Title 6. GOOD CLINICAL PRACTICE - CDSCO GUIDELINES.pdf ✅

PHARMD GURU Page 1 INTRODUCTION:  CDSCO: Central drugs standard control organization.  CDSCO is the central drug authority for discharging functions assigned to the central government under the drugs and Cosmetic Act.  CDSCO has - Six zonal offices, four sub-zonal offices, 13 port offices, seven laboratories under its control. OBJECTIVES:  To protect and promote health in India.  To safeguard and enhance the public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices. FUNCTIONS OF CDSCO:  Approval of new drugs and clinical trials.  Import registration and licensing.  Amend to Drug and Cosmetic Act and rules.  Participation in WHO GMP certification schemes.  Testing of drugs by Central labs.  Publication of Indian pharmacopoeia.  Monitoring of adverse drug reactions.  Grant of test license, personal license. PRE-REQUISITES FOR THE STUDY: 1) 2.1: INVESTIGATIONAL PHARMACEUTICAL PRODUCT. 2) 2.2: PRECLINICAL SUPPORTING DATA. 3) 2.3: PROTOCOL. a) 2.3.1: RELEVANT COMPONENTS OF PROTOCOL. 2.3.1.2 Objectives & justification. 2.3.1.3 Ethical considerations GOOD CLINICAL PRACTICE - CDSCO GUIDELINES
PHARMD GURU Page 2 b) 2.3.2: SUPPLEMENTARIES & APPENDICES. 4) 2.4: ETHICAL & SAFETY CONSIDERATIONS. a) 2.4.1: ETHICAL PRINCIPLES.  Principles of essentiality.  Principles of voluntariness, informed consent, and community agreement.  Principles of non-exploitation.  Principles of privacy and confidentiality.  Principles of precaution and risk minimization.  Principles of professional competence.  Principles of accountability and transparency.  Principles of maximization of the public interest of distributive justice.  Principles of institutional agreements.  Principles of public domain.  Principles of totality of responsibility and principles of compliance. b) 2.4.2: ETHICS COMMITTEE. 2.3.1.4 Study design. 2.3.1.5 Inclusion, exclusion and withdrawal of subjects. 2.3.1.6 Handling of products. 2.3.1.7 Assessment of efficacy. 2.3.1.8 Assessment of safety. 2.3.1.9 Statistics. 2.3.1.10 Data handling and management. 2.3.1.11 Quality control and quality assurance. 2.3.1.12 Finance and insurance 2.3.1.13 Publication policy 2.3.1.14 Evaluation. 2.4.3.1 Basic responsibilities. 2.4.3.2 Composition.