Module NameDownload


Sl.No Chapter Name MP4 Download
1Courses OverviewDownload
2Overview of Indian regulatory systemDownload
3Overview of Drugs & Cosmetics Act and Rules thereunderDownload
4Overview of New Drugs and Clinical Trials Rules, 2019Download
5PRE-CLINICAL DATA REQUIREMENTSDownload
6RULES GOVERNING CLINICAL TRIALSDownload
7Phases of clinical trial, forms, and feesDownload
8Regulatory pathway and data requirements for NDCT, 2019Download
9BA/BE study and study centers: Legal provisionsDownload
10Guidelines to conduct BA/BE studiesDownload
11Ethics Committee registration and re-registrationDownload
12Ethical ConsiderationsDownload

Sl.No Chapter Name English
1Courses OverviewPDF unavailable
2Overview of Indian regulatory systemPDF unavailable
3Overview of Drugs & Cosmetics Act and Rules thereunderPDF unavailable
4Overview of New Drugs and Clinical Trials Rules, 2019PDF unavailable
5PRE-CLINICAL DATA REQUIREMENTSPDF unavailable
6RULES GOVERNING CLINICAL TRIALSPDF unavailable
7Phases of clinical trial, forms, and feesPDF unavailable
8Regulatory pathway and data requirements for NDCT, 2019PDF unavailable
9BA/BE study and study centers: Legal provisionsPDF unavailable
10Guidelines to conduct BA/BE studiesPDF unavailable
11Ethics Committee registration and re-registrationPDF unavailable
12Ethical ConsiderationsPDF unavailable


Sl.No Language Book link
1EnglishNot Available
2BengaliNot Available
3GujaratiNot Available
4HindiNot Available
5KannadaNot Available
6MalayalamNot Available
7MarathiNot Available
8TamilNot Available
9TeluguNot Available