Describe schedule - Z of drug and cosmetic act for AUS drugs.
1. Introduction :-
Drugs and Cosmetics Act, 1940 is the main legislation in India that regulates the import, manufacture,
distribution and sale of drugs and cosmetics. The Act contains various schedules that specify rules
and standards for drugs.
Schedule Z provides guidelines for the clinical evaluation of ASU drugs (Ayurvedic, Siddha and Unani
medicines). It ensures that traditional medicines are scientifically tested for safety, efficacy and
therapeutic value.
2. Objectives of Schedule Z :-
The main objectives are:
To establish scientific standards for evaluation of ASU drugs.
To ensure safety, efficacy and quality of traditional medicines.
To promote systematic clinical research on Ayurvedic, Siddha and Unani formulations.
To provide uniform guidelines for conducting clinical trials of ASU drugs.
3. Important Provisions of Schedule Z :-
1. Clinical Trial Protocol
Clinical trials should follow scientific and ethical guidelines.
Protocol must include:
Objective of study
Selection criteria of patients
Dose and dosage schedule
Duration of treatment
Evaluation methods and outcome measures.
2. Ethical Clearance
Clinical trials must be approved by an Institutional Ethics Committee (IEC).
Ethics committee must ensure protection of rights and safety of participants.
3. Informed Consent
Written informed consent is mandatory from participants.
Participants must be informed about:
Purpose of study
Procedure
Possible risks and benefits.
4. Phases of Clinical Trials (for ASU Drugs)
Schedule Z follows phases similar to modern drugs:
Phase I – Safety and tolerability in healthy volunteers.
Phase II – Preliminary efficacy and dose determination in patients.
Phase III – Large-scale clinical trials to confirm safety and efficacy.
Phase IV – Post-marketing surveillance to monitor long-term effects.
5. Documentation and Reporting
Proper recording of trial data must be maintained.
Adverse effects and results must be reported to regulatory authorities.
4. Conclusion :-
Schedule Z plays an important role in the regulation of Ayurvedic, Siddha and Unani drugs by
providing guidelines for clinical evaluation, ethical approval, informed consent and monitoring of
clinical trials, ensuring that ASU medicines are safe, effective and scientifically validated.
Describe in detail functions and composition of ASU DTAB and ASU DCC.
1. ASU-DTAB (Ayurvedic, Siddha and Unani Drugs Technical Advisory Board)
Composition :-
ASU-DTAB is constituted by the Central Government under the Drugs and Cosmetics Act, 1940 to
advise on technical matters related to ASU drugs.
It generally consists of the following members:
Director General of Health Services (DGHS) – Chairman
Adviser (Ayurveda / Siddha / Unani), Ministry of AYUSH
Drugs Controller General of India (DCGI)
Director of Pharmacopoeia Laboratory for Indian Medicine (PLIM)
Director of Central Research Institute for Ayurveda / Siddha / Unani
Two experts in Ayurveda
Two experts in Siddha
Two experts in Unani
One expert in Pharmacognosy or Phytochemistry
One expert in Pharmaceutical Chemistry
One teacher in ASU medicine nominated by Central Government
Functions :-
The main functions of ASU-DTAB are:
Advises the Central and State Governments on technical matters related to ASU drugs.
Recommends standards for manufacture and quality control of ASU drugs.
Suggests amendments in rules related to ASU drugs.
Guides development of pharmacopoeial standards for Ayurvedic, Siddha and Unani medicines.
Promotes research and scientific development of ASU drug systems.
Provides recommendations regarding licensing and regulation of ASU drug manufacture.
2. ASU-DCC (Ayurvedic, Siddha and Unani Drugs Consultative Committee)
Composition :-
ASU-DCC is constituted by the Central Government to ensure uniform administration of the Drugs
and Cosmetics Act related to ASU drugs across India.
It consists of:
Two representatives from the Central Government
One representative from each State Government dealing with ASU drugs regulation
Members are usually Drugs Controllers or officers responsible for enforcement of the Act.
Functions :-
The important functions of ASU-DCC are:
Advises Central and State Governments for uniform implementation of the Drugs and Cosmetics Act
for ASU drugs.
Promotes coordination between State Governments regarding regulation of ASU drugs.
Discusses problems related to enforcement of laws for ASU drugs.
Recommends measures to improve drug control administration.
Ensures uniform standards of manufacture, sale and distribution of ASU drugs throughout the
country.
Conclusion :-
ASU-DTAB provides technical and scientific advice, while ASU-DCC ensures coordination and uniform
enforcement of laws related to Ayurvedic, Siddha and Unani drugs in India.