CDSCO Directs Drug Controllers To Tighten Watch On Banned Chloramphenicol, Nitrofurans Formulations

New Delhi: In line with the ban of drug formulations containing chloramphenicol and nitrofurans for use in any food-producing animal rearing system, the Ministry of Health and Family Welfare, Government of India, has directed all state and UT drug controllers to keep a strict vigil on the manufacture, sale, and distribution of chloramphenicol and its formulations and nitrofurans and their formulations to prevent use in any food-producing animal rearing system and to take necessary action under the provisions of the Drug and Cosmetic Act and Rules.

This came as reports have appeared from time to time about the use of drug formulations containing chloramphenicol or nitrofurans; drugs are likely to involve risk in any food-producing animal rearing system in the country. Accordingly, the Ministry of Health and Family Welfare, Government of India, has taken up the matter and issued Notification on dated 12th March, 2025, S.O. 1158(E). New Delhi.

Regarding the above, earlier the Medical Dialogues Team reported that 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 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) Nitrofuran and its formulations."

Chloramphenicol is an antibiotic and is in the class of antimicrobials that inhibits protein synthesis. Chloramphenicol inhibits microbial protein synthesis by binding to the 50S subunit of the 70S 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 light of the above, the Ministry of Health and Family Welfare, Government of India, has requested all state and UT drug controllers to sensitize inspectorate staff to keep a strict vigil on the manufacture, sale, and distribution of chloramphenicol and its formulations and nitrofuran and its formulations to prevent use in any food-producing animal rearing system and to take necessary action under the provisions of the Drug and Cosmetics Act and Rules.

In addition to the above, the notice added, "Details of action taken in the matter may please be forwarded to this office for further action."

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To view the official notice, click the link below: