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. Status: Not banned for humans · vet use banned.

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.

Primary government sourceTier 1: government primary source

CDSCO: List of prohibited FDC drugs, 156 FDCs dated 02.08.2024

CDSCO / Ministry of Health and Family Welfare · Veterinary ban 2006 (GSR, being verified; multi-dose vial restriction 2015 (GSR, being verified; no human-use ban · 2 August 2024

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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 Always check the linked government document for the current position, and tell us if something is out of date.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 / combinationActionNotificationDateStatus note
Paracetamol + Diclofenac Potassium + Caffeine AnhydrousBannedS.O. 3417(E)2 August 2024Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024.
Diclofenac Sodium + Thiocolchicoside InjectionBannedS.O. 3418(E)2 August 2024Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024.
Methocarbamol + Diclofenac Sodium InjectionBannedS.O. 3435(E)2 August 2024Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024.
Chlormezanone + Paracetamol + Diclofenac SodiumBannedS.O. 185(E)11 January 2019One 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 HydroxideBannedS.O. 187(E)11 January 2019One 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 SodiumBannedS.O. 188(E)11 January 2019One 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 + SerratiopeptidaseBannedS.O. 204(E)11 January 2019One 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 MaleateBannedS.O. 205(E)11 January 2019One 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 + ParacetamolBannedS.O. 218(E)11 January 2019One 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 HydrochlorideBannedS.O. 224(E)11 January 2019One 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 + LignocaineBannedS.O. 257(E)11 January 2019One 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 + DiclofenacBannedS.O. 4380(E)7 September 2018In 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
Showing 15 of 25 records

Official sources and primary records