New Drugs

Demonstration of safety and efficacy of the drug product for use in humans is essential before the drug product can be approved for import or manufacturing and marketing in the country. The Rules 122A, 122B, 122 DAB, 122DAC, 122 DD and 122E of Drugs and Cosmetics Rules and Appendix I- XII of Schedule Y, describe the information/data required for approval of clinical trial and/or to import or manufacture of new drug for marketing in the country.

New drugs as define under Rule 122-E of Drugs and Cosmetics Rules as drug, including bulk drug substance or phytopharmaceutical drug which has not been used in the country to any significant extent under the conditions prescribed, recommended or suggested in the labeling thereof and has not been recognized as effective and safe by the licensing authority mentioned under rule 21 for the proposed claims. A drug already approved by the Licensing Authority mentioned in Rule 21 for certain claims, which is now proposed to be marketed with modified or new claims, namely, indications, dosage, dosage form (including sustained release dosage form) and route of administration. fixed dose combination of two or more drugs, individually approved earlier for certain claims, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in an already marketed combination is proposed to be changed, with certain claims, viz. indications, dosage, dosage form (including sustained release dosage form) and route of administration. All vaccines and Recombinant DNA (r-DNA) derived drugs shall be new drugs unless certified otherwise by the Licensing Authority under Rule 21. A new drug shall continue to be considered as new drug for a period of four years from the date of its first approval.


  1. Rule 122-A -Application for permission to import new drug
  2. Rule 122-B -Application for approval to manufacture new drug
  3. Rule 122-DA-Mandatory requirement of permission from DCG (I) for conduct of clinical trial of new drug;
  4. Rule 122 DAB -Provision for examination of serious adverse event (SAE) of injury and death and payment of compensation in clinical trial related cases. Provision for debarment of the applicant in case of failure to pay compensation;
  5. Rule 122 DAC -Conditions of permission for conduct of clinical trial which includes mandatory requirement to follow Good Clinical Practice (GCP) guidelines, guidelines and requirements specified in Schedule Y of Drugs and Cosmetics Rules and other applicable regulations. Provision for debarment of applicant and investigator in case of non- compliance
  6. Rule 122 E-Definition of new drug
  7. Schedule Y-Detailed guidelines and requirements for conduct of clinical trial and approval of new drug
  8. Good Clinical Practice Guidelines -issued by CDSCO, Directorate General of Health Services, Govt. of India
  • Processing of applications received for New Drug Approval (IND/NDA/Veterinary/Phyto-pharmaceuticals i.e. Form 44), review and approval as per Schedule Y, Rule 122 A, 122 B, 122 DA, 122 DAB, 122 DAC and 122 E under Drugs & Cosmetics Rules 1945)
  • Processing of applications received for approval of clinical trials (Phase-I/II/III/IV) review and approval as per Schedule Y, Rule 122 A, 122 B, 122 DA, 122 DAB, 122 DAC and 122 E under Drugs & Cosmetics Rules 1945)
  • Review of Academic Clinical Trials as GSR 313 E dated 16th March 2016.
  • Deliberation of proposals in Subject Expert Committee/Technical/Apex committee
  • Review/ Handling of RTI/Parliament questions
  • Review of notifications like Minor protocol amendments, Investigator's Brochure (IB), Informed Consent Form (ICD), Investigational Medicinal Product Dossier (IMPD), Development Safety Update Reports (DSUR), Change in Principal investigators/Co-investigators, Clinical Trial Agreements, Ethics committee approval of PI sites, Annual Status Reports, End of clinical trial notifications& Clinical Study Reports (CSR) etc.
  • Handling/Monitoring of safety of approved medicinal products for marketing in the country based on documents like PSURs, SAE reports, complaints received etc.
  • Handling and processing of documents submitted for updatation of Prescribing Information.
  • Handling and processing of Signal Review Panel (PvPI-NCC, IPC) recommendations for Regulatory Action. Title Release Date Download Pdf Pdf Size
1 newdrug_advisory_commitee 2018-Feb-09 4796kb
2 Circular Regarding Approval of Safety and Efficacy Marketed in the Country of FDC Without Approval from DCG(I) 2014-Feb-03 323 KB
3 Updated Package Insert PI for empagliflozin Tablets 10mg and 25mg based on company Core Data Sheet (CCDS) 2014-Jan-04 60 KB
4 Draft guidance on approval of clinical trials & new drug 2014-Jan-04 643 KB
5 Draft Guidelines For Industry on Reporting Serious Adverse Events occurring in Clinical Trials ( 27 Jul 2012 ) 2014-Jan-04 415 KB
6 FAQ on Phytopharmaceutical Drugs 2014-Jan-04 372 KB
7 Twelve New Drug Advisory Committees (NDAC) ( 27 Jul 2012 ) 2014-Jan-04 4796 KB
8 Approved for Marketing in India 2013-Nov-27 433 KB
9 Report of Prof. Ranjit Roy Chaudhury Expert Committee 2013-Jul-23 826 KB
10 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
11 Draft Guidance for Industry on Fixed Dose Combinations 2010-Aug-20 422 KB Title Release Date Download Pdf Pdf Size
2 Guidance CMC & Stability Data 2018-Feb-09 2599kb 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 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