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Contract Research and Manufacturing Services (CRAMS) in India by G Gokhale, M Antani

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Appendix 4: Schedule Y

SCHEDULE Y

[See rules 122A, 122B, 122D, 122DA, 122DAA and 122E]

REQUIREMENTS AND GUIDELINES FOR PERMISSION TO IMPORT AND/OR MANUFACTURE OF NEW DRUGS FOR SALE OR TO UNDERTAKE CLINICAL TRIALS

1. Application for permission.- (1) Application for permission to import or manufacture new drugs for sale or to undertake clinical trials shall be made in Form 44 accompanied with following data in acccordance with the appendices, namely:-

(i) chemical and pharmaceutical information as prescribed in item 2 of Appendix I;

(ii) animal pharmacology data as prescribed in item 3 of Appendix I and Appendix IV;

(a) specific pharmacological actions as prescribed in item 3.2 of Appendix I, and demonstrating, therapeutic potential for ...

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