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Slide 1: A PRESENTATION ON Presented by Yash Yadav
Slide 2: PRESENTATION OVERVIEW  SCHEDULE Y –SCOPE, APPLICABILITY AND ASSOCIATED RULE  RESPONSIBILITIES OF SPONSOR, INVESTIGATOR AND ETHICS COMMITTEE  APPLICATION FOR PERMISSION UNDER FORM 44, REGULATORY AUTHORITIES, FEES AND TEST LICENCE  APPENDICE OF SCHEDULE Y  LOOPHOLES & FURTHER REFINEMENT
Slide 3: SCOCPE APPLICABILITY, & ASSOCIATED RULE
Slide 4: SCOCPE,APPLICABILITY, ASSOCIATED RULE Schedule -Y is a part of section XA in Drugs and Cosmetics Act The Drugs Act was enacted in 1940 The Drugs Rules were promulgated in December 1945 and the enforcement started in 1947 Last amendment The Drugs and Cosmetics Act, 1995 The Drugs and Cosmetics Rules, 1945 as corrected up to 30.04.2003 D & C have Part -I to part XIX PART –XA=Import of manufacture of new drug for clinical trials or marketing
Slide 5: What is Schedule Y  Schedule Y:- the current valid regulatory process, for clinical trial (CT) permission and new drug development, which came into force in 1988 Schedule Y:-Requirements and guidelines for permission to import and / or manufacture of new drugs for sale or to undertake clinical trials Schedule Y-1 :-Requirements and Guidelines for registration of CRO Refer to rules 122A, 122B, 122D, 122DA, 122DAA ,122E and 122 DAB
Slide 6: Rule & Permission 122-A :-Application for permission to import new drug 122-B :-Application for approval to manufacture new drug 122-C :-Deleted 122-D :-Permission to import or manufacture FDC 122-DA :-Permission to conduct clinical trials for New Drug /IP* 1-DAA :- Clinical Trial definition* 122 -E :- New drug definition 122 DAB:- Registration of CRO for conducting CT* * Schedule Y-1
Slide 7: 122-DAA “Clinical trial” means a systematic study of new drug(s) in human subject(s) to generate data for discovering and / or verifying the clinical, pharmacological (including pharmacodynamic and pharmacokinetic) and /or adverse effects with the objective of determining safety and / or efficacy of the new drug
Slide 8: 122-E(new drug)  Not been used in the country under labeling conditions  Approved but now proposed to be marketed with modified or new claims – indications, dosage, dosage form , route of administration FDC, individually approved, to be combined for the first time in a fixed ratio or if ratio is changed • Vaccines are new drugs unless otherwise certified • Considered new drug for 4 years or inclusion in IP
Slide 9: Investigational New Drug New chemical entity or a product having therapeutic indication but which has never been earlier tested on human beings
Slide 10: RESPONSIBILITIES OF SPONSOR INVESTIGATOR AND ETHICS COMMITTEE
Slide 11: Responsibilities of Sponsor Quality Assurance : - Adopt GCP Guidelines of CDSCO Trial Status Report to Licensing Authority : Annually Premature Termination : Summary report within 3 month ( Study, Pt. no., Dose, Duration, ADR & reasons for discontinuation ) Serious Adverse Event : Report to LA & other investigators within 14 days
Slide 12: Responsibilities of Investigator  Adhere to approved Protocol & GCP Guidelines  SOPs required to be documented  Management of all ADR / AE  Reporting unexpected AE to : - Sponsor within 24 hours - EC within 7 days
Slide 13: Responsibilities of Ethics Committee  Safeguard rights, safety & well being of all trial subjects  Protect vulnerable subjects  Obtain and maintain record of SOPs  Ongoing review based on Periodic progress report  If EC revokes its approval - Record reasons for it - Inform the Investigator & LA immediately
Slide 14: Application for permission under Form 44, Regulatory Authorities, Fees and Test License
Slide 15: Regulatory Authorities
Slide 16: PROCESS APPLICATION FORM 44   APPROVAL FORM 45 (IMP FF) Imp ff APPROVAL FORM 45 A (IMP RM) Imp rm  Mfg ff  Mfg rm  CT APPROVAL FORM 46 (MFG FF) APPLICATION FORM 46 A (MFG RM) NOC FOR CT + Test License for Import
Slide 17: Fees   Import ff/ Mfg ff/ Import bulk + Mfg ff of new drug Application by same applicant, for modified dosage form or with new claim Secondary applicants after 1 year of approval Import / Mfg FDC = Rs 50,000/-   = Rs 15,000/-   = Rs 15,000/-  = Rs 15,000/-  Conduct Clinical trial with ND/IND  Phase I = Rs 50,000/ Phase II = Rs 25,000/ Phase III = Rs 25,000/ No separate fee to be paid along with application for import / mfg based on successful completion
Slide 18: Form-44 1.Particulars of New Drug 2.Data submitted along with the application  Permission to market new drug  Subsequent approval / permission for manufacture of already approved new drug  C Approval / permission for FDC  approval for new indication
Slide 19: Test License    Application form No. 12 Material Justification Plan Treasury Challan ( Rs. 100 ) Test License obtained in form 11 FORM 11:-License to import drugs for the purposes of examination, test or analysis FORM 12:- Application for license to import drugs for purpose of examination, test or analysis
Slide 20: APPENDICE OF SCHEDULE Y APPENDIX I:- Data required to be submitted with application for permission to market a New Drug (Ind) APPENDIX 1-A :- Data required to be submitted by an applicant for grant of permission to import manufacture an already approved new drug. APPENDIX II :- Format for submission of clinical Trial Reports(ICH E6) APPENDIX III:- Animal toxicity requirements for clinical trials and marketing of a New Drug.
Slide 21:  APPENDIX IV:-Animals Pharmacology  APPENDIX V:- Patient consent form APPENDIX VI:-Fixed Dose Combination (FDC) fall into four groups and their data requirements accordingly. APPENDIX VII:- Undertaking by Investigator APPENDIX VIII:- Ethics Committee
Slide 22: APPENDIX IX :- Stability testing of new drugs APPENDIX X :- Contents of the proposed protocol for clinical trial APPENDIX XI :- Data elements for reporting serious adverse events occurring in a clinical trial
Slide 23: LOOPHOLES & FURTHER REFINEMENT  New drug remains new for 4 years. Thus, Phase IV trials require permission. However, Approved drug and indication need not require permission.  Approval of Amendment could be a problem.  SOPs for investigators and documentation of tasks – Template required.  Unmet medical needs to be added to CT waiver.  All clinical trial supplies to be included in FORM 11 SUSARS within 15 calendar days (Suspected unexpected serious adverse event). 24 hour timeline for reporting to sponsor required