Documents Required for Submitting an Application to DCGI
Name of Documents
Phase I (molecules which are discovered in India)
BE/BA study
(Export)- New Molecule not approved in India
Cover letter
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Protocol with Sponsor’s Signature
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Copy of NOC for conducting Pre-Clinical Study
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×
Pre-clinical data
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√
List of Investigators
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×
Form No 44
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Sponsor’s letter of Authorization
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CV & Undertaking of the Investigators
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√
Investigator’s Brochure
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×
Case Record Form
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×
Informed Consent
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×
Certificate of Analysis
√
√
Stability data
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√
Safety & Efficacy
√
√
Site approval letter
√
√
Treasury Challan (fee)
√
√
Regulatory Status of the drug in other countries
×
√
Package insert
×
√
Test license request
×
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