India’s Marketing Regulations of Drugs
Approval of the drug product for import, manufacturing and marketing in India, its demonstration for safety and efficacy in humans is essential. The Rules 122A, 122B and 122D, 122 DA, 122DAA, 122E and Appendix I, IA and VI of Schedule Y of the Drugs & Cosmetics Act, 1945, describes the information/data required for approval of clinical trial and/or to import, manufacture, or market any new drug in the country. However, the requirements for approval of clinical trials and new drugs may vary depending on the nature of new drugs.
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