The Central Drugs Standard Control Organization (CDSCO) is India's main drug regulatory body. It oversees the approval process for pharmaceuticals, medical devices, and clinical trials. The approval process involves submitting application forms along with documents covering chemistry/manufacturing, pre-clinical and clinical trial data to CDSCO. Applications are reviewed and may receive approval, approvable, or non-approvable letters in around one year. Bioequivalence studies require separate approval and involve submitting protocols, ethics committee approval and other documents through the online SUGAM portal.

1. Approval
Process in
india
Presented By: Gaurav

2. INTRODUCTION
• The Central drug standard and control organization (CDSCO) is the
main regulatory body of India for regulation of pharmaceutical,
medical devices & Clinical trials.
• CDSCO head office in New Delhi.
• Functioning under the control of Directorate General of Health
Services, ministry of health and family welfare, Government of India.

3. Drug
approval
Process in
INDIA

4. APPLICATION FORMS
Form No. & Rules Purpose
Form 44 Application for permission to import or
manufacture a new drug or to begin a new clinical
trial.
112-A Application for permission to import new drug
122-B Application for approval to manufacture new drug
other than the drugs specified under Schedule C.
122-D Permission to import or manufacture fixed dose
combination
122-DA Application for permission to conduct clinical
trials for New Drug/Investigational New Drug
122-DAB Compensation in the case of injury or death
during the clinical trials.
122-E Definition of new drug
Sawant AM, Mali DP, Bhagwat DA. Regulatory Requirements and Drug Approval Process in India, Europe and US. Pharmaceut Reg Affairs. 2018;7(210):2.

5. SUGAM- Online portal
• An online licensing portal of CDSCO to file
application for various services like application
submission, processing & grants of permission.
• Applicant can track the status of application.
https://cdscoonline.gov.in/CDSCO/homepage

12. Application for (permission for manufacture /import /clinical trial – purpose should be
clearly mentioned)
Name of the applicant
Application requirements for IND
https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/New-Drugs/Checklist/Update_Checklist_10July2018.pdf
(Also shown in previous slides)

13. Form 44 complete
Copy of valid manufacturing license in
Form 25/28
Source of bulk drug.
Chemical and Pharmaceutical
Information
Treasury challan
Name of the New Drug
Composition, dosage form &
indication
50,000/- INR for phase 1 or
25,000/- INR for phase 2/3

14. Therapeutic exploratory trials
(Phase II)
Therapeutic confirmatory trials
(Phase III)
Special Studies (BA/BE)
Clinical trial (Phase-1) summary
Animal toxicology data
Animal Pharmacology

15. Structure, content & format of
clinical trial
Structure, content & format of
clinical study report
Samples and Testing Protocols
Prescribing Information
Regulatory status in other
countries

16. Timeline & Fees for NDA
fresh application - Challan of INR 50000/- is required
Generally takes about one
year to scrutinize these
documents by technical data
Associates/ DI of CDSCO
https://cdscoonline.gov.in/CDSCO/resources/app_srv/cdsco/global/Online_Payment_User_Manual_v1.0.pdf

17. At The End
1). APPROVAL LETTER –
It state that the drug is approved.
The authority is required to respond with an
action letter.
Vishal P, Rahulgiri G, Pratik M, Kumar BJ. A review on drug approval process for US, Europe and India. Int J Drug Regul Affairs. 2014 Mar 1;2(1):1-1.

18. 2). APPROVABLE LETTER- It means that
drug can be approved but has minor
deficiencies that can be corrected like-
labeling changes & possible request
commitment to do post approval study.
3).NON APPROVABLE LETTER- In this
letter list of deficiencies & explain
reason.
Vishal P, Rahulgiri G, Pratik M, Kumar BJ. A review on drug approval process for US, Europe and India. Int J Drug Regul Affairs. 2014 Mar 1;2(1):1-1.

19. BA/BE
application
Process
Application to SUGAM
portal
Review by Assistant DI/ DI
Review by ADC(I)
Application sent to DDC(I)
(Deputy decision Authority)
DCG(I) (Licencing Authority)
will grant
https://cdsco.gov.in/opencms/opencms/en/bioequi_bioavail/index.html

20. Documents require For BE application
Application in Form-44
Treasury Challan of INR 50.000/-
Undertaking by the Principal
Investigator (PI)
https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/BA_BE/BE_NOC_Pre-Screening_Checklist_April_2014.pdf

21. Sponsor’s Authorization letter
BA/BE Centre approval copy issued by DCG(I)
Copy of registration of Ethics
Committee (IEC)
study synopsis
Undertaking letter from the
sponsor/applicant
study protocols
For provide complete care &
Compensation for injury / death
Sponsor’s Authorization letter
Copy of registration of Ethics
Committee (IEC)
study synopsis
Undertaking letter from the
sponsor/applicant
study protocols

22. Names of the countries where the drug
is currently being marketed
Prescribing information
Chemical and Pharmaceutical data
Regulatory approval status of the drug
Published reports of PK and PD studies
Non-clinical and clinical data

23. Report of any study related deaths
during last 3 years at BA/BE center
Address details of the IEC Location and
study site location
For all Injectable, the sub-acute toxicity
study data
Adequate safety data for multiple dose
BE
Certificate of Analysis (COA

24. REFERENCES
1) https://www.fda.gov/
2) https://cdsco.gov.in/opencms/opencms/en/Drugs/New-Drugs/
3) Sawant AM, Mali DP, Bhagwat DA. Regulatory Requirements and Drug
Approval Process in India, Europe and US. Pharmaceut Reg Affairs.
2018;7(210):2.
4) https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryin
formation/guidances/ucm077097.pdf
5) https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsare
DevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA
/default.htm
6) https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-
documents/BA_BE/BE_NOC_Pre-Screening_Checklist_April_2014.pdf
7) https://cdscoonline.gov.in/CDSCO/resources/app_srv/cdsco/global/Onlin
e_Payment_User_Manual_v1.0.pdf