Central Drugs Standard Control Organization

Directorate General of Health Services
Ministry of Health & Family Welfare
Government of India

Investigational New Drugs

About IND

  • Investigational New Drug Division (IND) of the Central Drugs Standard Control Organization (CDSCO), plays a crucial role in regulatory framework for approval of investigational New Drugs in India and ensures that new drugs meet established safety, efficacy, and quality standards.
  • As per New Drugs and Clinical Trials Rules, 2019 (NDCT), investigational new drug defined as a new chemical or biological entity or substance that has not been approved for marketing as a drug in any country .
  • Investigational New Drug division deals with new chemical entity or substance that has not been approved for marketing as a drug in any country.
  • The Investigational New Drug (IND) application is a crucial step in the drug development process in India. Applicant submits application for grant of permission to conduct Clinical Trial and to import and manufacture Investigational New Drug along with requisite document and fee as prescribed in NDCT Rules 2019 through online Sugam Portal.
  • The IND application is necessary before any human subject is exposed to an Investigational New Drug, to ensure that clinical research is conducted under rigorous scientific and ethical standards.
  • For more detailed information, applicants can refer to New Drugs and Clinical Trials Rules, 2019 and consult with the CDSCO's IND divisions for specific guidance on the IND application process.

Functionalities

  • Processing of applications received under Form CT-04, CT-05, CT-18 and CT-21 through online SUGAM portal of Investigational New Drug (IND) division as per New Drugs and Clinical Trials Rules, 2019 (NDCT Rules 2019).
  • Processing of Pre-submission meeting applications as per NDCT Rules 2019.
  • Processing of Post submission meeting application as per NDCT Rules 2019.
  • Deliberation of proposals related to approval of Clinical Trial before the Subject Expert Committee of Investigational New Drugs division.
  • Review and approval of Post Approval Changes (PAC) applications.
  • Attending Public Relationship Office for IND Division related matter.
  • Miscellaneous work like Ministry related work, Parliament questions reply, Right to information (RTI), Public Grievance (PG), etc.

Processes

Process flow for approval for applications for Clinical Trial or Bioavailability study or Import or Manufacture of New Drug for sale or distribution

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Guideline

S.no Title Release Date Download Pdf Pdf Size
1 newdrug_advisory_commitee 2018-Feb-09 4796kb
2 Updated Package Insert PI for empagliflozin Tablets 10mg and 25mg based on company Core Data Sheet (CCDS) 2014-Jan-04 60 KB
3 Draft guidance on approval of clinical trials & new drug 2014-Jan-04 643 KB
4 Draft Guidelines For Industry on Reporting Serious Adverse Events occurring in Clinical Trials ( 27 Jul 2012 ) 2014-Jan-04 415 KB
5 FAQ on Phytopharmaceutical Drugs 2014-Jan-04 372 KB
6 Twelve New Drug Advisory Committees (NDAC) ( 27 Jul 2012 ) 2014-Jan-04 4796 KB
7 Approved for Marketing in India 2013-Nov-27 433 KB
8 Report of Prof. Ranjit Roy Chaudhury Expert Committee 2013-Jul-23 826 KB
9 Draft Guidance for Industry on requirement of Chemical & Pharmaceutical Information including Stability Study data before Approval of Clinical Trials / BE Studies ( 27 Jul 2012 ) 2012-Jul-27 2599 KB
10 Draft Guidance for Industry on Fixed Dose Combinations 2010-Aug-20 422 KB
S.no Title Release Date Download Pdf Pdf Size
1 DRAFT POLICY FOR APPROVAL OF NEW DRUGS 2022-Nov-25 583 KB
2 Guidance CMC & Stability Data 2018-Feb-09 2599kb
S.no Title Release Date Download Pdf Pdf Size
1 Withdrawal of indication for Olaparib Tablets 100mg and 150mg in the treatment of patient with gBRCA mutution and advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy 2024-May-16 768 KB
2 Guidelines for approval of synthetically manufactured drug which has been previously approved as r-DNA derived drug. 2020-Mar-13 43 KB
3 Testing of all categories of new drugs for their approval 2020-Mar-13 47 KB
4 Requirement of process validation report for permission to conduct Clinical trial BA-BE studies. 2020-Mar-13 52 KB
5 Requirement of CMC documents for approval of additional indication of an already drug product 2020-Mar-13 45 KB
6 Notice regarding Fixing of limit of impurities in the specification of INDs 2020-Feb-21 347 KB
7 Notices for Streamlining Applications for New Drugs, Clinical Trials and Bioavailability/ Bioequivalence (BA/BE) Studies/ grant of COPP 1.Permission to conduct BA/BE study and Clinical trial. 2.Approval of FDCs containing new drugs. 3.Fixing of limit of impurities in the specification of INDs. 4.Pre-submission meeting. 5.Sub-acute toxicity study report for injectable products for BA/BE study in human for export. 6.Requirement of Stability Data for COPP 2020-Feb-21 9066 KB
8 Notice regarding Grant of Permission in Form CT-11/ CT-14/CT-15/ CT-17 under New Drugs and Clinical Trials rules 2019 2020-Feb-20 254 KB
9 Notice regarding New Drugs dated 18.02.2020 2020-Feb-18 943 KB
10 Notice regarding the FAQs on New Drugs and Clinical Trial dated 18/2/2020 2020-Feb-18 893 KB
11 Additional FAQ on New Drugs and Clinical Trial Rules, 2019 2019-Aug-23 152 KB
12 Frequently Asked Questions (FAQs) on New Drugs and Clinical Trials 2019-Apr-26 478 KB
13 Safety warning for SGLT2 Inhibitors 2019-Mar-25 9560 KB
14 Draft Guidelines for Evaluation of Nanopharmaceuticals in India 2019-Mar-07 31990 KB
15 Notice regarding sale of medicines without prescription 2018-Dec-15 84 KB
16 Filing of applications of New Drugs, FDC and SND through ‘SUGAM’ Portal only– Reg 2018-Jun-11 359KB
17 Confirmation of Drugs Inspectors after satisfactorily completion of probation period of 02 Years in CDSCO 2018-May-01 548KB
18 Notice regarding SUGAM for New Drugs FDC and SND 2018-Apr-27 372KB
19 Office Order regarding constitution of Indian Drug/Pharmaceuticals Association Forum 2018-Mar-14 295KB
20 FDC Guidelines _ Revised1 2018-Feb-23 422kb
21 Order regarding creation of 'Ayush' vertical in CDSCO 2018-Feb-05 734KB
22 Notice regarding Invitation for Inclusion of Professionals in the Subject Expert Committee Panels under CDSCO 2017-Nov-21 1.96MB
23 NOTICE regarding the SLP No.7061/2017 titled under Union of India Vs Pfizer and Ors and other connected matter relating to FDC drugs Cases Pending before the Hon'ble Supreme Court 2017-Sep-15 238KB
24 NOTICE regarding System of consultation meetings for cases of drug development of National Laboratories 2017-Sep-12 566KB
25 Notice regarding grant of licence for manufacture of new drugs including FDCs without prior approval from DCG (I) 2017-May-16 471KB
26 Public Notice regarding D-Penicillamine 2017-Feb-10 44.6KB
27 Notice regarding 32 meeting of the Apex Committee held on 03.11.2016 2017-Jan-17 47.6KB
28 Non availability of life saving drug(D-Penicillamine) across India-Regarding 2016-Sep-28 43KB
29 Office Order dated 03.07.2014 - Consideration of ethnicity for approval of new drugs 2014-Jul-03 211KB
30 Office Order 2013-Apr-16 391KB
31 Clarification with respect of the manufacturing and marketing of New Drugs 2011-Mar-10 300 KB
32 Cellular Biology Based Therapeutic Drug Evaluation Committee (CBTDEC) 2010-Sep-01 1248 KB
S.no Title Release Date Download Pdf Pdf Size
1 New Drugs and Clinical Trials Rules 2019 G.S.R. 227(E) 2019-Mar-20 3456 KB
2 CTD Guidance Final 2018-Feb-09 816kb