| Title | Type | Source | Release Date | Scraped | Download | Status |
|---|---|---|---|---|---|---|
| Unclassified |
CDSCO - New Drugs
Unknown
|
Jul 23, 2013
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Jul 23, 2013
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Jul 27, 2012
|
Jan 09, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Jul 27, 2012
|
Jan 09, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Jul 27, 2012
|
Jan 06, 2026
|
— | ⚠ Unavailable | |
|
Draft Guidance for Industry on requirement of Chemical & Pharmaceutical Informat...
▶ Summary
This document is a guidance issued by the Central Drugs Standard Control Organization (CDSCO) regarding the requirements for chemical and pharmaceutical information, including stability study data, needed before the approval of clinical trials and bioequivalence studies. It details the necessary data that must be submitted to assess the safety and quality of investigational drug products. The document sets out the regulatory framework and expectations for new drug formulations under the Drugs and Cosmetics Rules in India.
|
document |
CDSCO - New Drugs
Unknown
|
Jul 27, 2012
|
Dec 16, 2025
|
pdf ↓ | ✓ Relevant |
|
Draft Guidance for Industry on requirement of Chemical & Pharmaceutical Informat...
▶ Summary
This document is a draft guidance issued by the Central Drugs Standard Control Organization (CDSCO) concerning the necessary chemical and pharmaceutical information, including stability study data, required for the approval of clinical trials and bioequivalence studies in India. It outlines regulatory requirements based on the Drugs and Cosmetics Rules, providing detailed guidelines to ensure drug safety and quality before approval for clinical investigations. The guidance is intended for feedback and comments within a specified period.
|
document |
CDSCO - New Drugs
Unknown
|
Jul 27, 2012
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Jul 27, 2012
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
—
|
Dec 17, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
—
|
Dec 17, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
—
|
Dec 17, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
—
|
Dec 17, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
—
|
Dec 17, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
—
|
Dec 16, 2025
|
— | ⚠ Unavailable | |
|
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
|
—
|
Dec 12, 2025
|
doc ↓ | ✓ Relevant |
|
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.
|
document |
CDSCO - New Drugs
Unknown
|
—
|
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.
|
document |
CDSCO - New Drugs
Unknown
|
—
|
Dec 12, 2025
|
pdf ↓ | ✗ Filtered |
|
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.
|
document |
CDSCO - New Drugs
Unknown
|
—
|
Dec 12, 2025
|
pdf ↓ | ✓ Relevant |