| Title | Type | Source | Release Date | Scraped | Download | Status |
|---|---|---|---|---|---|---|
| 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 03, 2014
|
Jan 06, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 03, 2014
|
Jan 04, 2026
|
— | ⚠ Unavailable | |
|
Circular Regarding Approval of Safety and Efficacy Marketed in the Country of FD...
▶ Summary
This document is an advisory from the Drugs Controller General (India) requesting all State and UT Drugs Controllers to ensure that manufacturers of Fixed Dose Combinations (FDCs) provide safety and efficacy evidence for those FDCs approved without due authorization. The document prompts manufacturers to submit necessary applications and documents to the CDSCO for review by an Expert Committee.
|
advisory |
CDSCO - New Drugs
Unknown
|
Feb 03, 2014
|
Dec 16, 2025
|
pdf ↓ | ✓ Relevant |
|
Circular Regarding Approval of Safety and Efficacy Marketed in the Country of FD...
▶ Summary
This document, issued by the Directorate General of Health Services under the Ministry of Health & Family Welfare, is an official order to all State/UT Drugs Controllers regarding the approval of the safety and efficacy of Fixed Dose Combinations (FDCs) permitted for sale without prior approval from the DCGI. It directs manufacturers to submit necessary documents and applications to CDSCO for evaluation by expert committees to regularize these FDCs. The document emphasizes the need for timely compliance with the directive.
|
order |
CDSCO - New Drugs
Unknown
|
Feb 03, 2014
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 03, 2014
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Feb 03, 2014
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Jan 04, 2014
|
Jan 06, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Jan 04, 2014
|
Jan 06, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Jan 04, 2014
|
Jan 04, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Jan 04, 2014
|
Jan 04, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Jan 04, 2014
|
Jan 04, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Jan 04, 2014
|
Jan 04, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Jan 04, 2014
|
Jan 04, 2026
|
— | ⚠ Unavailable | |
|
Twelve New Drug Advisory Committees (NDAC) ( 27 Jul 2012 )
▶ Summary
This document is an official order from the Government of India's Ministry of Health & Family Welfare, dated March 31, 2011. It announces the formation of the New Drug Advisory Committee (NDAC) to advise the Drugs Controller General of India in matters related to the review and approval of new drug applications and clinical trials. The document outlines the committee's composition, terms of reference, and responsibilities, including the evaluation of pharmacological and toxicological data and ensuring no conflicts of interest among its members.
|
order |
CDSCO - New Drugs
Unknown
|
Jan 04, 2014
|
Dec 16, 2025
|
pdf ↓ | ✓ Relevant |
|
FAQ on Phytopharmaceutical Drugs
▶ Summary
This document, issued by the Central Drugs Standard Control Organization (CDSCO), provides a comprehensive set of frequently asked questions (FAQs) regarding the approval of new phytopharmaceutical drugs in India. It explains the definition of these drugs, the conditions under which they are considered new, and the process for clinical trials and permissions. The document aims to promote public awareness about the regulations but urges readers to refer to statutory provisions for legal advice.
|
document |
CDSCO - New Drugs
Unknown
|
Jan 04, 2014
|
Dec 16, 2025
|
pdf ↓ | ✓ Relevant |
|
Draft Guidelines For Industry on Reporting Serious Adverse Events occurring in C...
▶ Summary
This document is a draft guidance from the Central Drugs Standard Control Organization (CDSCO) on reporting serious adverse events occurring in clinical trials. It is intended to standardize the reporting process for pharmaceutical companies and contract research organizations, ensuring uniformity and completeness in the data submitted. The document details responsibilities, timelines, and includes templates for reporting these events to the Drugs Controller General (India).
|
document |
CDSCO - New Drugs
Unknown
|
Jan 04, 2014
|
Dec 16, 2025
|
pdf ↓ | ✓ Relevant |
|
Draft guidance on approval of clinical trials & new drug
▶ Summary
This document is a draft guidance issued by the Central Drugs Standard Control Organization (CDSCO) for the approval of clinical trials and new drugs in India. It outlines the requirements and procedures for obtaining approval to import or manufacture new drugs for marketing, based on the Drugs and Cosmetics Rules. It is intended for feedback and aims to streamline the application and review process for new drugs, excluding biologicals and vaccines.
|
document |
CDSCO - New Drugs
Unknown
|
Jan 04, 2014
|
Dec 16, 2025
|
pdf ↓ | ✓ Relevant |
|
Updated Package Insert PI for empagliflozin Tablets 10mg and 25mg based on compa...
▶ Summary
The document issued by the Directorate General of Health Services at CDSCO is an advisory regarding the updated package insert for Empagliflozin tablets due to revised safety communications from the US FDA. It highlights the added warnings about the risks of diabetic ketoacidosis and serious urinary tract infections associated with the drug. This advisory is directed to all state drug controllers and related organizations.
|
advisory |
CDSCO - New Drugs
Unknown
|
Jan 04, 2014
|
Dec 16, 2025
|
pdf ↓ | ✓ Relevant |
|
Twelve New Drug Advisory Committees (NDAC) (27 Jul 2012)
▶ Summary
This document is an official order issued by the Ministry of Health & Family Welfare, Government of India, dated March 31, 2011, concerning the constitution of a New Drug Advisory Committee (NDAC). The committee will advise the Drugs Controller General of India (DCG(I)) on matters related to the review of applications, approval of new drugs, and clinical trials. The order outlines the committee's composition, terms of reference, and operational guidelines, emphasizing the assessment of new drugs' risks, innovation, and necessity in India.
|
order |
CDSCO - New Drugs
Unknown
|
Jan 04, 2014
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
FAQ on Phytopharmaceutical Drugs
▶ Summary
This document is an FAQ released by the Central Drugs Standard Control Organization (CDSCO) concerning the approval process for new phytopharmaceutical drugs in India. It provides detailed explanations on various aspects, including the definition of these drugs, the clinical trial requirements, application processes, and related fees. The document is aimed at public awareness and guidance for applicants looking to import or manufacture new phytopharmaceutical drugs.
|
document |
CDSCO - New Drugs
Unknown
|
Jan 04, 2014
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
Draft Guidelines For Industry on Reporting Serious Adverse Events occurring in C...
▶ Summary
This document is a draft guidance issued by the Drugs Controller General (India) under the Central Drugs Standard Control Organization (CDSCO) regarding the reporting of serious adverse events (SAEs) occurring in clinical trials. It aims to standardize the format and processes for SAE reporting to ensure uniformity and completeness of data submitted to CDSCO. The document includes definitions, regulatory responsibilities, and specific reporting requirements.
|
document |
CDSCO - New Drugs
Unknown
|
Jan 04, 2014
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
Draft guidance on approval of clinical trials & new drug
▶ Summary
This document is a draft guidance issued by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health & Family Welfare, Government of India. It provides guidelines on the approval process for clinical trials and new drugs in India, including different categories of new drugs and the data required for their approval. Comments and suggestions on this draft are invited from the public, with a deadline of August 24, 2011.
|
document |
CDSCO - New Drugs
Unknown
|
Jan 04, 2014
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
|
Updated Package Insert PI for empagliflozin Tablets 10mg and 25mg based on compa...
▶ Summary
This document from the Central Drugs Standard Control Organization (CDSCO) addresses the updated package insert for Empagliflozin tablets, reflecting new warnings about potential side effects issued by the US FDA. It specifically discusses risks such as diabetic ketoacidosis and serious urinary tract infections. The Directorate General of Health Services directs all state drug controllers to be informed and take necessary actions.
|
advisory |
CDSCO - New Drugs
Unknown
|
Jan 04, 2014
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Jan 04, 2014
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Jan 04, 2014
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Jan 04, 2014
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Jan 04, 2014
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Jan 04, 2014
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Jan 04, 2014
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Jan 04, 2014
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Jan 04, 2014
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Jan 04, 2014
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Nov 27, 2013
|
Jan 06, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Nov 27, 2013
|
Jan 04, 2026
|
— | ⚠ Unavailable | |
|
Approved for Marketing in India
▶ Summary
This document is a detailed list issued by an authority, likely related to the Indian government, of approved drugs from January 1, 2013, to December 31, 2013. It includes information about various drugs, their approved indications, and the date of approval. The list is comprehensive and provides insights into the spectrum of medications and their therapeutic uses approved during 2013.
|
document |
CDSCO - New Drugs
Unknown
|
Nov 27, 2013
|
Dec 16, 2025
|
pdf ↓ | ✓ Relevant |
|
Approved for Marketing in India
▶ Summary
The document is a comprehensive list issued by a regulatory authority detailing drugs approved between January 1, 2013, and December 31, 2013. Each entry includes the drug name, indication, and date of approval. It acts as a record for clinicians and pharmaceutical stakeholders to reference the approved drugs during that period.
|
document |
CDSCO - New Drugs
Unknown
|
Nov 27, 2013
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Nov 27, 2013
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Nov 27, 2013
|
Dec 12, 2025
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Jul 23, 2013
|
Jan 06, 2026
|
— | ⚠ Unavailable | |
| Unclassified |
CDSCO - New Drugs
Unknown
|
Jul 23, 2013
|
Jan 04, 2026
|
— | ⚠ Unavailable | |
|
Report of Prof. Ranjit Roy Chaudhury Expert Committee
▶ Summary
This document is a report from the Prof. Ranjit Roy Chaudhury Expert Committee, which outlines policy and guidelines for the approval of new drugs, clinical trials, and the banning of drugs in India. It includes detailed recommendations for the accreditation of clinical trial centers and investigators, the establishment of a Central Accreditation Council, and guidelines for informed consent and compensation in clinical trials. The report is highly relevant for stakeholders in new drug approvals and clinical trial processes in India.
|
document |
CDSCO - New Drugs
Unknown
|
Jul 23, 2013
|
Dec 16, 2025
|
pdf ↓ | ✓ Relevant |
|
Report of Prof. Ranjit Roy Chaudhury Expert Committee
▶ Summary
This is a report from the Prof. Ranjit Roy Chaudhury Expert Committee, tasked with formulating policy and guidelines for new drug approvals, clinical trials, and the banning of drugs. It includes recommendations for the accreditation of trial institutions, consent requirements, and compensation protocols. The report was intended to guide the development of policies by the Drugs Controller General of India and other stakeholders in clinical research.
|
document |
CDSCO - New Drugs
Unknown
|
Jul 23, 2013
|
Dec 15, 2025
|
pdf ↓ | ✓ Relevant |
| 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 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 |