Ingredient record · Enzyme sold to reduce swelling
Serratiopeptidase: 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
23 entries containing Serratiopeptidase are on India's banned-drugs list, and 16 are banned today. 48 batches of medicines containing Serratiopeptidase failed a government lab test between February 2019 and September 2026, from 43 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
Not banned Is Serratiopeptidase banned in India? Enzyme not banned · 4 combos banned. Read the full status record
16
Banned combinations in force
7
Other listed orders (stayed, restricted, quashed)
48
Batches failed a lab test
Sep 2026
Latest lab alert
Is it banned? Our answer pages
Banned since 11 Jun 2026
Enzyme not banned · 4 combos banned
Not banned · watch list
On the banned-drugs list
Serratiopeptidase 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 |
|---|---|---|---|---|---|
| Amoxicillin + Serratiopeptidase + Lactobacillus SporogenesFixed-dose combination · antibiotics | Banned | S.O. 3070(E) | 11 June 2026 | 16 FDCs · Jun 2026 | Prohibited under s.26A with immediate effect, 11.06.2026 (CDSCO list published 21.07.2026). |
| Amoxicillin + SerratiopeptidaseFixed-dose combination · antibiotics | Banned | S.O. 3072(E) | 11 June 2026 | 16 FDCs · Jun 2026 | Prohibited under s.26A with immediate effect, 11.06.2026 (CDSCO list published 21.07.2026). |
| Amoxicillin + Cloxacillin + Lactic Acid Bacillus + SerratiopeptidaseFixed-dose combination · antibiotics | Banned | S.O. 3081(E) | 11 June 2026 | 16 FDCs · Jun 2026 | Prohibited under s.26A with immediate effect, 11.06.2026 (CDSCO list published 21.07.2026). |
| Cefuroxime + SerratiopeptidaseFixed-dose combination · antibiotics | Banned | S.O. 3083(E) | 11 June 2026 | 16 FDCs · Jun 2026 | Prohibited under s.26A with immediate effect, 11.06.2026 (CDSCO list published 21.07.2026). |
| Cephalexin Monohydrate + SerratiopeptidaseFixed-dose combination · antibiotics | Banned | S.O. 3414(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Doxycycline HCl + Betacyclodextrin + SerratiopeptidaseFixed-dose combination · antibiotics | Banned | S.O. 3420(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Etodolac + Paracetamol + SerratiopeptidaseFixed-dose combination · painkillers | Banned | S.O. 3422(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Dicyclomine + SerratiopeptidaseFixed-dose combination · gi | Banned | S.O. 193(E) | 11 January 2019 | Other orders | 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 + SerratiopeptidaseFixed-dose combination · antibiotics | Banned | S.O. 204(E) | 11 January 2019 | Other orders | 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 + SerratiopeptidaseFixed-dose combination · painkillers | Banned | S.O. 4389(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Lornoxicam + Paracetamol + SerratiopeptidaseFixed-dose combination · painkillers | Banned | S.O. 4408(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Combikit of 3 Tablets of Serratiopeptidase (Enteric Coated 20000 Units) + Diclofenac Potassium & 2 Tablets of DoxycyclineFixed-dose combination · painkillers | Banned | S.O. 4412(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Doxycycline + SerratiopeptidaseFixed-dose combination · antibiotics | Banned | S.O. 4434(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Amoxicillin + Dicloxacillin + SerratiopeptidaseFixed-dose combination · antibiotics | Banned | S.O. 4440(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Roxithromycin + SerratiopeptidaseFixed-dose combination · antibiotics | Banned | S.O. 4566(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Guaifenesin + Bromhexine + Chlorpheniramine + Phenylephrine + Paracetamol + Serratiopeptidase (as Enteric Coated Granules) 10000 S P UnitsFixed-dose combination · cough-cold | Banned | S.O. 4654(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Nimesulide + SerratiopeptidaseFixed-dose combination · painkillers | Quashed | S.O. 717(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Lornoxicam + Paracetamol + SerratiopeptidaseFixed-dose combination · painkillers | Quashed | S.O. 737(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Combikit of 3 Tablets of Serratiopeptidase (Enteric Coated 20000 Units) + Diclofenac Potassium & 2 Tablets of DoxycyclineFixed-dose combination · painkillers | Quashed | S.O. 742(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Doxycycline + SerratiopeptidaseFixed-dose combination · antibiotics | Quashed | S.O. 765(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Amoxicillin + Dicloxacillin + SerratiopeptidaseFixed-dose combination · antibiotics | Quashed | S.O. 771(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Roxithromycin + SerratiopeptidaseFixed-dose combination · antibiotics | Quashed | S.O. 904(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Guaifenesin + Bromhexine + Chlorpheniramine + Phenylephrine + Paracetamol + Serratiopeptidase (as Enteric Coated granules)10000 SP UnitsFixed-dose combination · cough-cold | Quashed | S.O. 1000(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 |
|---|---|---|---|
| Aceclofenac Paracetamol Serratiopeptidase | 24 | 22 | Sep 2026 |
| Serratiopeptidase | 7 | 5 | Jun 2026 |
| Meloxicam Paracetamol Serratiopeptidase Bolus | 4 | 4 | Sep 2026 |
| Diclofenac Potassium Serratiopeptidase | 2 | 2 | Sep 2026 |
| Diclofenac Potass Um Serratiopeptidase | 1 | 1 | Aug 2026 |
| Aceclofena Paracetamol Serratiopeptidase | 1 | 1 | Dec 2025 |
| Aceclofenac Paracetamol Serratiopeptidase Getwalk Sp | 1 | 1 | Dec 2025 |
| Acclofenac Paracetamol Serratiopeptidase | 1 | 1 | Oct 2025 |
| Spade Serratiopeptidase | 1 | 1 | Sep 2025 |
| Diclofenac Potassium Paracetamol Serratiopeptidase | 1 | 1 | Jul 2025 |
| Diclofenac Paracetamol Serratiopeptidase | 1 | 1 | Mar 2024 |
| Diclofenac Sodium Paracetamol Serratiopeptidase | 1 | 1 | Jul 2023 |
| Sn Plus | 1 | 1 | Jul 2023 |
| Dsp | 1 | 1 | Dec 2022 |
| Atriflam | 1 | 1 | May 2019 |
Most recent failed batches
| 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 48 records
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.