Regulatory status record
Is Diclofenac banned in India?
Last checked 19 September 2026. A few details are still being checked against the original document.
Diclofenac is not banned for human use in India as of 19 Sep 2026; its veterinary use has been prohibited since 2006 and multi-dose vials above 3 ml since 2015, both to protect vultures.
- Classification
- No ban or recall found in official records
- Decided by
- CDSCO / Ministry of Health and Family Welfare
- Reference
- Veterinary ban 2006 (GSR, being verified; multi-dose vial restriction 2015 (GSR, being verified; no human-use ban
- Latest action
- 2 August 2024
- Last checked
- 19 September 2026details being verified
Diclofenac sodium 50 mg tablets made by Aurobindo (India). Photo: Diclofenac Natrium 50mg Aurobindo.jpg by Bluberryman (CC BY 4.0). Brand names and logos belong to their owners and are used here to identify the product this entry is about. All photo credits.
CDSCO: List of prohibited FDC drugs, 156 FDCs dated 02.08.2024
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 Always check the linked government document for the current position, and tell us if something is out of date.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
- Human use
- Not banned
- Veterinary use
- Banned since 2006 (vulture conservation; GSR, being verified
- Injection vials
- Multi-dose vials above 3 ml banned 2015 to stop diversion to cattle
- Related vet bans
- Ketoprofen and aceclofenac (Aug 2023), nimesulide (Jan 2025)
- Banned diclofenac FDCs
- Diclofenac + tramadol + chlorzoxazone (2018); PCM + diclofenac + caffeine, methocarbamol + diclofenac inj, diclofenac + thiocolchicoside inj (2024)
Where the claim comes from
Diclofenac is genuinely banned in India, for animals. The 2006 veterinary ban, the 2015 restriction on multi-dose vials and the 2023 and 2025 bans on other veterinary NSAIDs all made headlines about 'diclofenac ban'. Searchers then ask whether Voveran or Voveran injection is banned for people; it is not.
Diclofenac is one of the most used painkillers in India, and it is also the subject of one of the country's best-known drug bans, which is why the question needs a two-part answer.
For humans, diclofenac is legal. Tablets, sustained-release forms, gels and single-dose injections such as Voveran and Volini are licensed and sold. No Section 26A notification restricts human use of the single ingredient.
For animals, it has been banned since 2006. Diclofenac residues in cattle carcasses caused kidney failure in vultures that fed on them, and three species declined by more than 95 per cent. The government prohibited veterinary diclofenac in 2006 and, in 2015, limited human injectable diclofenac to single-dose vials of 3 ml or less because larger vials were being diverted to livestock. The Delhi High Court has dealt with challenges to the vial rule. Ketoprofen and aceclofenac were added to the veterinary ban in 2023 and nimesulide in January 2025.
Some human combinations are banned. Diclofenac + tramadol + chlorzoxazone went in the September 2018 wave, and the 2 August 2024 list added paracetamol + diclofenac + caffeine, methocarbamol + diclofenac injection and diclofenac + thiocolchicoside injection.
The notification numbers for the 2006 and 2015 orders are not in our sources and are flagged for verification.
What this means for you
Tablets, gels and single-dose injections are legal
Voveran, Volini and similar brands can be sold for human use.
Some combinations are gone
Triple combinations with tramadol or muscle relaxants were banned in 2018 and 2024; ask your pharmacist if a pack lists three actives.
Never use human stock on animals
Veterinary use is illegal and is the reason vultures nearly disappeared from India.
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 Voveran injection banned in India?
No. Single-dose injections are legal. Multi-dose vials above 3 ml were restricted in 2015.
Entries on the banned drugs list
| Drug / combination | Action | Notification | Date | Status note |
|---|---|---|---|---|
| Paracetamol + Diclofenac Potassium + Caffeine Anhydrous | Banned | S.O. 3417(E) | 2 August 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Diclofenac Sodium + Thiocolchicoside Injection | Banned | S.O. 3418(E) | 2 August 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Methocarbamol + Diclofenac Sodium Injection | Banned | S.O. 3435(E) | 2 August 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Chlormezanone + Paracetamol + Diclofenac Sodium | Banned | S.O. 185(E) | 11 January 2019 | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Chlorzoxazone + Ibuprofen + Paracetamol + Diclofenac + Oxyphenbutazone + Magnesium Hydroxide | Banned | S.O. 187(E) | 11 January 2019 | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Chlorzoxazone + Paracetamol + Ibuprofen + Diclofenac Sodium | Banned | S.O. 188(E) | 11 January 2019 | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Paracetamol + Diclofenac Sodium + Amoxicillin + Cloxacillin + Pantoprazole + Lactic Acid Bacillus + Serratiopeptidase | Banned | S.O. 204(E) | 11 January 2019 | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Paracetamol + Diclofenac Sodium + Magnesium Trisilicate + Chlorpheniramine Maleate | Banned | S.O. 205(E) | 11 January 2019 | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Diclofenac + Pitofenone Hydrochloride + Fenpiverinium Bromide + Paracetamol | Banned | S.O. 218(E) | 11 January 2019 | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Fenpiverinium Bromide + Diclofenac Sodium + Pitofenone Hydrochloride | Banned | S.O. 224(E) | 11 January 2019 | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Ofloxacin + Diclofenac + Lignocaine | Banned | S.O. 257(E) | 11 January 2019 | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Nimesulide + Diclofenac | Banned | S.O. 4380(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
Batches declared Not of Standard Quality
Batches of products containing Diclofenac 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 |
|---|---|---|---|---|---|
| Drotaverine Hydrochloride & Diclofenac Potassium Tablets | KFCR6023Mfg 2026-03 · Exp 2028-02 | Cris Pharma (India) Ltd. E-11Uttarakhand | Identification - Doesn't conforms to I.P.Identification | Lucknow LabState lab | Jul 2026 |
| Diclofenac Sodium and Paracetamol Tablets IP | I501103Mfg 2025-02 · Exp 2027-01 | Zydus Healthcare LtdSikkim | Description & DissolutionDissolution | Lucknow LabState lab | Jul 2026 |
| Diclofenac Sodium Tablets IP 50mg | SP250935Mfg 2025-09 · Exp 2027-08 | Sharun Pharmaceuticals Pvt.LtdPuducherry | DissolutionDissolution | Drugs Testing Laboratory, Chennai-06State lab | Jul 2026 |
| Diclofenac Sodium Tablets IP 50mg | SP250934Mfg 2025-09 · Exp 2027-08 | Sharun Pharmaceuticals Pvt.LtdPuducherry | DissolutionDissolution | Drugs Testing Laboratory, Chennai-06State lab | Jul 2026 |
| Diclofenac Sodium Tablets IP 50 mg | DG 5033Mfg 2025-03 · Exp 2027-02 | Kerala State Drugs Pharmaceuticals LtdKerala | The sample does not conform to IP standards with respect to the test Dissolution and also shows Category B defect of tablets (Capping).Dissolution | DTL, ThrissurState lab | Jul 2026 |
| Diclofenac Sodium Injection I.P. | ZYCD15018Mfg 2025-10 · Exp 2027-09 | Laborate Pharmaceuticals India Ltd. 111Himachal Pradesh | Content of Diclofenac SodiumOther | KANPUR LAB, UPState lab | Jul 2026 |
| Diclofenac Sodium Gastro -Resistant Tablets IP | T-25056Mfg 2025-09 · Exp 2027-08 | Geson Pharma Pvt. Ltd Industrial AreaUttar Pradesh | Disintegration TestDisintegration | MEERUT LABState lab | Jul 2026 |
| Diclofenac Sodium & Paracetamol Tablets | AHT-2502262Mfg 2026-02 · Exp 2028-01 | Aru Health Care Pvt. Ltd. - K-12 | Disintegration TestDisintegration | Lucknow LabState lab | Jul 2026 |
| Diclofenac Gastro-Resistant Tablets IP | 250264AMfg 2025-05 · Exp 2028-04 | Bal Pharma LimitedUttarakhand | The sample does not conform to I.P 2022 with respect to test for Related substancesRelated substances | CDTL, MumbaiCDSCO lab | Jul 2026 |
| Diclofenac Diethylamine, Virgin Linseed oil, Menthol & Methyl Salicylate Gel | JDB766Mfg 2025-02 · Exp 2027-01 | Curetech SlincareHimachal Pradesh | The sample does not conform to label claim with respect to the content of Diclofenac Diethylamine,and Methyl SalicylateLabelling | Drugs Testing Laboratory, Chennai-06State lab | Jul 2026 |
| Tolperisone Hydrochloride 150 mg and Diclofenac Sodium 50 mg | WON24021GMfg 2024-11 · Exp 2026-10 | Windlas Biotech Limited (Plant-2)Uttarakhand | ContentOther | DTL, Madurai-19State lab | Jun 2026 |
| Diclofenac Sodium Tabelts IP 50 mg | DG5034Mfg 2025-03 · Exp 2027-02 | Kerala State Drugs & Pharmaceuticals LtdKerala | The sample does not conform to IP standards. If fails the Descriptive part as per IP,as specified in the Laboratory Protocol.Other | DTL TVPMState lab | Jun 2026 |
| Diclofenac Sodium Tablets IP 50mg | DG 5031Mfg 2025-02 · Exp 2027-01 | Kerala State Drugs and Pharmaceuticals LtdKerala | Dissolution.Dissolution | DTL ThiruvananthapuramState lab | May 2026 |
| Diclofenac Sodium Injection | PGY25252Mfg 2025-04 · Exp 2027-03 | Affy Parenterals Vill Gulerwa;laHimachal Pradesh | The sample does not conform to IP 2022 requirements w.r.t pHpH | DTL,Dalgate Srinagar kashmirState lab | May 2026 |
| Diclofenac Diethylamine linseed oil, Methyl Slaicylate & Menthol Gel | R G 5Mfg 2025-04 · Exp 2027-03 | Pilco Healthcare Pvt. Ltd. Plot No. 28 Sector-3 I.I.E Pantnagar Sidcul | AssayAssay | RDTL, Bellary, KarnatakaState lab | May 2026 |
Official sources and primary records
- News
- SAVE: Gazette notification of aceclofenac and ketoprofen (veterinary) banNewsSaving Asia's Vultures from Extinction
- CDSCO: List of prohibited FDC drugs, 156 FDCs dated 02.08.2024RegulatorCDSCO · 2 August 2024
- News