Ingredient record · Diabetes medicine (sulfonylurea)
Gliclazide: 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
13 entries containing Gliclazide are on India's banned-drugs list, and 7 are banned today. 4 batches of medicines containing Gliclazide failed a government lab test between June 2020 and July 2026, from 4 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
Banned Is Gliclazide banned in India? Banned since 11 Jun 2026. Read the full status record
Is it banned? Our answer pages
On the banned-drugs list
Gliclazide 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 |
|---|---|---|---|---|---|
| Gliclazide + Chromium PicolinateFixed-dose combination · diabetes | Banned | S.O. 3080(E) | 11 June 2026 | 16 FDCs · Jun 2026 | Prohibited under s.26A with immediate effect, 11.06.2026 (CDSCO list published 21.07.2026). |
| Gliclazide 80mg + Metformin 325 mgFixed-dose combination · diabetes | Banned | S.O. 4468(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Metformin 500mg/500mg + Gliclazide SR30mg/60mg + Pioglitazone7.5mg/7.5mgFixed-dose combination · diabetes | Banned | S.O. 4475(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Metformin ER + Gliclazide MR + VogliboseFixed-dose combination · diabetes | Banned | S.O. 4482(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Metformin Hydrochlopride + Gliclazide + Piogllitazone + Chromium PolynicotinateFixed-dose combination · diabetes | Banned | S.O. 4484(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Metformin + Gliclazide + Chromium PolynicotinateFixed-dose combination · diabetes | Banned | S.O. 4485(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Gliclazide 40mg + Metformin 400mgFixed-dose combination · diabetes | Banned | S.O. 4682(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Gliclazide 80 mg + Metformin 325 mgFixed-dose combination · diabetes | Quashed | S.O. 803(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Metformin 500mg/500mg + Gliclazide SR 30mg/60mg + Pioglitazone 7.5mg/7.5mgFixed-dose combination · diabetes | Quashed | S.O. 810(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Metformin ER + Gliclazidemr + VogliboseFixed-dose combination · diabetes | Quashed | S.O. 818(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Metformin Hydrochlopride + Gliclazide + Piogllitazone + Chromium PolynicotinateFixed-dose combination · diabetes | Quashed | S.O. 820(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Metformin + Gliclazide + Chromium PolynicotinateFixed-dose combination · diabetes | Quashed | S.O. 821(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Gliclazide 40mg + Metformin 400mgFixed-dose combination · diabetes | Quashed | S.O. 1029(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 |
|---|---|---|---|
| Gliclazide | 2 | 2 | Jul 2026 |
| Gliclazide Metformin Hydrochloride | 1 | 1 | May 2026 |
| Glicot | 1 | 1 | Jun 2020 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Gliclazide Extended release Tablets 60 mg | Batch T511617Mfg Nov 2025 · Exp Oct 2027 | ION Healthcare Pvt. Ltd.Baddi- Barotiwala Road Baddi Distt. Solan (H.P) 173205Himachal Pradesh | test for Dissolution for Gliclazide at 4th hour and 12th hour as per Manufacturer's methodDissolution | RDTL. Bellary KarnatakaState lab | Jul 2026 |
| Gliclazide & Metformin hydrochloride sustained release tablets | Batch 475TGC002Mfg Jan 2026 · Exp Dec 2027 | Swiss Garnier Life SciencesHimachal Pradesh | ContentOther | DTL, Madurai-19State lab | May 2026 |
| GLICLAZIDE TABLETS IP 40 mg | Batch CHT-3850Mfg Aug 2023 · Exp Jul 2025 | Cotec Healthcare Pvt. LtdUttarakhand | Assay & Related substances of GliciazideAssay | CDL KolkataCDSCO lab | Nov 2023 |
| Glicot -60 (Gliclazide Extended release Tablets 60 mg) | Batch MT190903Mfg Jul 2019 · Exp Jun 2021 | Mascot Health Series Pvt. LtdUttarakhand | DissolutionDissolution | CDL KolkataCDSCO lab | Jun 2020 |
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.