Pharma Regulatory Essentials (CDSCO, DCA)

📘 Module 1: Introduction to Indian Pharma Regulatory Environment (45 Minutes)

📖 Section 1.1: Evolution of Pharma Regulations in India

• Historical background: From colonial era to present
• Importance of regulatory oversight in public health

📖 Section 1.2: Key Regulatory Bodies

• CDSCO: Role as the national regulatory authority
• MoHFW: Ministry of Health and Family Welfare
• State Drug Controllers: Local implementation

📘 Module 2: Drugs and Cosmetics Act, 1940 & Rules, 1945 (1 Hour)

📖 Section 2.1: Overview of the DCA

• Objective and structure
• Scope: Drugs, cosmetics, medical devices

📖 Section 2.2: Key Provisions

• Definitions and classifications
• Prohibition of spurious/adulterated drugs

📖 Section 2.3: Important Schedules

• Schedule M: GMP guidelines
• Schedule Y: Clinical trials
• Schedule H/X: Prescription drug control

📘 Module 3: CDSCO Structure and Functions (1 Hour)

📖 Section 3.1: CDSCO Overview

• Operates under DCGI
• Zonal, sub-zonal, and port offices

📖 Section 3.2: Regulatory Responsibilities

• Approval of new drugs, generics, FDCs
• Import/export regulations
• Clinical trial permissions
• Medical device regulation (MDR, 2017)

📖 Section 3.3: Online Portals

• SUGAM portal for online applications
• e-Governance initiatives

📘 Module 4: Licensing and Approvals Process (1 Hour)

📖 Section 4.1: Types of Licenses

• Manufacturing license (Form 25, 28, etc.)
• Import and wholesale/retail drug licenses

📖 Section 4.2: Drug Approval Procedure

• Pre-clinical and clinical trials
• BE/BA studies
• Post-approval surveillance (Pharmacovigilance)

📖 Section 4.3: Role of State Licensing Authorities

• Coordination with CDSCO
• Local GMP inspections

📘 Module 5: Compliance, Inspections & Quality Standards (1 Hour)

📖 Section 5.1: Good Manufacturing Practices (GMP)

• WHO-GMP, Schedule M, and other benchmarks

📖 Section 5.2: Regulatory Inspections

• CDSCO and State Drug Controller inspections
• Common audit observations and warnings

📖 Section 5.3: Product Recalls & Penalties

• Voluntary and mandatory recalls
• Prosecution under DCA

📘 Module 6: Clinical Trials, Pharmacovigilance & Trends (45 Minutes)

📖 Section 6.1: Clinical Trial Regulations

• Ethics committee approvals
• Schedule Y and NDCTR 2019 compliance

📖 Section 6.2: Pharmacovigilance in India

• PvPI program and AE reporting
• Regulatory action mechanisms

📖 Section 6.3: Regulatory Updates & Trends

• Draft Drugs, Medical Devices & Cosmetics Bill 2023
• Global harmonization: ICH, USFDA, EMA standards
• COVID-19 fast-track pathways

🧪 Navigate the complexities of Indian pharma compliance with up-to-date regulatory knowledge and hands-on case insights.