TAG: GS 3: SCIENCE AND TECHNOLOGY
THE CONTEXT: Following a significant policy shift in 2019 that banned the use of colistin in food-producing animals, the Central Drugs Standard Control Organization (CDSCO) is poised to recommend a further prohibition on two additional antibiotics: chloramphenicol and nitrofurans.
EXPLANATION:
- This recommendation comes from the Drugs Consultative Committee (DCC), an apex advisory body within CDSCO, in response to ongoing concerns about antibiotic misuse and food safety.
Background and Context
- The move to ban chloramphenicol and nitrofurans follows deliberations at the DCC’s 63rd meeting held on January 30, 2024.
- Detailed minutes of the meeting, released on February 14, 2024, highlighted that the recommendation stems from a representation by the Marine Products Export Development Authority (MPEDA) to the Department of Animal Husbandry and Dairying (DAHD).
- MPEDA, the nodal agency for seafood industry development in India, particularly in relation to exports, has emphasized the need to control the use of these antibiotics.
Previous Bans
- In 2019, the Ministry of Health and Family Welfare (MoHFW) banned colistin, a critically important last-resort antibiotic, in food-producing animals.
- This was in line with the World Health Organization’s (WHO) classification of colistin as a Highest Priority Critically Important Antimicrobial (HPCIA).
- A 2021 report by the Centre for Science and Environment (CSE) highlighted the use of several HPCIAs and other critically important antimicrobials in animal food production in India.
Current Recommendations
- The DCC has now proposed a complete ban on the import, production, distribution, and sale of chloramphenicol and nitrofurans for use in food animal production systems.
- This decision is supported by various regulatory bodies and agencies, including the Coastal Aquaculture Authority (CAA), which has already listed these substances among the 20 antibiotics banned for use in shrimp aquaculture.
Specific Antibiotics Targeted
- Chloramphenicol:
- broad-spectrum antibiotic recognized by WHO as a Highly Important Antimicrobial (HIA).
- It is used for treating infections like superficial eye infections, enteric fever, typhoid fever, and acute bacterial meningitis.
- Nitrofurans:
- Classified as Important Antimicrobials (IA) by WHO, nitrofuran derivatives like nitrofurantoin are used for treating urinary tract infections.
- The banned nitrofuran types include furaltadone, furazolidone, furylfuramide, nifuratel, nifuroxime, nifurprazine, nitrofurantoin, and nitrofurazone.
Rationale for the Ban
- The misuse of chloramphenicol and nitrofurans in poultry and animal feed supplements has been identified as a significant contributor to the development of antibiotic-resistant bacteria.
- It was posing a global health risk due to antimicrobial resistance (AMR).
- Detection of these antibiotics in exported shrimp has led to shipment rejections, particularly from markets with stringent regulations like the European Union, the United States, and Japan, thus impacting trade.
Support and Implementation
- The DAHD’s Empowered Committee on Animal Health (EACH) reviewed MPEDA’s proposal and supported the ban in a memorandum dated October 6, 2023.
- Following this endorsement, MPEDA requested MoHFW to implement the ban.
- The DCC’s recommendation aligns with previous actions by the Food Safety and Standards Authority of India (FSSAI), which set stringent residue limits for these antibiotics in food products.
Regulatory Process and Future Steps
- The DCC’s recommendation awaits final approval from the Drugs Technical Advisory Board (DTAB), the highest decision-making body on drug regulations in India.
- The DTAB will consider these recommendations in its forthcoming meeting, as confirmed by a DCC committee member.
Central Drugs Standard Control Organization (CDSCO)
- The Central Drugs Standard Control Organisation (CDSCO) is India’s national regulatory body for cosmetics, pharmaceuticals and medical devices.
- It serves a similar function to the Food and Drug Administration (FDA) of the United States or the European Medicines Agency of the European Union.
- The Indian government has announced its plan to bring all medical devices, including implants and contraceptives under a review of the Central Drugs and Standard Control Organisation (CDSCO).
- Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceutical and medical devices and is positioning within the Ministry of Health and Family Welfare.
- The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC).
- Divided into zonal offices, each one carries out pre-licensing and post-licensing inspections, post-market surveillance, and drug recalls (where necessary).
- Manufacturers who deal with the authority required to name an Authorized Indian Representative (AIR) to represent them in all dealings with the CDSCO in India.
