Is it banned? Our answer pages
Not banned · 3-drug version halted
On the banned-drugs list
Drotaverine on its own is not on CDSCO's banned list. The entries below are specific combinations that contain it. Status follows CDSCO's own notes on each entry.
| Drug / combination | Action | Notification | Date | Order | Status note |
|---|---|---|---|---|---|
| Drotaverine + OmeprazoleFixed-dose combination · gi | Banned | S.O. 223(E) | 11 January 2019 | Other orders | 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 + DrotaverineFixed-dose combination · gi | Banned | S.O. 251(E) | 11 January 2019 | Other orders | 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. |
| Drotaverine + Clidinium + ChlordiazepoxideFixed-dose combination · gi | Banned | S.O. 4461(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Drotaverine + Clidinium + ChlordiazepoxideFixed-dose combination · gi | Quashed | S.O. 794(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
Products that failed lab tests
Product names as printed by the testing labs, grouped. Open a product to see every batch number.
| Product | Batches | Makers | Latest |
|---|---|---|---|
| Drotaverine Hydrochloride | 5 | 5 | May 2026 |
| Drotaverine Hydrochloride Mefenamic Acid | 2 | 2 | Jun 2026 |
| Drotaverine Hydrochloride Diclofenac Potassium | 1 | 1 | Jul 2026 |
| Drotaverine Hcl Ped Ds | 1 | 1 | Dec 2025 |
| Drotaverine Hydrochloride Dratovis | 1 | 1 | Feb 2025 |
| Aceclofenac Drotaverine Hydrochlori De / | 1 | 1 | Jan 2025 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Drotaverine Hydrochloride & Diclofenac Potassium Tablets | KFCR6023Mfg 2026-03 · Exp 2028-02 | Cris Pharma (India) Ltd. E-11Uttarakhand | Identification - Doesn't conforms to I.P.Identification | Lucknow LabState lab | Jul 2026 |
| Drotaverine Hydrochloride & Mefenamic Acid Tablets | DMR-504Mfg 2026-01 · Exp 2027-12 | Healer's Lab Unit IIHimachal Pradesh | The sample does not conforms to the claim with respect to description as it show physical instability in the form of Mottling.Description | DTL, UdaipurState lab | Jun 2026 |
| Drotaverine HCL Suspension | L-25244Mfg 2025-10 · Exp 2027-09 | Daffohils Laboratories Pvt. LtdUttarakhand | ContentOther | DTL, Chennai-06State lab | May 2026 |
| Drotaverine Hydrochloride Suspension | OL25619Mfg 2025-11 · Exp 2027-10 | Devbhoomi PharmaceuticalsUttarakhand | That the sample received does not conform to Manufactureres specification with respect to the test for Assay of Drotaverine HydrochlorideAssay | CDTL, MumbaiCDSCO lab | Feb 2026 |
| Drotaverine Hydrochloride Suspension | A20718Mfg 2025-04 · Exp 2027-03 | Aspen Lifescieces PvtPunjab | ContentOther | DTL, Madurai-19State lab | Feb 2026 |
| Drotaverine HCl Suspension PED-DS suspension 60ml | L-250901Mfg 2025-09 · Exp 2030-08 | Dr. Pal'S Pharmaceuticals 10B-1Uttarakhand | The sample does not conform to claim with respect to The test for Microbial contamination (Total Aerobic Viable Count and Total Fungal Count).Microbial limits | CDTL, MumbaiCDSCO lab | Dec 2025 |
| Drotaverine Hydrochloride & Mefenamic Acid Tablets (SPASMIC) | UT6035Mfg 2024-05 · Exp 2027-04 | Uttaranchal Pharmaceuticals Pvt Ltd. Kh No. 673Uttarakhand | The Sample does not conform to the claim with respect to colour presence of Quinoline Yellow in place of Erythrosine on label claimLabelling | DTL, JaipurState lab | Oct 2025 |
| Drotaverine Hydrochloride Tablets 40 mg. (Dratovis-40 ) | 12680Mfg 2024-01 · Exp 2026-12 | Syncom Formulations (India) LtdMadhya Pradesh | Assay of Drotaverine HydrochlorideAssay | CDL KolkataCDSCO lab | Feb 2025 |
| Aceclofenac & Drotaverine Hydrochlori de Tablets (100 mg/ 80 mg) | PRT2401 -01Mfg 2024-01 · Exp 2025-12 | Regent Ajanta BiotechUttarakhand | DescriptionDescription | State Lab KarnatakaState lab | Jan 2025 |
| DROTAVERINE HYDROCHLORIDE IP | DTV/170/2021Mfg 2021-10 · Exp 2026-09 | Punjab Chemical & Crop Protection LtdPunjab | Loss on DryingLoss on drying | RDTL ChandigarhCDSCO lab | Dec 2021 |
| Drotaverine Hydrochloride Injection | DTB-003Mfg 2017-10 · Exp 2019-09 | Radico RemediesHimachal Pradesh | Description & Particulate MatterDescription | CDL KolkataCDSCO lab | Jun 2019 |
Holding a strip or bottle? The batch number is printed after "B. No." Check it against every alert. If it matches, return it to the pharmacy. What the labels mean: status guide.