This guidance documents has been prepared to specify the general requirements for approval of clinical trial and different categories of New Drugs viz. Investigational New Drugs, New drugs substances, additional strength, additional indication, modified release form etc. This guidance will help the industry to submit the required documents in a more realistic manner, which in turn will also help reviewer of CDSCO to review such application in systematic manner. It is apparent that this structured application with comprehensive and rational contents will help the CDSCO to review and take necessary actions in a better way and would also ease the preparation of electronic submissions, which may happen in the near future at CDSCO.
These guidelines apply to approval of clinical trial and approval of manufacture/import for marketing of various categories of new drugs in the form of API and finished formulation which are considered as new drug as per Rule 122E of Drugs and Cosmetics Rules.
This guideline describes requirements for approval of clinical trials and new drugs and the procedure for review of technical dossiers of such applications by CDSCO under Rule 122 A, 122B, 122DA, 122DAA, 122E and Schedule-Y of Drugs and Cosmetics Rules.
(b) This guideline does not apply to biologicals and vaccines.