drug regulation in india, licensing requirement and approval procedure

1. REGULATORY REQUIREMENT AND
APPROVAL PROCEDURES FOR DRUGS
Atul Bhombe
M Pharmacy (RA)
1st year
Sanjivani college of pharmaceutical
education and research, MH
31/3/2021

2. INTRODUCTION
 The new drug and clinical trials rules, 2019 is apply
to all new drugs, investigational new drugs for
human use, clinical trial, bioequivalence study,
bioavailability study and Ethics Committee.

4. MANUFACTURE OF NEW DRUGS OR INVESTIGATIONAL
NEW DRUGS FOR CLINICAL TRIAL, BIOAVAILABILITY OR
BIOEQUIVALENCE STUDY OR FOR EXAMINATION, TEST
AND ANALYSIS.

5. IMPORT OF NEW DRUGS AND IND FOR CLINICAL
TRIAL/BA-BE STUDY OR FOR EXAMINATION, TEST AND
ANALYSIS

6. IMPORT OR MANUFACTURE OF NEW DRUG
FOR SALE OR FOR DISTRIBUTION.

7. CONDUCT CLINICAL TRIALS OR IMPORT OR
MANUFACTURE OF
NEW DRUGS FOR SALE IN THE COUNTRY

11. REFERENCE
 The New Drug and Clinical Trials Rules,2019.