Abstract

HIGHLIGHTING KEY DIFFERENCES AND SIMILARITIES: A COMPARATIVE REVIEW ON THE SCHEDULES OF INDIA AND USA

Adarsh Thakur, *Deepika, Komal Pathania, Alpana Chandel

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Abstract

The Drugs and Cosmetics Rules, 1945, formulated under the Drugs and Cosmetics Act, 1940, provide a comprehensive framework for the classification, manufacture, sale, storage, and labelling of drugs in India. These schedules regulate pharmaceutical practices by categorizing drugs based on their use, toxicity, potential for abuse, and specific regulatory requirements. Key Indian schedules such as G, H, H1, X, and M outline guidelines for prescription drugs, narcotic and psychotropic substances, antibiotics, good manufacturing practices, and more. Comparatively, the U.S. drug scheduling system, governed by the FDA and DEA, classifies controlled substances into five categories based on abuse potential and medical utility. The document also covers schedules specific to traditional systems of medicine (Ayurveda, Siddha, Unani), cosmetics, and medical devices. The inclusion of labelling, record-keeping, and clinical trial requirements underscores the importance of pharmaceutical governance in ensuring drug safety, efficacy, and ethical compliance in India.

Keywords: Pharmaceutical Schedules, Drugs and Cosmetics Act, Schedule G, Schedule H, Schedule H1, Schedule X, Good Manufacturing Practices (GMP), Controlled Substances, Ayurveda, Siddha, Unani, FDA, Labelling, Prescription Drugs, Narcotic Drugs, Psychotropic Substa