Schedule Z outlines regulatory requirements for conducting clinical trials on Ayurvedic, Siddha, and Unani (ASU) medicines to ensure their safety, efficacy, and therapeutic value through systematic research.
Purpose and Scope
Introduced to promote scientifically validated clinical studies on ASU drugs.
Ensures standardized protocols for evaluating safety, efficacy, and therapeutic benefits.
Key Guidelines Under Schedule Z
A) Clinical Trial Protocols
Must follow scientifically accepted methodologies and ethical standards.
Protocols should define objectives, patient selection criteria, dosage, study duration, outcome measures, and evaluation criteria.
B) Ethical Clearance
Trials must be reviewed and approved by Institutional Ethics Committees (IEC) registered with the Ministry of AYUSH or other competent authorities.
C) Informed Consent
Written informed consent is mandatory for all participants.
Participants must be informed about the trial objectives, potential benefits, risks, and procedures.
D) Clinical Trial Phases (for ASU drugs)
Schedule Z classifies trials into four phases, similar to modern medicine trials:
1) Phase I (Safety Assessment)
Tests safety, tolerability, and dosage in a small group of healthy volunteers.
2) Phase II (Exploratory/Preliminary Efficacy)
Evaluates therapeutic efficacy, optimal dosage, and preliminary safety in patients.
3) Phase III (Confirmatory Trials)
Conducted on a larger patient population to confirm safety and effectiveness.
4) Phase IV (Post-Marketing Surveillance)
Monitors long-term effects, rare adverse reactions, and real-world effectiveness.
E) Documentation and Reporting
Detailed documentation of trial procedures, observations, results, and adverse reactions.
Clinical trial data must be submitted to regulatory authorities for approval and registration
