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SCHEDULE Y

SCHEDULE Y. REGULATORY TOOL TO MANAGE RISK. SCENARIO FOR TODAY’S DISCUSSION:. Schedule Y. IEC. SCOPE. UTILITY. NEW DRUG DEVELOPMENT PROCESS IN INDIA. RIGHTS SAFETY WELL BEING OF HUMAN SUBJECTS. FUTURE DIRECTION. BENEFITS. RISKS. SCHEDULE Y. DEFINE NEW DRUG

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SCHEDULE Y

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  1. SCHEDULE Y REGULATORY TOOL TO MANAGE RISK

  2. SCENARIO FOR TODAY’S DISCUSSION: Schedule Y IEC SCOPE UTILITY NEW DRUG DEVELOPMENT PROCESS IN INDIA RIGHTS SAFETY WELL BEING OF HUMAN SUBJECTS FUTURE DIRECTION BENEFITS RISKS

  3. SCHEDULE Y • DEFINE NEW DRUG • SCOPE:REGULATE THEIR INTRODUCTION BASED ON SAFETY AND EFFICACY CONSIDERATIONS • ENSURE QUALITY • IMPLEMENTATION

  4. SCHEDULE Y (RULE 122 E) NEW DRUG DRUG SUBSTANCE(API) DRUG PRODUCT(FORMULATION) NOT USED IN COUNTRY * • SR/FDC/VACCINES • USE < 4 YEARS EFFICACY=??? SAFETY=???

  5. SCOPE OF SCHEDULE Y Rule 122-A, 122-B, 122-D, 122-E under Drugs & Cosmetics Rules 1945in 1988/2000/2001/2002/2005 DRUG SUBSTANCE DRUG PRODUCT DEVELOPMENT STUDIES /PRECLINICAL DATA IMPORT FOR TESTING ANALYSIS & EXAMINATION CLINICAL STUDIES/BE STUDIES DECISIONS BASED ON BEST AVAILABLE SCIENTIFIC EVIDENCE

  6. SCOPE OF SCHEDULE Y • HERBALS:INDIAN SYSTEM OF MEDICINE & HOMEOPATHY • :APPROVAL BY STATE DRUG CONTROLLER • BIOTECHNOLOGY PRODUCTS:RECOMBINANT PRODUCTS: DCGI DBT RDAC RCGM IBSC GEAC

  7. Ethical Guidelines for Biomedical Research on Human Subjects ICMR 2000 STATEMENT SPECIFIC PRINCIPLES GENERALPRINCIPLES

  8. SPECIFIC GUIDELINES • Guidelines by DBT under DST: Biotechnology Products (Preclinical, clinical data for r-DNA based vaccines; diagnostics and other biological products • DCGI guidelines :BA/BE Studies • DCGI guidelines: Pharmacovigilance

  9. PROCESS OF NEW DRUG DEVELOPMENT IN INDIA NDA vs. ANDA Review Process

  10. IMPLEMENTATION:SCHEDULE Y

  11. DOCUMENT SUBMISSION TO DCGI IN ADDITION TO FORM 44 • PROTOCOL • CASE REPORT FORMS • PRODUCT INFORMATION (Appendix I,II,III) • INVESTIGATOR UNDERTAKING [Appendix IV) • IEC APPROVAL [Appendix V] [Amendments/approvals] • INFORMED CONSENT FORMS(TRANSLATIONS): [Appendix VI ] • MARKETING /REGULATORY STATUS IN OTHER COUNTRIES

  12. Which studies ? When ? Therapeutic confirmatory studies Trials are generally allowed to be initiated at one phase earlier to the phase of trials in other countries

  13. Which studies ? When ?

  14. Which studies ? When ?

  15. ENSURE QUALITY:STABILITY STUDIES

  16. RESPONSIVE IEC COMPOSITION FUNCTION DOCUMENTATION APPROVAL REVISED SCHEDULE Y(2005):PROTOCOL BASED ON INDIAN GCP(2002) & ICMR ETHICAL GUIDELINES(2000) SPONSOR INDIAN GCP SCIENTIFIC IEC GCP INVESTIGATOR HUMAN SUBJECT ETHICAL ICMR GUIDELINES

  17. NON THERAPEUTIC THERAPEUTIC RESEARCH NON- RESEARCH

  18. Before CONSIDERING the study :IEC SHOULD OBTAIN

  19. WHILE CONSIDERING the study :

  20. AFTER CONSIDERING the study :

  21. Adverse Drug Reaction (ADR) All noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase responses to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e. the relationship cannot be ruled out.

  22. Adverse Event (AE) Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product

  23. Seriousadverse event (SAE) Any adverse experience occurring that results in any of the following outcomes

  24. SAE/AR Reporting • Related to or associated with the use of the investigational product • There is a reasonable possibility that the event was caused by the investigational product. • Reasonable: Temporal Relationship Known Pattern

  25. UNEXPECTED SAE • Expected/unexpected/unanticipated An expected event is one where the specificity and severity of the event are consistent with the information in the investigator brochure, labeling for the product, or contained else where in the investigational plan. Unexpected events are all other occurrences.

  26. FUTURE DIRECTION: PRDC (1999) Recommendations on CDSCO • PROTOCOL :ADVISORY BOARD • FULL TIME EXPERTS/EXPERT PANELS • TIME SCHEDULE FOR DRUG APPROVAL * IND PHASEI :WITH IN 3 MONTHS * IND PHASEII:WITHIN 6 MONTHS * MARKETING APPROVAL:3 MONTHS Pharmaceutical Research & Development Committee (PRDC)

  27. FUTURE DIRECTION: INVESTIGATOR SPONSOR REGULATOR RISK MANAGEMENT ACCESSIBILITY IEC HUMAN SUBJECT

  28. Thank You

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