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Regulatory status record

Is Serratiopeptidase banned in India?

Last checked 1 October 2026

Serratiopeptidase. Status: Enzyme not banned · 4 combos banned.
No current action

Serratiopeptidase as a single ingredient is not banned in India as of 1 Oct 2026; four of its fixed-dose combinations were prohibited, two on 2 Aug 2024 and two, with amoxicillin and cefuroxime, on 11 Jun 2026.

Classification
No ban or recall found in official records
Decided by
CDSCO / Ministry of Health and Family Welfare
Reference
S.O. 3072(E), 3070(E), 3081(E), 3083(E), 11 Jun 2026; cephalexin + serratiopeptidase and etodolac + PCM + serratiopeptidase, 2 Aug 2024 (S.O. numbers)
Evidence
Government document
Latest action
11 June 2026
Last checked
1 October 2026
See the source Report a mistake

Indian aceclofenac + paracetamol + serratiopeptidase tablet pack. Photo: Tainac-sp.jpg by Taionremedies (CC BY-SA 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 · S.O. 3072(E), 3070(E), 3081(E), 3083(E), 11 Jun 2026; cephalexin + serratiopeptidase and etodolac + PCM + serratiopeptidase, 2 Aug 2024 (S.O. numbers) · 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 Always check the linked government document for the current position, and tell us if something is out of date.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
Serratiopeptidase alone
Not banned
Banned 11 Jun 2026
Amoxicillin + serratiopeptidase (S.O. 3072(E)); + lactobacillus sporogenes (3070(E)); amoxicillin + cloxacillin + LAB + serratiopeptidase (3081(E)); cefuroxime + serratiopeptidase (3083(E))
Banned 2 Aug 2024
Cephalexin + serratiopeptidase; etodolac + paracetamol + serratiopeptidase
Halted 11 Apr 2025
Nimesulide + PCM + serratiopeptidase; trypsin-chymotrypsin + diclofenac + serratiopeptidase combinations
Still legal
Aceclofenac + PCM + serratiopeptidase (Zerodol-SP), diclofenac + serratiopeptidase, watch list

Where the claim comes from

Each new FDC notification since 2024 has removed serratiopeptidase combinations, and the June 2026 list, in which four of the 16 entries contain the enzyme, was reported under headlines about 'serratiopeptidase banned'. Patients on painkiller-enzyme products such as Zerodol-SP assumed the ban covered the enzyme itself.

Serratiopeptidase is a proteolytic enzyme, originally from silkworm bacteria, marketed in India as an anti-inflammatory add-on to antibiotics and painkillers. Its evidence base is thin, and the regulator has been removing its combinations in stages. The enzyme itself is not banned.

The first removals came on 2 August 2024, when the 156-FDC notification prohibited cephalexin + serratiopeptidase and etodolac + paracetamol + serratiopeptidase. On 11 April 2025 the CDSCO's direction on 35 unapproved combinations halted several more, including nimesulide + paracetamol + serratiopeptidase and trypsin-chymotrypsin + diclofenac + serratiopeptidase products. Then on 11 June 2026 the 16-FDC notification prohibited four antibiotic-enzyme products: amoxicillin + serratiopeptidase (S.O. 3072(E)), the same with lactobacillus sporogenes (3070(E)), amoxicillin + cloxacillin + lactic acid bacillus + serratiopeptidase (3081(E)) and cefuroxime + serratiopeptidase (3083(E)). The ministry's reasoning in each case was that there is no therapeutic justification for combining an antibiotic with an enzyme, and that the combination may involve risk.

What remains legal is serratiopeptidase on its own and its combinations with aceclofenac + paracetamol (Zerodol-SP, Hifenac-SP) or with diclofenac. Those are in a class the regulator is clearly watching, and a claim that 34 further combinations are under review circulates without a source we could find.

Patients on an antibiotic-enzyme product should ask for the plain antibiotic; patients on a painkiller-enzyme product can continue but might ask their doctor whether the enzyme is needed.

What this means for you

Antibiotic + enzyme packs should be gone

If your antibiotic strip lists serratiopeptidase, it is a prohibited combination; ask the pharmacist for the plain antibiotic.

Painkiller + enzyme products are mostly still legal

Zerodol-SP-type products are not banned as of today, though the class is under review.

The enzyme has weak evidence

Whether serratiopeptidase adds anything is a fair question for your doctor, regardless of the legal position.

This is a record of official orders, not medical advice. Do not stop a prescribed medicine without asking your doctor or pharmacist.

Entries on the banned drugs list

Drug / combinationActionNotificationDateStatus note
Amoxicillin + Serratiopeptidase + Lactobacillus SporogenesBannedS.O. 3070(E)11 June 2026Prohibited under s.26A with immediate effect, 11.06.2026 (CDSCO list published 21.07.2026).
Amoxicillin + SerratiopeptidaseBannedS.O. 3072(E)11 June 2026Prohibited under s.26A with immediate effect, 11.06.2026 (CDSCO list published 21.07.2026).
Amoxicillin + Cloxacillin + Lactic Acid Bacillus + SerratiopeptidaseBannedS.O. 3081(E)11 June 2026Prohibited under s.26A with immediate effect, 11.06.2026 (CDSCO list published 21.07.2026).
Cefuroxime + SerratiopeptidaseBannedS.O. 3083(E)11 June 2026Prohibited under s.26A with immediate effect, 11.06.2026 (CDSCO list published 21.07.2026).
Cephalexin Monohydrate + SerratiopeptidaseBannedS.O. 3414(E)2 August 2024Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024.
Doxycycline HCl + Betacyclodextrin + SerratiopeptidaseBannedS.O. 3420(E)2 August 2024Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024.
Etodolac + Paracetamol + SerratiopeptidaseBannedS.O. 3422(E)2 August 2024Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024.
Dicyclomine + SerratiopeptidaseBannedS.O. 193(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.
Nimesulide + SerratiopeptidaseBannedS.O. 4389(E)7 September 2018In force per CDSCO list as on 22.11.2021
Lornoxicam + Paracetamol + SerratiopeptidaseBannedS.O. 4408(E)7 September 2018In force per CDSCO list as on 22.11.2021
Combikit of 3 Tablets of Serratiopeptidase (Enteric Coated 20000 Units) + Diclofenac Potassium & 2 Tablets of DoxycyclineBannedS.O. 4412(E)7 September 2018In force per CDSCO list as on 22.11.2021

Ingredient records

Every banned combination and failed batch containing each ingredient.

SerratiopeptidaseAceclofenacParacetamolAmoxicillinDiclofenac

Batches declared Not of Standard Quality

Batches of products containing Serratiopeptidase 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
Serratiopeptidase & Diclofenac Potassium Tablets Batch ST-25874Mfg Dec 2024 · Exp Nov 2026 Sunvij Drugs Private LimitedGujarat test for Disintegration onlyDisintegration RDTL, Hubli, KarnatakaState lab Sep 2026
Meloxicam, Paracetamol And Serratiopeptidase Bolus (Vet) Batch PT25367Mfg Dec 2025 · Exp May 2028 Prispag PharmaPunjab Uneven Light Brown Coloured Spots are observed on the Surface of Almost all the Bolus.Description FDAL, M. S Chhatrapatri Sambhajinagar, F.D.A Mahrasthra StateState lab Sep 2026
Aceclofenac, Paracetamol & Serratiopeptidase Tablets) Batch TG25-2242FMfg Dec 2025 · Exp Nov 2027 Athens Life SciencesHimachal Pradesh The Content of Serratiopeptidase in the Sample is less (i.e. 32.33% of Stated Amount) than Schedule V Limit. (Schedule V Limit:- Not less than 90% of Stated Amount)Other FDAL, M. S Chhatrapatri Sambhajinagar, F.D.A Mahrasthra StateState lab Sep 2026
Meloxicam, Paracetamol & Serratiopeptidase Bolus Batch ZSBA2519Mfg Aug 2025 · Exp Jul 2027 Acme Life Tech-LLPHimachal Pradesh DescriptionDescription DTL, Bengaluru, KarnatakaState lab Aug 2026
Diclofenac Potassium, & Serratiopeptidase Tablets Batch T25K035BMfg Nov 2025 · Exp Oct 2027 Bajaj FormulationsUttarakhand The sample is not of Standard Quality with respect to DisintegrationDisintegration LUCKNOW LABState lab Aug 2026
Diclofenac Potass um & Serratiopeptidase Tablets Batch 25010040Mfg Oct 2025 · Exp Nov 2027 Aban PharmaceuticalsKerala The Sample does not confirm to the standards of Disintegration Test mentioned under General Requirements of IP as per Standards for Patent and Proprietary Medicines in Schedule-V of Drugs and Cosmetics Act, 1940 and Rules there under.Disintegration SDTL, Andhra PradeshState lab Aug 2026
Aceclofenac 100mg, Serratiopeptidase 15mg & Paracetamol 325mg Tablets Batch FND0725001BHMfg Jan 2025 · Exp Jun 2027 Ipca Laboratories LtdSikkim The sample does not conform to claim with respect to Identification and Assay/content of Aceclofenac, Paracetamol and Serratiopeptidase activity.Assay CDL, KolkataCDSCO lab Aug 2026
Aceclofenac, Paracetamol and Serratiopeptidase Tablets Batch F9AHY065Mfg Oct 2025 · Exp Sep 2027 Pharma Force Lab 53-55Himachal Pradesh Identity test negative for Aceclofenac and Content of ParacetamolOther Lucknow LabState lab Jul 2026
Aceclofenac, Paracetamol & Serratiopeptidase Tablets Batch TG25-1919BMfg Oct 2025 · Exp Sep 2027 Menrik Biomerge Pvt. Ltd. 5Delhi Content of AceclofenacOther GORAKHPUR LAB, UPState lab Jul 2026
Aceclofenac 100 mg, Serratiopeptidase 15 mg & Paracetamol 325 mg Tablets Batch FND0825055AKMfg Dec 2025 · Exp May 2028 Ipca Laboratories LtdSikkim Identity test negative for Aceclofenac and ParacetamolOther Lucknow LabState lab Jul 2026
Serratiopeptidase Tablets I P 10 mg Batch MT260002Mfg Jan 2026 · Exp Dec 2027 Mancare Laboratories Pvt. LtdUttarakhand It fails the test Disintegration as per IPDisintegration RDTL ErnakulamState lab Jun 2026
Aceclofenac, Paracetamol & Serratiopeptidase Tablets Batch FND0826009AKMfg Feb 2026 · Exp Jul 2028 Ipca Laboratories LtdUttarakhand Description Rough surface on each Tablets.Description SDFTL US Nagar,UKState lab Jun 2026
Aceclofenac, Paracetamol and Serratiopeptidase Tablets Batch C24T140EMfg Jan 2025 · Exp Dec 2026 Cartel LaboratoriesTelangana Assay for SerratiopeptidaseAssay DTL, Bengaluru, KarnatakaState lab Apr 2026
Serratiopeptidase Tablets IP Batch MT250227Mfg Feb 2025 · Exp Jan 2027 Mancare Laboratories Pvt. LtdUttarakhand DisintegrationDisintegration RDTL, ErnakulamState lab Mar 2026
Meloxicam, Paracetamol & Serratiopeptidase Bolus (Vet.) Batch T-24451Mfg Nov 2024 · Exp Oct 2027 Minil Laboratories Pvt. LtdJammu & Kashmir Assay for SerratiopeptidaseAssay DTL, Bengaluru, KarnatakaState lab Feb 2026
Showing 15 of 25 records

Sources

Government documents

News reports

Researched and written by The Blacklisted team
We are not doctors or pharmacists. Everything on this page comes from the documents listed above, which you can open and check. Last checked 1 October 2026. How we check · Who we are · Spotted a mistake? Tell us.