CDSCO Bans Chloramphenicol, Nitrofurans in food producing animal rearing system

New Delhi: The Central Drug Standard Control Organisation (CDSCO), Ministry of Fertiliser and Chemicals, Government of India, has banned the import, manufacture, sale, and distribution of drug formulations containing chloramphenicol and nitrofurans for use in any food-producing animal rearing system, with immediate effect due to the safety risks associated with their use.

This came in exercise of powers conferred by Section 26A of the Drugs and Cosmetics Act, 1940, and after consultation with the Drugs Technical Advisory Board.

Section 26A of the Drugs and Cosmetics Act, 1940, empowers the Central Government to regulate, restrict, or prohibit the manufacture, sale, or distribution of drugs and cosmetics in the public interest.

According to the notice, the Central Government is satisfied that the use of drug formulations containing chloramphenicol or nitrofurans drugs is likely to involve risk in any food-producing animal rearing system, whereas safer alternatives to the said drugs are available.

In addition, the notice stated that the Central Government is satisfied that it is necessary and expedient in the public interest to prohibit the import, manufacture, sale, and distribution of all formulations containing chloramphenicol or nitrofurans drugs for use in any food-producing animal rearing system.

Chloramphenicol is an antibiotic and is in the class of antimicrobials that inhibits protein synthesis. Chloramphenicol inhibits microbial protein synthesis by binding to the 50 S subunit of the 70 S ribosome and inhibiting the action of peptidyl transferase, thus preventing peptide bond formation. This mechanism also prevents the binding of aminoacyl transfer RNA to the peptidyl transferase active site.

Nitrofurans are a class of synthetic antibacterial drugs. They are broad-spectrum antibiotics with a history of use in treating bacterial infections, including in livestock, but concerns about toxicity and resistance have led to some restrictions. The mechanism of action of nitrofurantoin is unique. It is decreased by bacterial flavoproteins to reactive intermediates that inhibit bacterial ribosomes and other macromolecules. Protein synthesis, aerobic energy metabolism, DNA and RNA synthesis, and cell wall synthesis are inhibited.

In exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940, and after consultation with the Drugs Technical Advisory Board, the Central Government has prohibited the import, manufacture, sale and distribution of the following drugs, for use in any food producing animal rearing system, with immediate effect, namely

"(1) Chloramphenicol and its formulations; and

(2) Nitrofurans and its formulations."

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