Ingredient record · Diabetes medicine (sulfonylurea)
Glimepiride: bans, restrictions and failed batches in India
Last checked 3 November 2026. Sources: CDSCO banned-drugs notifications and monthly NSQ alerts, Jan 2019 to Sep 2026
19 entries containing Glimepiride are on India's banned-drugs list, and 6 are banned today. 102 batches of medicines containing Glimepiride failed a government lab test between January 2019 and September 2026, from 67 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
6
Banned combinations in force
13
Other listed orders (stayed, restricted, quashed)
102
Batches failed a lab test
Sep 2026
Latest lab alert
Is it banned? Our answer pages
Not banned · some combos halted (2025)
On the banned-drugs list
Glimepiride 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 |
|---|---|---|---|---|---|
| Metformin Hydrochloride 500mg (Extended Release) + Glimepiride 3mg + Dapagliflozin 10mg Film Coated Bilayered TabletsFixed-dose combination · diabetes | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 3 | 11 April 2025 | 35 FDCs · Apr 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Glimepiride 1mg + Metformin HCl 500mg TabletFixed-dose combination · diabetes | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 29 | 11 April 2025 | 35 FDCs · Apr 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Glimepiride 2mg + Metformin Hydrochloride (Sustained Release) 500mg + Voglibose 0.3mg TabletFixed-dose combination · diabetes | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 30 | 11 April 2025 | 35 FDCs · Apr 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Glimepiride1mg/2mg/3mg + Pioglitazone15mg/15mg/15mg + Metformin1000mg/1000mg/1000mgFixed-dose combination · diabetes | Quashed | S.O. 4471(E) | 7 September 2018 | 328 FDCs · Sep 2018 | Quashed by Delhi HC order dated 13.02.2019; CDSCO appealed, sub judice (CDSCO list as on 22.11.2021, note 5#). |
| Glimepiride 1mg/2mg + Pioglitazone 15mg/15mg + Metformin 850mg/850mgFixed-dose combination · diabetes | Quashed | S.O. 4472(E) | 7 September 2018 | 328 FDCs · Sep 2018 | Quashed by Delhi HC order dated 13.02.2019; CDSCO appealed, sub judice (CDSCO list as on 22.11.2021, note 5#). |
| Metformin 1000/1000/500/500mg + Pioglitazone 7.5/7.5/7.5/7.5mg + Glimepiride 1/2/1/2mgFixed-dose combination · diabetes | Banned | S.O. 4467(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Metformin 850mg + Pioglitazone 7.5mg + Glimepiride 2mgFixed-dose combination · diabetes | Banned | S.O. 4473(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Metformin 850mg + Pioglitazone 7.5mg + Glimepiride1mgFixed-dose combination · diabetes | Banned | S.O. 4474(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Metformin + Glimepiride + MethylcobalaminFixed-dose combination · diabetes | Banned | S.O. 4478(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Glimepiride + Pioglitazone + MetforminFixed-dose combination · diabetes | Banned | S.O. 815(E) as printed (2016 number repeated in the 2018 block of the CDSCO list), 2018 S.O. number not confirmed | 7 September 2018 | 328 FDCs · Sep 2018 | Listed in the 07.09.2018 block of the CDSCO list as on 22.11.2021 but printed with its 10.03.2016 notification number; the 2018 S.O. number (possibly the unlisted S.O. 4616(E)) must be VERIFIED against the Gazette. In force per CDSCO list as on 22.11.2021 |
| Metformin (Sustained Release) 500mg + Pioglitazone15mg + Glimepiride 3mgFixed-dose combination · diabetes | Banned | S.O. 4486(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Metformin 1000/1000/500/500mg + Pioglitazone 7.5/7.5/7.5/7.5mg + Glimepiride 1/2/1/2mgFixed-dose combination · diabetes | Quashed | S.O. 802(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Glimepiride 1mg/2mg/3mg + Pioglitazone 15mg/15mg/15mg + Metformin 1000mg/1000mg/1000mgFixed-dose combination · diabetes | Quashed | S.O. 806(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Glimepiride 1mg/2mg + Pioglitazone 15mg/15mg + Metformin 850mg/850mgFixed-dose combination · diabetes | Quashed | S.O. 807(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Metformin 850mg + Pioglitazone 7.5 mg + Glimepiride 2mgFixed-dose combination · diabetes | Quashed | S.O. 808(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Metformin 850mg + Pioglitazone 7.5 mg + Glimepiride 1mgFixed-dose combination · diabetes | Quashed | S.O. 809(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Metformin + Glimepiride + MethylcobalaminFixed-dose combination · diabetes | Quashed | S.O. 813(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Glimepiride + Pioglitazone + MetforminFixed-dose combination · diabetes | Quashed | S.O. 815(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Metformin (Sustained Release) 500mg + Pioglitazone 15 mg + Glimepiride 3mgFixed-dose combination · diabetes | Quashed | S.O. 823(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.
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Glimepiride, Voglibose & Metformin HCL SR Tablets | Batch OT-250933Mfg Aug 2025 · Exp Jul 2027 | Orchid Biotech LtdDelhi | Assay of GlimepirideAssay | SDTL, Andhra Pradesh, VijayawadaState lab | Sep 2026 |
| Glimepiride Tablets IP 1mg | Batch M25799027Mfg Oct 2025 · Exp Sep 2027 | Dr.Miltons Laboratories Private LimitedPuducherry | DissolutionDissolution | DTL, Chennai-06State lab | Aug 2026 |
| Metformin Hydrochloride Prolonged-Released and Glimepiride Tablets IP | Batch 60002727Mfg Mar 2026 · Exp Feb 2028 | USV Private LimitedGujarat | The sample does not conform to claim as per Manufacture's Specification with respect to the test for Dissolution of Metformin Hydrochloride.Dissolution | CDTL, IndoreCDSCO lab | Jul 2026 |
| Glimepiride, Ploglitazonehci & Metformin HCI (SR) Tablets | Batch DPT-016Mfg Apr 2025 · Exp Mar 2027 | Demexico Pharmaceuticals Pvt. LtdUttarakhand | The sample has been declared as NSQ as it does not conform to label claim with respect to Assay for Metformin Hydrochloride and PioglitazoneAssay | RDTL. Bellary KarnatakaState lab | Jul 2026 |
| Glimepiride Tablets IP 4mg | Batch T2512152Mfg Dec 2025 · Exp Nov 2027 | Rivpra Formulation Pvt. LtdUttarakhand | Does not conform to IP Standards with respect to Dissolution TestDissolution | Food & Drugs Laboratory Bambolim, GoaState lab | Jul 2026 |
| Glimepiride Tablets IP 2mg | Batch CHPLT1027Mfg Dec 2025 · Exp Nov 2027 | Cureza Healthcare Pvt. LtdMadhya Pradesh | The Sample does not Comply with IP Requirements for the Dissolution Test.Dissolution | FDAL, Chhatrapati SambhajinagarState lab | Jul 2026 |
| Glimepiride Tablets IP 1mg | Batch GTA-2501Mfg Jan 2025 · Exp Jan 2027 | Apple Formulations Pvt. LtdUttarakhand | The sample does not conform to standard quality in respect of the test for ?Description? performed.Description | SDTL, Tripura, AgartalaState lab | Jul 2026 |
| Glimepiride Tablets IP | Batch 5GAC030Mfg Dec 2025 · Exp Nov 2028 | Sanofi India LimitedGoa | DissolutionDissolution | Lucknow LabState lab | Jul 2026 |
| Metformin Hydrochloride Prolonged Release and Glimepiride Tablets IP (500mg/2mg) | Batch PRT-250229Mfg Feb 2025 · Exp Jan 2027 | Preet Remedies LtdHimachal Pradesh | DescriptionDescription | DTL, Bengaluru, KarnatakaState lab | Jun 2026 |
| Glimepiride Tablets IP 1mg | Batch M25799027Mfg Oct 2025 · Exp Sep 2027 | Dr.Miltons Laboratories Private LimitedPuducherry | DissolutionDissolution | DTL, Chennai-06State lab | Jun 2026 |
| Glimepiride Tablets IP 1mg | Batch M25799030Mfg Nov 2025 · Exp Oct 2027 | Dr.Miltons Laboratories Private LimitedPuducherry | DissolutionDissolution | DTL, Chennai-06State lab | Jun 2026 |
| Voglibose, Glimepiride & Metformin HCl (SR) Tablets). | Batch TPT26010Mfg Jan 2026 · Exp Dec 2027 | Taj Pharma India LtdGujarat | Description: one out of 20 tablets blue layer half broken found. & Assay of Glimepiride IP- less than Prescribed limitAssay | SDTL, UttarakhandState lab | May 2026 |
| Metformin Hydrochloride & Glimepiride Tablets (GLIMAFF-2 Tablets | Batch GVGT1138Mfg Oct 2025 · Exp Sep 2027 | Voizmed Pharma Pvt. LtdHimachal Pradesh | AssayAssay | RDTL, Bellary, KarnatakaState lab | May 2026 |
| Metformin HCl I.P. (as Prolonged Release Form & Glimepiride I.P | Batch TPT26008Mfg Jan 2026 · Exp Dec 2027 | Taj Pharma India LtdGujarat | Assay of Glimepiride IP- less than Prescribed limitAssay | SDTL, UttarakhandState lab | May 2026 |
| Metformin Hydrochloride Prolonged Release and Glimepiride Tablets IP | Batch T5107Mfg Jul 2025 · Exp Jun 2027 | Merril Pharma Pvt. LtdGujarat | The sample does not conform to IP with respect to the Test of Dissolution for Glimepiride.Dissolution | CDL, KolkataCDSCO lab | Apr 2026 |
Showing 15 of 102 records
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.