Ministry of Health and Family Welfare
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National Institute of Health and Family Welfare (NIHFW)
RITP Newly Recruited Drugs Inspectors
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About the Course
Earn a career certificate
No Instructor(s)
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Background, objective and expected outcomes of Induction training
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Need of drug regulation in India
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Genesis of drug regulations
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Overview of Indian Drug Regulatory System
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Issues and Challenges in Drug Regulation Structure, Function and role of CDSCO and State Drugs Control Organisations
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Introduction to Indian Pharma industry and Role of Indian Pharma industry in meeting health care need
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Definition of Drugs, Cosmetic, Manufacture, spurious, adulterated and misbranded
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Role of Statutory Bodies:DTAB, DCC & CDL
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Power and duties of Licensing Authority, Controlling Authority, Drugs Inspector and Govt. analyst
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Offences and Penalties in the Drugs & Cosmetics Act
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Procedure of Banning of Drugs
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National List of Essential Medicines (NLEM) in India
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Hathi_Committee_report_1975_0
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MashelkarCommitteeReport
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Overview of the CLAA scheme
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Overview of WHO-GMP Certification Scheme
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An Introduction to GCP
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An introduction to Drugs & Magic Remedies Act
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Role of PHARMEXCIL, NPPA, Department of Pharmaceuticals (DOP)
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Overview of DPCO and Essential Commodity Act
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Overview of Narcotic Drugs and Psychotropic Substances Act
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Overview of Indian Pharmacopoeia and role of Indian Pharmacopoeia Commission
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Overview of Right to information Act
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Overview of Bharatiya Nagarik Suraksha Sanhita (BNSS)
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CrPC + BNSS Comparison Table
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BNSS 1
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BNSS 2
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Risk Based inspection of Manufacturing Premises
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RBI checklist
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Overview of Clinincal Trial- Regulations, Phases of Clinical trials
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RBI of Manufacturing Premises
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Overview of Prevention of Corruption Act
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Cyber Crime Investigation
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Intelligence gathering in respect of Counterfeit drug manufacturers and conducting secret/discreet verification
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Inspection of Drugs Sales Premises, Samples Collection, Handling and Reporting
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Investigation of spurious and Not of standard quality (NSQ) drugs, Procedure for launching prosecution
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Veterinary Drugs and Misuse of drugs in Animals
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Serious Adverse Events (SAE) in Clinical Trial and Reporting, and Causality Assessement of SAE and Compensation
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CT-SAE-Death- 353-2015
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Compensation Order
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CT-SAE-Death- 88-2016
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Schedule M Objectives and components
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Marketing Authorization process of New Drugs, Investigational New Drugs, Fixed Dose Combination and Subsequent New Drugs
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Post Marketing Surveillance and its Monitoring
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Import & Registeration of Drugs and Import of Drugs under Dual use/ Test License/ Personal Use
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Non compliances Observed During GMP Audit
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Regulation Provisions for grant of manufacturing licence
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Aseptic Processing Techniques
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Seizure and Arrest
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Qualification and Validation Principles, Process Validation
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Cleaning Validation
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Utility System Validation (HVAC, Water System etc.) in Pharmaceutical Industry
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Concept and Definition of OOS, Change Control, Deviation, and Self Inspection
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Good Laboratory Practices- Schedule L1 of Drugs Rules, 1945
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Pharmacovigilance Programme of India (PvPI), Haemovigilance Programme of India (HvPI), Materiovigilance Programme of India (MvPI)
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Overview of Bharatiya Sakshya Adhiniyam (BSA)
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Validation of Analytical Methods
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Basic Principles of Stability of Drugs; Stability Studies of Pharmaceutical Products
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Administrative Matter CONDUCT RULES
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CCS_Conduct_Rules_1964_Updated_27Feb15_0
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Administrative Matters Sexual Harrasments
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Neutral drug Code/ Special code, Written Confirmation and export NOC, BA/BE Export NOC
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GOOD DISTRIBUTION PRACTICES
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Biological Products- Basic of Vaccines, Recombinant Technology, Regenerative Medicines and Monoclonal Antibodies
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Biocompatibility Study, Standards and Classification of Medical devices and Diagnostics
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Current Regulation on Medical Devices & IVD, Drugs Vs Devices
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NRA Assessment of Vaccines
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Inspection-Planning, Preparation, collection of evidences and report prepartion
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Regulatory Requirement for the functioning and operation of a blood centres and preparation of blood components
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General Non Compliance observed in inspections in BB
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Online portals of CDSCO-Website , Sugam, ONDLS, NSWS, eHRMS, MD Online
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Administrative Matter
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Leave Rules
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CCS CCA Rules
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Administerative Matters Medical Bills
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Administrative Matters -Leave-Rules-1972
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Functions of Port office
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Stress Management
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Administrative Matter:- Noting and Drafting
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VIP References
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Post Assessment
Assessment
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Certificate
CDSCO Certificate
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