Tiêu đề 10. OVERVIEW OF REGULATORY ENVIRONMENT IN USA, EUROPE AND INDIA.pdf ✅

PHARMD GURU Page 1 REGULATORY ENVIRONMENT IN INDIA  The principal regulatory body involved in the approval of "manufacture, drug development and marketing of quality drugs in India is CDSCO.[The central drug standards under control organization].  At the state level, state drug control organization issues licenses to manufacture the approved drugs and to monitor the quality of drugs along with CDSCO.  In India, the regulation of drugs, medical devices, biologicals and r-DNA products is distributed within various ministries. INDIA – WELL DEFINED DRUG REGULATORY SYSTEM GOVT. OF INDIA  Enforcement & GMP audit Div.  Quality Control Division – CDTL  Registration Div.  New Drugs Div.  Pharmacovigilance  Trainings MINISTRY OF HEALTH & FAMILY WELFARE DGHS CDSCO DCGI DTAB MINISTRY OF CHEMICALS & FERTILIZERS DEPARTMENT OF PHARMACEUTICALS NPPA MINISTRY OF COMMERCE PATENT OFFICE CONTROLLER GENERAL OF PARENTS MINISTRY OF SCIENCE & TECHNOLOGY ICMR DBT CSIR LABS OVERVIEW OF REGULATORY ENVIRONMENT IN USA, EUROPE AND INDIA
PHARMD GURU Page 2 REGULATORY BODIES: a) DRUG CONTROL GENERAL OF INDIA (DCGI): Main authority for clinical trials, ensures standards, registers all imported drugs, new drugs, biologics and medical devices. b) INDIAN COUNCIL OF MEDICAL RESEARCH (ICMR): Main Center for biomedical research. c) DRUGS CONSULTATIVE COMMITTEE (DCC): Provides technical guidance to the CDSCO d) CENTRAL DRUGS LABORATORY (CDL): Maintains quality control of drugs. e) CENTRAL LICENSE APPROVAL AUTHORITY (CLAA): Provides approval for manufacturing licenses f) DRUGS TECHNICAL ADVISORY BOARD (DTAB): Provides technical guidance to the CDSCO. g) NATIONAL PHARMACEUTICAL PRICING AUTHORITY (NPPA): NPPA fixes (or) revises the prices of decontrolled bulk drugs and formulations and periodically updates the list under the price control, according to guidelines. h) GENETIC ENGINEERING APPROVAL COMMITTEE (GEAC): Deals with genetic engineering and the molecule biology trials, in which biotech products are used will be referred here by DCGI. i) DEPARTMENT OF BIOTECHNOLOGY (DBT): Oversees the development of modern biology and biotechnology in India. j) ATOMIC ENERGY REVIEW BOARD (AERB): Has regulatory control over radiation equipment.
PHARMD GURU Page 3 k) BABA ATOMIC RESEARCH CENTRE (BARC): Approves all radiation related projects & radio-pharmaceuticals in India. CLINICAL RESEARCH REGULATIONS IN INDIA: DRUG CONTROLLER GENERAL OF INDIA (DCGI):  CDSCO under the ages of ministries of health and family welfare, have the duty of regulating and ensuring the quality of medicines and pharmaceuticals under the Drug and cosmetic Act.  Drug Controller General of India (DCGI) under Central Drug Standard Control Organization (CDSCO) has primary responsibility for regulating clinical trials in India.  CDSCO is organized into various headquarters, zonal offices, sub-zonal offices, Port offices and laboratories. FUNCTIONS OF CDSCO:  Approval of new drugs & clinical trials.  Import registration & licensing.  Licensing of blood banks, LVPs, vaccines, R-DNA products & some medical devices. DRUGS CONTROLLER GENERAL (I) HEAD QUATER New Drugs CLAA Imports DTAB/DCC ZONAL OFFICE (4) GMP Audits Coordinations with sales SUB-ZONAL OFFICE (2) GMP Audits Coordinations with sales PORT OFFICE (7) Imports Exports LABORATORY (6) Testing of drug samples validation of test protocol
PHARMD GURU Page 4  Amendment of drugs and Cosmetic Act and rules.  Banning of drugs and cosmetics.  Grant of test license, personal license, NOCs for export.  Testing of drugs. CLINICAL TRIALS GUIDELINES IN INDIA:  The guidelines that govern the conduct of clinical trials in India include:  Schedule y of drugs and costs Act, 1940.  Ethical guidelines for biomedical Research of human subjects, 2000.  GCP guidelines as Per CDSCO.  GLP guidelines as per CDSCO.  Bioavailability and Bioequivalence guidance.  National Pharmacovigilance program, 2004. IMPORTANCE OF SCHEDULE Y:  Regulations and guidelines for permission to import and/or manufacture of new drugs for sale (or) to undertake clinical trials.  It has outlined extensive study criteria in line with the globally accepted formats such as ICH & USFDA guidelines. RULES GOVERNING REGISTRATION OF DRUGS IN INDIA: RULE 122A PERMISSION TO IMPORT A NEW DRUG RULE 122B PERMISSION TO MANUFACTURE A NEW DRUG RULE 122D PERMISSION TO IMPORT (OR( MANUFACTURE A FDC’S RULE 122DA PERMISSION TO CONDUCT CLINICAL TRIALS FOR NEW DRUGS RULE 122E DEFINITION OF NEW DRUG APPLICATION FOR PERMISSION TO CONDUCT CLINICAL TRIALS: A sponsor needs to file an IND application (Form 44) with the CDSCO to get permission to conduct clinical trials. The same form-44 can be used to import (or) manufacture a new drug. INDs contents described in schedule-Y are similar to those of a submission to USFDA. IND mainly includes: 1. Chemical and Pharmaceutical information. 2. Animal pharmacology data.