This notification, S.O. 2607(E), issued by the Ministry of Health and Family Welfare, Department of Health and Family Welfare, Government of India, prohibits the manufacture, sale, and distribution of the drug Colistin and its formulations for use in food-producing animals, poultry, aqua farming, and animal feed supplements, effective July 19, 2019. This decision follows recommendations from the Drugs Technical Advisory Board, which considered the potential risk to human health associated with such use. The notification, issued under the authority of Section 26A of the Drugs and Cosmetics Act, 1940, also mandates that manufacturers of Colistin and its formulations label drug containers and include package inserts and promotional literature with the conspicuous warning: "NOT TO BE USED IN FOOD PRODUCING ANIMALS, POULTRY, AQUA FARMING AND ANIMAL FEED SUPPLEMENTS." The notification is referenced as F. No. X. 11014/8/2019-DR and was issued by Dr. Mandeep K. Bhandari, Joint Secretary.
Key Entities Referenced
Ministry of Health and Family Welfare: A department of the Government of India responsible for health policy.
Colistin: A drug whose manufacture, sale, and distribution for use in food-producing animals, poultry, aqua farming, and animal feed supplements is prohibited.
Drugs Technical Advisory Board: An advisory board that considered the matter of Colistin use and recommended its prohibition for food-producing animals, poultry, aqua farming, and animal feed supplements.
Drugs and Cosmetics Act, 1940: An act of the Indian Parliament under which the Central Government prohibits the manufacture, sale, and distribution of Colistin for specific uses. Section 26A is specifically mentioned.
Central Government: The government of India, which issued the notification prohibiting the use of Colistin.
New Delhi: The location where the notification was issued.
Mandeep K. Bhandari: Joint Secretary who signed the notification.
Mayapuri, New Delhi: Location of the Government of India Press.
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[फा. सं. ए!स.11014/8/2019-डीआर]
डॉ. मनदीप के. भX डारी, संयु!त सिचव
3729 GI/2019 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 19th July, 2019
S.O. 2607(E).—Whereas, it is brought to the notice of the Central Government that the use of the
drug Colistin and its formulations for food producing animals, poultry, aqua farming and animal feed
supplements is likely to involve risk to human beings;
And whereas, the Drugs Technical Advisory Board has considered the said matter and recommended
for prohibiting the said drug and its formulations for food producing animals, poultry, aqua farming and
animal feed supplements;
And whereas, the Central Government is satisfied that it is necessary and expedient in the public
interest to prohibit the manufacture, sale and distribution of the drug Colistin and its formulations for food
producing animals, poultry, aqua farming and animal feed supplements;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940
(23 of 1940), the Central Government hereby―
(a) prohibits the manufacture, sale and distribution of the following drug with immediate effect,
namely:―
“Colistin and its formulations for food producing animals, poultry, aqua farming and animal
feed supplements”; and
(b) directs that the manufacturer of Colistin and its formulations shall label the container of the drug
and mention the words “NOT TO BE USED IN FOOD PRODUCING ANIMALS, POULTRY,
AQUA FARMING AND ANIMAL FEED SUPPLEMENTS” in conspicuous manner on the
package insert and promotional literature of the said drug and its formulations.
[F. No. X. 11014/8/2019-DR]
Dr. MANDEEP K. BHANDARI, Jt. Secy.
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.