Clinical_Trials_CDSCO_Presentation by Abhijeet.pdf

This is document consists of clinical trial procedures in India by Abhijeet Acharya, a student pursuing B. Pharmacy from Sri Sukhmani Institute of Pharmacy as of October 2025.

1. CLINICALTRIALSOFDRUGSAS
PERREGULATORYAFFAIRSOF
CDSCO,INDIA
PRESENTEDBY:ABHIJEETACHARYA
COURSE:B.PHARMACY
INSTITUTION:SRISUKHMANIINSTITUTEOFPHARMACY
SUBJECT:REGULATORYAFFAIRS/PHARMACOLOGY
DATE:15-10-2025

2. Introduction
•Definition of a clinical trial
•Importance in ensuring drug safety and
efficacy
•Role of CDSCO (Central Drugs Standard
Control Organization) as India’s regulatory
authority
•Objective: To understand the phases of
clinical trials as per CDSCO guidelines

3. Regulatory Framework in India
•Regulatory Body: CDSCO under
Ministry of Health & Family Welfare
•Key authority: Drugs Controller
General of India (DCGI)
•Governed under: Drugs and
Cosmetics Act, 1940 and New Drugs
and Clinical Trials Rules, 2019
•Clinical trial approval via SUGAM
Portal

4. Preclinical Studies
•Conducted before human testing
•Performed on animals to evaluate toxicity
and pharmacokinetics
•Data used to file for Clinical Trial
Application (CTA) with CDSCO

5. Phase 0 –Microdosing Studies
•Conducted on 10–15 volunteers
•Aim: Assess pharmacokinetics with
subtherapeutic doses
•Helps decide whether to proceed
further
•Not mandatory for all drugs

6. Phase I –Human Safety Trials
•Conducted on 20–100 healthy
volunteers
•Objective: Evaluate safety,
tolerability, dosage range, and
pharmacokinetics
•Duration: Several months
•Outcome: Determination of safe
dosage and initial side effects

7. Phase II –Efficacy and Dose-Finding
•Conducted on 100–300 patients
with the target disease
•Objective: Evaluate efficacy and
further safety
•Helps identify optimal dosage
regimen
•Randomized and controlled
studies

8. Phase III –Confirmation of Efficacy
•Conducted on 1,000–3,000 patients
across multiple centers
•Objective: Confirm efficacy and
monitor adverse effects
•Data used for New Drug Application
(NDA) submission to CDSCO
•Duration: 1–4 years

9. Phase IV –Post-Marketing Surveillance
•Conducted after marketing
approval
•Objective: Long-term monitoring
of safety and effectiveness
•Detects rare or delayed adverse
effects
•Important for pharmacovigilance

10. Ethical Considerations
•Informed consent from all
participants
•Ethics Committee approval
mandatory before initiation
•Adherence to Good Clinical Practice
(GCP) guidelines
•Ensures protection of human rights
and safety

11. Role of Investigator and Sponsor
•Investigator: Conducts the study and
ensures protocol compliance
•Sponsor: Funds and manages the trial
•Responsibilities include reporting
Serious Adverse Events (SAEs) to
DCGI within 14 days

12. Key Documents and Submissions
1.Clinical Trial Application (CTA)
2.Investigator’s Brochure (IB)
3.Protocol and Case Report Forms
(CRFs)
4.Informed Consent Documents
5.Periodic safety reports to CDSCO

13. Challenges in Indian Clinical Trials
i.Patient recruitment and retention
ii.Ethical concerns and public
perception
iii.Infrastructure and monitoring
limitations
iv.Regulatory delays and data
transparency

14. Recent Developments
•New Drugs and Clinical Trials Rules,
2019 simplified procedures
•Introduction of Accelerated Approval
Process
•Promotion of Make-in-India and
indigenous drug research
•Digitalization and real-time monitoring
by CDSCO

15. Conclusion
i.Clinical trials are the backbone of drug
development and safety assurance
ii.CDSCO ensures ethical and scientific
conduct as per global standards
iii.India’s regulatory environment is evolving
to promote innovation and patient safety

16. References
•CDSCO Guidelines
•Drugs and Cosmetics Act, 1940 &
NDCT Rules, 2019
•ICMR Ethical Guidelines for
Biomedical Research
•WHO Good Clinical Practice
Guidelines