Ingredient record · Diabetes medicine
Pioglitazone: 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
28 entries containing Pioglitazone are on India's banned-drugs list, and 10 are banned today. 10 batches of medicines containing Pioglitazone failed a government lab test between June 2020 and March 2026, from 10 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
10
Banned combinations in force
18
Other listed orders (stayed, restricted, quashed)
10
Batches failed a lab test
Mar 2026
Latest lab alert
Is it banned? Our answer pages
Ban revoked
On the banned-drugs list
Pioglitazone itself appears on the list as a single drug, see the entries marked "Single molecule" below. Status follows CDSCO's own notes on each entry.
| Drug / combination | Action | Notification | Date | Order | Status note |
|---|---|---|---|---|---|
| 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#). |
| Pioglitazone 30mg + Metformin 500mgFixed-dose combination · diabetes | Quashed | S.O. 4479(E) | 7 September 2018 | 328 FDCs · Sep 2018 | Quashed by Delhi HC order dated 22.02.2019; 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 |
| Pioglitazone 7.5/7.5mg + Metformin 500/1000mgFixed-dose combination · diabetes | Banned | S.O. 4470(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 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 |
| Voglibose + Pioglitazone + MetforminFixed-dose combination · diabetes | Banned | S.O. 4476(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., being verifiedunder verification | 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 |
| Pioglitazone 15mg + Metformin 850mgFixed-dose combination · diabetes | Banned | S.O. 4481(E) | 7 September 2018 | 328 FDCs · Sep 2018 | 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 (SR) 500mg + Pioglitazone5mgFixed-dose combination · diabetes | Banned | S.O. 4487(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 |
| Pioglitazone 7.5/7.5mg + Metformin 500/1000mgFixed-dose combination · diabetes | Quashed | S.O. 805(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 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 |
| Voglibose + Pioglitazone + MetforminFixed-dose combination · diabetes | Quashed | S.O. 811(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Pioglitazone 30 mg + Metformin 500mgFixed-dose combination · diabetes | Quashed | S.O. 814(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 |
| Pioglitazone 15mg + Metformin 850 mgFixed-dose combination · diabetes | Quashed | S.O. 817(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Glibenclamide + Metformin (SR) + PioglitazoneFixed-dose combination · diabetes | Quashed | S.O. 822(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 |
| Metformin (SR) 500mg + Pioglitazone 5mgFixed-dose combination · diabetes | Quashed | S.O. 824(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Pioglitazone and All Formulations containing Pioglitazone for Human UseSingle molecule · diabetes | Ban revoked | GSR 379(E) | 18 June 2013 | Classic bans | Suspension vide GSR 379(E) 18.06.2013 revoked vide GSR 520(E) dated 31.07.2013, allowing use with conditions (boxed warning; not first-line therapy). |
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 |
|---|---|---|---|
| Pioglitazone Hydrochloride | 4 | 4 | Mar 2026 |
| Glimepiride Pioglitazone Metformin | 3 | 3 | Oct 2025 |
| Glimepiride Pioglitazone Hydrochloride Metformin | 1 | 1 | Nov 2025 |
| Glimepride Pioglitazone Hydrochloride Metformin | 1 | 1 | Nov 2024 |
| Pioglitazone Metformin Hydrochloride | 1 | 1 | Jun 2020 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Pioglitazone Hydrochloride Tablets IP | GT27476AMfg 2025-08 · Exp 2027-07 | J.M. LaboratoriesHimachal Pradesh | Test for DissolutionDissolution | DTL, Bengaluru, KarnatakaState lab | Mar 2026 |
| Glimepiride, Pioglitazone Hydrochloride and Metformin Hydrochloride Sustained-release Tablets (2mg/15mg/500mg) | GMPT-1050Mfg 2024-01 · Exp 2025-12 | Wings Biotech LLPHimachal Pradesh | Assay for Glimepiride" onlyAssay | RDTL, Hubli, KarnatakaState lab | Nov 2025 |
| Glimepiride, Pioglitazone & Metformin (Extended Release) Tablets (AXYLIM-PM 1 Tablets) | 424-73Mfg 2024-01 · Exp 2026-06 | Zee Laboratories 47Himachal Pradesh | The sample does not conform to claim as per Manufacturer Specification with respect to the test for "Assay" of Pioglitazone Hydrochloride equivalent to Pioglitazone.Assay | RDTL, GuwahatiCDSCO lab | Oct 2025 |
| Pioglitazone Hydrochloride Tablets IP (Biodib-15) | SPA250363Mfg 2025-02 · Exp 2027-01 | Skymap Pharmaceuticals Pvt Ltd. B-3Uttarakhand | Dissolution test for PioglitazoneDissolution | KarnatakaState lab | Jul 2025 |
| Pioglitazone Hydrochloride Tablets (GLITO 15) | D40292Mfg 2024-05 · Exp 2027-04 | Medley Pharmaceuticals LtdDaman & Diu | "Dissolution"Dissolution | CDTL MumbaiCDSCO lab | Apr 2025 |
| PIOGLITAZONE 15, GLIMEPIRIDE 2mg+ METFORMIN 500 mg (Lanzpride- PM2) | SP/T/74 3Mfg ? · Exp ? | Signoret Pharmaceuticals Pvt.Ltd | For the received sample PIOGLITAZONE 15, GLIMEPIRIDE 2mg+ METFORMIN 500 mg (Lanzpride-PM2), 1. The label is mentioned as ?Approved colour used? but common name of the permitted colour used in the formulation as prescribed under rule 127(2) of the Drugs Rules,1945 was not mentioned. 2.For the received sample PIOGLITAZONE 15, GLIMEPIRIDE 2mg+ METFORMIN 500 mg (Lanzpride-PM2), On visual inspection pink coloured spots were observed on other side (white colour) of the tablets .-MisbrandedMisbranded | PuducherryState lab | Feb 2025 |
| Glimepride, Pioglitazone Hydrochloride & Metformin Hydrochloride (Extended Release) Tablets (OZOMET-PG 2 ) | BE32456Mfg 2024-05 · Exp 2026-04 | Ozone Pharmaceuticals LtdHimachal Pradesh | Assay of PioglitazoneAssay | CDL KolkataCDSCO lab | Nov 2024 |
| Glimepiride, Pioglitazone and Metformin (PR) Tablets (GLEM- GMP2 Tablets) | MPT-22149Mfg 2022-09 · Exp 2024-08 | Magnatek EnterprisesHimachal Pradesh | Identification and Assay of Pioglitazone Hydrochloride calculated as PioglitazoneAssay | RDTL ChandigarhState lab | Jan 2024 |
| Pioglitazone Hydrochloride Tablets IP 30 mg | GM21077Mfg 2021-08 · Exp 2023-07 | Skymap Pharmaceuticals Pvt. LtdUttarakhand | DissolutionDissolution | CDTL KolkataCDSCO lab | Mar 2023 |
| Pioglitazone & Metformin Hydrochloride (Prolonged Release) Tablets | CT9620Mfg 2019-08 · Exp 2022-01 | Cian Healthcare LtdUttarakhand | Dissolution of Metformin HydrochlorideDissolution | 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.