Regulatory status record
Is Metformin banned in India?
Last checked 3 November 2026
Metformin is not banned in India; it is an essential medicine. Specific metformin combinations are banned or halted, including three unapproved ones halted by the CDSCO on 11 Apr 2025.
- 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 alone; CDSCO letter F.No. 4-01/2023-DC (Misc. 3), 11 Apr 2025, Annexure Sr. 3, 29 and 30; S.O. 3304(E), 2 Aug 2024; 2018 FDC wave
- Evidence
- Government document
- Latest action
- 1 May 2026
- Last checked
- 3 November 2026
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 letter F.No. 4-01/2023-DC (Misc. 3), 11 Apr 2025: 35 FDCs to be halted
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 Always check the linked government document for the current position, and tell us if something is out of date.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
- Metformin ER 500 mg + glimepiride 3 mg + dapagliflozin 10 mg; glimepiride 2 mg + metformin SR 500 mg + voglibose 0.3 mg; glimepiride 1 mg + metformin 500 mg tablet. A CDSCO direction to states on unapproved licences, not a Section 26A ban
- Banned in 2018
- Several metformin FDCs, for example metformin + atorvastatin (S.O. 4453(E)), telmisartan + metformin (S.O. 4694(E)), glipizide 2.5 mg + metformin 400 mg (S.O. 4480(E))
- 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 three unapproved 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, three of which contained metformin: metformin ER + glimepiride + dapagliflozin, glimepiride + metformin SR + voglibose, and a glimepiride 1 mg + metformin 500 mg tablet. The direction concerned products licensed by states without central approval, so a centrally approved glimepiride + metformin product is not covered by it; check the pack with your pharmacist. 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 itself. 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.
Combination packs need a check
If your tablet lists dapagliflozin or voglibose with glimepiride and metformin, or is a glimepiride 1 mg + metformin 500 mg tablet, ask your doctor whether it is an approved 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 metformin banned in India?
No. Metformin is an essential medicine; only specific combinations containing it are banned or halted.
Is glimepiride + metformin + voglibose banned?
A glimepiride 2 mg + metformin SR 500 mg + voglibose 0.3 mg tablet was halted by CDSCO on 11 Apr 2025 as an unapproved combination.
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 |
Ingredient records
Every banned combination and failed batch containing each ingredient.
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 Tablets I.P. 500 mg | Batch SMF-103Mfg Jun 2025 · Exp May 2027 | MARC Life Sciences SikkimSikkim | TESTS PERFORMED FOR UNIFORMITY OF WEIGHT.Uniformity of weight/content | DTL, DelhiState lab | Sep 2026 |
| Glimepiride, Voglibose & Metformin HCL SR Tablets | Batch OT-250933Mfg Aug 2025 · Exp Jul 2027 | Orchid Biotech LtdDelhi | Assay of GlimepirideAssay | SDTL, Andhra Pradesh, VijayawadaState lab | Sep 2026 |
| Sitagliptin Phosphate and Metformin Hydrochloride Tablets (Sitarise-M) | Batch TG242142Mfg Dec 2024 · Exp Nov 2026 | Symbiosis Pharmaceuticals Pvt. Ltd. Suketi RoadHimachal Pradesh | Description and test for Uniformity of weight as per indian PharmacopoeiaDescription | DTL, Bengaluru, KarnatakaState lab | Aug 2026 |
| Metformin Hydrochloride Prolonged-Released and Glimepiride Tablets IP | Batch 60002727Mfg Mar 2026 · Exp Feb 2028 | 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 | Batch DPT-016Mfg Apr 2025 · Exp Mar 2027 | 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) | Batch PRT-250229Mfg Feb 2025 · Exp Jan 2027 | Preet Remedies LtdHimachal Pradesh | DescriptionDescription | DTL, Bengaluru, KarnatakaState lab | Jun 2026 |
| Voglibose, Glimepiride & Metformin HCl (SR) Tablets). | Batch TPT26010Mfg Jan 2026 · Exp Dec 2027 | 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 | Batch T-2503098Mfg Mar 2025 · Exp Feb 2027 | 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 | Batch GVGT1138Mfg Oct 2025 · Exp Sep 2027 | Voizmed Pharma Pvt. LtdHimachal Pradesh | AssayAssay | RDTL, Bellary, KarnatakaState lab | May 2026 |
| Metformin HCl I.P. (as Prolonged Release Form & Glimepiride I.P | Batch TPT26008Mfg Jan 2026 · Exp Dec 2027 | Taj Pharma India LtdGujarat | Assay of Glimepiride IP- less than Prescribed limitAssay | SDTL, UttarakhandState lab | May 2026 |
| Metformin Hydrochloride Prolonged Release Tablets IP 500mg | Batch TB-167Mfg Mar 2026 · Exp Feb 2028 | Carewell Steuart Pharma Pvt.Ltd | DescriptionDescription | DTL, Chennai-06State lab | May 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 |
| Sitagliptin & Metformin Prolonged-Release Tablets BP | Batch AXC0111Mfg Jul 2025 · Exp Jun 2027 | 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 | Batch T5107Mfg Jul 2025 · Exp Jun 2027 | 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 | Batch T5110Mfg Jul 2025 · Exp Jun 2027 | 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 |
Sources
Government documents
- CDSCO letter F.No. 4-01/2023-DC (Misc. 3), 11 Apr 2025: 35 FDCs to be haltedRegulatorCDSCO · 11 April 2025
- CDSCO: Updated banned drugs list with present status (as on 22.11.2021)RegulatorCDSCO · 22 November 2021
- CDSCO: List of prohibited FDC drugs, 156 FDCs dated 02.08.2024RegulatorCDSCO · 2 August 2024
- Regulator
News reports
- Business Today: India halts 35 drug combinations over health risks, full listNewsBusiness Today · 17 April 2025
- PharmaTutor: CDSCO flags 157 drug samples as not of standard quality, 2 declared spurious in May 2026NewsPharmaTutor