Colistin Prohibition Act
Colistin Prohibition Act
Identity
A statutory drug restriction legally banning the manufacture, retail sale, distribution, and clinical administration of the antibiotic colistin and its formulations in food-producing animals.
Overview
Enacted by the Ministry of Health and Family Welfare in July 2019, the Colistin Prohibition Act imposes an absolute ban on colistin across poultry farms, animal feed manufacturing, and aquaculture. By prohibiting its use as an agricultural growth promoter or prophylactic, the legislation aims to protect colistin's efficacy as a last-resort drug for human multi-drug resistant Gram-negative infections.
Structured Facts
Classification
Statutory Standards & Regulations
Purpose
To interrupt the transfer of the plasmid-mediated mcr-1 resistance gene to human populations, preserving the clinical efficacy of polymyxin antibiotics in human critical care.
Scope & Applicability
Applies comprehensively to food-producing animals, poultry farms, aquaculture operations, and animal feed manufacturing. Completely prohibits any use of Colistin and its formulations.
Regulatory Requirements
Any detection of Colistin in poultry meat, eggs, or compound animal feed is a regulatory violation.
Compliance Criteria
Manufacturers of animal medications and feed additives must affix a distinct warning label on all veterinary drug packaging prohibiting its use in food-producing animals.
Monitoring & Inspection
Compliance is monitored through random feed sampling at mills and tissue residue testing in processing facilities.
Penalties / Non-Compliance
Off-label clinical use triggers prosecution for regulatory violation and contributes to the emergence of antimicrobial resistance.
Best Practices
Implement improved biosecurity protocols, dry cleaning systems, and feed-grade probiotics to maintain flock health without prohibited antimicrobials.
Quantitative Data
- Maximum Permissible Limits: The Extraneous Maximum Residue Limit (EMRL) is set to a strict 0.001 mg/kg (1.0 µg/kg), representing the baseline analytical limit of quantification.
- Compliance Thresholds: Absolute ban; any detectable trace above 0.001 mg/kg constitutes a violation.
- Unit: mg/kg or µg/kg
Relationships
- Biosecurity: Biosecurity protocols
- Diseases: Colibacillosis, Salmonella
- Medicines: Colistin & its formulations
- Regulatory Authorities: Ministry of Health and Family Welfare (MoHFW)