SCHEDULE Y

1
SCHEDULE Y
REGULATORY TOOL TO MANAGE RISK
2
SCENARIO FOR TODAYS DISCUSSION
Schedule Y
IEC
UTILITY
SCOPE
NEW DRUG DEVELOPMENT PROCESS IN INDIA
RIGHTS SAFETY WELL BEING OF HUMAN SUBJECTS
FUTURE DIRECTION
BENEFITS
RISKS
3
SCHEDULE Y

• DEFINE NEW DRUG
• SCOPEREGULATE 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 lt 4 YEARS

EFFICACY???
SAFETY???
5
SCOPE OF SCHEDULE Y
Rule 122-A, 122-B, 122-D, 122-E under Drugs
Cosmetics Rules 1945 in 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

• HERBALSINDIAN SYSTEM OF MEDICINE HOMEOPATHY
• APPROVAL BY STATE DRUG
  CONTROLLER
• BIOTECHNOLOGY PRODUCTSRECOMBINANT PRODUCTS

DCGI
DBT
RDAC
RCGM
IBSC
GEAC
7
Ethical Guidelines for Biomedical Research on
Human Subjects ICMR 2000
STATEMENT
SPECIFIC PRINCIPLES
GENERAL PRINCIPLES

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

10
IMPLEMENTATIONSCHEDULE 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 QUALITYSTABILITY 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

Serious adverse 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 PHASE I WITH IN 3 MONTHS
• IND PHASE IIWITHIN 6 MONTHS
• MARKETING APPROVAL3 MONTHS

Pharmaceutical Research Development Committee
(PRDC)
27
FUTURE DIRECTION
INVESTIGATOR
SPONSOR
REGULATOR
RISK MANAGEMENT
ACCESSIBILITY
IEC
HUMAN SUBJECT
28
Thank You