Regulatory status record
Is Metformin banned in India?
Last checked 19 September 2026. A few details are still being checked against the original document.
Metformin is not banned in India as of 19 Sep 2026; it is an essential medicine, and the only actions involving it are the CDSCO's 11 Apr 2025 halt of two three-drug combinations and batch-level NSQ findings.
- Classification
- No ban or recall found in official records
- Decided by
- CDSCO / Ministry of Health and Family Welfare
- Reference
- No Section 26A notification for metformin; CDSCO direction 11 Apr 2025 covers dapagliflozin + glimepiride + metformin and glimepiride + metformin + voglibose
- Latest action
- 1 May 2026
- Last checked
- 19 September 2026details being verified
Metformin 500 mg tablet pack. Photo: Metformin 500mg Tablets.jpg by User:Ash (Public domain). Brand names and logos belong to their owners and are used here to identify the product this entry is about. All photo credits.
CDSCO: Drugs banned in India (consumer section)
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 Always check the linked government document for the current position, and tell us if something is out of date.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
- Ban notification
- None; metformin is first-line therapy on the NLEM
- Halted 11 Apr 2025
- Dapagliflozin + glimepiride + metformin; glimepiride + metformin + voglibose
- Banned FDC
- Ursodeoxycholic acid + metformin, 2 Aug 2024 (not a diabetes product)
- NSQ note
- A Taj Pharma glimepiride + metformin batch was NSQ in the May 2026 alert
- Common brands
- Glycomet, Glyciphage, Glycomet-GP, Glimestar-M
Where the claim comes from
Three sources: the April 2025 halt of two three-drug metformin combinations, reported as 'diabetes combinations halted'; the August 2024 ban on ursodeoxycholic acid + metformin, which reads as 'metformin banned' on a list; and periodic NSQ batches of glimepiride + metformin. Glycomet, the leading brand, and 'Glycomet Trio' collect the searches.
Metformin is the first-line drug for type 2 diabetes, on the National List of Essential Medicines and taken by tens of millions of Indians. It is not banned, and no proposal to ban it exists.
The question comes from three unrelated regulatory events. On 2 August 2024 the 156-FDC notification prohibited ursodeoxycholic acid + metformin, a liver-and-diabetes combination that most patients have never heard of; on a news list it appears as "metformin" in bold. On 11 April 2025 the CDSCO directed state licensing authorities to halt 35 combinations licensed without central approval, two of which were three-drug diabetes tablets: dapagliflozin + glimepiride + metformin, and glimepiride + metformin + voglibose. The two-drug glimepiride + metformin products, such as Glycomet-GP, were not affected. And in most months a metformin or glimepiride + metformin batch from some manufacturer appears in the CDSCO's quality alerts, in May 2026 a Taj Pharma batch was listed, because the drug is made in enormous volume.
None of these touches the licence for metformin or for the standard two-drug combinations. Glycomet, Glyciphage and their generics remain on sale.
A patient on a three-ingredient tablet should ask their doctor whether it is one of the halted products and what to replace it with. Everyone else should keep taking metformin as prescribed; an unsupervised gap in diabetes treatment is the real risk in this story.
What this means for you
Keep taking metformin as prescribed
Stopping a diabetes medicine unsupervised is far riskier than any rumour; nothing about metformin's licence has changed.
Three-drug packs need a check
If your tablet lists dapagliflozin or voglibose with glimepiride and metformin, ask your doctor about the halted product.
Batch findings are batch-specific
Compare the number on your strip if an alert names your brand.
This is a record of official orders, not medical advice. Do not stop a prescribed medicine without asking your doctor or pharmacist.
Common questions
Is Glycomet Trio banned?
Three-drug glimepiride + metformin combinations with voglibose or dapagliflozin were halted in April 2025; check the composition of your pack with your doctor.
Entries on the banned drugs list
| Drug / combination | Action | Notification | Date | Status note |
|---|---|---|---|---|
| Metformin Hydrochloride 500mg (Extended Release) + Glimepiride 3mg + Dapagliflozin 10mg Film Coated Bilayered Tablets | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 3 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Glimepiride 1mg + Metformin HCl 500mg Tablet | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 29 | 11 April 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 Tablet | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 30 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Metformin Hydrochloride (Prolonged Release) 500mg + Voglibose 0.2mg Tablet | Ban revoked | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 31 | 11 April 2025 | Excluded from the 11.04.2025 list by CDSCO corrigendum dated 10.09.2025: found to be approved by CDSCO (recorded by Delhi HC on 14.07.2025). Originally: CDSCO direction to SLAs 11 Apr 2025, not a Section 26A ban. |
| Ursodeoxycholic Acid + Metformin HCl | Banned | S.O. 3304(E) | 2 August 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| 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 + Atorvastatin | Banned | S.O. 4453(E) | 7 September 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 1/2/1/2mg | Banned | S.O. 4467(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Gliclazide 80mg + Metformin 325 mg | Banned | S.O. 4468(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Voglibose + Metformin + Chromium Picolinate | Banned | S.O. 4469(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
Batches declared Not of Standard Quality
Batches of products containing Metformin 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 |
|---|---|---|---|---|---|
| Metformin Hydrochloride Prolonged-Released and Glimepiride Tablets IP | 60002727Mfg 2026-03 · Exp 2028-02 | 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 | DPT-016Mfg 2025-04 · Exp 2027-03 | 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 |
| Metformin Hydrochloride Prolonged Release and Glimepiride Tablets IP (500mg/2mg) | PRT-250229Mfg 2025-02 · Exp 2027-01 | Preet Remedies LtdHimachal Pradesh | DescriptionDescription | DTL, Bengaluru, KarnatakaState lab | Jun 2026 |
| Voglibose, Glimepiride & Metformin HCl (SR) Tablets). | TPT26010Mfg 2026-01 · Exp 2027-12 | 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 |
| Teneligliptin & Metformin Hydrochloride Extended Release tablets IP | T-2503098Mfg 2025-03 · Exp 2027-02 | Rivpra Formulation Pvt. LtdUttarakhand | The sample does not conform to I.P. with respect to the Dissolution and Assay of TeneligliptinAssay | CDL, KolkataCDSCO lab | May 2026 |
| Metformin Hydrochloride & Glimepiride Tablets (GLIMAFF-2 Tablets | GVGT1138Mfg 2025-10 · Exp 2027-09 | Voizmed Pharma Pvt. Ltd. Plot No. 133Himachal Pradesh | AssayAssay | RDTL, Bellary, KarnatakaState lab | May 2026 |
| Metformin HCl I.P. (as Prolonged Release Form & Glimepiride I.P | TPT26008Mfg 2026-01 · Exp 2027-12 | Taj Pharma India LtdGujarat | Assay of Glimepiride IP- less than Prescribed limitAssay | SDTL, UttarakhandState lab | May 2026 |
| Metformin Hydrochloride Prolonged Release Tablets IP 500mg | TB-167Mfg 2026-03 · Exp 2028-02 | Carewell Steuart Pharma Pvt.Ltd. Plot no. G-24 | DescriptionDescription | DTL, Chennai-06State lab | May 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 |
| Sitagliptin & Metformin Prolonged-Release Tablets BP | AXC0111Mfg 2025-07 · Exp 2027-06 | Exemed Pharmaceuticals | The sample does not conform to B.P. with respect to the Assay of Sitagliptin.Assay | CDL, KolkataCDSCO lab | Apr 2026 |
| Metformin Hydrochloride Prolonged Release and Glimepiride Tablets IP | T5107Mfg 2025-07 · Exp 2027-06 | 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 |
| Metformin Hydrochloride Prolonged Release and Glimepiride Tablets IP | T5110Mfg 2025-07 · Exp 2027-06 | Merril Pharma Pvt. LtdGujarat | The sample does not conform to IP with respect to the test of Dissolution of Glimepiride.Dissolution | CDL, KolkataCDSCO lab | Apr 2026 |
| Metformin Hydrochloride (SR) Tablets IP 1000MG) | JDT-8355Mfg 2024-09 · Exp 2026-08 | Jpee DrugsUttarakhand | Description onlyDescription | DTL, Bengaluru, KarnatakaState lab | Mar 2026 |
| Metformin Hydrochloride Prolonged Release and Glimepiride Tablets IP | GVGT1119CMfg 2025-10 · Exp 2027-09 | Voizmed Pharma Pvt. LtdHimachal Pradesh | The sample does not conform to IP standards with respect to the Dissolution test for Glimepiride IPDissolution | Directorate of Food & Drugs, Bambolim, GoaState lab | Feb 2026 |
| Metformin & Sitagliptin Tablets BP | TMSG-017Mfg 2025-07 · Exp 2027-06 | J.P IndustriesHimachal Pradesh | Sample fails the test Assay of Sitagliptin and Dissolution of Metformin Hydrochloride and Sitagliptin as per BP, as specified in the in the laboratory protocol.Assay | DTL ThiruvananthapuramState lab | Feb 2026 |
Official sources and primary records
- Business Today: India halts 35 drug combinations over health risks, full listNewsBusiness Today · 17 April 2025
- CDSCO: List of prohibited FDC drugs, 156 FDCs dated 02.08.2024RegulatorCDSCO · 2 August 2024
- PharmaTutor: CDSCO flags 157 drug samples as not of standard quality, 2 declared spurious in May 2026NewsPharmaTutor
- Regulator