Deputy State Drugs Controller |
Food and Drugs Administration, Haryana, India. |
Email ID: fdazone@gmail.com
Food and Drugs Administration, Haryana, India. |
Email ID: fdazone@gmail.com
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Last Updated on April 1, 2024 by Lalit Kr. Goel
Ketamine
Ketamine, a well-known anaesthetic and analgesic drug, has garnered attention not only for its medical applications but also for its classification under regulatory frameworks.
Understanding Ketamine’s Classification
The Categorization Process
- Ketamine’s classification as a psychotropic substance was formalized through notification no. S.O. 311(E) dated 10.02.2011, issued by the Department of Revenue, Ministry of Finance, Government of India.
- Ketamine also classifies as small quantity (10gm) and commercial quantity (500gm) under NDPS Act 1985 vide notification No. S.O. 1430(E) dated 21.06.2011 issued by the Department of Revenue, Ministry of Finance, Government of India.
Scheduled X Drug Declaration:
- Further, it was declared as a Scheduled X drug under notification no. GSR 724(E) dated 07.11.2013, issued by the Department of Health, Ministry of Health and Family Welfare, Government of India.
Regulatory Requirements for Ketamine
Mandatory Label Warnings
Labelling Mandates
- Both warnings for psychotropic substances and Scheduled X drugs are obligatory to be printed on the label of ketamine.
- NRx should be printed in red colour on the top left corner on the label.
Licensing Regulations
Necessity of Separate License
- Manufacturing and sale of ketamine drug require a separate license under Schedule X, as mandated by regulatory authorities.
- Ketamine is not Essential Narcotics Drugs (END) for the purpose of Recognized Medical Institute (RMI).
Compliance and Enforcement
Ensuring Adherence to Regulations
Regulatory Oversight
- Regulatory bodies enforce stringent measures to ensure compliance with labelling requirements and licensing regulations for ketamine
Monitoring Supply Chains
- Inspection and monitoring of supply chains are conducted to verify adherence to regulatory mandates concerning ketamine
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