A review presentation on: 1. Regulatory Bodies in Pharm. Industry 2. Contract Research Organization

1. 1st M.Pharm
Dept. of Pharmaceutics
AL – AMEEN COLLEGE OF PHARMACY
1

2. Content Box
CDSCO OTHER
ANVISA
MHRA & EMEA
TGA & MCC
USFDA & WHO
Vision, Mission,
Strategies, Values &
Functions of CDCSO
& GLP
Organization and
Health Infrastructure in
India
Evolution
Introduction to
Ministry of Health &
Family Welfare
2

3. CDSCO
3

4. CDSCO – An Outline
Organization and Health Infrastructure in India
Evolution of Indian Drug Legislation
Introduction to Ministry of Health & Family Welfare
Vision, Mission, Strategies, Values of CDCSO
Principles of Good Laboratory Practice (GLP)
4

5. Organization and Health Infrastructure in
India
 Based on the federal nature of constitution, areas of operation
have been divided into
1. Central Government &
2. State Government
 7th schedule of constitution describes 3 items namely:
a) Union List,
b) State List and
c) Concurrent list.
1. Public health,
2. Hospitals,
3. Sanitization etc.
1. Family Welfare,
2. Population Control,
3. Medical Education,
4. Prevention of Food
Adulteration,
5. Quality Control in
manufacturing of
drugs etc.
5

6. Evolution of Indian Drug Legislation
PREAMBLE
 To regulate manufacture, sale, distribution and import of drugs,
cosmetics, biological, medical devices and other products.
OBJECTIVE
 The Objective of Drugs & Cosmetics Act is to ensure that public are
supplied with safety, efficacy and quality of drugs (Sec. 3b).
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7. Evolution of Indian Drug Legislation
BASIC PHILOSOPHY
The basic philosophy of Drugs & Cosmetics Act is that:-
1. The manufacturer is responsible for the quality of drugs
manufactured by them &
2. The government/Regulatory Agencies will monitor the quality of
drugs by
 Periodic inspections
 Monitoring – Post market surveillance.
7

8. PRINCIPLE
 A System – manufacture , sale and distribution of Drugs &
Cosmetics are controlled.
DRUG REGULATORY SYSTEM IN INDIA
 Drug is in concurrent list of Indian Constitution.
 It is governed by both Central and State Governments under the
Drugs & Cosmetics Act, 1940 and Rules 1945 thereunder.
Evolution of Indian Drug Legislation
8

9. Indian Drug Regulatory System:
Government of India
Ministry of Health
& Family Welfare
DGHS
Central Drugs
Standard
Control
Organization
(CDSCO)
Ministry of Science
& Technology
Indian
Council of
Medical
Research
(ICMR)
Council of
Scientific &
Industrial
Research
(CSIR)
BARC
(Radioactive)
Ministry of
Chemicals &
Petrochemicals
National
Pharmaceutical
Pricing Authority
(NPPA)
Department of
Chemical &
Petrochemicals
(DCP)
Department of
Pharmaceuticals
Ministry of
Commerce &
Industry
Patent
Office
Dept. of
Commerce &
Pharmexil
Controller
General of
Patent
DGFT
Ministry of
Environment &
Forest
GEAC-
[Genetic
Engineering
Approval
Committee]
Department of
Biotechnology
r-DNA
Advisory
Committee
Review
Committee
Genetic
Manipulation
9

10. • CDSCO
• ICMR
• GEAC
• DBT
• AERB
• BARC
• DTAB
• RCGM
• DCC
1. Laying down standards,
2. Clearance of new drugs,
3. CLAA items,
4. Banning Drugs,
5. Clinical Trails etc.
1. Formulates,
2. Coordinates and
3. Promotes biomedical research
&
4. Ethical Principles
1. Manufacture, Use, Import of
 Hazards Microorganisms
 Genetically Engineered
 Organisms or Cells
It promote
 transgenic research,
 molecular biology of human
genetic disorders,
 brain research, and
commercialization of
diagnostic kits and
 vaccines for communicable
diseases
Promotes
 Isotopes application in
Medicine &
 monitoring usage of
radioactive materials
Advise
 Central & State Govt. on
Technical Matters arising out
of the Drugs & CosmeticsNOC for
 Clinical Trial &
 r-DNA strains,
Advisory Committee to
 DTAB and
 Central & State Govt.
for uniform implementation of
Various provisions of the Act
Promotes
 Radio therapy & Research,
 Safety review for Gamma
Irradiators (Devices)
Functions
10

11. Introduction to Ministry of Health & Family Welfare
(MOH&FW)
• MOH&FW comprises 04 departments each of which is headed by a
Secretary to the Govt. of India
i. Department of Health & Family welfare
ii. Department of AYUSH
iii. Department of Health Research
iv. Department of AIDS Control
NOTE: CDSCO is a separate division comes under DGHS, headed
by DCG(I).
• Public health is one of the major objectives of Govt. of India and to
achieve this
It is important that drugs/vaccines
are available to the public are :
 Quality,
 Safety,
 Purity and
 Efficacious
11

12. 12

13. Functions of CDSCO
Approval of new drugs and clinical trials
Import Registration and Licensing
License approving of Blood Banks, LVPs, Vaccines, r-DNA,ETC
Amendment to D &C Act and Rules
Banning of drugs and cosmetics
Grant of Test License, Personal License, NOCs for Export
Testing of New Drugs
13

14. Principles of GLP andRegulatory requirements
Objectives of GLP
 GLP makes sure that the data submitted are a true reflection of the results
that are obtained during the study.
 GLP also makes sure that data is traceable.
 Promotes international acceptance of tests.
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15. What is GLP?
• Good Laboratory Practice (GLP) deals with the –
 organization,
 process and
 conditions
under which laboratory studies are –
 planned,
 performed,
 monitored, recorded,
 reported &
 archived.
• Intended to promote the quality and validity of test data (part 58 CFR
2).
15

16. GLP-Process Overview
Pharmaceutical product
Submitted to regulatory authority
Verification
Repetition of experiment or Reconstruction of all
activities activities
(Direct confirmation) ( Indirect confirmation)
Judgment taken
Accept / Reject
16

17. GLP Concerns
(as Per WHOTRS957 2010Guidelines )
GLP
Part 1
Management and
infrastructure
• Organization and
management
• Quality management
system
• Control of documentation
• Records
• Data-processing
equipment
• Personnel
• Premises
• Equipment, instruments
and other devices
• Contracts
Part 2
Materials,
equipment,
instruments and
other devices
• Reagents
• Reference
substances and
reference materials
• Calibration, verifi
cation of
performance and
• qualification of
equipment,
instruments and
other devices
• Traceability
Part 3
Working
procedures
• Incoming
samples
• Analytical
worksheet
• Validation of
analytical
procedures
• Testing
• Evaluation of
test results
• Certificate of
analysis
• Retained
samples
Part 4
Safety
• General
rules
17

18. GLP Concerns
(as Per Schedule- L1 Guidelines )
Internal Quality
System Audits
Premises
Personal
Equipments
Chemicals and Reagents
Quality System
Microbiological Cultures
Reference Materials
Maintenance, Calibration,
and
Validation of Equipments
Good House Keeping
and Safety
General Requirements
Management Review
Standard Operating
Procedures
Protocols and
Specifications Archive
Raw Data
Storage and Archival
GLP
18

19. WHO
19

20. WHO
• Specialized agency for health for US Nations.
• Established on 7th April, 1948.
• Governed by 192 states.
NOTE: States which are members of United Nations,
may become members of WHO.
NOTE: This day, 7th april, also known as the World
Health Day.
20

21. Responsibilities
• Global health matters.
• Shaping the health research agenda.
• Setting norms and standards.
• Articulating evidence based policy option.
• Providing technical support to countries.
• Monitoring and assessing health trends.
21

22. Organization
• Executive Board – 32 members.
• Term – 3 years.
• Head – Director General
• Head is appointed by Health assembly after
nomination by the executive board.
• Who member states – Divided in 6 regions.
22

23. Functions
• Worldwide guidance in the field of health.
• Set global standards for health.
• Cooperate with governments in strengthening
national health programs.
• Develop and transfer appropriate health technology
information.
23

24. WHO guidelines
• Guidelines covers:
1. Stability
2. Sampling
3. Production
4. Quality Control
5. Distribution
1. Stability studies of:
 Final product
 Test samples
 Test conditions
 Frequency of testing
& evaluation
1. Purpose
2. Controls to be
applied
3. Sampling operations
& precautions.
4. Storage & retention
5. Sampling for
regulatory purpose
6. Sampling plans for
starting material,
packaging, & final
product.
1. GMP
2. cGMP
1. Intl. specifications
2. WHO Model COA
3. Considersation for
sampling request
4. QC Lab
1. Guidelines for intl.
commerce.
 GTDP
 GDP
 GSP
24

25. WHO – “6” Point Agenda
• Promoting development
• Fostering health security
• Strengthening health systems
• Harnessing research, information & evidence.
• Enhancing partnerships
• Improving performance.
25

26. US-FDA
26

27. US-FDA (Responsibilities)
• FDA is responsible for protecting the public health by
assuring the
 safety,
 efficacy and
 security of human and veterinary drugs,
 biological products,
 medical devices,
 US nation’s food supply,
 cosmetics, and
 products that emit radiation.
27

28. US-FDA (Responsibilities)…..
• FDA is also responsible for advancing the public health:-
1. By helping to speed innovations that make medicines more
 effective,
 safer, and
 more affordable
2. By helping the public get the
 accurate,
 science-based information they need to use medicines
and
 foods to maintain and improve their health.
28

29. US-FDA (What it Regulates)…..
• Foods
 safety and truthful labelling - food products including
dietary supplements (except - livestock meat & poultry
products)
 venison and other game meat
 bottled water, food additives & infant formulas
29

30. US-FDA (What it Regulates)…..
• Human Prescription and Non-prescription Drugs
 safety, effectiveness, quality, and labeling
 manufacturing standards
 Vaccines, Blood Products, and Other Biologics
 product and manufacturing establishment licensing
 safety of the nation's blood supply
 research to establish product standards and develop
improved testing methods
30

31. US-FDA (What it Regulates)…..
• Medical Devices
 from simple items like tongue depressors, to complex
technologies such as heart pacemakers
 premarket approval of new devices
 manufacturing and performance standards
 tracking reports of device malfunctioning and serious
adverse reactions
31

32. US-FDA (What it Regulates)…..
• Electronic Products
 products that give off radiation, such as microwave
ovens and X-ray equipment
 radiation safety performance standards for microwave
ovens, television receivers, diagnostic
 x-ray equipment, cabinet x-ray systems (such as
baggage x-rays at airports), laser products,
 ultrasonic therapy equipment, mercury vapor lamps,
and sunlamps
 accrediting and inspecting mammography facilities
32

33. US-FDA (What it Regulates)…..
• Cosmetics
 safety
 labelling
• Veterinary Products
 livestock feeds
 pet foods
 veterinary drugs and devices
 veterinary biologics not regulated by USDA are
considered new animal drugs
• Tobacco Product
33

34. US-FDA (What it NOT Regulates)…..
• ADVERTISING:
• CONSUMER PRODUCTS
• ILLEGAL DRUGS OF ABUSE
• HEALTH INSURANCE
• MEAT AND POULTRY
• RESTAURANTS AND GROCERY STORES
• VACCINES
34

35. EMEA
35

36. EMEA
• It consists of :
 EL
 EDQM
 EMEA
 HMA
36

37. EMEA
• Decentralized agency of European Union.
• Setup – 1995, Headquartered – London.
• Responsible for:
 Scientific evaluation
 Supervision of medicines
• Major responsibility:
 Protection & promotion of Public & animal
healthcare
37

38. EMEA
• European procedures for marketing authorization:
 Centralized (biotech & innovative medicines)
 Mutual recognition (all except biotech)
• Co-operates closely with international parties like: ICH, FDA,
WHO,etc.
38

39. EMEA - Committee
• ‘6’ – Scientific Committees:
1. CHMP (Committee for medicinal products for Human use)
2.CVMP (Committee for medicinal products for Animal use)
3.COMP (Committee for Orphan Medicinal products)
4.HMPC (Committee for Herbal Medicinal products)
5.PDCO (Paediatric Committee)
6.CAT (Committee for Advanced therapy)
39

40. EMEA - Functions
• Pharmacovigilance
• Product defects reporting (PDR)
• Certification of a Medical Product
• PMF/VAMF Certifications
• Medicine for human or animal use.
• Paediatric formulation advantages.
40

41. MHRA
41

42. MHRA
• Setup on April, 2003, London.
Early stages od DD
MOA
Drug Discovery
Preformulation
No interest
Clinical
Trials
Comes into play
42

43. MHRA - Regulates
1. Protecting public health through regulation
2. Promoting public health
3. Improving public health
43

44. MHRA - Objectives
1. Safeguard public health
2. Carry out the communication role (accurate, timely and
authoritative information)
3. Support research,
4. Influence the shape of the future regulatory framework (Intl.)
5. Organization - skilled and equipped workforce
44

45. MHRA – Objectives (Achieve)
1. Authorising medicines before they can be marketed, (safety +
Efficacy)
2. Ensuring clinical trials (meet robust standards and safeguard
patient’s interests)
3. Inspecting the quality of medicines
4. Overseeing UK-Notified Bodies(medical device manufacturers)
5. Encouraging everyone to report suspected problems
6. Investigating, and prosecuting (cases of non-compliance +
advertising claims) 45

46. ANVISA
46

47. ANVISA
• The Brazilian Health Surveillance Agency (ANVISA) was
created by Law 9782, enacted in 1999.
• It is a governmental regulatory agency characterized by its
 administrative
 independence,
 financial autonomy, and
 the stability of its directors.
NOTE: Ruled by a Collegiate Board of Directors composed of
five members.
47

48. MCC
48

49. MCC
• The Medicines Control Council applies standards laid down
by the Medicines and Related Substances Control Act, (Act
101 of 1965)
• It governs the –
 manufacture,
 distribution,
 sale, and
 marketing of medicines.
• The prescribing and dispensing of medicines – controlled -
the determination of schedules. 49

50. References
50

51. References
• Official websites of:
1. CDSCO
2. WHO
3. MCC
4. ANVISA
5. MHRA
51

52. Contract Research Organizations
52

53. Content Box
Introduction
Types
Functions
Basic
Terms
CRO -
Industry
53

54. Introduction
54

55. CRO
• CROs are the companies that execute most of the
outsourced R&D activities.
• Takes on several tasks - drug development process, -
not explicitly limited clinical trials.
• CROs are generally recognised as performing clinical
trial management.
55

56. Types of CRO’s
56

57. CRO - functions
1. Functional outsourcing: fee-for-service model.
2. Full-service model, where CROs functions as a ‘one-
stop shop’ across the development cycle.
57

58. Functions
58

59. CRO - functions
• This includes activities such as:
design of study protocol,
case report
form design,
trial site and
investigator recruitment,
patient enrolment,
study monitoring and
Data collection, data management, report writing &
 medical services 59

60. CRO – Additional functions
 preclinical services,
 laboratory services,
 filing of Investigational New Drugs (INDs),
 formulation, manufacturing and packaging services,
 regulatory affairs services,
 medical and safety reviews and
 post-marketing studies
60

61. Basic Terms
61

62. Outsourcing
• The strategic use of outside resources to perform
activities.
• traditionally handled by internal staff and resources.
• ADVANTAGES:
more effective
less time consuming
lower cost
62

63. Off-shoring
• The relocation by a company of a business process
from one country to another
• Typically an operational process, such as
manufacturing, or
supporting processes
• The economic logic here is to reduce costs by
lowering labour costs or tax advantages.
63

64. Selection of a Country for Outsourcing
• high patient enrolment rate
• profits of patent exclusivity (faster processing)
• broad spectrum of diseases,
• a more rapid approval of trials,
• availability of human resources and technical skills,
• differing ethnic responses to drugs and
• cost advantages
64

65. CRO - Industry
65

66. Ethical considerations
• how well trials in non traditional regions are
conducted.
• This includes
1. compliance with good clinical practice (GCP,
guidelines, as well as
2. adherence to the available framework for the
supervision of these trials
66

67. CRO- Industry
• Contract research is a multi-billion dollar industry
and has seen an explosive growth over the past
decade.
67

68. CRO- Top CRO’s
 Quintiles Transnational Corp.
 Covance
 Pharmaceutical Product
Development
 Charles River Laboratories
 PAREXEL
 ICON
 INC Research
 PharmaNet Development
Group Inc.
 PRA International
-
 CMIC
 WuXi App Tec
 Galapagos NV
 LAB Research Inc
 ReSearch Pharmaceutical
Services
 Omnicare Clinical Research,
Inc
 SGS
 United BioSource Corporation
 BioClinica
68

69. India- CRO growth
69

70. References
70

71. References
• Mariëtte van Huijstee & Irene Schipper. Putting Contract
Research Organisations on the Radar. SOMO, 2011.
• Report- Top 20 Contract Research Organizations (CRO) -
Asia-Pacific, Especially India and China, Positioned to Benefit
from Rising Financial and Regulatory Pressures in Western
Pharmaceutical Markets. GBI RESEARCH, 2011.
71