| Title | Type | Source | Release Date | Scraped | Download | Status |
|---|---|---|---|---|---|---|
| Unclassified |
CDSCO - New Drugs
Unknown
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Dec 17, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
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—
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Dec 17, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
—
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Dec 17, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
—
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Dec 17, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
—
|
Dec 17, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
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Dec 16, 2025
|
— | ⚠ Unavailable | |
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Update_Checklist_10July2018.pdf
▶ Summary
This document outlines the application requirements and evaluation criteria for investigational new drugs (INDs), as per Appendix I of Schedule Y to the Drugs and Cosmetics Rules. It details the necessary documentation and studies involved in Phase I, II, and III clinical trials, including toxicological and pharmacological data requirements. This serves as a guideline for entities applying for permits to manufacture, import, or conduct clinical trials of new drugs in India.
|
document |
CDSCO - New Drugs
Unknown
|
—
|
Dec 12, 2025
|
pdf ↓ | ✓ Relevant |
|
New_Drugs_FAQs.doc
▶ Summary
This document is a Frequently Asked Questions (FAQs) guide about the approval process for new phytopharmaceutical drugs by the Central Drugs Standard Control Organization (CDSCO) in India. It provides detailed information on what constitutes a phytopharmaceutical drug, the requirements for clinical trials, application processes, and related fees. The document aims to inform the public about the regulations governing phytopharmaceutical drugs.
|
document |
CDSCO - New Drugs
Unknown
|
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|
Dec 12, 2025
|
doc ↓ | ✓ Relevant |
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faqonndandctRules24set25.pdf
▶ Summary
This document is a Frequently Asked Questions (FAQs) guide issued by the Central Drugs Standard Control Organization (CDSCO) regarding new drugs and clinical trials regulations in India. It provides answers to common questions about the New Drugs and Clinical Trials Rules, 2019, including definitions of terms such as 'new drug', 'investigational new drug', and 'orphan drug', as well as guidelines for academic and professional clinical trials. The purpose of this document is to create public awareness rather than to serve legal or professional advisory purposes.
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document |
CDSCO - New Drugs
Unknown
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Dec 12, 2025
|
pdf ↓ | ✓ Relevant |
|
SUGAM_user_manual.pdf
▶ Summary
This document is a user manual for the e-Governance solution of the Central Drug Standard Control Organization (CDSCO), developed by the Centre for Development of Advanced Computing (C-DAC). It provides detailed guidance on using the SUGAM portal, covering aspects such as user registration, application submissions, and various administrative functions related to drug regulatory processes. The manual is aimed at helping industry applicants navigate the online system for tasks such as obtaining licenses and regulatory approvals.
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document |
CDSCO - New Drugs
Unknown
|
—
|
Dec 12, 2025
|
pdf ↓ | ✗ Filtered |
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NDD_APPL_Organogram.pdf
▶ Summary
This document outlines the procedural pathway for the approval of drug substances and drug products by the Drugs Controller General of India (DCGI). It details the application submission process, required fees, and various stages of evaluation including facility inspection, NOC issuance for bioequivalence/clinical trial, and final regulatory approval. The document also specifies the relevant forms for permissions to import and manufacture new drug substances or formulations.
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document |
CDSCO - New Drugs
Unknown
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Dec 12, 2025
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pdf ↓ | ✓ Relevant |