Current Regulatory Requirements for Conducting Clinical Trials in India for IND/New Drug PDF

CURRENT REGULATORY REQUIREMENTS FOR CONDUCTING CLINICAL TRIALS IN INDIA FOR IND/NEW DRUG (Version 2.0)  OVERVIEW OF INDIAN DRUG RE REGULATORY SYSTEM (CDSCO/SLA)  LEARNING OBJECTIVES The The faculty...

CURRENT REGULATORY REQUIREMENTS FOR CONDUCTING CLINICAL TRIALS IN INDIA FOR IND/NEW DRUG (Version 2.0)  OVERVIEW OF INDIAN DRUG RE REGULATORY SYSTEM (CDSCO/SLA)  LEARNING OBJECTIVES The The faculty faculty will will W HAT cover cover WILLthe the following WE following LEARN IN in in this this LECTURE lecture: lecture: 1? Introduction to CDSCO and its different offices, laboratories Hierarchy at CDSCO State Licensing Authority Responsibilities of Central Government and State Government Achievements of CDSCO Other Ministries/Department involved Regulatory gaps/challenges/initiatives CURRENT REGULATORY REQUIREMENTS FOR CONDUCTING CLINICAL TRIALS IN INDIA FOR IND/NEW DRUG (VERSION 2.0)  INTRODUCTION § Indian drug regulatory system regulates drugs, cosmetics and medical devices through Drugs and Cosmetics Act, 1940, and Rules thereunder 1945. § It is exercised at two levels (i. e. at Central level and State level). § The subject (health) ‘drug’ falls under concurrent list in the Constitution of India. CURRENT REGULATORY REQUIREMENTS FOR CONDUCTING CLINICAL TRIALS IN INDIA FOR IND/NEW DRUG (VERSION 2.0)  INTRODUCTION § At central level, the regulatory agency is Central Drugs Standard Control Organization (CDSCO), which is attached office to the Directorate General of Health Services (DGHS) under the Ministry of Health and Family Welfare (MoH&FW), Government of India (GOI). § At every state level, it is State Licensing Authority (SLA). CURRENT REGULATORY REQUIREMENTS FOR CONDUCTING CLINICAL TRIALS IN INDIA FOR IND/NEW DRUG (VERSION 2.0)  CDSCO § CDSCO is the central drug regulatory authority, headed by Drugs Controller General (India) [DCG(I)], under the Ministry of Health & Family Welfare, Government of India. § It is the National Regulatory Authority (NRA) of India. § CDSCO headquarter is situated at the FDA Bhawan, Kotla Road, New Delhi. CURRENT REGULATORY REQUIREMENTS FOR CONDUCTING CLINICAL TRIALS IN INDIA FOR IND/NEW DRUG (VERSION 2.0)  CDSCO § CDSCO is mainly responsible for the approval of clinical trials, new drugs, medical devices, biopharmaceuticals including vaccines, biosimilars, stem cell products, etc. § CDSCO has thirteen (zonal and sub-zonal) offices across the country which are also involved in the monitoring of clinical trials. CURRENT REGULATORY REQUIREMENTS FOR CONDUCTING CLINICAL TRIALS IN INDIA FOR IND/NEW DRUG (VERSION 2.0) HIERARCHY  HIERARCHY CURRENT REGULATORY REQUIREMENTS FOR CONDUCTING CLINICAL TRIALS IN INDIA FOR IND/NEW DRUG (VERSION 2.0) CDSCO OFFICES & LABORATORIES  CDSCO OFFICES & LABORATORIES ZONAL OFFICES (SIX) Ghaziabad, Mumbai, Chennai, Kolkata, Ahmedabad, Hyderabad. SUB ZONAL OFFICES (SEVEN) Chandigarh, Bangalore, Goa, Jammu, Guwahati, Indore, Varanasi. CURRENT REGULATORY REQUIREMENTS FOR CONDUCTING CLINICAL TRIALS IN INDIA FOR IND/NEW DRUG (VERSION 2.0)  CDSCO OFFICES & LABORATORIES CENTRAL DRUGS LABORATORIES (EIGHT) Kolkata, Mumbai, Chennai, Hyderabad, Chandigarh, Guwahati, Kasuali, NIB Noida. PORT OFFICES (THIRTEEN) For import and export. CURRENT REGULATORY REQUIREMENTS FOR CONDUCTING CLINICAL TRIALS IN INDIA FOR IND/NEW DRUG (VERSION 2.0) VARIOUS DIVISIONS AT CDSCO, NEW DELHI  VARIOUS DIVISIONS AT CDSCO, HQ, New Delhi New drugs Biologicals Medical Cosmetics devices & IVD IND New Registration SND Biological CI GCT Biosimilar CPE FDC GCT NMD BA/BE Import/ Import Import Registration TL TL TL SAE AEFI EC Abbreviations: IVD = in vitro Diagnostics; IND = Investigational New Drug; SND = Subsequent New Drug; GCT= Global Clinical Trial; FDC = Fixed Dose Combination; BA/BE = Bioavailability/Bioequivalence; TL = Test License; SAE = Serious Adverse Event; EC = Ethics Committee; AEFI = Adverse Events Following Immunization; CI = Clinical Investigation; CPE = Clinical Performance Evaluation; NMD = New Medical Device CURRENT REGULATORY REQUIREMENTS FOR CONDUCTING CLINICAL TRIALS IN INDIA FOR IND/NEW DRUG (VERSION 2.0)  CDSCO ORGANOGRAM Drugs Controller General (India) ZONAL SUB ZONAL PORT OFFICE LABORATORY HEAD QUARTER OFFICE (6) OFFICE (6) (13) (8) § New drugs Enforcement § GMP audits § Import § Testing of drugs § Clinical trials GMP audits § Coordination § Export § Validation of § Imports Drawing drug § with states test protocols § Biologicals samples § sampling § Medical devices QMS audit § Quality Assurance Clinical trial § Pharmacovigilance audit § Legal etc. Abbreviations: GMP = Good Manufacturing Practice; QMS = Quality Management System CURRENT REGULATORY REQUIREMENTS FOR CONDUCTING CLINICAL TRIALS IN INDIA FOR IND/NEW DRUG (VERSION 2.0) STATE LICENSING AUTHORITY (SLA)  SLA State licensing authority (SLA) is known by various names such as FDA, DCA, Drug license authority, DCO, DCA ,etc. Every state/union territory of the country has established its own licensing authority to regulate drug/cosmetics in their state. The SLA is headed by Commissioner or Drug Controlling Authority and supported by Joint Commissioner/Assistant Commissioner/Deputy Drug Controller/Assistant Drug Controller /Drugs Inspector etc. CURRENT REGULATORY REQUIREMENTS FOR CONDUCTING CLINICAL TRIALS IN INDIA FOR IND/NEW DRUG (VERSION 2.0) OTHER MINISTRIES DEPARTMENTS INVOLVED  OTHER MINISTRIES/DEPARTMENTS INVOLVED Related ministries and other department involved are: Ministry of Chemicals & Fertilizers National Pharmaceutical Pricing Authority (NPPA) Genetic Engineering Appraisal Committee (GEAC) Indian Council of Medical Research (ICMR) Department of Biotechnology - Review Committee on Genetic Manipulation (DBT - RCGM) Department of Science & Technology (DST) CURRENT REGULATORY REQUIREMENTS FOR CONDUCTING CLINICAL TRIALS IN INDIA FOR IND/NEW DRUG (VERSION 2.0) VARIOUS MINISTERIES/DEPARTMENTS INVOLVED Ministry of Ministry of Health Ministry of State Licensing Chemicals & Fertilizers Environment & Forest Authority Directorate General of Genetic Department of Health Services Engineering Manufacturing, Pharmaceuticals (DGHS) Genetic Appraisal Engineering sales & inspections Approval Committee Committee (GEAC) Central Drugs Standard Control Department of National Biotechnology (DBT) Pharmaceutical Organisation (CDSCO) Pricing Authority (NPPA) Review Committee of Gene Manipulation (RCGM) Pricing regulations CURRENT REGULATORY REQUIREMENTS FOR CONDUCTING CLINICAL TRIALS IN INDIA FOR IND/NEW DRUG ( VERSION 2.0) REGULATORY FUNCTIONS  REGULATORY FUNCTIONS CENTRAL RESPONSIBILITIES STATE RESPONSIBILITIES § Approval of new drug § License to manufacture, /medical devices sale and distribution § Import of drugs/medical § Monitoring quality of drugs devices/cosmetics and cosmetics § Clinical trials § Investigations and § EC registration prosecutions § SAE evaluation § Enforcement of DMR Act, & § Amendments to D&C Act & DPCO Rules thereunder § Joint inspection etc. § Pharmacovigilance § DTAB/DCC Abbreviations: DTAB = Drugs Technical Advisory Board; DCC = Drugs Consultative Committee; DMR = Drugs and Magic Remedies; DPCO = Drugs Price Control Order CURRENT REGULATORY REQUIREMENTS FOR CONDUCTING CLINICAL TRIALS IN INDIA FOR IND/NEW DRUG (VERSION 2.0) CDSCO ACHIEVEMENTS  ACHIEVEMENTS 344 Irrational Fixed Dose Combinations (FDCs) prohibited under D & C Act. (matter is subjudiced in court of law). Various measures taken for ease of doing business: Ø E-Governance system introduced (SUGAM Portal). Ø GSR 227 (E) “New Drug & Clinical Trial Rules, 2019” has been published (w.e.f. 19/03/2019). Ø Medical Devices Rules, 2017 published (w.e.f. 01/01/2018). CURRENT REGULATORY REQUIREMENTS FOR CONDUCTING CLINICAL TRIALS IN INDIA FOR IND/NEW DRUG (VERSION 2.0)  ACHIEVEMENTS ü Nation wide drug survey conducted and around 47000 drugs samples tested in different Government labs. ü Pharmacovigilance, haemovigillance, materiovigilance programme started. ü Testing of cosmetics on animals prohibited. ü Timelines prescribed for processing of applications. CURRENT REGULATORY REQUIREMENTS FOR CONDUCTING CLINICAL TRIALS IN INDIA FOR IND/NEW DRUG (VERSION 2.0)  ACHIEVEMENTS ü 24X7 clearance of consignments at ports offices. ü The CDSCO was declared by WHO as a functional National Regulatory Authority (NRA) against stringent international indicators. ü Public Relation Office (PRO) as a single window system for grievance redressal started. ü Intelligence cell constituted at CDSCO, HQ. This cell conducted several raids. CURRENT REGULATORY REQUIREMENTS FOR CONDUCTING CLINICAL TRIALS IN INDIA FOR IND/NEW DRUG (VERSION 2.0) GAPS/CHALLENGES  GAPS/CHALLENGES Shortage of manpower Space constraints Technical, administration. CDSCO, HQ, New Delhi, other locations. Inadequate drug testing facilities/ laboratories To notify all medical devices Chemical, biological, medical available in market. device, cosmetics. Enforcement Additional work added in last few years Complete monitoring of clinical trials (site inspections). Registration of all Ethics Committees in India. Responsibility of DCGI in causality assessment and decision on amount of compensation in case of trial related deaths. CURRENT REGULATORY REQUIREMENTS FOR CONDUCTING CLINICAL TRIALS IN INDIA FOR IND/NEW DRUG (VERSION 2.0)  SUMMARY In Lecture 1 (L1), we briefly learned about: CDSCO structure including hierarchy, zonal, sub zonal offices, laboratories. Various departments at CDSCO, HQ, New Delhi. Responsibilities of the state and centre. Achievements by CDSCO. Regulatory gaps/challenges faced by CDSCO. CURRENT REGULATORY REQUIREMENTS FOR CONDUCTING CLINICAL TRIALS IN INDIA FOR IND/NEW DRUG (VERSION 2.0)  RECAP State true or false: CDSCO is responsible for approval of new drugs and clinical trials in India. True § NRA Fill in the blanks: § CDSCO is headed by ________________________. Drugs Controller General (India) [DCG(I)] CURRENT REGULATORY REQUIREMENTS FOR CONDUCTING CLINICAL TRIALS IN INDIA FOR IND/NEW DRUG (VERSION 2.0) CURRENT REGULATORY REQUIREMENTS FOR CONDUCTING CLINICAL TRIALS IN INDIA FOR IND/NEW DRUG Version 2.0 DISCLAIMER The information within this presentation is based on the presenter’s expertise and experience and represents the views of the presenter for the purpose of training. END OF LECTURE L1- OVERVIEW OF INDIAN DRUG REGULATORY SYSTEM THANK YOU.