SCHEDULE Y, OECD PRINCIPLE OF GLP & IMPORTANCE DRUG DEVELOPMENT

1. SUBJECT: TOXICOLOGY SCREENING METHOD II
TOPIC : SCHEDULE Y, OECD PRINCIPLE OF GLP &
IMPORTANCE DRUG DEVELOPMENT
PRESENTED BY
ANSARI AASHIF RAZA
(IInd semester , M.PHARM)
DEPARTMENT OF PHARMACOLOGY
Department of Pharmacology

2. SCHEDULE -Y
•Requirement and guidelines for permission to import and /or
manufacture of new drugs for sale or to undertake clinical
trials.
•PURPOSE OF SCHEDULE-Y
• To frame guideline for conduct of clinical research control
and regulation for new drugs
CDSCO and DTAB formulated GCP under schedule Y in
2005

3. DRUGS AND COSMETIC ACT 1945
RULE PERMISSION FOR
122A To import new drugs
122B To manufacture new drugs
122D To import or manufacture fixed dose combinations
122DA To conduct clinical trials for new drug/investigations new drug
122DAA Definition of clinical trials

4. Requirement And Guideline On Clinical Trials For
Importing And Manufacturing Of New Drugs.
1. Application for permission
2. Clinical trial
3. Studies in specific population
4. Post marketing surveillance
5. Special studies : bioavailability/ bioequivalence.

9. APPENDICES OF SHEDULE Y
 Appendix 1: Data to be submitted along with the application to conduct clinical
trials/import/manufacture of new drugs for marketing in the country
 Appendix 1A: Data required to be submitted by an applicant for grant of permission to
import and /or manufacture a new drug already approved in the country
 Appendix 2 : Structure, contents and format for clinical study reports
 Appendix 3 : Animal toxicology (non-clinical toxicity studies)
 Appendix 4: Animal pharmacology
 Appendix 5 : Informed consent
 Appendix 6 : Fixed dose combinations ( FDC’s )
 Appendix 7 : Undertaking by investigator
 Appendix 8 : Ethics committee
 Appendix 9 : Stability testing of new drugs
 Appendix 10 : Contents of the proposed protocol for conducting clinical trial
 Appendix 11 : Data elements for reporting serious adverse events occurring in a
clinical trial.

10. OECD
 The Organisation for Economic Co-operation and Development, abbreviated
as OECD and based in Paris (FR), is an international organisation of 38
countries committed to democracy and the market economy.

11. OECD PRINCIPLE OF [GLP]GOOD LABORATORY
PRACTICE.
• The Principles of Good Laboratory Practice (GLP) are a managerial quality control system
covering the organisational process and the conditions under which non-clinical health and
environmental studies are planned, performed, monitored, recorded, reported and retained (or
archived).
• The OECD Principles of GLP are followed by test facilities carrying out studies to be
submitted to receiving authorities for the purposes of assessing the health and environmental
safety of chemicals and chemical products which may also be of natural or biological origin
and, in some circumstances, may be living organisms.
• The Principles of GLP define the responsibilities of test facility management, study director,
study personnel and quality assurance personnel that are operating within a GLP system, and
minimum standards concerning the suitability of facilities and equipment to perform studies,
the need for standard operating procedures, documentation of raw data, study reports, the
archiving of records, etc.

18. REFERENCE
• Pharmacology and toxicology screening method by pubmed press
• https://www.slideshare.net/aiswarya95thomas/drug-discovery-
history-evolution-and-stages
• https://www.oecd.org/chemicalsafety/testing/good-laboratory-
practiceglp.htm