Ingredient record · Diabetes medicine (sulfonylurea)
Gliclazide: 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
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.
7
Banned combinations in force
6
Other listed orders (stayed, restricted, quashed)
4
Batches failed a lab test
Jul 2026
Latest lab alert
Is it banned? Our answer pages
Banned since 11 Jun 2026
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 | T511617Mfg 2025-11 · Exp 2027-10 | 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 | 475TGC002Mfg 2026-01 · Exp 2027-12 | Swiss Garnier Life SciencesHimachal Pradesh | ContentOther | DTL, Madurai-19State lab | May 2026 |
| GLICLAZIDE TABLETS IP 40 mg | CHT-3850Mfg 2023-08 · Exp 2025-07 | Cotec Healthcare Pvt. LtdUttarakhand | Assay & Related substances of GliciazideAssay | CDL KolkataCDSCO lab | Nov 2023 |
| Glicot -60 (Gliclazide Extended release Tablets 60 mg) | MT190903Mfg 2019-07 · Exp 2021-06 | 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.