dra 1

Views:
 
Category: Education
     
 

Presentation Description

No description available.

Comments

By: sonaliwelcomeu (121 month(s) ago)

hi riddhi...sonali here...riddhi i need your presentation for my project work in clinical research, i really like that and i would appreciate if you can provide me with the access to download the file, i assure you i will not share this anywhere else and will not make any other use of it. Thanks

Presentation Transcript

A SEMINAR ON DRUG REGULATORY AGENCIES IN INDIA :

A SEMINAR ON DRUG REGULATORY AGENCIES IN INDIA PREPARED BY : RIDDHI S. CHavda M.PHARM (SEM-II ) (Q.A) GUIDED BY : D r . rina h. gokani M.PHARM , PhD ( associate professor) DEPARTMENT OF QUALITY ASSURANCE s. J . THAKKAR pharmacy college, Rajkot , GUJARAT. 1

CONTENT::

CONTENT : 1 . INTRODUCTION 2. DRUG REGULATORY AGENCIES IN INDIA (Historical perspectives, organization structure activities & responsibilities) 3. CENTRAL DRUG STANDERD CONTROL ORGANIZATION (CDSCO) 4. MINISTRY OF HEALTH & FAMILY WELFARE (MHFW) 5. INDIAN COUNCIL OF MEDICAL RESEARCH (ICMR) 6. MINISTRY OF CHAMICAL AND FERTILIZER 7. MINISTRY OF SCIENCE AND TECHNOLOGY 8. MINISTRY OF COMMERCE 9. REFERENCES 2

1.INTRODUCTION::

1.INTRODUCTION: Drugs play an important role in the health of both people and the economy of a country. Pharmaceutical drugs are available from a large number of sources. People and Governments willing to spend money on drugs for many reasons so, it must be safe, effective and good quality and used appropriately. Problems relating to drug safety and efficacy exist in many places around the world today in developing and developed countries alike. Some incidents have ended in tragedy, often with children as the victims. E.g. Sulfanilamide incident that led to the deaths of 107 children in USA in mid 1930s . E.g. The Thalidomide disaster of 1960s that caused birth defects in children. 3

Slide 4:

This means, in turn, that development, production, importation, exportation and subsequent distribution of drugs must be regulated to ensure that they meet prescribed standards. Therefore, effective drug regulation is required to ensure the safety, efficacy and quality of drugs as well as accuracy and appropriateness of the drug information available to the public . 4

Slide 5:

KEY FUNCTIONS OF DRUG REGULATORY AGENCY: 1. Product registration (drug evaluation and authorization, and monitoring of drug efficacy and safety); 2. Regulation of drug manufacturing, importation, and distribution; 3. Regulation & Control of drug promotion and information. 4. Adverse drug reaction (ADR) monitoring. 5. Licensing of premises, persons and practices. Main goal of drug regulation is to guarantee the safety, efficacy and quality of drugs available to public. 5

Slide 6:

The drug regulation consists of 1. Drug Laws 2. Drug Regulatory Agencies 3. Drug Regulatory Boards 4. Quality Control 5. Drug Information Centers etc. 6

2. DRUGS REGULATORY SYSTEM IN INDIA:

2. DRUGS REGULATORY SYSTEM IN INDIA Drugs and Health is in concurrent list of Indian Constitution It is governed by both Centre and State Governments under the Drugs & Cosmetics Act, 1940. MAIN BODIES: Central Drug Standard Control Organization (CDSCO) Ministry Of Health & Family Welfare (MHFW) Government of India Directory of Health Organizations Indian Council Of Medical Research (ICMR) 7

INDIA – WELL DEFINED DRUG REGULATORY SYSTEM Govt. of india:

INDIA – WELL DEFINED DRUG REGULATORY SYSTEM Govt. of india 8 Ministry of Health and Family Welfare DGHS CDSCO DCGI DTAB Enforcement & GMP audit Div Quality Control Division – CDTL Registration Div New Drug Div Pharmacovigilance Trainings Ministry of Chemical & Fertilizer Department of Pharmaceutical NPPA Ministry of Commers Patent Office Controller General of Patents Ministry of Science & Technology DBT CSIR Labs Ministry of Environment Environmental Clearance at Manufacturing site

3.CENTRAL DRUG STANDARD CONTROL ORGANIZATION (CDSCO)1:

3.CENTRAL DRUG STANDARD CONTROL ORGANIZATION (CDSCO) 1 CDSCO is a licensing authority( regulatory agency) for the approval of new drugs . Head office of CDSCO  New Delhi  Functioning The control of Directorate General of Health Services, ministry of health and family welfare Government of India . 9

Slide 10:

10

Slide 11:

11

STRUCTURE AT STATE LEVEL::

STRUCTURE AT STATE LEVEL: 12 State Drug Control Organization Drug Controller/ Commissioner Drug Testing Laboratory Deputy Drug Controller Gov. Analyst Drug Inspector Analyst Supportin Staff Supporting Staff

Slide 13:

FUNCTIONS OF CDSCO : Approval of New Drug and Clinical Trials. Import Registration and Licensing. Licensing of Blood Bank , LVPs ,Vaccines ,r-RNA product and some Medical Devices Amendment to D & C Act and Ru le Banning of Drugs and Cosmetics Grant of Test License ,Personal License ,NOCs for Export Testing of Drugs FUNCTION UNDERTAKEN BY STATE GOVERNMENT: Licensing of drug testing laboratories drug manufacturing and sales establishments. Monitoring of quality of Drugs & Cosmetics, manufactured by respective state units and those marketed in the state. 13

Slide 14:

Approval of drug formulations for manufacture. Recall of sub-standard drugs. FUNCTIONS UNDERTAKEN BY CENTRAL GOVERNMENT: Monitoring adverse drug reactions. To regulate market authorization of new drugs. Publication of Indian Pharmacopoeia. Participation in the WHO GMP certification scheme. Testing of drugs by Central Drugs Labs. To regulate clinical research in India. Laying down standards of drugs, cosmetics, diagnostics and devices . 14

DRUG TECHNICAL ADVISORY BOARD (DTAB):

DRUG TECHNICAL ADVISORY BOARD (DTAB) The Central Government constitute a Board (to be called the Drugs Technical Advisory Board) to advise the Central Government and the State Governments on technical matters arising out of the administration of D&C, Act 1940 The Board shall consist of the following members, 18 Members 10 ex-officio Members 5 Nominated Members 5 Elected Members 15

Slide 16:

ACTIVITIES AND RESPONSIBILITIES : It advices matter related to Drugs. The nominated and elected members of the Board shall hold office for three years, but shall be eligible for re-nomination and re-election. The Board may, subject to the previous approval of the Central Government, make bye-laws fixing a quorum and regulating its own procedure. 16

DRUG CUNSULTATIVE COMMITTEE (dcc):

DRUG CUNSULTATIVE COMMITTEE (dcc) It is constitute by the Central Government. It consist of: 2 Representatives of the Central Government 1 Representative of each State Government It advises the Central Government, the State Governments and the Drugs Technical Advisory Board on any matter tending to secure uniformity throughout India in the admistration of D&C Act,1940 The Drugs Consultative Committee shall meet when required to do so by the Central Government and shall have power to regulate its own procedure . 17

CENTRAL DRUG TESTING LABORATORY (CDTL):

CENTRAL DRUG TESTING LABORATORY (CDTL) The central drug laboratory, Kolkata is national statutory laboratory of the government of India for quality control of drug and cosmetic and established under the D&C act ,1940. Oldest quality control laboratory of the drug control authorities in India. Function under the director general of Health Services in the Ministry of Health and Family Welfare. 18

Slide 19:

FUNCTIONS UNDER TAKEN: Statutory Function: To Act as an Appellate authority. To function as Government Analyst for such states who do not have their own testing facilities. Analytical quality control of majority of the imported drugs. Analytical quality control of drug formulations manufactured within the country on behalf of the Central & State Drug control organization Other Functions: Procurement, establishment, maintenance, storage and distribution of I.P & International Reference standards. Preparation and standardization of I.P. reference standards against USP, BP primary standards. To undertake analytical research in standardization and methodology development of drug. 19

Slide 20:

Central Drug Testing Laboratory (CDTL) Chennai  D& C Act 1940 Kolkata  DCGI, MHFW, DGHS Mumbai  DCGI, MHFW, DGHS CRI Kasauli  D & C Act 1940 Regional Drug Testing Laboratory (RDTL) Guwahati  2002, DCGI, MHFW Chandigarh  2007, D&C Act 1940 20

CENTRAL LICENSE APPROVING AUTHORITY (CLAA) :

CENTRAL LICENSE APPROVING AUTHORITY (CLAA) Appointed by Central Government. Handling of License for all Medical Devices. Licensing of Blood products. 21

FOOD AND DRUG CONTROL ADMINISTRATION (FDCA-Gujarat):

FOOD AND DRUG CONTROL ADMINISTRATION (FDCA-Gujarat) 1960  FDCA Gujarat (Food and Drugs Control Administration) is established . The Department was famous as Drugs Control Administration having its office at Civil Hospital Compound,Ahmedabad headed through Director in the area of Pharmacy. 1984  The FDCA Gujarat office shifted to Gandhinagar in the year Recruitment almost of all the vacant posts of labs drug analysts and food analysts. Sampling of various drugs & cosmetics from the licensee firms is carried out by Drugs Inspectors. Stop the manufracture of drug banned by Union Health Ministry o 22

4. MINISTRY OF HEALTH AND FAMILY WELFARE2:

4. MINISTRY OF HEALTH AND FAMILY WELFARE 2 Ministry of Health and Family Welfare(MHFW) is charged with health policy in India. The Minister of Health and Family Welfare holds cabinet rank as a member of the Council of Ministers. Minister  assisted by Ministers of State for Health and Family Welfare Ministry is composed of two departments: A. The Department of Health and Family Welfare B. Department of AYUSH (Ayurveda, Yoga, Unani, Siddha and Homoeopathy). 23

a .DEPARTMENT OF HEALTH AND FAMILY WELFARE:

a . DEPARTMENT OF HEALTH AND FAMILY WELFARE National Institute of Health and Family Welfare (NIHFW) National Institute of Health and Family Welfare (NIHFW) is an Apex Technical Institute, funded by Ministry of Health and Family Welfare, for promotion of health and family welfare programmers in the country through education, training, research, evaluation, consultancy and specialized services. The NIHFW was established on March 9, 1977 by a merger of the National Institute of Health Administration and Education (NIHAE) with the National Institute of Family Planning (NIFP). 24

Slide 25:

List of Governing Body Members of NIHFW 18 members 1 Chairman (ex-officio) 1 Vice Chairman (ex-officio) 9 Member ( ex-officio) 6 Member 1 Member Secretary (ex-officio) 25

Slide 26:

26

Slide 27:

ACTIVITIES AND RESPONSIBILITIES: Measuring weight of children to assess the nutritional status. Assessment of level of anemia. Testing of cooking salt for level iodine. To release fund on the advice of the Ministry. It is responsible for all governmental programs relating to family planning in India. 27

b. DEPARTMENT OF AYUSH::

b. DEPARTMENT OF AYUSH: March,1995  Department of Indian Systems of Medicine and Homoeopathy (ISM&H) November, 2003 R e-named as Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) Providing focused attention to development of Education & Research in Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy systems. The Department of AYUSH handles educational standards, quality control and standardization of drugs, improving the availability of medicinal plant material, research and development and awareness generation about the efficacy of the systems domestically and internationally. 28

INDIAN PHARMACOPOEIA COMMISSION (IPC):

INDIAN PHARMACOPOEIA COMMISSION (IPC) Autonomous Institution  Ministry of Health and Family Welfare The Indian Pharmacopoeia Commission has been registered as a Society under the provision of the Societies Registration Act, 1860 (Act No.21 of 1860) for the registration of Literary, Scientific and Charitable Societies, on 9 December 2004. 29

Slide 30:

30 Indian Pharmacopoeia was prepared by Indian Pharmacopoeia Commission(IPC)

Slide 31:

31 COMPOSITION : Indian Pharmacopoeia Commission (IPC) General Body 19 Members Governing Body 10 Members Scientific Body 23 Experts CIPL Lab IPC Secretariat 31

ACTIVITIES AND RESPONSIBILITIES::

ACTIVITIES AND RESPONSIBILITIES: Development of comprehensive monographs. Accord priority to monographs of drugs included in the national Essential Drug List and their dosage forms. Preparation of monograph for products that have normally been in the market for not less than 2 years. Collaborate with pharmacopoeias like the BP, USP, JP and International Pharmacopoeia with a view to harmonizing with global standards. 32

CENTRAL COUNCIL OF INDIAN MEDICINE (CCIM):

CENTRAL COUNCIL OF INDIAN MEDICINE (CCIM) 33 It is the statutory body constituted under the Indian Medicine Central Council Act, 1970 ,Since its establishment in 1971 ,the Central Council has been framing on and implementing various regulations including the Curricula and Syllabi in Indian Systems of Medicine , which is followed by Colleges of Indian Systems of Medicine The main object of the Central Council are as under:- To prescribe minimum standards of education in Indian Systems of Medicine To advise Central Government in matters relating to recognition of medical qualification in/from second schedule to Indian Medicine Council Act, 1970. To maintain a Central Register on Indian Medicine and revise the register from time to time.

DIRECTORATE GENERAL OF HEALTH SERVICES (dghs):

DIRECTORATE GENERAL OF HEALTH SERVICES (dghs) The Directorate General of Health Services, a repository of technical knowledge, is an attached office of this Ministry. The DGHS also renders technical advice on all medical and public health matters and in the implementation of various health schemes. In order to implement the policies and programmes of the Ministry in an effective manner, there are three subordinate offices located at various places in the country which function directly under the Ministry. The Ministry is also administratively concerned with 29 autonomous/statutory bodies. There are also three Public Sector Undertakings under the administrative control of the Ministry. 34

4.INDIAN COUNCIL OF MEDICAL RESEARCH (ICMR):

4.INDIAN COUNCIL OF MEDICAL RESEARCH (ICMR) 1911  Indian Research Fund Association (IRFA). 1949  The Indian Council of Medical Research (ICMR) ICMR  funded by The Government of India through the Ministry of Health and Family Welfare 35

Slide 36:

36 Network of ICMR Institutes

STRUCTURE AND ORGANIZATION ::

STRUCTURE AND ORGANIZATION : presides 37 Union Health Minister Governing Body assists Scientific Advisory Board Scientific Advisory Groups Expert Groups Scientific Advisory Committee Steering Committee Task Forces

Slide 38:

ACTIVITIES AND RESPONSIBILITIES: Extramural research is promoted by ICMR by establishing Centers for Advanced Research in different research areas. The ICMR also funds task force studies which emphasize a time-bound, goal-oriented approach. Open-ended research is conducted on the basis of applications for grants-in-aid received from scientists in non-ICMR Research Institutes, Medical colleges and Universities located in different parts of the country. In the context of the changing public health scene. Balancing of research efforts between different competing fields, especially when resources are severely limited, is a typical problem encountered in the management of medical research, particularly in developing countries. 38

6.MINISTRY OF CHEMICAL AND FERTILIZER6:

6.MINISTRY OF CHEMICAL AND FERTILIZER 6 1963  The Department was placed in the newly set up Ministry of Petroleum and Chemicals. 1975  The appointment of a separate Cabinet Minister for Chemicals & Fertilizers, the Ministry of Chemicals & Fertilizers comprising the Department of Petroleum and the Department of Chemicals & Fertilizers came into being . June, 1991, I t become part of newly created Ministry of Chemicals & Fertilizers 39

STRUCTURE AND ORGANIZATION::

STRUCTURE AND ORGANIZATION: 40 Ministry Of Chemical And Fertilizer Minister of State Secretary Secy. & Financial Advisor Joint Secretary Economic Advisor Director General Joint Secretary

ACTIVITIES AND RESPONSIBILITIES::

ACTIVITIES AND RESPONSIBILITIES: All matters relating to NPPA including its functions of price control and monitoring. Responsible for development of infrastructure, manpower and skills for the pharmaceutical sector. Work for the promotion and coordination of basic, applied and other research in areas related to the pharmaceutical sector and for international co-operation in pharmaceutical research. 41

DEPARTMENT OF PHARMACEUITICAL ORGANIZATION AND STRUCTURE::

DEPARTMENT OF PHARMACEUITICAL ORGANIZATION AND STRUCTURE: 42 Secretary Economic Advisor DDG Joint Secretary Joint Secretary Director Director Deputy Secretary

ACTIVITIES AND RESPONSIBILITY ::

ACTIVITIES AND RESPONSIBILITY : Implement and enforce the provisions of the Drugs. Monitor the availability of drugs. Collect/ maintain data on production, exports and imports, market share of individual companies, profitability of companies etc, for bulk drugs and formulation. To render advice to the Central Government on changes/ revisions in the drug policy; 43

NATIONAL PHARMACEUTICAL PRICING AUTHORITY (NPPA):

NATIONAL PHARMACEUTICAL PRICING AUTHORITY (NPPA) The National Pharmaceutical Pricing Authority (NPPA), an independent body of experts in the Ministry of Chemicals and Fertilizers was formed by the Govt. of India vide at 1997 NPPA is an organization of the Government of India which was established, inter alia, to fix/ revise the prices of controlled bulk drugs and formulations and to enforce prices and availability of the medicines in the country, under the Drugs (Prices Control) Order, 1995. 44

STRUCTURE AND ORGANIZATION::

STRUCTURE AND ORGANIZATION: 45 Chairman Member Secretary Advisor Director (Monitoring and Enforcement Division) Director (Legal Division ) Director (Admin Division) 1.Establishment. 2.General Admn. 3. Co ordination. Identified cases of overcharging on bulk drugs & formulations and related issues. Monitoring & Enforcement of prices of bulk drugs & formulations, both Scheduled and non-scheduled 1.Bulk Drug Pricing 2. Policy Matter 1.Formulation Pricing 2. Production & Import/Export of drugs & formulations

ACTIVITES AND RESPNSIBILITIES::

ACTIVITES AND RESPNSIBILITIES : To collect/ maintain data on production, exports and imports, market share of individual companies, profitability of companies etc. for bulk drugs and formulations; To undertake and / or sponsor relevant studies in respect of pricing of drugs / pharmaceuticals; To render advice to the Central Government on changes / revisions in the drug policy; To render assistance to the Central Government in the parliamentary matters relating to the drug pricing. 46

7.MINISTRY OF SCIENCE AND TECHNOLOGY5:

7.MINISTRY OF SCIENCE AND TECHNOLOGY 5 1971  Department of Science & Technology (DST) objective : Promoting new areas of Science & Technology and to play the role of a nodal department for organizing, coordinating and promoting S&T. 47

Slide 48:

48

Organization and structure:

Organization and structure 49

Slide 50:

FUNCTIONS: Formulation of policies relating to Science and Technology. Promotion of new areas of Science and Technology with special emphasis on emerging   areas. Undertaking or financially sponsoring scientific and technological surveys, research design and development, where necessary. Promotion of Science and Technology at the State, District, and Village levels for grass- roots development through State Science and Technology Councils and other mechanisms. 50

DEPARTMENT OF BIOTECHNOLOGY (DBT):

DEPARTMENT OF BIOTECHNOLOGY (DBT) 1986  S eparate Department of Biotechnology (DBT) , under the Ministry of Science and Technology. 51

Slide 52:

52 Department of Biotechnology National Institute of Immunology, New Delhi Grant in aid for Research,Training,National Facilities and Large-scale Demonstration Infrastructure for Service in Biology and Bioinformatics National Facility for Animal Tissue and cell Culture, Pune Human Resource Development International Centre for Genetic Engineering and Biotechnology, New Delhi Bharat Immunological & Biological Corporation Ltd., New Delhi Indian Vaccines Corporation Ltd., New Delhi

ACTIVITIES AND RESPONSIBILITIES:

ACTIVITIES AND RESPONSIBILITIES Promote large scale use of Biotechnology. Support R&D and manufacturing in Biology. Identify and Set up Centers of Excellence for R&D. Integrated Programme for Human Resource Development . Evolve Bio Safety Guidelines, manufacture and application of cell based vaccines. 53

Slide 54:

An autonomous body, was constituted in 1942 by a resolution of the Central Legislative Assembly. Promotion, Guidance and Coordination of scientific and industrial research in India Publication of scientific papers and journals CSIR has been continually trying to achieve these objectives leading to generation of new knowledge and new products, processes and technologies in diverse areas ranging form chemicals and drugs to materials and electronics; from safe drinking water and food technology to aerospace; and proenvironment protection and toxicology to petroleum processing. 54

Slide 55:

55

STRUCTURE AND ORGANIZATION ::

STRUCTURE AND ORGANIZATION : 56 Department of S&T Department of atomic energy Department of Biotechnology Central Gov. S&T Department Department of Scientific & Industrial Research Department of Space Department of Ocean Development & Earth Science Council of Scientific & Industrial Research

GENETIC ENGINEERING APPROVAL COMMITTEE (GEAC):

GENETIC ENGINEERING APPROVAL COMMITTEE (GEAC) To permit the use of Genetically Modified Organisms(GOMs) and products thereof for commercial applications. To adopt producers for restriction or prohibition, production, sale, import & use of GMOs both for research and applications under Environment Protection Act(EPA) To authorize large-scale production and release of GMOs and products thereof into the environment. 57

RECOMBINANT DNA ADVISORY COMMITTEE (RDAC):

RECOMBINANT DNA ADVISORY COMMITTEE (RDAC) Review developments in Biotechnology at National and International levels. Recommend suitable and appropriate safety regulations for India in r-DNA research, use and applications . 58

REVIEW COMMITTEE ON GENETIC MANIPULATION (RCGM): :

REVIEW COMMITTEE ON GENETIC MANIPULATION (RCGM): To note and to approve r-DNA work. To ensure adherence of r-DNA safety guidelines of government. To act as nodal point for interaction with statutory bodies. 59

INSTITUTIONAL BIOLOGICAL SAFETY COMMITTEE (IBSC):

INSTITUTIONAL BIOLOGICAL SAFETY COMMITTEE (IBSC) To review all on going r-DNA projects involving high risk category and controlled field experiments. To lay down producers for restriction or prohibition, production, sale, import & use of GMOs both for research and applications. 60

8.MINISTRY OF COMMERCE:

8.MINISTRY OF COMMERCE Autonomous Bodies/ Public Sector Undertakings/ Export Promotion Councils/Other Organizations. The Controller General supervises the working of the Patents Act, 1970, as amended, the Designs Act, 2000 and the Trade Marks Act, 1999 and also renders advice to the Government on matters relating to these subjects. Patenting of drugs. Regulation, development and promotion of India’s international trade. 61

Slide 62:

P 62 Ministry of Commerce & Industry Deptt. Of Industrial Policy & Promotion CGPDTM Patent Office Trade Marks Registry Geographical Indication Registry Patent Information System Kolkata Delhi Mumbai Chennai NIIPM Nagpur Chennai Mumbai Kolkata Delhi Chennai Ahmadabad

DIRECTOR GENERAL BY FOREIGN TRADE (DGFT):

DIRECTOR GENERAL BY FOREIGN TRADE (DGFT) The agency of the Ministry of Commerce Till 1991  Chief Controller of Imports & Exports (CCI&E). Headquarter  Udyog Bhavan, New Delhi. 4 Zonal Offices  Delhi, Mumbai, Kolkata and Chennai  headed by Zonal Joint Director General of Foreign Trade. 35 Regional Authorities all over the country 63

ACTIVITIES AND RESPONSIBILITIES: :

ACTIVITIES AND RESPONSIBILITIES: Responsible for administering laws regarding foreign trade and foreign investment in India. Implementing various policies regarding trade for example, Foreign Trade Policy. Licensing authority for exporters, importers, and export and import business, prohibit, restrict and regulate exports and imports. 64

STUDY QUESTIONS:

STUDY QUESTIONS Describe the functions of Central Drug Laboratory (CDL). 65

9. REFERANCE::

9. REFERANCE: 1.www.cdsco.nic.in 2.www.mohfw.nic.in 3.www.health.cg.gov.in 4.www.icmr.nic.in 5.www.dst.gov.in 6. en. Wikipedia.org/wiki/Ministry-of- che 7. india.gov.in/Min_dep.php/3fminid/3002 8.http.//chemicals.nic.in/inst.htm. 66

Slide 67:

67 THANK YOU

authorStream Live Help