Role of who in pharmaceutical management

1. ROLE OF WHO IN
PHARMACEUTICAL MANAGEMENT
NAME: ANANT NAG
ID: MPH/10016/21
SUB: SEMINAR/ASSIGMENT
BRANCH: PHARMACEUTICAL QUALITY ASSURANCE
SEMINAR 3

2. INDEX
Introduction.
Focus of the WHO.
Health policy of the who.
Contributions of the WHO in india.
Who’s role in drug regulation.(Pharmaceutical management)

3. INTRODUCTION
WORLD HEALTH ORGANIZATION
 Formation: 7 April 1948; 73 years ago
 Type: United Nations specialized agency
 Headquarter: Geneva, Switzerland
 Head (Director-General): Tedros Adhanom
 Parent organization United Nations Economic and Social Council

4.  The World Health Organization (WHO) is a specialized
agency of the United Nations responsible for
international public health.
The WHO Constitution, which establishes the agency's
governing structure and principles, states its main objective as
"the attainment by all peoples of the highest possible level of
health"

5. Who is the directing and coordinating authority for health
within the united nations system,
It is responsible for providing leadership on global health
matters,
Shaping the health research agenda,
Setting norms and standards,
Articulating evidence-based policy options,
Providing technical support to countries and monitoring and
assessing health trends.

6. Focus of the WHO
The WHO Constitution states that the organization’s objective
“is the attainment by all people of the highest possible level of health”.
The WHO fulfills this objective through the following functions:
 By playing a role as the directing and coordinating authority on
international health work.
 Maintaining and establishing collaboration with the UN and any other
appropriate bodies.
 Assisting governments, upon request, in strengthening their health services.
 Giving appropriate technical assistance and in case of emergencies,
required aid upon the request or acceptance of governments.

7. Health Policy of WHO
The WHO addresses government health policy with the
following two aims:
To address the social and economic determinants of health
through policies and programs “that enhance health equity and
integrate pro-poor, gender-responsive, and human rights-based
approaches”.
To promote a healthier environment, intensify primary
prevention, and influence public policies in all sectors to
address the root causes of environmental threats to health”.

8. Contribution of the WHO in India
India is a member of the WHO and the organization has its offices in various
parts of the country.
The WHO Country Office (WCO) is headquartered in New Delhi.
 The WHO Country Cooperation Strategy (CCS) – India has been jointly
developed by the Ministry of Health and Family Welfare of the GOI and the
WCO.
 Its chief aim is to contribute to improving health and equity in the country.
 The National Strategic Plan for Elimination of Malaria (2017-2022) was
launched by the Union Minister for Health and Family Welfare.

9. Its chief aim is to eliminate Malaria by 2027.
The National Strategic Plan has formulated year wise
elimination targets in various parts of the country.
It is formulated with the support of the World Health
Organization’s Global Technical Strategy for Malaria (2016-
2030).

10. Who’s role in drug regulation
First, issuing necessary norms and standards through its
Expert Committees (such as who expert Committee on
Specifications for Pharmaceutical Preparations and WHO
Expert Committee on Biological Standardization).
Expert Committee like bodies (such as International Non-
proprietary Names Expert Group and International Working
Group for Drug Statistics Methodology issuing Anatomical,
Therapeutic and Chemical or ATC codes and Daily Defined
Doses or ddds for drug utilization research).

11. Second, supporting regulatory capacity building leading to
implementation of drug regulation on national level and its
harmonization on regional and Global level.
This activity involves assessment of regulatory activities on
country level and various technical training courses (such as
GMP and GCP, how to assess generic medicines,
bioequivalence, safety monitoring and pharmacovigilance,
quality assurance and quality control) and customized
technical assistance (in cooperation with numerous WHO
collaborating centers and other partners) to the countries.

12. Third, in selected areas of essential products, ensuring the
quality, safety and efficacy of limited high public health value
essential medicines (such as anti-retrovoirals to treat
HIV/AIDS, or medicines to treat malaria) and vaccines (used
in national vaccination programs) through “prequalification”.
 De facto prequalification, although primarily meant for UN
procurement and international donors, is a regulatory activity
mimicking medicines registration (marketing authorization) in
its all elements to ensure that products prequalified meet all
international standards for quality, safety and efficacy.
Prequalification program has also a very strong capacity
building element built into it.

13.  Fourth, WHO plays a very important role in facilitating exchange of
regulatory information for which it has developed a number of tools. Since
1980 WHO convenes every second year International Conference of Drug
Regulatory Authorities (ICDRA) and publishes their proceedings. These
conferences provide drug regulatory authorities of WHO Member States
with a forum to meet and discuss ways to strengthen collaboration.
 The icdras have been instrumental in guiding through its recommendations
regulatory authorities, WHO and interested stakeholders and in
determining priorities for action in national and international regulation of
medicines, vaccines, biomedicines and herbals.

14.  WHO manages also a system for regular exchange of information between
Member States on the safety and efficacy of pharmaceutical products,
using a network of designated national drug information officers.
 WHO ensures the prompt transmission to national health authorities of new
information on serious adverse effects of pharmaceutical products and it
also responds to individual requests for information.
“These goals are achieved by the regular publication of regulatory
information in the WHO Pharmaceuticals and by the dissemination of one-
page Drug Alerts on an adhoc basis.”