Ingredient record · Blood thinner given by injection
Heparin: bans, restrictions and failed batches in India
Last checked 3 November 2026. Sources: CDSCO banned-drugs notifications and monthly NSQ alerts, Jan 2019 to Sep 2026
2 entries containing Heparin are on India's banned-drugs list, and 1 is banned today. 26 batches of medicines containing Heparin failed a government lab test between April 2019 and May 2026, from 12 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
On the banned-drugs list
Heparin 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 |
|---|---|---|---|---|---|
| Heparin + DiclofenacFixed-dose combination · painkillers | Banned | S.O. 4403(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Heparin + DiclofenacFixed-dose combination · painkillers | Quashed | S.O. 731(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 |
|---|---|---|---|
| Heparin Sodium / | 18 | 8 | Nov 2024 |
| Heparin Sodium /ml | 2 | 1 | May 2026 |
| Heparin /ml | 2 | 2 | Jul 2025 |
| Heparin | 2 | 2 | May 2023 |
| Flagorin | 1 | 1 | Jun 2023 |
| Hepacel / | 1 | 1 | Feb 2023 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Heparin Sodium Injection IP 5000 IU/ml | Batch HSV22406Mfg Nov 2024 · Exp Oct 2026 | Nandani Medical Laboratories Pvt. LtdMadhya Pradesh | The sample does not conform to I.P. with respect to the Assay of Heparin (Anti-factor IIa activity)Assay | CDL, KolkataCDSCO lab | May 2026 |
| Heparin Sodium Injection IP 5000 IU/ml | Batch BSV22501Mfg Feb 2025 · Exp Jan 2027 | Nandani Medical Laboratories Pvt. LtdMadhya Pradesh | The sample does not conform to I.P. with respect to Assay of Heparin (Anti-factor IIa activity)Assay | CDL, KolkataCDSCO lab | May 2026 |
| Heparin Injection IP 1000 IU/ml (Flagorin) | Batch DP4111Mfg Mar 2024 · Exp Feb 2027 | Divine Laboratories Pvt. Ltd. Block No. 471 DabhasaGujarat | Assay of Heparin (Anti-factor IIa activity)Assay | CDL, KolkataCDSCO lab | Jul 2025 |
| Heparin Injection IP 5000 IU/ml (Flagorin) | Batch DP2143Mfg Aug 2022 · Exp Jun 2025 | Divine Laboratories Pvt. LtdGujarat | pH and Assay of Heparin (Anti- factor-IIa activity)Assay | CDL KolkataCDSCO lab | Jun 2025 |
| Heparin Sodium Injection IP 25000 IU / 5 ml | Batch GV3H001Mfg Aug 2023 · Exp Jul 2026 | Scott-Edil Pharmacia LtdHimachal Pradesh | pH, Particulate Matter, DescriptionDescription | CDL KolkataCDSCO lab | Nov 2024 |
| Heparin Sodium Injection IP 25000 IU / 5 ml | Batch GV3E001Mfg May 2023 · Exp Apr 2026 | Scott-Edil Pharmacia LtdHimachal Pradesh | pH, Particulate Matter, Assay of Heparin (Anti- factor Iia activity), DescriptionAssay | CDL KolkataCDSCO lab | Nov 2024 |
| Heparin Sodium Injection IP 5000 IU / 5ml (Hepathin 5000 Injection 5 ml / vial) | Batch L1192317GMfg Aug 2023 · Exp Jul 2025 | Protech TelelinksHimachal Pradesh | Description & Particulate matterDescription | CDL KolkataCDSCO lab | Sep 2024 |
| Heparin Sodium Injection IP 5000 IU / 5ml (Hepathin 5000 Injection 5 ml / vial) | Batch L1192317CMfg Aug 2023 · Exp Jul 2025 | Protech TelelinksHimachal Pradesh | Description, Particulate matter and Assay of Heparin (Anti- factor IIa activity)Assay | CDL KolkataCDSCO lab | Sep 2024 |
| Heparin Sodium Injection IP 25000 IU / 5ml | Batch GV3C002Mfg Mar 2023 · Exp Feb 2026 | Scott-Edil Pharmacia LtdHimachal Pradesh | Description & Particulate MatterDescription | CDL KolkataCDSCO lab | Aug 2024 |
| Heparin Sodium Injection 5000 Units (Hostranil Injection) | Batch HIHE23028AMfg Oct 2023 · Exp Sep 2025 | Health Biotech LtdHimachal Pradesh | Particulate Matter, Bacterial Endotoxins & SterilitySterility | CDL KolkataCDSCO lab | Aug 2024 |
| Heparin Sodium Injection I.P. 5000 IU / 5ml (Astriparin Injection 5000 IU / 5 ml) | Batch AGI-23077Mfg May 2023 · Exp Apr 2025 | Astrica Healthcare Pvt. LtdHimachal Pradesh | Description & Particulate Matter & AssayAssay | CDL KolkataCDSCO lab | Mar 2024 |
| Heparin Sodium Injection IP 25000 IU/5ml | Batch 22HE16Mfg Oct 2022 · Exp Sep 2024 | SAI Parenterals LimitedTelangana | Description, Extractable Volume, Particulate Matter and AssayAssay | CDL KolkataCDSCO lab | Feb 2024 |
| Heparin Sodium Injection IP 5000 IU/5ml,(INFA-HEP) | Batch A23LV060BMfg May 2023 · Exp Apr 2025 | Infallible Pharma Pvt. LtdMaharashtra | pH, Particulate Matter and DescriptionDescription | CDL KolkataCDSCO lab | Dec 2023 |
| Heparin Sodium Injection IP 5000 IU/5ml | Batch AGI-23111Mfg May 2023 · Exp Apr 2025 | Alliance BiotechHimachal Pradesh | pH, Particulate Matter and DescriptionDescription | CDL KolkataCDSCO lab | Dec 2023 |
| Heparin Sodium Injection IP 5000 IU/5ml | Batch AGI-23110Mfg May 2023 · Exp Apr 2025 | Alliance BiotechHimachal Pradesh | pH, Particulate Matter and DescriptionDescription | CDL KolkataCDSCO lab | Dec 2023 |
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.