New Drugs Division deals with applications for approval of a new drug already approved
for import/ manufacturing and marketing in any country for certain claims, indications,
dosage, dosage form and route of administration.

New Drug application can be made for the following cases:

• Bulk Drug already approved in any other country.
• New drug (Formulation) already approved in any country

1. Processing of applications received for manufacturing and import of New Drug Approval first time in country which approved in any other country in the world for certain claims, indications, dosage, dosage form and route of administration, review and approval as per New Drugs and Clinical Trial Rules 2019 under Drug and Cosmetic Act 1940 and Rules made thereunder.
2. Processing of applications received for approval of clinical trials (Phase-I/II/III/IV) and active post marketing surveillance study as per New Drugs and Clinical Trial Rules,2019 and Drugs & Cosmetics Rules ,1945.
3. Processing of applications received for grant of license to import new drug for clinical trial and bioavailability or bioequivalence study
4. Processing of regularization applications received for grant of permission to manufacture and import in first time in country of an Active Pharmaceutical Ingredients (APIs) of a drug which has earlier been approved as New Drug in finished formulation for import and marketing and / or allowed for import under import registration and licensing.
5. Deliberation of proposals of New Drug application in Subject Expert Committee/Technical/Apex committee to take subject expert recommendation.
6. Review/ Handling of Parliament Questions/ RTI/PG.
7. Conduct Onsite evaluation at manufacturing site (Formulation and API) on the risk base approach with respect to New Drug application for review of CMC data submitted with application.
8. Conduct onsite evaluation at Clinical trial site/BABE site on the risk base approach with respect to New Drug application for review the study related data.
9. Review of Academic Clinical Trials received from Ethics committee (in case of overlap) as per New Drugs and Clinical Trial Rules,2019.
10. Review of notifications like Minor protocol amendments, Investigator's Brochure (IB), Informed Consent Form (ICD), Investigational Medicinal Product Dossier (IMPD), 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.

•     Guidelines Document
•     Sugam User Manual
•     FAQ
  1. Frequently Asked Questions (FAQs) on New Drugs and Clinical Trials Rules, 2019 dated 24.09.2025   
  2. FAQ on Phytopharmaceutical Drugs  
•     Checklist Documents
  1. Checklist Document  

• Draft guidance on approval of clinical trials & new drug