sachinjangra14@gmail.com

1. SCHEDULE Y
Presented by :-
sachin jangra
mPHARMA2ndSEM
Rollno. 03
Supervisor :-
DR. rajesh kumar
AssistantProfessor,
KurukshetrAuniversity,kurukshetra

2. Through notification recently certain rules of Drugs
and cosmetic act have been amended to facilitate the
drug discovery process in india. These amendments
are described in SCHEDULE Y.
INTRODUCTION

3. THE ESSENCE OF THE NOTIFICATION ARE:-
 Manufacture new drug for sale
 Requirements and guidelines for permission of
import
 To under take clinical trial in india
TWO BROAD AREA COVERED UNDER THE NOTIFICATION
 Animal pharmacology
 Animal toxicology

4. FORM 44
Chemical and pharmaceutical information
 It include information on
1. Active ingredients
2. Physiochemical data
3. Analytical data
4. Validation
5. Stability studies

5.  Animal pharmacology data
 It includes
1. General pharmacological actions
2. Pharmacokinetic data related to ADME
 Human clinical pharmacology
 Clinical trail on new drug shall be initiated only
after permission granted by the licensing
authority and approval obtained feom
respective ethics committee.
 It to be ensured that clinical trail is conducted
and documented by Central Drugs Standard
Control Organization.

6.  ANIMAL TOXICOLOGY DATA
 Toxic studies must follow the GLP.
 Toxicokinetic studies.
 REGULATORY STATUS IN OTHER COUNTRIES
 Include the information in respect of restrictions
imposed & dose limit’s.

7.  FULL PRESCRIBING INFORMATION
 Should be submitted as a part of the new drug
application for the marketing
 And all other information related to the drug like
generic name , dosage form etc.
COMPLETE TESTING PROTOCOLS
FOR QUALITY CONTROL TESTING