Regulatory status record

Is Amoxicillin + Serratiopeptidase banned in India?

Last checked 1 October 2026

Amoxicillin + Serratiopeptidase. Status: Banned since 11 Jun 2026.

Amoxicillin + serratiopeptidase has been prohibited in India since 11 Jun 2026 under S.O. 3072(E), together with its lactobacillus and cloxacillin variants; single-ingredient amoxicillin and amoxicillin + clavulanate remain legal.

Classification
Prohibited under Section 26A, Drugs and Cosmetics Act, 1940
Decided by
CDSCO / Ministry of Health and Family Welfare
Reference
S.O. 3072(E), 11 Jun 2026; related S.O. 3070(E) and S.O. 3081(E) of the same date
Evidence
Government document
Latest action
20 June 2026
Last checked
1 October 2026

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

Prohibition of 16 FDCs, S.O. 3068(E) to S.O. 3083(E) dated 11.06.2026 (CDSCO Gazette Notifications)

CDSCO / Ministry of Health and Family Welfare · S.O. 3072(E), 11 Jun 2026; related S.O. 3070(E) and S.O. 3081(E) of the same date · 11 June 2026

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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 Always check the linked government document for the current position, and tell us if something is out of date.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
Notification
S.O. 3072(E), 11 Jun 2026 (16-FDC list)
Variants also banned
+ Lactobacillus sporogenes, S.O. 3070(E); amoxicillin + cloxacillin + LAB + serratiopeptidase, S.O. 3081(E); cefuroxime + serratiopeptidase, S.O. 3083(E)
Effective
Immediate
Brands
Widely sold under many labels, mapping to be verified from 1mg/PharmEasy listings
Not affected
Amoxicillin; amoxicillin + clavulanate (Augmentin, Clavam)

Amoxicillin + serratiopeptidase was, until June 2026, one of the more widely sold antibiotic combinations in India, a common antibiotic paired with an enzyme marketed for swelling and faster recovery. On 11 June 2026 the Health Ministry prohibited it under Section 26A of the Drugs and Cosmetics Act, with immediate effect.

The notification, S.O. 3072(E), was one of 16 issued that day. Three of the others cover close relatives: amoxicillin + serratiopeptidase + lactobacillus sporogenes (S.O. 3070(E)), amoxicillin + cloxacillin + lactic acid bacillus + serratiopeptidase (S.O. 3081(E)) and cefuroxime + serratiopeptidase (S.O. 3083(E)). The ministry's stated ground, as with earlier FDC bans, was that the combination has no therapeutic justification and may involve risk to people, following a review by the expert committee and the Drugs Technical Advisory Board. The June 2026 order was reported by Medical Dialogues, Business Standard and TheHealthMaster, and we have not seen any report of a court stay.

The combination was sold under many brand names. The plan we work from asks that brand mapping be verified from retail listings before names are published, so this page lists none for now.

Single-ingredient amoxicillin and amoxicillin + clavulanate are unaffected. A patient with a prescription for the banned combination can be given amoxicillin alone at the same dose; the enzyme was never essential to the treatment.

What this means for you

Ask for plain amoxicillin

If a prescription or old pack pairs amoxicillin with serratiopeptidase, the pharmacist can dispense the antibiotic alone at the same dose.

Do not cut a course short

An antibiotic course should be completed; swap the product, not the treatment, and check with your doctor.

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

If you have this at home

  1. Check that the product name, strength, batch number and maker on your pack match this record. Only the batches or the formula named here are affected.
  2. Do not stop a medicine your doctor prescribed without talking to your doctor or pharmacist first.
  3. Keep the pack and the bill. Ask the shop that sold it to take it back.
  4. Report it to your state drug controller, or through CDSCO's consumer page. You can also check a batch number.

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).

Ingredient records

Every banned combination and failed batch containing each ingredient.

Sources

Government documents

News reports