On July 19, 2019, the Central Government banned the manufacture, sale and distribution of Colistin and its formulations for food producing animals, poultry, aqua farming and animal feed supplements with immediate effect1 . The regulatory measure was taken to ensure the cautious use of anti-microbial agents in humans and animals to tackle the issue of anti-microbial resistance.
The announcement follows the 81st Meeting of Drugs Technical Advisory Board (DTAB) held on November 29, 2018 which recommended the ban of colistin. The DTAB deliberated the representation received from Dr Abdul Ghafur, Coordinator, Chennai Declaration on Antimicrobial Resistance, which demanded an immediate ban of growing promotional use of Colistin in poultry and aqua farming.
The DTAB conducted a detailed examination of the matter with the Department of Animal Husbandry, Dairying and Fisheries (DADF), Ministry of Agriculture & Farmer's Welfare and Food Safety and Standards Authority of India (FSSAI), MoHFW, has concluded that the use of Colistin as feed premix/feed supplement, is likely to involve risk to human beings.
Now, the Central Government in exercise of the powers conferred by section 26A2 of the Drugs and Cosmetics Act, 1940, and also agreeing with DTAB recommendation, has announced the immediate ban of Colistin for the use of promoting growth in livestock. in addition to the ban, the Government has also directed the manufacturers of said drug and its formulations to follow labelling requirement for the drugs and mention the words "NOT TO BE USED IN FOOD PRODUCING ANIMALS, POULTRY, AQUA FARMING AND ANIMAL FEED SUPPLEMENTS" in a conspicuous manner on the package insert and promotional literature.
About Colistin and AMR
Antimicrobial resistance (AMR) is one of the top 10 global threats to human health, driven by the overuse of antimicrobials in people, and also in animals, especially those used for food production, as well as in the environment. As a result, standard treatments become ineffective, infections persist and may spread to others. Colistin is an antibiotic produced by certain strains of the bacteria Paenibacillus polymyxa. C. Colistin is effective against most Gram-negative bacilli and considered as a last resort drug for multidrug resistant gram-negative infections such as pneumonia and bacteremia in critically ill patients. Therefore, the WHO has marked Colistin as 'Reserved' antibiotic, and recommends to use it cautiously.
Banning non-therapeutic use of colistin in animals is a significant step to tackle colistin resistance, which is part of Indian National Action Plan on AMR. And also a part of multisectoral approaches of Global Action Plan to address AMR.
2. Section 26A: Power of Central Government to prohibit manufacture, etc., of drug and cosmetic in public interest.— Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied, that the use of any drug or cosmetic is likely to involve any risk to human beings or animals or that any drug does not have the therapeutic value claimed or purported to be claimed for it or contains ingredients and in such quantity for which there is no therapeutic justification and that in the public interest it is necessary or expedient so to do, then, that Government may, by notification in the Official Gazette, regulate, restrict or prohibit the manufacture, sale or distribution of such drug or cosmetic.
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