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. The DCC functions as the advisory committee to the Central Drugs Standard Control Organization (CDSCO), the central drug regulatory agency.
This decision follows deliberations at the 63rd DCC meeting held on January 30, 2024, detailed the minutes of the meeting released February 14, 2024 on the DCC website.
The DCC’s decision stems from concerns raised by Marine Products Export Development Authority (MPEDA), 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. In this regard, Delhi-based think tank Centre for Science and Environment (CSE) reached out to MPEDA to understand the context and rationale behind this representation. However, until the time of publishing this article, a response from MPEDA is still awaited.
As per Coastal Aquaculture Authority (CAA) guidelines, 20 antibiotics and other pharmacologically active substances are banned for use in shrimp aquaculture. This includes chloramphenicol and types of nitrofurans, including furaltadone, furazolidone, furylfuramide, nifuratel, nifuroxime, nifurprazine, nitrofurantoin and nitrofurazone.
Despite these restrictions, their detection in exported shrimp is a matter of significant concern, leading to shipment rejections, especially for markets with strict regulations like the European Union, United States and Japan. This poses a barrier to expanding trade into these markets.
The DAHD’s regulatory subcommittee, the Empowered Committee on Animal Health (EACH), reviewed MPEDA’s proposal and conveyed its support in a memorandum on October 6, 2023. Following this endorsement, MPEDA has requested the Union Ministry of Health and Family Welfare (MoHFW) to implement the ban.
Earlier in 2019, MoHFW banned colistin, a last-resort antibiotic listed as a highest priority critically important antimicrobial (HPCIA) by the World Health Organization (WHO), in food-producing animals, poultry, aquaculture, and animal feed supplements. A 2021 report by CSE shed light on the use of many HPCIAs and critically important antimicrobials (CIA) in animal food production sectors in India.
The DCC members opined in the meeting that chloramphenicol and nitrofurans are also often misused in poultry and other animal feed supplements. This misuse can contribute to the development of antibiotic-resistant bacteria and the global health issue of antimicrobial resistance (AMR).
Chloramphenicol, recognised by the WHO as a Highly Important Antimicrobial (HIA), is a broad-spectrum antibiotic used for various infections, including superficial eye infections, enteric fever, typhoid fever and central nervous system infections such as acute bacterial meningitis, according to the National Centre for Disease Control’s treatment guidelines.
Nitrofuran derivatives are classified as Important Antimicrobials (IA) by WHO. Nitrofurantoin, a type of nitrofuran derivative, is used for treating urinary tract infections. Many countries, including parts of the European Union and the USA, have already banned the use of nitrofurans in food-producing animals.
Thus, the DCC’s recommendation for banning chloramphenicol and nitrofurans is an important step. If implemented, the ban would be a significant measure towards controlling antibiotic misuse for medically important antibiotics beyond HPCIAs and CIAs, thus preserving the efficacy of these drugs for human medicine.
The DCC’s decision also aligns with previous actions taken by the Food Safety and Standards Authority of India (FSSAI), which, in a notification dated July 20, 2018, stated that the use of several antibiotics and veterinary drugs, including nitrofurans and chloramphenicol, are not permitted at any stage in the processing of 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.
The DCC’s recommendation now awaits final approval from the Drugs Technical Advisory Board (DTAB), the highest decision-making body on drug regulations in India. The committee’s recommendations in this matter will be placed before DTAB in its forthcoming meeting for its consideration, as confirmed to CSE by a DCC committee member via email.
Source: Down To Earth
