| Title | Type | Source | Release Date | Scraped | Download | Status |
|---|---|---|---|---|---|---|
|
Notice regarding Fixing of limit of impurities in the specification of INDs
▶ Summary
This document is an official communication from the Drugs Controller General (India) regarding the establishment of impurity limits in the specification of Investigational New Drugs (INDs). It provides insights into the processing and consideration of clinical trial applications by the CDSCO. The document originates from the office of the Drugs Standard Control Organization, emphasizing regulatory aspects of new drug development.
|
document |
CDSCO - New Drugs
Unknown
|
Feb 21, 2020
|
Dec 16, 2025
|
pdf ↓ | ✓ Relevant |
|
Notices for Streamlining Applications for New Drugs, Clinical Trials and Bioavai...
▶ Summary
This document consists of several public notices issued by the Central Drugs Standard Control Organization (CDSCO) under the Directorate General of Health Services, India. The notices address various regulatory concerns such as clarifications on BA/BE study permissions, approval processes for Fixed Dose Combinations, impurity specifications for Investigational New Drugs (INDs), and procedures for pre-submission meetings under the New Drugs and Clinical Trials Rules 2019. These notices inform stakeholders about regulatory procedures and clarifications in drug trials and approvals.
|
public notice |
CDSCO - New Drugs
Unknown
|
Feb 21, 2020
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
Notice regarding Fixing of limit of impurities in the specification of INDs
▶ Summary
The document is issued by the Drugs Standard Control Organization (CDSCO) under the Government of India, focusing on the subject of setting impurity limits in the specifications of Investigational New Drugs (INDs). It discusses the procedures for processing applications related to clinical trials. As an internal document, it addresses specifics relevant to regulatory affairs in drug control.
|
document |
CDSCO - New Drugs
Unknown
|
Feb 21, 2020
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 21, 2020
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 21, 2020
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 21, 2020
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 21, 2020
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 20, 2020
|
Jan 06, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 20, 2020
|
Jan 04, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 20, 2020
|
Dec 31, 2025
|
— | ⚠ Unavailable | |
|
Notice regarding Grant of Permission in Form CT-11/ CT-14/CT-15/ CT-17 under New...
▶ Summary
This is a public notice from the CDSCO regarding the grant of permissions for manufacturing or importing new drugs under the New Drugs and Clinical Trials Rules 2019. It addresses issues concerning the submission and processing of Form CT applications, detailing that these will be processed within seven working days. The notice provides clarity on the procedural guarantees and reorganizes the application process for trial batch approvals.
|
public notice |
CDSCO - New Drugs
Unknown
|
Feb 20, 2020
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 20, 2020
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
|
Notice regarding Grant of Permission in Form CT-11/ CT-14/CT-15/ CT-17 under New...
▶ Summary
This public notice from the Central Drugs Standard Control Organization (CDSCO) informs about the processing of applications for permissions related to new drugs under the New Drugs and Clinical Trials Rules 2019. It addresses concerns about application submissions and aims to streamline the application process, detailing that they will be processed by CDSCO offices within seven working days. The notice, issued by the Drugs Controller General of India, provides relevant information to stakeholders and CDSCO officers.
|
public notice |
CDSCO - New Drugs
Unknown
|
Feb 20, 2020
|
Dec 12, 2025
|
pdf ↓ | ✓ Relevant |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 18, 2020
|
Jan 06, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 18, 2020
|
Jan 04, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 18, 2020
|
Jan 04, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 18, 2020
|
Dec 31, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 18, 2020
|
Dec 31, 2025
|
— | ⚠ Unavailable | |
|
Notice regarding the FAQs on New Drugs and Clinical Trial dated 18/2/2020
▶ Summary
This public notice from the CDSCO provides updated FAQs related to the New Drugs and Clinical Trials Rules, 2019. It addresses applicability concerns about these rules for non-new drugs, the process for obtaining manufacturing permission for investigational drug trials, and necessary approvals for BA/BE studies. Key clarifications are made on submission procedures and regulatory requirements for drugs under these rules.
|
public notice |
CDSCO - New Drugs
Unknown
|
Feb 18, 2020
|
Dec 16, 2025
|
pdf ↓ | ✓ Relevant |
|
Notice regarding New Drugs dated 18.02.2020
▶ Summary
This document is a public notice from the Central Drug Standard Control Organization (CDSCO) in India. It updates the FAQs regarding the New Drugs & Clinical Trial Rules 2019 and addresses concerns related to the applicability of these rules and the submission process for obtaining permission to manufacture trial batches of new drugs. Key updates include clarifications on where to submit applications and modifications to several frequently asked questions.
|
public notice |
CDSCO - New Drugs
Unknown
|
Feb 18, 2020
|
Dec 16, 2025
|
pdf ↓ | ✓ Relevant |
|
Notice regarding the FAQs on New Drugs and Clinical Trial dated 18/2/2020
▶ Summary
This document is a notice from the Central Drug Standard Control Organization (CDSCO) concerning updates to FAQs on the New Drugs & Clinical Trial Rules 2019. It clarifies the applicability of these rules and provides updated guidance on the submission process for manufacturing and testing new drugs and investigational new drugs. Dr. V. G. Somani, Drugs Controller General (India), is associated with this release.
|
public notice |
CDSCO - New Drugs
Unknown
|
Feb 18, 2020
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
Notice regarding New Drugs dated 18.02.2020
▶ Summary
This document, issued by the Central Drug Standard Control Organization (CDSCO), provides updated FAQs on the New Drugs and Clinical Trial Rules 2019. It clarifies the applicability of these rules for new and investigational drugs, and details the submission process for applications related to manufacturing and study permissions. The updates aim to address concerns raised regarding rule applications for non-new drugs.
|
public notice |
CDSCO - New Drugs
Unknown
|
Feb 18, 2020
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 18, 2020
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 18, 2020
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 18, 2020
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 18, 2020
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Mar 20, 2019
|
Jan 04, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Mar 20, 2019
|
Dec 31, 2025
|
— | ⚠ Unavailable | |
|
New Drugs and Clinical Trials Rules 2019 G.S.R. 227(E)
▶ Summary
The document is an official government notification published in part II, section 3, sub-section (i) of the Extraordinary Gazette of India, dated March 19, 2019. It details the New Drugs and Clinical Trials Rules, 2019, and outlines definitions and provisions related to new drugs, clinical trials, bioavailability, and bioequivalence studies among others. This is a directive issued by the Central Government under the Drugs and Cosmetics Act, 1940.
|
order |
CDSCO - New Drugs
Unknown
|
Mar 20, 2019
|
Dec 16, 2025
|
pdf ↓ | ✓ Relevant |
|
New Drugs and Clinical Trials Rules 2019 G.S.R. 227(E)
▶ Summary
This document is a public notice published in the Gazette of India, Extraordinary Issue, concerning the Drugs and Cosmetics Act, 1940. Issued by the Ministry of Health and Family Welfare, it announces the publication of the New Drugs and Clinical Trials Rules, 2019. These rules concern the regulation and standards for new drugs and clinical trials in India.
|
public notice |
CDSCO - New Drugs
Unknown
|
Mar 20, 2019
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Mar 20, 2019
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Mar 20, 2019
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 09, 2018
|
Jan 06, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 09, 2018
|
Jan 06, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 09, 2018
|
Jan 04, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 09, 2018
|
Jan 04, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 09, 2018
|
Jan 01, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 09, 2018
|
Dec 31, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 09, 2018
|
Dec 31, 2025
|
— | ⚠ Unavailable | |
|
newdrug_advisory_commitee
▶ Summary
This order, issued by the Ministry of Health & Family Welfare, Government of India, details the constitution of the New Drug Advisory Committee (NDAC) to advise the Drugs Controller General of India in matters regarding the review of new drug applications and clinical trials. It includes the composition of the committee and outlines its terms of reference, such as evaluating clinical trial data and providing guidelines for new drug approvals. The document is dated March 31, 2011.
|
order |
CDSCO - New Drugs
Unknown
|
Feb 09, 2018
|
Dec 16, 2025
|
pdf ↓ | ✓ Relevant |
|
CTD Guidance Final
▶ Summary
This document is a draft guidance from the Central Drugs Standard Control Organization (CDSCO) in India, providing instructions for the preparation of a Common Technical Document (CTD) for the import, manufacture, and marketing approval of new drugs for human use. It details the background, scope, and guidelines for organizing data to facilitate regulatory review and alignment with international standards. Feedback on the draft was solicited with a 60-day comment period following its release.
|
document |
CDSCO - New Drugs
Unknown
|
Feb 09, 2018
|
Dec 16, 2025
|
pdf ↓ | ✓ Relevant |
|
Guidance CMC & Stability Data
▶ Summary
This document is a draft guidance from the Central Drugs Standard Control Organization (CDSCO) providing guidelines for the required chemical and pharmaceutical information, including stability study data, necessary before the approval of clinical trials or bioequivalence studies. It outlines the regulatory requirements under the Drugs and Cosmetics Rules for new drug applications, aiming to ensure the safety and quality of clinical trials. Stakeholders are invited to provide feedback within 30 days of its publication.
|
document |
CDSCO - New Drugs
Unknown
|
Feb 09, 2018
|
Dec 16, 2025
|
pdf ↓ | ✓ Relevant |
|
CTD Guidance Final
▶ Summary
This document is a draft guidance issued by the Central Drugs Standard Control Organization (CDSCO), intended for the industry on preparing the Common Technical Document (CTD) for new drug applications. It aims to standardize the submission format for importing, manufacturing, and marketing approvals of new pharmaceuticals for human use in India, which is aligned with international standards. The document invites feedback from stakeholders within 60 days of publication.
|
document |
CDSCO - New Drugs
Unknown
|
Feb 09, 2018
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
Guidance CMC & Stability Data
▶ Summary
This document is a draft guidance prepared by the Central Drugs Standard Control Organization of India outlining the requirements for submitting chemical and pharmaceutical information, including stability study data, for the approval of clinical trials and bioequivalence studies. It is aimed at ensuring the safety and quality of proposed clinical trials by mandating thorough submission of relevant data before approval is granted. This guidance specifically applies to new drug formulations and excludes biologicals and vaccines.
|
document |
CDSCO - New Drugs
Unknown
|
Feb 09, 2018
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
newdrug_advisory_commitee
▶ Summary
This document is an official government order issued by the Ministry of Health & Family Welfare, India, on the constitution of the New Drug Advisory Committee (NDAC). The committee is tasked with advising the Drugs Controller General of India (DCGI) on the review and regulatory approval of new drugs, excluding investigational new drugs, for categories such as reproductive and urology, as well as cardiovascular and renal. The order outlines the terms of reference, committee composition, and operational guidelines for the NDAC.
|
order |
CDSCO - New Drugs
Unknown
|
Feb 09, 2018
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 09, 2018
|
Dec 13, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 09, 2018
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 09, 2018
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 09, 2018
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 09, 2018
|
Dec 12, 2025
|
— | ⚠ Unavailable |