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noc20_ge13_assigment_1noc20_ge13_assigment_1
noc20_ge13_assigment_2noc20_ge13_assigment_2
noc20_ge13_assigment_3noc20_ge13_assigment_3
noc20_ge13_assigment_4noc20_ge13_assigment_4
noc20_ge13_assigment_5noc20_ge13_assigment_5
noc20_ge13_assigment_6noc20_ge13_assigment_6
noc20_ge13_assigment_7noc20_ge13_assigment_7
noc20_ge13_assigment_8noc20_ge13_assigment_8
noc20_ge13_assigment_9noc20_ge13_assigment_9


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
13Good Clinical Practice Download
14Requirements for import/ manufacture of new drug/ IND for conducting clinical trials in IndiaDownload
15Requirements for import/ manufacture of new drug/ IND for sale/ distribution & unapproved new drug for patientsDownload
16Important issuesDownload
17Special concernDownload
18Clinical trial related guidelines (NDCT Rules)Download
19Content of Proposed Clinical Trial ProtocolDownload
20Content of a Clinical Trial ReportDownload
21Post Marketing Assessment & Clinical Trial CompensationDownload
22Common observations during submission of CT/BA/BE protocolDownload
23Common observations during CT/BA/BE centre inspectionsDownload
24Drug development process: OverviewDownload
25Salient feature of NDCT 2019 - what's new in NDCT?Download
26Online Submission 23A: SUGAMDownload
27ONLINE SUBMISSION (CTRI)Download
28TABLES GIVEN IN NDCT 2019 AND ITS CONTENTDownload

Sl.No Chapter Name English
1Courses OverviewDownload
Verified
2Overview of Indian regulatory systemDownload
Verified
3Overview of Drugs & Cosmetics Act and Rules thereunderDownload
Verified
4Overview of New Drugs and Clinical Trials Rules, 2019Download
Verified
5PRE-CLINICAL DATA REQUIREMENTSDownload
Verified
6RULES GOVERNING CLINICAL TRIALSDownload
Verified
7Phases of clinical trial, forms, and feesDownload
Verified
8Regulatory pathway and data requirements for NDCT, 2019Download
Verified
9BA/BE study and study centers: Legal provisionsDownload
Verified
10Guidelines to conduct BA/BE studiesDownload
Verified
11Ethics Committee registration and re-registrationDownload
Verified
12Ethical ConsiderationsDownload
Verified
13Good Clinical Practice Download
Verified
14Requirements for import/ manufacture of new drug/ IND for conducting clinical trials in IndiaDownload
Verified
15Requirements for import/ manufacture of new drug/ IND for sale/ distribution & unapproved new drug for patientsDownload
Verified
16Important issuesDownload
Verified
17Special concernDownload
Verified
18Clinical trial related guidelines (NDCT Rules)Download
Verified
19Content of Proposed Clinical Trial ProtocolDownload
Verified
20Content of a Clinical Trial ReportDownload
Verified
21Post Marketing Assessment & Clinical Trial CompensationDownload
Verified
22Common observations during submission of CT/BA/BE protocolDownload
Verified
23Common observations during CT/BA/BE centre inspectionsDownload
Verified
24Drug development process: OverviewDownload
Verified
25Salient feature of NDCT 2019 - what's new in NDCT?Download
Verified
26Online Submission 23A: SUGAMDownload
Verified
27ONLINE SUBMISSION (CTRI)Download
Verified
28TABLES GIVEN IN NDCT 2019 AND ITS CONTENTDownload
Verified


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1EnglishNot Available
2BengaliNot Available
3GujaratiNot Available
4HindiNot Available
5KannadaNot Available
6MalayalamNot Available
7MarathiNot Available
8TamilNot Available
9TeluguNot Available