| Title | Type | Source | Release Date | Scraped | Download | Status |
|---|---|---|---|---|---|---|
| Unclassified |
CDSCO - New Drugs
Unknown
|
May 16, 2024
|
Jan 06, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
May 16, 2024
|
Jan 04, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
May 16, 2024
|
Dec 31, 2025
|
— | ⚠ Unavailable | |
|
Withdrawal of indication for Olaparib Tablets 100mg and 150mg in the treatment o...
▶ Summary
This document is a public notice issued by the Central Drugs Standard Control Organization (CDSCO) informing about the withdrawal of specific indications for Olaparib Tablets 100mg and 150mg. These indications were previously approved for treating patients with gBRCA mutation and advanced ovarian cancer after three or more chemotherapy lines. The decision was based on clinical evidence suggesting a potential detrimental effect on overall survival for these patients, and consequently, manufacturers are instructed to withdraw the marketing of these indications and submit revised package inserts.
|
public notice |
CDSCO - New Drugs
Unknown
|
May 16, 2024
|
Dec 16, 2025
|
pdf ↓ | ✓ Relevant |
|
Withdrawal of indication for Olaparib Tablets 100mg and 150mg in the treatment o...
▶ Summary
This document from the Central Drugs Standard Control Organization (CDSCO) announces the withdrawal of the indication for Olaparib Tablets in certain ovarian cancer treatments due to potential detrimental effects on survival. The directive requires manufacturers to withdraw marketing for these specific uses and revise package inserts. The order follows analysis and expert consultation regarding the drug's efficacy.
|
order |
CDSCO - New Drugs
Unknown
|
May 16, 2024
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
| Unclassified |
CDSCO - New Drugs
Unknown
|
May 16, 2024
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
May 16, 2024
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Nov 25, 2022
|
Jan 06, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Nov 25, 2022
|
Jan 04, 2026
|
— | ⚠ Unavailable | |
|
DRAFT POLICY FOR APPROVAL OF NEW DRUGS
▶ Summary
This is a draft policy document issued by the Central Drugs Standard Control Organization (CDSCO) detailing the processes and requirements for the approval of new drugs in India. It outlines policies for new drug applications, clinical trials, and the evaluation of new drug safety and efficacy. The document emphasizes the importance of regulatory transparency and the use of global clinical data in the approval process.
|
document |
CDSCO - New Drugs
Unknown
|
Nov 25, 2022
|
Dec 16, 2025
|
pdf ↓ | ✓ Relevant |
|
DRAFT POLICY FOR APPROVAL OF NEW DRUGS
▶ Summary
This document, issued by the Central Drugs Standard Control Organization under the Ministry of Health & Family Welfare, outlines the draft policy for the approval of new drugs in India. It details the process for new drug applications, including pre-submission discussions, necessary evaluations, and considerations for local and global clinical data. The document aims to establish clear regulatory procedures to ensure the safety and effectiveness of new drugs.
|
document |
CDSCO - New Drugs
Unknown
|
Nov 25, 2022
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Nov 25, 2022
|
Dec 13, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Nov 25, 2022
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Nov 25, 2022
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
|
Notice regarding Guidance for approval Covid-19 vaccine in India for restricted ...
▶ Summary
This document is a public notice from the Central Drugs Standard Control Organization (CDSCO) in India, outlining the guidance for the approval of COVID-19 vaccines for restricted use in emergency situations. It specifies the conditions and procedures for vaccine approval, including the requirements for safety assessments, bridging clinical trials, and import registration processes. The notice aims to expedite vaccine availability in India by facilitating imports and manufacturing processes.
|
public notice |
CDSCO - New Drugs
Unknown
|
Apr 15, 2021
|
Dec 12, 2025
|
pdf ↓ | ✓ Relevant |
|
DCGI Message 2021
▶ Summary
This is a New Year message from Dr. V. G. Somani, the Drugs Controller General of India, issued by the Central Drugs Standard Control Organisation. The message highlights the commitment of CDSCO towards improving regulatory systems for medical products in India and wishes stakeholders a prosperous New Year 2021.
|
press release |
CDSCO - New Drugs
Unknown
|
Jan 01, 2021
|
Dec 12, 2025
|
pdf ↓ | ✗ Filtered |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Mar 13, 2020
|
Jan 06, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Mar 13, 2020
|
Jan 06, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Mar 13, 2020
|
Jan 06, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Mar 13, 2020
|
Jan 04, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Mar 13, 2020
|
Jan 04, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Mar 13, 2020
|
Jan 04, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Mar 13, 2020
|
Jan 04, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Mar 13, 2020
|
Dec 31, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Mar 13, 2020
|
Dec 31, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Mar 13, 2020
|
Dec 31, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Mar 13, 2020
|
Dec 31, 2025
|
— | ⚠ Unavailable | |
|
Requirement of CMC documents for approval of additional indication of an already...
▶ Summary
This document is a notice from the Central Drugs Standard Control Organization (CDSCO), issued by the Drugs Controller General of India, regarding the requirement of Chemistry, Manufacturing, and Controls (CMC) documents for approval of additional indications of an already approved drug. It outlines the conditions under which CMC data may be omitted as per the New Drugs and Clinical Trials Rules, 2019, depending on existing approvals and marketing status within India.
|
public notice |
CDSCO - New Drugs
Unknown
|
Mar 13, 2020
|
Dec 16, 2025
|
pdf ↓ | ✓ Relevant |
|
Requirement of process validation report for permission to conduct Clinical tria...
▶ Summary
This document is a notice issued by the Central Drugs Standard Control Organization (CDSCO) through the Directorate General of Health Services regarding the requirement of process validation reports for clinical trial approvals under the New Drugs and Clinical Trials Rules, 2019. It clarifies that for Phase I and II clinical trials, process validation is not required similarly to commercial batches, with Phase III requirements varying by product complexity. Dr. V.G. Somani, the Drugs Controller General (India), addresses this notice to all stakeholders.
|
public notice |
CDSCO - New Drugs
Unknown
|
Mar 13, 2020
|
Dec 16, 2025
|
pdf ↓ | ✓ Relevant |
|
Testing of all categories of new drugs for their approval
▶ Summary
This is a public notice issued by the Drugs Controller General of India from the Central Drugs Standard Control Organization (CDSCO). It addresses the testing requirements for new drugs under the New Drugs and Clinical Trials Rules, 2019, highlighting the streamlined timelines for testing at Central Government Laboratories. The notice is intended for government laboratories and all stakeholders involved in drug approval processes.
|
public notice |
CDSCO - New Drugs
Unknown
|
Mar 13, 2020
|
Dec 16, 2025
|
pdf ↓ | ✓ Relevant |
|
Guidelines for approval of synthetically manufactured drug which has been previo...
▶ Summary
This public notice issued by the Central Drugs Standard Control Organization outlines the regulatory guidelines for the approval of synthetically manufactured drugs that have been previously approved as r-DNA derived drugs. The notice specifies the requirement for applications to be submitted as subsequent new drugs under the New Drugs and Clinical Trials Rules, 2019. This applies to both synthetic peptides and non-biological products.
|
public notice |
CDSCO - New Drugs
Unknown
|
Mar 13, 2020
|
Dec 16, 2025
|
pdf ↓ | ✓ Relevant |
|
Requirement of CMC documents for approval of additional indication of an already...
▶ Summary
This document is an official notice issued by the Central Drugs Standard Control Organization (CDSCO) under the Government of India. It outlines the requirements for CMC documents necessary for the approval of additional indications for an already approved drug product, according to the New Drugs and Clinical Trials Rules, 2019. Specifically, it addresses requirements for importing or manufacturing drugs that are already approved and marketed in India with new claims.
|
public notice |
CDSCO - New Drugs
Unknown
|
Mar 13, 2020
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
Requirement of process validation report for permission to conduct Clinical tria...
▶ Summary
This is a public notice issued by the Central Drugs Standard Control Organization (CDSCO) on the requirements for process validation reports for clinical trial/BA-BE studies under the New Drugs and Clinical Trials Rules, 2019. It clarifies the data submissions needed for clinical trial applications and specifies that process validation for commercial batches may not be required for early-phase studies, although proof of process standardization might be necessary. The notice is aimed at stakeholders in the drug approval process.
|
public notice |
CDSCO - New Drugs
Unknown
|
Mar 13, 2020
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
Testing of all categories of new drugs for their approval
▶ Summary
This public notice from the Central Drugs Standard Control Organization (CDSCO) informs stakeholders about new timelines for laboratory testing required for the approval of new drugs. The document details different timelines based on drug categories to streamline the approval process under the New Drugs and Clinical Trials Rules, 2019. It addresses concerns regarding current requirements and provides specifics on testing periods for various types of new drugs.
|
public notice |
CDSCO - New Drugs
Unknown
|
Mar 13, 2020
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
Guidelines for approval of synthetically manufactured drug which has been previo...
▶ Summary
This document issued by the CDSCO outlines guidelines for the approval of synthetically manufactured drugs that were previously approved as r-DNA derived drugs. It specifies that applications for such drugs must consider safety and efficacy according to the New Drugs and Clinical Trials Rules, 2019, and mentions the treatment of first-time synthetically manufactured peptides. The notice is signed by Dr. V.G. Somani, the Drugs Controller General of India.
|
public notice |
CDSCO - New Drugs
Unknown
|
Mar 13, 2020
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Mar 13, 2020
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Mar 13, 2020
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Mar 13, 2020
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Mar 13, 2020
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Mar 13, 2020
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Mar 13, 2020
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Mar 13, 2020
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Mar 13, 2020
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 21, 2020
|
Jan 06, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 21, 2020
|
Jan 06, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 21, 2020
|
Jan 04, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 21, 2020
|
Jan 04, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 21, 2020
|
Dec 31, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 21, 2020
|
Dec 31, 2025
|
— | ⚠ Unavailable | |
|
Notices for Streamlining Applications for New Drugs, Clinical Trials and Bioavai...
▶ Summary
This document consists of multiple notices issued by the Directorate General of Health Services, CDSCO, regarding the processing of applications related to clinical trials, the approval of Fixed Dose Combinations (FDCs), the fixing of impurity limits for Investigational New Drugs (INDs), and guidelines for required meetings prior to application submissions. The notices clarify the rules under the New Drugs and Clinical Trials Rules 2019, addressing concerns raised by stakeholders on these topics. Each notice is signed by Dr. V.G. Somani, the Drugs Controller General of India.
|
public notice |
CDSCO - New Drugs
Unknown
|
Feb 21, 2020
|
Dec 16, 2025
|
pdf ↓ | ✓ Relevant |