Pharmacy Law and Ethics

PHARMACEUTICAL
LEGISLATION
15 October 2014

PHARMACEUTICAL LEGISLATION
ESTABLISHMENT OF STATUTORY DRUG
LEGISLATION IN DEVELOPING COUNTRIES
WHO recommendations of drug legislation for
developing countries
Basic elements of a drug Act
i. General provisions;

Title; long title or the scope as well as the short title.

Purpose: in the overall national pharmaceutical supply
system, safe and effective drugs for intended uses and of
quality reach the consumer.
Extent: territorial area to which the Act applies
Application/relation to other laws not barred
Interpretation or Definitions of various terms

PHARMACEUTICAL
LEGISLATION
ii. Specific Provisions

Should provide authority through licensing

for the following;
a. Import and export of drugs;

conditions for import/export,

persons qualified to import/export,
fees,
types of permit required to import/export,
storage at places of import of drugs pending
release,
records to be kept

PHARMACEUTICAL
LEGISLATION
b.
c.
d.
e.

Drug registration
Scheduling of drugs
Control of Manufacture
Control of distribution, supply,
storage and sale of drugs
f. Labelling
g. Information and Advertising
h. Imposition of fees for licences, etc.

PHARMACEUTICAL
LEGISLATION
iii. Drug Control Administration
a. Organisation and functions - DRU
b. Drug advisory board; registration, evaluation, revocation
etc.
c. Inspectorate services
d. Laboratory services for quality control

iv. Prohibitions, offences, penalties and legal procedures

v. Powers to make rules and regulations appropriate
authority to establish schedules and regulations for
the purpose of the Act
vi. Repeals and transitional provisions
vii.Exemptions from the provisions of the law

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LEGISLATION
DEVELOPMENT OF NATIONAL DRUG POLICY

8 Steps Involved in formulating a National drug Policy;

Step 1: Organize the policy process
Step 2: Identify the main problems
Step 3: Make a detailed situation analysis
Step 4: Set goals and objectives for a national drug
policy
Step 5: Draft the text of the policy
Step 6: Circulate and revise the draft policy
Step 7: Secure formal endorsement of the policy
Step 8: Launch the national drug policy

DEVELOPMENT OF NATIONAL DRUG POLICY

Step 1: Organize the policy process

the ministry of health takes the lead role in formulating a
national drug policy.
development process that will identify the structure of
the policy, its major objectives and its priority
components.
identify stakeholders,
necessary resources,
This stage can be carried out within the ministry of health
with support from a small committee of selected experts.

DEVELOPMENT OF NATIONAL DRUG POLICY

Step 2: Identify the main problems

carrying out an initial situation analysis.
bring together a team of experts from the
ministry of health and from other disciplines and
backgrounds.
identify the main problems,
make recommendations
identify possible approaches.
formulate consolidated advice to the government.

DEVELOPMENT OF NATIONAL DRUG

POLICY
Step 3: Make a detailed situation analysis

A more detailed situation analysis of the

pharmaceutical sector and its components may
be needed.
further analyse the source of the problems,
identify potential solutions,
choose the most appropriate strategies,
set priorities,
serve as a baseline for monitoring and evaluation.

DEVELOPMENT OF NATIONAL DRUG

POLICY
Step 4: Set goals and objectives for a national drug policy

Set goals
Identify priority objectives, e.g. if the problem is lack of access
to essential drugs, one of the priority objectives should be to
improve the selection, affordability and distribution of essential
drugs.
A workshop involving a small number of key policymakers may
be helpful. The situation analysis should justify the choices and
serve as the basis for decisions.
Discuss the main objectives and strategies with all stakeholders
Broad consultation are necessary to set achievable objectives
and to formulate appropriate strategies to attain them.

DEVELOPMENT OF NATIONAL DRUG

POLICY
Step 5: Draft the text of the policy

A draft text of the national drug policy should follow

It should set out the general objectives of the policy
For example;
to ensure that essential drugs are accessible to the entire
population;
that the drugs are safe, efficacious and of good quality; and
that they are used rationally by health professionals and
consumers.

The specific objectives should also be described,

followed in each case by the strategy to be adopted.

DEVELOPMENT OF NATIONAL DRUG

POLICY
Step 6: Circulate and revise the draft policy

Wide circulation of the draft document for

comments by all stakeholders including the
private and academic sectors.
Endorsement by government sectors responsible
for planning, finance and education is important
Once this wide consultation is complete, the
draft document should be revised in the light of
the comments received, and finalised.

DEVELOPMENT OF NATIONAL DRUG

POLICY
Step 7: Secure formal endorsement of the policy

an administrative document that serves as a basis for

implementation plans and changes in the law and
regulations.
In some countries the entire national drug policy
document has become law.
a demonstration of political commitment but it can also
cause problems, as future adjustments to the policy may
become difficult.
certain enabling components of the policy are
incorporated into law, without too many operational
details.

DEVELOPMENT OF NATIONAL DRUG

POLICY
Step 8: Launch the national drug policy

Introducing a national drug policy is much more than a technical

task.
To a large extent the policy's success will depend on the level of
understanding of different sectors of society, and on their support
for its objectives.
The implications and benefits for all interested parties should
therefore be stressed.
The policy should be promoted through a clear and well-designed
information campaign.
Information should be disseminated through a variety of channels
to reach different target groups. The media can play a major role
in ensuring public understanding and support for the policy.
Some countries have organized high profile launches.

BOTSWANA NATIONAL DRUG POLICY

(BNDP)
GENERAL AIM;
In accordance with the philosophy of the
National Health Policy to attain health for all,
the BNDP is established with an aim to make the
drugs of acceptable safety, efficacy and quality,
available and affordable to all those who need
them, and to promote their rational use by
prescribers, dispensers and consumers.

BOTSWANA NATIONAL DRUG POLICY

(BNDP)
OBJECTIVES;
1. Health objectives
2. Economic and developmental
objectives

BOTSWANA NATIONAL DRUG POLICY

(BNDP)
Health objectives are to;
i.

Ensure the availability and accessibility of essential

drugs to all citizens
ii. Ensure the use of safe, efficacious and quality drugs
iii. Ensure good dispensing and prescribing practices
iv. Promote the rational use of drugs by prescribers,
dispensers and patients
v. Provide the necessary training, education and
information
vi. Promote preventive care, informed decision making and
overall individual responsibility for health
vii. Contribute to the control of drug use and prevention of
drug misuse and abuse.

BOTSWANA NATIONAL DRUG POLICY

(BNDP)
Economic and developmental objectives are
to;
Promote the lowering of drug cost in both the
private and public sector
ii. Promote the cost effective use of drugs
iii. Create a conducive environment for
partnership between governmental and nongovernmental providers in the
pharmaceutical sector by means of an
appropriate regulatory and administrative
framework
i.

BOTSWANA NATIONAL DRUG POLICY

(BNDP)
iv. Optimise the use of scarce resources and
facilitate cross fertilisation of ideas through
co-operation with international and regional
agencies
v. Promote, support and encourage the
development of local pharmaceutical
industry and the production and distribution
of essential drugs and raw materials
vi. Promote knowledge, efficiency,
management skills and productivity in the
pharmaceutical sector.

ASSURANCE OF DRUG
QUALITY
DEF;
A system for monitoring the entire
process from the acquisition of the
raw materials to its conversion into a
finished product which is made
available to the consumer

ASSURANCE OF DRUG
QUALITY
PURPOSE;
To ensure that the consumer receives
a product that meets all established
official specifications and standards.
AIM;
The minimum acceptable quality for
drugs should be the same in each
country.

ASSURANCE OF DRUG
QUALITY
ELEMENTS OF A DRUG ASSURANCE SYSTEM
Legal base
Regulatory facet
Technical facet

Legal base; the legislation should provide

the necessary authority for the
development of specific regulations relating
to quality assurance and assessment during
manufacture, importation and distribution
of drug products. E.g. DRSA.

ASSURANCE OF DRUG
QUALITY
Regulatory facet; should have a central
administrative body having a provision for
inspection and recall as well as a drug
quality control laboratory. E.g. Drug
Regulatory Unit (DRU).
Technical facet; includes quality
specifications and basic tests and
requirements for Good Manufacturing
Practices (GMP). E.g. National Drug Quality
Control Laboratory (NDQCL) and CMS.

ASSURANCE OF DRUG
QUALITY
WHO certification Scheme on quality
of pharmaceutical products;
Under this certification the exporting country
must certify that the drug is registered and
committed to be sold in that country
Reasons must be stated if not registered
The importing country must also certify that
the manufacturers facilities are inspected
regularly and that they comply with WHO
standards of GMP and quality control (QC)

ASSURANCE OF DRUG
QUALITY
WHO basic standards of GMP for
pharmaceutical products
i. Basic standards for personnel
ii. Premises
iii. Equipment
iv. Sanitation and hygiene
v. Manufacturing procedures
vi. Quality control
vii. Batch manufacturing records
viii.Retention of records
ix. Complaints
x. Self audit

ASSURANCE OF DRUG
QUALITY
1. Basic standards for personnel
a) Shall have a responsible person approved by
the authorities
b) Head for manufacture and quality
c) Adequate personnel with technical and
scientific background and practical experience
d) Special attention directed to continuing
training of personnel at all levels
e) Personnel in contact with the product shall
undergo periodic medical checks

ASSURANCE OF DRUG
QUALITY
2. Premises
i.
ii.
iii.
iv.

Shall be of suitable construction

Sufficient size for the intended for purpose
Shall have suitable illumination and ventilation
Shall have facilities for changing clothes, washing and
toilet purposes

3. Equipment
i.
ii.
iii.
iv.
v.

Suitable for its intended purposes

Easy to clean
Non-reactive to raw materials
Weighing and measuring equipment shall be accurate
Regularly validated

ASSURANCE OF DRUG
QUALITY
4. Sanitation and hygiene
i.

Detailed sanitation programmes shall

be adapted to each plant
ii. Written cleaning programme for
premises and equipment
iii. Instructions for hygienic manufacture
and handling of goods and procedures
relating to health, hygienic behaviour
and clothing of personnel

ASSURANCE OF DRUG
QUALITY
5. Manufacturing procedures
i. The master formula; setting out in writing the
components of manufacturing and QC procedures for
each product. The formula shall not contain any hand
written amendments or comments
ii. Starting material; inventory shall be maintained,
such materials shall be; identified and containers
stored until released by QC dept, properly sampled by
QC and tested for compliance with official
requirements, released or rejected by QC by written
instruction.
iii. Bulk products; shall normally be tested before
filling, packaging and labelling

ASSURANCE OF DRUG
QUALITY
iv. Labelling and packaging; all packages and
containers of finished products shall be identified by
appropriate labelling. Tables, packaging areas, printing
machines and other equipment shall be cleared of
labels and other materials used in the previous
operations
v. Finished products; shall be properly stored and held
separately until released for sale
vi. Distribution; shall maintain written instructions
concerning distribution and recall.
vii.Rejected materials; shall maintain written
instructions concerning the disposal of rejected
materials,

ASSURANCE OF DRUG
QUALITY
6. Quality control
i.
ii.

iii.
iv.
v.

Every manufacturer shall maintain a QC of

appropriate capacity.
Shall control all starting materials and quality and
stability of pharmaceutical products according to
official requirements.
Shall plan, establish and monitor control cheks at
all stages
Samples for starting materials shall be kept for a
period of five years.
Samples of finished products shall be retained for a
period of at least one year beyond the expiry date.

ASSURANCE OF DRUG
QUALITY
7. Batch manufacturing records; shall be prepared
for each batch of product and it shall include:

Name of preparation and batch number

Date of manufacturing
Manufacturing details
Batch number of starting material
A record of in-process control followed and results
obtained
Signature of person responsible for manufacture and
date of signature
All analytical records relating to the batch and a
reference to enable the retrieval

ASSURANCE OF DRUG
QUALITY
8. Retention of records; all records shall be
legibly written and readily traced at all times
9. Complaints; the manufacture shall maintain a
written instruction for dealing with complaints
of quality, reports of ADR resulting from
improper manufacture or product deterioration
shall be forwarded to appropriate authority
10.Self audit; shall designate an expert or a
team of to conduct regular independent
inspections for its overall manufacturing and
control procedures