Controlling Substandard and Counterfeit
Session 17: Controlling Substandard and Counterfeit
Medicines
Total Session Time: 60 minutes
Prerequisites
Learning Tasks
By the end of this session students are expected to be able to:
Tanzania
Resources Needed:
SESSION OVERVIEW
Activity/
Step Time Content
Method
1 05 minutes Presentation Introduction, Learning Tasks
25 minutes Presentation and Methods for Controlling Substandard and
2
Buzzing Counterfeit Medicines
20 minutes Curbing Spread of Substandard and Counterfeit
Presentation and
3 Medicines in Tanzania
Brainstorming
4 05 minutes Presentation Key Points
5 05 minutes Presentation Evaluation
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SESSION CONTENTS
STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)
READ or ASK students to read the learning tasks and clarify
ASK students if they have any questions before continuing.
STEP 2: Methods for Controlling Substandard and Counterfeit Medicines
(25 minutes)
Activity: Buzzing (5 minutes)
ASK students to pair up and buzz on the following question for 2 minutes
ALLOW few pairs to respond and let other pairs to add on points not mentioned
WRITE their response on the flip chart/board
CLARIFY and SUMMARIZE by using the content below
Given the diverse and complex nature of the issues and challenges related to substandard and
counterfeit medical products, a wide range of interventions are needed to effectively address
them.
products and engage in updating, developing, implementation and monitoring of national
medicines policies.
and institutional capacity to ensure and strictly enforce compliance of medical products with
standards of quality, safety and efficacy; and to effectively
labeled/falsified/counterfeit medicines.
Member States should develop and implement a sustainable human resource strategy for the
pharmaceutical sector that ensures adequate human resource capacity including specialized
training and retention of regulatory personnel
to enhance the knowledge and skills of health personnel to enable them to prevent,
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recognize and appropriately deal with cases of substandard and counterfeit medical
products.
resources to ensure the availability of quality and affordable essential medical products in
public health facilities. Comprehensive quality assurance systems for procurement and
distribution should be strengthened for the public, private and other health care providers.
safety standards should be incorporated and given due emphasis in national health policies
and strategic plans. Government authorities should monitor and regulate the prices of
medical products to ensure their availability and affordability
market surveillance to quantify the magnitude of the problem and to inform the
development and implementation of appropriate policies and regulations
and use of these medical products.
and communication strategies to increase awareness of policy makers, health workers and
the general public about the dangers of using substandard/spurious/ falsely labeled/falsified/
counterfeit medical products
and collaboration mechanisms including reinforcing regulatory networks and exchange of
information among public health, law enforcement, professional associations, NGOs and
other relevant authorities to improve prevention, detection, investigation and prosecution of
cases related to substandard/ spurious/falsely labeled/ falsified/counterfeit medical products.
o further develop tools and guidelines enabling Member States to adapt and implement
policies and strategies;
o Continue to assess and strengthen National Medicine Regulatory Aauthorities in order
to ensure the quality, efficacy and safety of medical products
o (Support Member States to mobilize more resources for developing human resource
capacity for the pharmaceutical sector;
o Continue to facilitate the exchange of objective and independent regulatory information
among Member States
o Intensify the promotion and implementation of good governance, accountability and
transparency in Member States;
o Strengthen the conduct and dissemination of operational research on
substandard/spurious/falsely labeled/falsified/counterfeit medical products and
encourage Member States to use evidence for policy actions; and
o Strengthen monitoring and evaluation of programmes dedicated to combating the
manufacture, distribution and use of substandard and counterfeit medicines.
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STEP 3: Curbing Spread of Substandard and Counterfeit Medicines in
Tanzania (20 minutes)
Activity:Brainstorming (5 minutes)
Ask students to brainstorm on the following question:
Tanzania?
ALLOW few students to respond
WRITE their responses on the flip chart/ board
CLARIFY and SUMMARISE by using the content below
counterfeitmedicines in Tanzania
o At the national levels, the government must:
Improve the availability and affordability of medicines;
Enact deterrent legislation prohibiting the manufacture, importation, exportation,
distribution and sale of substandard and counterfeit medicines;
strengthen TFDA by clearly setting out its power, duties and responsibilities;
Provide the necessary human, financial and other resources to the TFDA and
regulatory authorities;
Training the regulatory authorities personnel‘s, including enforcement officers such
the police in the detection and investigation of substandard and counterfeit
medicines;
Foster cooperation between TFDA and other national law enforcement agencies such
as police, customs, and the judiciary which will reduce corruption among these
agencies in the effort to reduce spread of counterfeit and substandard medicines
Ensure that personnel working in national medicine regulation and those involved in
the detection and investigation of counterfeit medicines sign conflict of interest
forms;
Ensure that the medicine legislation is enforced;
Ensure that courts speedily dispose of cases involving counterfeit and substandard
medicines and that sentences passed by the judiciary reflect the seriousness of the
problem and the offence;
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Ensure that substandard and counterfeit medicines are confiscated and destroyed
o TFDA (regulatory authorities) must:
Ensure that all medicine manufacturing, importation, exportation and distribution
activities are carried out in premises approved by the TFDA and pharmacy council,
and that individuals and companies engaged have license to operate such activities;
Inspect medicine establishments regularly to ensure that they comply with the
specification and standards of that particular drug;
Ensure that all medicines are assessed and authorized before they are introduced to
the market;
Define the ports of entry for medicines and starting materials used for the
manufacture of pharmaceutical products and should have adequate number of staffs.
Control importation of finished pharmaceutical products and starting materials by
issuing import permits and inspecting consignments at points of entry as necessary
Inspect the informal market to prevent any illegal trade in medicines;
Monitor the quality of medicines on the market to detect and prevent any
substandard and counterfeit medicines from reaching the public;
Work closely with national law enforcement agencies such as the police and custom
officers inform the public about the problem of counterfeit medicines and educate
and advise them to buy medicines from TFDA authorized sources rather than from
market places and streets;
Encourage and advise consumers to report to their prescribers or physicians any lack
of improvement in their health status in spite of the treatment or any adverse
reactions experienced;
Foster bilateral and multilateral agreements with other countries, in particular with
countries sharing common borders such Kenya, Zambia, Malawi, Mozambique and
Uganda where many counterfeit and substandard drug crosses these boarders;
Seek international cooperation with organizations such as WHO, Interpol, the World
Customs Organization
o Consumers should:
Buy medicines only from licensed pharmacies and medicine outlets;
Be suspicious of heavily discounted medicines;
Be insisted to get receipts when buying medicines;
Check packaging carefully if it is properly sealed;
Check if the packaging indicates the batch number, manufacturing date, expiry date,
and the manufacturer's name and this should be encourage through mass media so as
consumers to get this knowledge.
Report to health worker or doctors any lack of improvement after taking a medicine
o Raising awareness
Government must encourage a more widespread recognition of the multidimensional
nature of this growing threat and institute appropriate collaborative mechanisms.
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Legitimate private industry must also recognize their role in prevention and work more
transparently with the government.
o Development of a transparent and verifiable chain of custody from point of production
to point of sale
Governments should work collaboratively with industry to identify common e-
pedigree standards and, where necessary, incent compliance with those criteria.
Regular inspection.
Post marketing inspection.
Education on counterfeit identification.
Legal gap analysis:the government should be encouraged to ensure that they have
relevant, up-to-date laws as well as rigorous penalties consistent with the sale and
distribution of counterfeit medicines. Our legislations govern control of drug should
be reviewed to analyze the gap exist.
Develop a communication strategy to ensure that health professionals , the general
public and the media are aware of the dangers associated with counterfeit
medicines.
Improve collaboration among government entities like health, police, customs; local
administration and judiciary they work together in order to effectively combat
counterfeiters.
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STEP 4: Key Points(5 minutes)
o Further develop tools and guidelines enabling Member States to adapt and implement
policies and strategies;
o Strengthen monitoring and evaluation of programmes dedicated to combating the
manufacture, distribution and use of substandard and counterfeit medicines.
TFDA must ensure that all medicine manufacturing, importation, exportation and
distribution activities are carried out in premises approved by the TFDA and pharmacy
council, and that individuals and companies engaged have license to operate such activities;
STEP 5: Evaluation (5 minutes)
Tanzania?
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References
Quick, J. D. (1997). Managing drug supply the selection, procurement, distribution and use of
pharmaceuticals. West Hartford, CT: KumarianPress.Bartsch, S. (2007).
The Global Fund to Fight AIDS, Tuberculosis and Malaria. Global Health Governance and the
Fight Against HIV/AIDS,146-171. doi:10.1057/9780230591349
WHO Operational package for assessing, monitoring and evaluating country pharmaceutical
situations. (2015, November 20). Retrieved from
https://www.who.int/medicines/publications/WHO_TCM_2007.2/en/
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