Antibiotics in explained: this guide covers what it means, who it applies to, the step-by-step process, documents required, fees, due dates and penalties in India — so you can stay compliant with confidence and avoid costly mistakes.
Regulation 2.3.2, headed "Antibiotic and other pharmacologically active substances", has four clauses. Clause (1) fixes tolerance limits for four antibiotics in seafood, clause (2) lists veterinary drugs that may not be used at any stage of production of animal foods, clause (3) deals with antibiotics in honey, and clause (4) is the large veterinary drug Table covered in our next article. Seafood and honey exporters can get reports reviewed through FSSAI compliance support.
This article reads the text as amended up to 14 May 2026 (FSSAI Compendium Version IX dated 03.02.2026, consolidated to the notification of 17 October 2024; the Amendment Regulations, 2026 of 14 May 2026 apply from 1 December 2026). FSSAI compendia are reference consolidations and the Gazette text prevails. Later notifications should be checked on fssai.gov.in.
Clause (1) fixes tolerance limits, in mg/kg (ppm), for four antibiotics on seafood: tetracycline, oxytetracycline, trimethoprim and oxolinic acid. Clause (2) names fourteen antimicrobials and other drugs that are not permitted at any stage of production of meat, milk, poultry, eggs and aquaculture products, with an extraneous maximum residue limit of 0.001 mg/kg, and 0.0003 mg/kg for Chloramphenicol. Clause (3) forbids antibiotics in honey production and sets limits for testing misuse. From 1 December 2026 clause (1) is omitted. Seafood exporters, apiaries, packers, dairies and poultry farms are affected.
Clause (1): antibiotics on seafood
The amount of antibiotic in column (2), on sea foods including shrimps, prawns or any other variety of fish and fishery products, shall not exceed the tolerance limit in column (3). The Table is in mg/kg (ppm).
| S.No. | Name of antibiotic | Tolerance limit mg/kg (ppm) |
|---|---|---|
| 1 | Tetracycline | 0.1 |
| 2 | Oxytetracycline | 0.1 |
| 3 | Trimethoprim | 0.05 |
| 4 | Oxolinic acid | 0.3 |
Clause (2): drugs not permitted in food animal production
Substituted by the notification of 17 October 2024 (footnote 16), clause (2) says the following antimicrobials and other drugs used in veterinary practices are not permitted to be used at any stage of production of meat and meat products, milk and milk products, poultry and eggs, aquaculture and its products. The Extraneous Maximum Residue Limits (EMRL) of 0.001 mg/kg shall be applicable, except for Chloramphenicol, for which it shall be 0.0003 mg/kg (0.3 ug/kg).
The list as printed, by name:
- Carbadox
- Chloramphenicol
- Chlorpromazine
- Clenbuterol
- Colistin
- Crystal Violet (Sum of Crystal Violet and Leucocrystal Violet)
- Glycopeptides
- Malachite Green (Sum of Malachite green and Leucomalachite green)
- Nitrofurans and its metabolites furazolidone (AOZ), nitrofurazone (SEM), furaltadone (AMOZ) and nitrofurantoin (AHD)
- Streptomycin and its metabolite dihydrostreptomycin
- Nitroimidazoles, including Dimetridazole (DMZ), Ronidazole (RNZ) and its metabolite HMMNI, Ipronidazole (IPZ) and its metabolite Hydroxyipronidazole, and Metronidazole (MNZ) and its metabolite 3 hydroxymetronidazole
- Steroids
- Stilbenes
- Sulphamethoxazole
The structure is a prohibition on use plus a residue figure. Because the drug is not permitted at any stage, the EMRL is not a permission to use it. It is the figure the regulation prints for extraneous residues. An invented example: Delta Shrimp Farms receives a lab report showing Chloramphenicol in a batch of prawns. Clause (2) prints 0.0003 mg/kg for that substance and 0.001 mg/kg for the other listed drugs, and use at any stage of production is not permitted.
Clause (3): antibiotics in honey
The use of any antibiotic is not permitted during honey production. To test for misuse of antibiotics, the antibiotics in column (2) shall not exceed the Minimum Required Performance Limit (MRPL) in column (3), stated in ug/kg. The Table has eleven serial numbers.
Sample rows exactly as printed (MRPL in ug/kg)
| Serial | Name of antibiotics | MRPL |
|---|---|---|
| 1 | Chloramphenicol | 0.3 |
| 2 | Nitrofurans and its metabolites | 1 |
| 3 | Sulphonamides and its metabolites | 10 either individually or collectively |
| 4 | Streptomycin | 10 either individually or collectively |
| 5 | Tetracycline | 10 |
| 6 | (a) Oxytetracycline; (b) Chlortetracycline | 10 each |
| 7 to 11 | Ampicillin, Enrofloxacin, Ciprofloxacin, Erythromycin, Tylosin | 10 each |
The column heading in the compendium reads "Maximum Residue Performance Limit (MRPL)", while the clause text says "Minimum Required Performance Limit"; both abbreviations are printed as MRPL. For the honey product standard, see our post on honey standards and purity testing.
Notified change, in force from 1 December 2026
The Contaminants, Toxins and Residues Amendment Regulations, 2026 (14 May 2026) come into force on 1st December, 2026. Until then clause (1) and its four-row Table stand as printed above. From that date, in sub-regulation 2.3.2, clause (1) is omitted. Two entries are added to the clause (4) Table, which carries the veterinary drug limits: against serial number 45 (Trimethoprim) an entry for "Sea foods including shrimps, prawns or any other variety of fish and fishery products" with 0.05 is inserted, and a new serial number 50 for Oxolinic acid is inserted after serial 49, for the same sea foods, with 0.3. The details of clause (4) are in our article on veterinary drug residues.
So from that date, the seafood limits for trimethoprim and oxolinic acid sit in clause (4). The amendment adds no entry for tetracycline or oxytetracycline, so exporters should compare the two Tables before December 2026.
Where this fits
The pesticide Table that precedes this regulation is in our article on regulation 2.3.1. The Act's section on residues is section 21 of the FSS Act. For a general overview, see pesticide residues and antibiotics in food. Seafood and honey exporters who want help reading test reports against these Tables can ask for FSSAI compliance support.
Need help with antibiotic residue compliance?
Residue reports for seafood and honey often come from overseas buyers as well as Indian labs, and each uses its own units. Our FSSAI compliance support service helps map a report to the Table line the Regulations print.
Key takeaways
- Clause (1) lists four antibiotics for seafood in mg/kg (ppm); it is omitted from 1 December 2026.
- Clause (2) names fourteen drug groups not permitted at any stage of animal food production, with EMRL 0.001 mg/kg (Chloramphenicol 0.0003 mg/kg).
- Clause (3) bars antibiotics in honey production and sets MRPL figures in ug/kg.
- The trimethoprim and oxolinic acid seafood limits move into clause (4) from 1 December 2026.
Read next
- Regulation 2.3.2(4): veterinary drug residues
- Regulation 2.3.1: pesticide MRL Table
- Pesticide residues and antibiotics in food
- Honey standards: purity and testing
Disclaimer: Based on the FSSAI regulations named above as consolidated in FSSAI's compendium versions or as published in the Gazette, with the later notifications the article names (consulted on fssai.gov.in on 2-3 October 2026). Later notifications and the Food Safety and Standards Act, 2006 provisions referred to should be checked. This article is general information, not legal advice; check the official text before acting.