CDSCO - Guidance for Industry - Central Drugs Standard Control ...

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Guidance for Industry Central Drugs Standard Control Organization Page 12   SECTION D: PROPOSED PHASE-I/II STUDIES (Compliance as per Schedule Y)   1. Protocol for Phase-I / II studies References: 1. Schedule – Y, Amendment version 2005, Drugs and Cosmetics Rules, 1945. 2. GCP guidelines published by CDSCO, DGHS, Govt. of India. 3. Ethical Guidelines for Biomedical Research on Human Subjects published by Indian Council of Medical Research, New Delhi.
Guidance for Industry Central Drugs Standard Control Organization Page 13   Biological products: Phase-III   TABLE OF CONTENTS SECTION A GENERAL INFORMATION SECTION B CHEMISTRY MANUFACTURING CONTROL SECTION C NONCLINICAL DATA SECTION D PROPOSED PHASE-III STUDIES NOTE: Submit two hard copies and two soft copies i.e. CD’s (PDF format). Hard copies: It must be well labeled with document number, name of the firm, date of submission etc. Number of volumes to be labeled as Volume No. / Total number of volumes e.g. if there are five volumes, volume three will be labeled as Volume: 3/5. Soft Copies: They must be well labeled with document number, name of the firm, date of submission etc. Scanned copies of only signed document like test reports will be acceptable as soft copies. The table of content under each head should be linked to the files (s) or relevant document for easy tracking in CD’s. Manufacturer should preserve/maintain one hard copy and soft copy of submitted documents in his safe custody for any future reference, if required.
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  © Central Drugs Standard Contr
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