Lecture on CDSCO by Dr. Badrinath

Introduction

• CDSCO: Central Drugs Standard Control Organization
• Central organization located in Delhi
• Controls drug standards
• Works under Directorate General of Health Services (DGHS)
• Part of Ministry of Health and Family Welfare
• Government of India organization

Key Roles and Functions

• Main Objective: Safeguard public health
• WHO declared CDSCO as a functional National Regulatory Authority (NRA)
• Vision: Protect and promote public health (PPP)
• Mission: Ensure safety, efficacy, and quality of medicines

Structure

• Headquarters: Located in Delhi
• Zonal Offices: Four zonal offices (east, west, south, north)
• State Level: State Drugs Control Organizations, including drug testing laboratories
• Sub Zonal Offices: Two
• Laboratories: Six laboratories for drug testing

Key Responsibilities

• Approval of New Drugs: Including clinical trials
• Import Registration and Licensing: Drugs, biologicals, medical devices
• Regulation: Blood banks, large volume parenterals, vaccines, DNA products
• Banning Drugs: Based on contraindications or adverse effects
• Grant Licenses: For testing, personal use, export
• Market Surveillance: Conducted by inspectorate
• Amendments: Can modify the Drugs and Cosmetics Act and rules
• Online Licensing System: Sugam for application submissions

State Level Functions

• Licensing of manufacturing sites
• Approval of drug testing laboratories
• Maintenance of drug and cosmetic quality
• Investigations, prosecutions, and recalls
• Approval of clinical trials at state level

Clinical Trials

• Investigational New Drug (IND): Requires application to CDSCO
• Phases: Phase 1 (30 days), Phase 2 (45 days), Phase 3 (60 days)
• Required for global clinical trials

National Pharmacovigilance Program

• NPAC: National Pharmacovigilance Advisory Committee
• RPC: Regional Pharmacovigilance Centers
• PPC: Peripheral Pharmacovigilance Centers

International Collaborations

• Collaborations with US FDA, Brazil, South Africa, and other countries

Good Practices

• GCP: Good Clinical Practice for trials
• GMP: Good Manufacturing Practice for production
• GLP: Good Laboratory Practice for testing

Notable Facts

• Located in FDA Bhawan, Kotla Road, New Delhi
• Dr. V.G. Somani: Current Drug Controller General of India (as of September 2020)
• Historical importance: Inaugurated by Pranab Mukherjee and Ram Dass

Conclusion

• Highly important organization for drug regulation in India
• Essential for maintaining public health safeties such as quality and efficacy of drugs