Regulatory status record
Is Serratiopeptidase banned in India?
Last checked 19 September 2026. A few details are still being checked against the original document.
Serratiopeptidase as a single ingredient is not banned in India as of 19 Sep 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, being verified
- Latest action
- 11 June 2026
- Last checked
- 19 September 2026details being verified
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.
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 Always check the linked government document for the current position, and tell us if something is out of date.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
- 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 / combination | Action | Notification | Date | Status note |
|---|---|---|---|---|
| Amoxicillin + Serratiopeptidase + Lactobacillus Sporogenes | Banned | S.O. 3070(E) | 11 June 2026 | Prohibited under s.26A with immediate effect, 11.06.2026 (CDSCO list published 21.07.2026). |
| Amoxicillin + Serratiopeptidase | Banned | S.O. 3072(E) | 11 June 2026 | Prohibited under s.26A with immediate effect, 11.06.2026 (CDSCO list published 21.07.2026). |
| Amoxicillin + Cloxacillin + Lactic Acid Bacillus + Serratiopeptidase | Banned | S.O. 3081(E) | 11 June 2026 | Prohibited under s.26A with immediate effect, 11.06.2026 (CDSCO list published 21.07.2026). |
| Cefuroxime + Serratiopeptidase | Banned | S.O. 3083(E) | 11 June 2026 | Prohibited under s.26A with immediate effect, 11.06.2026 (CDSCO list published 21.07.2026). |
| Cephalexin Monohydrate + Serratiopeptidase | Banned | S.O. 3414(E) | 2 August 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Doxycycline HCl + Betacyclodextrin + Serratiopeptidase | Banned | S.O. 3420(E) | 2 August 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Etodolac + Paracetamol + Serratiopeptidase | Banned | S.O. 3422(E) | 2 August 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Dicyclomine + Serratiopeptidase | Banned | S.O. 193(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. |
| Nimesulide + Serratiopeptidase | Banned | S.O. 4389(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
| Lornoxicam + Paracetamol + Serratiopeptidase | Banned | S.O. 4408(E) | 7 September 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 Doxycycline | Banned | S.O. 4412(E) | 7 September 2018 | In force per CDSCO list as on 22.11.2021 |
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 |
|---|---|---|---|---|---|
| Aceclofenac, Paracetamol and Serratiopeptidase Tablets | F9AHY065Mfg 2025-10 · Exp 2027-09 | Pharma Force Lab 53-55Himachal Pradesh | Identity test negative for Aceclofenac and Content of ParacetamolOther | Lucknow LabState lab | Jul 2026 |
| Aceclofenac, Paracetamol & Serratiopeptidase Tablets | TG25-1919BMfg 2025-10 · Exp 2027-09 | Menrik Biomerge Pvt. Ltd. 5Delhi | Content of AceclofenacOther | GORAKHPUR LAB, UPState lab | Jul 2026 |
| Aceclofenac 100 mg, Serratiopeptidase 15 mg & Paracetamol 325 mg Tablets | FND0825055AKMfg 2025-12 · Exp 2028-05 | Ipca Laboratories Ltd. Unit-IISikkim | Identity test negative for Aceclofenac and ParacetamolOther | Lucknow LabState lab | Jul 2026 |
| Serratiopeptidase Tablets I P 10 mg | MT260002Mfg 2026-01 · Exp 2027-12 | Mancare Laboratories Pvt LtdUttarakhand | It fails the test Disintegration as per IPDisintegration | RDTL ErnakulamState lab | Jun 2026 |
| Aceclofenac, Paracetamol & Serratiopeptidase Tablets | FND0826009AKMfg 2026-02 · Exp 2028-07 | Ipca Laboratories LtdUttarakhand | Description Rough surface on each Tablets.Description | SDFTL US Nagar,UKState lab | Jun 2026 |
| Aceclofenac, Paracetamol and Serratiopeptidase Tablets | C24T140EMfg 2025-01 · Exp 2026-12 | Cartel LaboratoriesTelangana | Assay for SerratiopeptidaseAssay | DTL, Bengaluru, KarnatakaState lab | Apr 2026 |
| Serratiopeptidase Tablets IP | MT250227Mfg 2025-02 · Exp 2027-01 | Mancare Laboratories Pvt.LtdUttarakhand | DisintegrationDisintegration | RDTL, ErnakulamState lab | Mar 2026 |
| Meloxicam, Paracetamol & Serratiopeptidase Bolus (Vet.) | T-24451Mfg 2024-11 · Exp 2027-10 | Minil Laboratories Pvt. LtdJammu & Kashmir | Assay for SerratiopeptidaseAssay | DTL, Bengaluru, KarnatakaState lab | Feb 2026 |
| Aceclofenac, Paracetamol & Serratiopeptidase Tablets | ST-2531Mfg 2025-04 · Exp 2027-03 | Stafford Laboratories Pvt. LtdUttarakhand | The sample does not conform to the claim with respect to Assay of Aceclofenac.Assay | DTL JodhpurState lab | Feb 2026 |
| Aceclofenac, Paracetamol & Serratiopeptidase Tablets (100mg/325mg/15mg) | GT50230Mfg 2025-07 · Exp 2027-06 | Omega PharmaUttarakhand | The sample does not conform to Manufacturer Method with respect to Assay of Serratiopeptidase.Assay | CDL, KolkataCDSCO lab | Feb 2026 |
| Aceclofenac, Paracetamol & Serratiopeptidase Tablets | APSP-45Mfg 2025-04 · Exp 2027-03 | Franklin Laboratories (India) Pvt. LtdUttarakhand | DescriptionDescription | RDTL, Bellary, KarnatakaState lab | Jan 2026 |
| Aceclofenac, Paracetamol & Serratiopeptidase Tablets | MDT-4458Mfg 2025-09 · Exp 2027-08 | Mayasha LifesciencesHimachal Pradesh | The sample does not conform to the claim with respect to Assay of Aceclofenac.Assay | DTL JaipurState lab | Jan 2026 |
| Aceclofenac, Paracetamol & Serratiopeptidase Tablets Getwalk-SP) | SSPT-01929Mfg 2024-06 · Exp 2027-05 | Savya Pharmaceuticals | The sample does not conform to the claim with respect to Assay of Aceclofenac.Assay | DTL, JaipurState lab | Dec 2025 |
| Aceclofena? Paracetamol & Serratiopeptidase Tablets | RT2506062Mfg 2025-06 · Exp 2027-05 | Shri Ramesh Industry Pvt LtdHimachal Pradesh | The sample does not conform to the claim with respect to in Assay.Assay | DTL, JaipurState lab | Dec 2025 |
| Serratiopeptidase Tablets IP | MT240928Mfg 2024-10 · Exp 2026-09 | Plot No.11Uttarakhand | Sample fails the test DisintegrationDisintegration | DTL, Thiruvananthapuram, KeralaState lab | Oct 2025 |
Official sources and primary records
- Medical Dialogues: Health ministry bans 16 FDCs including amoxicillin + serratiopeptidase, full listNewsMedical Dialogues
- Business Standard: Centre bans sale, manufacture of 16 FDC drugs over public health concernsNewsBusiness Standard · 20 June 2026
- TheHealthMaster: India bans 16 fixed-dose combination drugsNewsTheHealthMaster · 22 June 2026
- CDSCO: List of prohibited FDC drugs, 156 FDCs dated 02.08.2024RegulatorCDSCO · 2 August 2024
- Business Today: India halts 35 drug combinations over health risks, full listNewsBusiness Today · 17 April 2025