News Excerpt:
Apex advisory body Drugs Consultative Committee (DCC) has recommended a complete ban on the import, production, distribution and sale of two antibiotics — chloramphenicol and nitrofurans — for use in food animal production systems.
Background of the Recommendation
- The DCC’s decision stems from concerns raised by the Marine Products Export Development Authority (MPEDA).
- MPEDA is the nodal agency for the development of the seafood industry in India, especially focusing on exports of marine products.
- In May 2023, MPEDA submitted a representation to the Department of Animal Husbandry and Dairying (DAHD) proposing a ban on the import and production of these two drugs.
- Many countries, including parts of the European Union and the USA, have already banned nitrofurans in food-producing animals
Existing Regulations and Concerns
- Coastal Aquaculture Authority (CAA) guidelines already ban 20 antibiotics and pharmacologically active substances in shrimp aquaculture.
- This includes chloramphenicol and types of nitrofurans, including furaltadone, furazolidone, furylfuramide, nifuratel, nifuroxime, nifurprazine, nitrofurantoin and nitrofurazone.
- Despite existing restrictions, detection of these antibiotics in exported shrimp has led to shipment rejections.
- This affects exports to markets with strict regulations like the European Union, United States, and Japan.
- In 2019, the Ministry of Health and Family Welfare banned colistin, an antibiotic, in food-producing animals, poultry, aquaculture, and animal feed supplements.
|
Chloramphenicol:
Nitrofurans:
Misuse and Implications of the use of the two drugs:
|
Alignment with Previous Regulations
- The DCC's recommendation aligns with a 2018 Food Safety and Standards Authority of India (FSSAI) notification.
- FSSAI prohibited the use of several antibiotics, including nitrofurans and chloramphenicol, in processing meat, poultry, eggs, seafood, and fishery products.
- The notification established stringent maximum residue limits of 0.001 milligrams per kilogram for these antibiotics, except for chloramphenicol, which has an even stricter limit of 0.0003 mg/kg.
Significance of the Proposed Ban
- It would be a significant step towards controlling antibiotic misuse beyond Highest Priority Critically Important Antimicrobials (HPCIAs) and Critically Important Antimicrobials (CIAs).
- The ban aims to preserve the efficacy of these drugs for human medicine.
Way Forward:
- The DCC's recommendation now awaits final approval from the Drugs Technical Advisory Board (DTAB).
- DTAB is the highest decision-making body on drug regulations in India.
- The recommendation will be considered in an upcoming DTAB meeting.
