CDSCO guidelines

GOOD CLINICAL PRACTICE (GCP) – CDSCO GUIDELINES

INTRODUCTION

CDSCO (Central Drugs Standard Control Organization) is the national regulatory authority of India functioning under the Ministry of Health & Family Welfare.

It discharges functions assigned to the Central Government under the Drugs and Cosmetics Act, 1940 and Rules, 1945.

Infrastructure under CDSCO

• 6 Zonal Offices
• 4 Sub-Zonal Offices
• 13 Port Offices
• 7 Central Drug Testing Laboratories

OBJECTIVES OF CDSCO

Mnemonic: “SAFE HEALTH”

·        S – Safety of drugs & devices

·        A – Assurance of quality

·        F – Fair regulation

·        E – Efficacy evaluation

·        H – Health protection

·        E – Enhancement of public health

·        A – Access to safe medicines

·        L – Legal enforcement

·        T – Transparency

·        H – Harmonization with global standards

FUNCTIONS OF CDSCO

Mnemonic: “AIM-PT PAG”

·        A – Approval of new drugs & clinical trials

·        I – Import registration & licensing

·        M – Amendments to Drugs & Cosmetics Act/Rules

·        P – Participation in WHO-GMP schemes

·        T – Testing of drugs (Central Labs)

·        P – Publication of Indian Pharmacopoeia

·        A – ADR monitoring (Pharmacovigilance)

·        G – Grant of test & personal licenses

PRE-REQUISITES FOR A CLINICAL STUDY (Section 2)

2.1 INVESTIGATIONAL PHARMACEUTICAL PRODUCT (IPP)

Definition

A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial.

Includes:

• New chemical entity
• Approved drug with new indication / dose / route
• Placebo
• Comparator drug

Requirements:

• Proper manufacturing
• Labeling as “For Clinical Trial Use Only”
• Stability data
• Accountability records

📌 Mnemonic: “ML-SAR”

• M – Manufacturing details
• L – Labeling
• S – Stability
• A – Accountability
• R – Reference comparator

2.2 PRECLINICAL SUPPORTING DATA

Purpose

To establish initial safety before human exposure.

Includes:

• Pharmacology studies
• Toxicity studies (acute, sub-acute, chronic)
• Genotoxicity
• Reproductive toxicity
• Carcinogenicity (if required)

📌 Mnemonic: “PT-GRC”

• P – Pharmacology
• T – Toxicity
• G – Genotoxicity
• R – Reproductive
• C – Carcinogenicity

2.3 PROTOCOL

A written document describing objectives, design, methodology, statistical considerations, and organization of a trial.

2.3.1 RELEVANT COMPONENTS OF PROTOCOL

Mnemonic: “OLD I SHARED SQF PE”

Component	Explanation
O	Objectives & justification
L	Ethical considerations
D	Study design
I	Inclusion / exclusion / withdrawal
S	Handling of study products
H	Assessment of efficacy
A	Assessment of safety
R	Statistics
E	Data handling & management
D	Quality control & assurance
S	Finance & insurance
Q	Publication policy
F	Evaluation

Key Components Explained (High-yield)

Objectives & Justification

• Primary & secondary objectives
• Scientific rationale

Ethical Considerations

• Risk-benefit assessment
• Subject safety
• Compliance with ethical principles

Study Design

• Randomized / non-randomized
• Controlled / uncontrolled
• Open / blinded

Inclusion & Exclusion Criteria

• Protect subject safety
• Ensure uniform study population

Handling of Products

• Storage
• Dispensing
• Accountability
• Destruction

Efficacy Assessment

• Primary endpoints
• Secondary endpoints

Safety Assessment

• Adverse events (AE)
• Serious adverse events (SAE)
• Reporting timelines

Statistics

• Sample size
• Statistical tests
• Analysis plan

2.3.2 SUPPLEMENTARIES & APPENDICES

• Case record forms (CRFs)
• Investigator brochure
• Informed consent documents
• Patient information sheet

2.4 ETHICAL & SAFETY CONSIDERATIONS

2.4.1 ETHICAL PRINCIPLES

Mnemonic: “V-NEPAL-PACT”

·        V – Voluntariness & informed consent

·        N – Non-exploitation

·        E – Essentiality

·        P – Privacy & confidentiality

·        A – Accountability & transparency

·        L – Least risk / Precaution

·        P – Professional competence

·        A – Public interest & distributive justice

·        C – Compliance

·        T – Total responsibility

2.4.2 ETHICS COMMITTEE (EC)

Purpose

To protect the rights, safety, and well-being of trial subjects.

2.4.3.1 BASIC RESPONSIBILITIES

• Review protocol
• Ensure ethical conduct
• Monitor ongoing trials

2.4.3.2 COMPOSITION

Mnemonic: “MILD LEGAL”

• M – Medical scientist
• I – Independent member
• L – Lay person
• D – Dental/other professional
• L – Legal expert
• E – Ethical expert
• G – Gender representation
• A – At least 7 members
• L – Local representation

2.4.3.3 TERMS OF REFERENCE

• Authority
• SOPs
• Quorum
• Conflict of interest policy

2.4.3.4 REVIEW PROCEDURES

• Initial review
• Continuing review
• SAE review

2.4.3.6 DECISION-MAKING PROCESS

• Consensus or majority vote
• Quorum mandatory

2.4.3.7 INTERIM REVIEW

• Periodic safety evaluation

2.4.3.8 RECORD KEEPING

• Maintain records ≥ 5 years

2.4.3.9 SPECIAL CONSIDERATIONS

• Vulnerable populations
• High-risk studies

2.4.3 INFORMED CONSENT PROCESS

2.4.3.1 INFORMED CONSENT OF SUBJECT

Must be:

• Voluntary
• Written
• Understandable
• Documented

📌 Mnemonic: “V-WUD”

• V – Voluntary
• W – Written
• U – Understood
• D – Documented

2.4.3.2 ESSENTIAL INFORMATION FOR SUBJECT

Mnemonic: “R-B FATE C”

• R – Risks
• B – Benefits
• F – Funding
• A – Alternative treatments
• T – Trial procedures
• E – Exit rights
• C – Confidentiality

2.4.3.3 NON-THERAPEUTIC STUDIES

• Special justification
• Minimal risk
• Extra EC scrutiny

2.4.4 CONFIDENTIALITY

• Subject identity protected
• Access limited to authorized persons
• Data anonymization

2.4.5 COMPENSATION FOR PARTICIPATION

• Reimbursement for:
• Travel
• Wage loss
• Not an inducement

2.4.6 SELECTION OF SPECIAL GROUPS

Mnemonic: “PCV”

2.4.6.1 Pregnant & Nursing Women

• Only if essential
• Risk minimization

2.4.6.2 Children

• Parental consent
• Child assent

2.4.6.3 Vulnerable Groups

• Prisoners
• Economically disadvantaged
• Mentally impaired

2.4.7 COMPENSATION FOR ACCIDENTAL INJURY

2.4.7.1 SPONSOR OBLIGATION

• Free medical management
• Financial compensation
• In case of:
• Trial-related injury
• Disability
• Death

📌 Mnemonic: “M-D-D”

• M – Medical care
• D – Disability compensation
• D – Death compensation

✅ EXAM TIP

Questions are commonly asked on:

• Ethical principles (mnemonics help)
• Ethics committee composition
• Informed consent essentials
• Sponsor compensation obligations