Different Regulatory Agencies

1. PRESENTED BY:
SRIDIVYA ANNAVARAPU
I/II M.PHARM(PHMRA)
REGULATORY
AGENCIES

2. CDSCOCDSCO
Different Regulatory
Agencies
US FDAUS FDA

4. WHO Headquarters In Geneva

5. INTRODUCTION
World Health Organization is
established in 7th
April 1948.
It is a specialized, non-political,
health agency of United Nation
with headquarter of Geneva,
Switzerland.
It is responsible for providing
leadership on global health
matters.

6. “The attainment by all people
the highest level of health”
VISION

10. GOD OF MEDICINE
ASCLEPIUS
WHO Symbol Originated from the story of
ASCLEPIUS

11. “To lead strategic collaborative
efforts among Member States
and other partners to promote
equity in health, and to improve
the quality of, and lengthen, the
lives of the all peoples of the
world.”
MISSION

12. ORGANIZATIONAL
STRUCTURE
Secretariat
Executive Board
World
Health
Assembly
Regions (6)
Member Countries (193)

13. WORLD HEALTH
ASSEMBLY
 It is the Supreme governing body of the
organization.
 It meets annually generally in the month
of May in headquarter Geneva.
 Main functions of assembly are:
 To determine international health
policy and program
 To review the work of past year.
 To approve the budget.
 To elect member state to designate a
person to serve for 3 year on
executive board.

14. EXECUTIVE BOARD
 The board composed of at least 18 members.
Now
there are 34 members.
 At least 3 members elected from each region.
 They are composed of Technically qualified
persons in the field of Health.
 The board meets at least twice a year.
 The main function of board is to give effect to
the decisions and policies of the assembly.
 It has also power to take action in an
emergency such as epidemics, earthquakes,

15. SECRETARIAT
 Secretariat is Headed by the Director General
who is the chief of technical and administrative
officer of the organization.
 There are 5 assistant Director General and
there responsibility is assigned by DG in
different Divisions.

16. DIVISIONS OF
SECRETARIAT
1. Epidemiological surveillance and
health situation and trend assessment
2. Communicable Disease
3. Vector biology and control
4. Environmental Health
5. Public information and education for
health
6. Diagnostic, therapeutic and
rehabilitative technology

17. 7. Mental health
8. Strengthening of health services
9. Family health
10. Non communicable disease
11. Health manpower development
12. Information system supports
13. Personal and general services
14. Budget and finance

18. WHO REGIONS
Regions Headquarters
 South East Asia New Delhi (India)
 Africa Brazzaville (Congo)
 American Washington DC
(U.S.A.)
 Europe Denmark
 Eastern Mediterranean Alexandria
(Egypt)

19. AMR
AFR
EMR
SEAR
EUR
WPR
N
S
WHO Regions

20. MEMBER STATES
193 Member states among
which 191 Members and 2
Associate members; Niue and
the Cook Islands.

21. MAIN WORKING AREAS
 Prevention and control of specific
diseases
 Development of comprehensive
health services
 Family health
 Environmental health
 Health statistics
 Bio-medical researches
 Health literatures and information
 Cooperation with other

22. ROLE IN PUBLIC
HEALTH
Providing leadership on matters
critical to health and engaging in
partnerships where joint action is
needed;
Shaping the research agenda and
stimulating the generation,
translation and dissemination of
valuable knowledge;
Setting norms and standards and
promoting and monitoring their

23. Articulating ethical and evidence-
based policy options;
Providing technical support,
catalyzing change, and building
sustainable institutional capacity; and
Monitoring the health situation and
assessing health trends.

24. GLOBAL HEALTH
SITUATION
Indicators EU
R
AM
R
W
PR
SEA
R
EM
R
AF
R
Glob
al
Total Population
“000” (05)
8932
00
88633
4
175
145
7
15655
29
53800
1
7380
83
64636
05
Annual population
growth rate (2005)
0.2 1.3 0.9 1.6 2.2 2.4 1.3
Life expectancy at
birth Male (2005)
69 72 71 62 62 48 64
Life expectancy at
birth Female (2005)
77 77 75 65 64 50 68
MMR/ lakh live birth
(00)
39 140 80 460 460 910 400

25. GLOBAL HEALTH
SITUATION
Indicators EU
R
AM
R
WP
R
SEA
R
EM
R
AF
R
Globa
l
IMR/1000 live birth
(2005)
16 20 23 51 66 99 51
U5MR/1000live birth
(2005)
19 24 28 68 90 165 74
Immunization Cov.
(2005)
93 92 87 65 82 65 77
Birth attended by
SHP
95 91 81 49 53 44 63
CPR 68.3 72.0 84.7 51.5 39.9 23.7 61.9
TFR/women 1.6 2.3 1.8 2.8 3.7 5.2 2.6

26. WHO PRIORITIES
1. Providing support to countries in moving to
universal coverage with effective public health
interventions;
2. Strengthening global health security;
3. Generating and sustaining action across sectors to
modify the behavioural, social, economic and
environmental determinants of health;
4. Increasing institutional capacities to deliver core
public health functions under the strengthened
governance of ministries of health;
5. Strengthening WHO’s leadership at global and
regional levels and supporting the work of
governments at country level.

27. MAJOR
ACHIEVEMENTS
Small Pox Eradication
Alma Ata Conference: Concept of
PHC
Global strategy for Health for all by
2000
Millennium Development Goals

28. DVANTAGES
Neutral Organization to all member
state.
 Nearly universal membership.
Global presence and Networking.
No parallel Organization in tackling
diseases.
Large no. of Expertise in all health
issues.
 Strong coordination and convincing
ability.
Strong fund collecting ability

29. MAJOR CHALLENGE
 Investing in health to reduce poverty.
 Building individual and global health
security.
 Promoting universal coverage, gender
equality and health-related human rights.
 Tackling the determinants of health.
 Harnessing knowledge, science and
technology.
 Strengthening governance, leadership and
accountability.
 Emerging Health problems.

31. CONCLUSION
“Although WHO has
both opportunities and
challenges; Its
contribution is great to
increase the quality of
live and living standard
globally.”

34. WHAT IS FDA
The Food and Drug Administration (FDA)
touches the lives of virtually every American,
every day. It’s FDA’s job to see that medicines
and medical devices are safe and effective
FDA is a federal science-based law
enforcement agency mandated to protect
public health. The agency has approximately
9.000 employees, most of whom are scientists,
inspectors, medical doctors, and other
professionals. FDA’s budged is $ 1.2 billion.

35. The U.S. Food and Drug Administration (FDA)
is an agency of the US Department of Health
and Human Services that is responsible for
the safety regulation of:
most types of foods
drugs
vaccines
blood products
medical devices
dietary supplements
biological medical products
radiation-emitting devices
veterinary products
cosmetics

36. JOB OF THE FDA
The FDA is the U.S. Government agency that
oversees most foods and medical products.
Its job is to make sure that:
 food is safe, healthy, and clean
 medicines and medical devices are reasonably
safe
and effective
 cosmetic products are safe
 animal foods and drugs are safe
 food and medical products have proper labels

37.  The FDA consists of employees drawn from a
wealth of science and public health professions
 biologists, physicians, chemists, biomedical
engineers, toxicologists, pharmacologists,
veterinarians, and specialists in the public health
education and communication
 FDA employs approximately 9,000 people who
work in locations around the United States
WHO MAKES UP THE
FDA?

38. FDA MISSION
 To promote and protect the public health by
helping safe and effective products reach the
market in a timely manner
 To monitor products for continued safety
after they are in use by the public
 To help the public get the accurate, science-
based information needed to improve health
 FDA’s mission is to ensure the safety and
effectiveness of the products under its
jurisdiction. These products are worth about a
trillion dollars a year and make up 22% of all
consumer expenditures.

39. BASIC HISTORY OF
THE FDA
 Food and Drugs Act of 1906 laid the foundation
for the modern food and drug law
 Safety of food additives was previously tested by the
“Poison Squad”
 In 1937, it was discovered that the drug
Sulfanilamide contained a poison which killed 107
people
 The previous law did not require testing for drug safety
before putting them on the market.
 The next year Congress passed the Federal
Food, Drug, and Cosmetic Law.
 FDA combines law and science to protect consumers

40. SECTORS OF THE FDA
 Food
 Drugs
 Biologics, Blood, and Vaccines
 Animal & Veterinary
 Cosmetics
 Medical Devices
 Radiation-Emitting Products
 Combination Products

41. SAFE, HEALTHY,
SANITARY FOODS
 FDA monitors the nation’s food
supply by making sure that all
ingredients used in foods are safe, and
that food is free of contaminants like
disease-causing organisms, chemicals,
or other harmful substances
*Meat & poultry products are regulated
by USDA*
 The agency must approve new food
additives before they can be used in
foods
 FDA monitors the safety of dietary

42.  Prescription drugs
Undergo New Drug Application Process
Orange Book lists all FDA approved
prescription drugs, updated monthly
DRUGS

43. OVER-THE-COUNTER
DRUGS
OTC drugs range from acne drug
products to weight control drug
products
 Potential for improper use must be
low, consumer can use them for
self- diagnosed problems, health
practitioners are not needed for
safe and effective use
OTC drug monographs contain
information on acceptable

44. ANIMAL DRUGS
 FDA regulates drugs and devices used for
animals (both pets and animals that
produce food)
 Before manufacturers can market animal
drugs (including drugs used in animal
feeds), they must gain FDA approval by
providing proof of their safety and
effectiveness
 Veterinary medical devices do not have to
be pre-approved by FDA before marketing,
but they still must be safe, effective, and
properly labeled

45. ANIMAL CLONING
In 2001 the FDA requested that
livestock producers keep food
produced from animal clones and
their offspring out of food supply
FDA had conducted thorough
evaluation on safety of food from
these animals and animal health risks
In January 2008 the FDA confirmed
that meat and milk from cow, goat,

46. COSMETICS
"Articles intended to be rubbed, poured,
sprinkled, or sprayed on, introduced into,
or otherwise applied to the human
body...for cleansing, beautifying,
promoting attractiveness, or altering the
appearance" [FD&C Act, sec. 201(i)].

47. Cosmetics from other countries are subject
to review by the FDA at the time of entry at
US Customs
Cosmetic companies are not required to
file any information with the FDA, but are
encouraged to file a Cosmetic Product
Ingredient Statement with the Voluntary
Cosmetic Registration Program
COSMETICS

48. MEDICAL DEVICES
A medical device is an object which
is useful for diagnostic or therapeutic
purposes.

49. MEDICAL DEVICES
Devices at FDA
Provides a search program to obtain info on
any device approved by the FDA
Examples of some medical devices are:
Breast Implants
Contact Lenses
Lasers for Eye Surgery
Laboratory Tests
Home Testing
Glucose
Pregnancy

50. MEDICAL DEVICES
MEDICAL IMAGING
Medical X-Rays
CT (Computed Tomography)
Fluoroscopy
Mammography
Ultrasound Imaging

51. SAFE MEDICAL RADIATION
PRODUCTS
 The FDA protects the public from unnecessary
exposure to radiation from electronic products
 Products include: microwave ovens, cell
phones, lasers, MRI machines, x-ray
equipment, medical ultrasound machines, and
many other consumer, industrial, and medical
products

52. ENFORCEMENT
 FDA works with manufacturers when problems
arise
 If that fails, FDA asks manufacturer to recall the
product while federal marshals seize the products
(if the recall is not voluntary)
 FDA can ask the courts to prosecute those in
violation of the law

56. INTRODUCTION
• The CDSCO of India is main regulatory
body for regulation of pharmaceutical,
medical devices and Clinical Trials.
• Head office of CDSCO is located in
NEW DELHI and functioning under the
control of Directorate General of Health
Services, ministry of health and family
welfare Government of India.

58. DRUGS CONTROLLER
GENERAL OF INDIA [DCGI]
• He/she is a responsible for approval of New
Drugs, Medical devices and Clinical Trails to be
conducted in India.
• He is appointed by the central government under
the DCGI the State drug control organization will
be functioning.
• The DCGI is advised by the Drug Technical
Advisory Board {DTAB} and the Drug
Consultative Committed {DCC}.

59. Organization Chart
HEAD QUATER
ZONAL OFFICE (6)
SUB ZONAL
OFFICE (3)
PORT/AIRPORT
OFFICE (7)
LABORATORIES (6)
•NEW DRUGS
•CLAA
•Imports
•DTAB/DCC
•GMP Audits
•Coordination
with states
•GMP Audits
•Coordination
with states
•Import
•Export
•Testing of
drug samples
•Validation of
test protocols
CLAA : CENTRAL LICENSING APPROVING AUTHORITY
DTAB : DRUG TECHNICAL ADVISORY BOARD
DCC : DRUG CONSULTATIVE COMMITTEE

60. ZONAL OFFICES
Mumbai
Kolkata
Chennai
Ghaziabad
Ahmadabad
Hyderabad
These are involved in GMP audits and
inspection of manufacturing units of
large volume parental, sera, vaccine and
blood products.

61. Sub-zonal office:-
I. Chandigarh
II.Jammu
III.Bangalore
These centre co-ordinate with state
drug control authorities under their
jurisdiction for uniform standard of
inspection and enforcement.

62. CENTRAL DRUGS TESTING
LABORATORIES
 Central Drug Laboratory, Kolkata
 Central Drug Testing Laboratory, Mumbai
 Central Drug Testing Laboratory, Chennai
 Central Drug Laboratory, Kasauli
 Regional Drug Testing Laboratory, Guwahati
 Regional Drug Testing Laboratory, Chandigarh
These laboratories are responsible for quality
control of drugs and cosmetics in the country.

64. FUNCTIONS OF CDSCO IN
CENTER
Approval of new drugs and clinical
trials.
Import Registration and Licensing
Licensing of Blood Banks, LVPs,
Vaccines, r-DNA products and some
Medical devices and Diagnostic
agents.
Amendment to D&C Act and Rules.
Participation in WHO GMP
certification schemes.

65. APPROVAL OF INVESTIGATIONAL
NEW DRUG
65

66. CENTRAL LICENSING

67. CLINICAL TRIALS
Schedule Y of drugs and
cosmetics act explain the
guideline for grant of permission
for conducting clinical trials in
India.
The protocol for such trials are
examined by the office of DCGI
before the permission are
granted.
Office of DCGI also grants

68. a. Registration of clinical trials has
been made mandatory with
centralized clinical trial registry of
ICMR with effect from 15th
2009.
b. Drug and Cosmetic rules are being
amended to make mandatory the
registration of clinical research
organizations.
c. Drug and Cosmetic act is proposed
to be amended to include a separate
chapter on clinical trials.

69. Summary:-
The Central Drug Standard Control
Organization works under The
Ministry of Health and Family
Welfare to enforce The Drug and
Cosmetics Act 1940, with main
object to regulate import,
manufacture, sale of Drugs and
Cosmetics.