Regulatory status record
Is Pioglitazone banned in India?
Last checked 19 September 2026. A few details are still being checked against the original document.
Pioglitazone is not banned in India as of 19 Sep 2026; its suspension under GSR 379(E) of 18 Jun 2013 was revoked in July 2013 with a mandatory boxed warning, while some pioglitazone triple combinations remain sub judice.
- Classification
- Cleared after review or testing
- Decided by
- CDSCO / Ministry of Health and Family Welfare
- Reference
- GSR 379(E), 18 Jun 2013 (suspension); revocation Jul 2013 (GSR number and date:, being verified
- Latest action
- 7 September 2018
- Last checked
- 19 September 2026details being verified
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CDSCO: Gazette notifications index
Scope. A record here does not by itself mean a product or company is unsafe or banned today. Regulatory actions can apply to one batch, one formulation, one period or one state. Always check the linked government document for the current position, and tell us if something is out of date. How we label records.
Below: Blacklisted's explanationWe organise and explain what the document says. The document above is the authority.
Key facts
- Governing authority
- CDSCO, Ministry of Health and Family Welfare
- Suspension
- GSR 379(E), 18 Jun 2013, same day as analgin and Deanxit
- Revocation
- July 2013, with boxed warning on bladder cancer and a requirement not to use as first-line (being verified)
- Triple FDCs
- Glimepiride + pioglitazone + metformin; pioglitazone 30 + metformin 500. S.O. 4471/4472/4479(E), 7 Sep 2018; quashed by Delhi HC, appealed
- Common brands
- Pioz, Pioglit, Piosafe; combinations Pioz-MF, Glimestar-PM
Pioglitazone is an oral diabetes drug whose Indian history is compressed into a few weeks of 2013, which is why searches still ask whether it is banned.
On 18 June 2013 the Health Ministry suspended its manufacture and sale under GSR 379(E), citing a signal for bladder cancer that had led France and Germany to withdraw the drug. The same notification round suspended analgin and the flupentixol + melitracen antidepressant. Diabetologists objected that pioglitazone was inexpensive, effective and used by millions, and that the cancer signal was small. The Drugs Technical Advisory Board reviewed the evidence, and in July 2013 the government revoked the suspension, attaching a boxed warning about bladder cancer and a condition that the drug not be used as first-line treatment. Deccan Herald reported both revocations. The number and exact date of the revocation notification are flagged for verification.
Single-ingredient pioglitazone has been legal since then and is sold as Pioz, Pioglit and others.
Some combinations have a separate history. The 328-FDC notification of 7 September 2018 banned glimepiride + pioglitazone + metformin and pioglitazone 30 mg + metformin 500 mg under S.O. 4471(E), 4472(E) and 4479(E). The Delhi High Court quashed those entries, and the CDSCO's appeal is pending, so those products are on sale pending a decision. Patients on any pioglitazone product should discuss the bladder-cancer warning with their doctor rather than stop treatment.
What this means for you
Single-ingredient pioglitazone is legal
It carries a boxed warning; your doctor should have weighed the bladder-cancer risk before prescribing.
Do not change diabetes medication on your own
If you are on a pioglitazone combination, ask your doctor which product you have and whether it is affected.
Report blood in urine
That symptom is the reason for the warning and should be checked promptly.
This is a record of official orders, not medical advice. Do not stop a prescribed medicine without asking your doctor or pharmacist.
Common questions
Why was pioglitazone banned in India?
A bladder-cancer signal led to a suspension in June 2013. It was revoked within weeks with a boxed warning after expert review.
Entries on the banned drugs list
| Drug / combination | Action | Notification | Date | Status note |
|---|---|---|---|---|
| Glimepiride1mg/2mg/3mg + Pioglitazone15mg/15mg/15mg + Metformin1000mg/1000mg/1000mg | Quashed | S.O. 4471(E) | 7 September 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/850mg | Quashed | S.O. 4472(E) | 7 September 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 500mg | Quashed | S.O. 4479(E) | 7 September 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 1/2/1/2mg | Banned | S.O. 4467(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Pioglitazone 7.5/7.5mg + Metformin 500/1000mg | Banned | S.O. 4470(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Metformin 850mg + Pioglitazone 7.5mg + Glimepiride 2mg | Banned | S.O. 4473(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Metformin 850mg + Pioglitazone 7.5mg + Glimepiride1mg | Banned | S.O. 4474(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Metformin 500mg/500mg + Gliclazide SR30mg/60mg + Pioglitazone7.5mg/7.5mg | Banned | S.O. 4475(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Voglibose + Pioglitazone + Metformin | Banned | S.O. 4476(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Glimepiride + Pioglitazone + Metformin | 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 | 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 850mg | Banned | S.O. 4481(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Metformin (Sustained Release) 500mg + Pioglitazone15mg + Glimepiride 3mg | Banned | S.O. 4486(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
Batches declared Not of Standard Quality
Batches of products containing Pioglitazone flagged in CDSCO monthly alerts. An NSQ result concerns one batch, not the molecule or the brand.
| 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 PharmaceuticalsHimachal 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 |
Official sources and primary records
- Deccan Herald: Ban on Analgin, pioglitazone revokedNewsDeccan Herald
- News
- Regulator