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Other Regulations/Consumer Regulations for INDIA

Other Regulations/Consumer Regulations
Drugs and cosmetics (2nd amendment) rules, 2006, Drugs and Cosmetics Act 1940 (D&C)
2006

In 2006, ketamine hydrochloride was included in the list of prescription drugs contained in ‘Schedule H’ of the Drugs & Cosmetics Act, under which the drug could only be sold on the prescription of a registered medical practitioner (see Drugs and Cosmetics - 2nd amendment) rules, 2006. In November 2013, the Food and Drug Administration (FDA) placed ketamine under 'Schedule X' of the Drugs and Cosmetics Act 1940 (D&C), requiring pharmacists to get a special license to stock or sell the drug, besides maintaining records of every unit sold, for at least two years. The notification also warns that any hospital or pharmacy found stocking the drug without the license could be prosecuted under the Drugs and Cosmetics Act.

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