Saturday, January 22

South Africa needs to tighten controls on counterfeit and substandard medicines

Poor-quality and counterfeit drugs can be extremely dangerous. Are fraudulently manufactured Mislead buyers about the quality, authenticity and efficacy of the product. These drugs do not meet regulatory and quality standards.

These drugs are usually manufactured by highly organized organizations. criminal groups who are often involved in cross-border trafficking. Products can be purchased online, in stores or at street markets. They sometimes find their way into legitimate supply chains, showing up at registered pharmacies and hospitals.

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Commonly called substandard and counterfeit drugs, they take many forms. These include anything from erectile dysfunction and weight loss pills to antidepressants, anabolic steroids, antibiotics, and pain relievers.

These drugs are accessible and affordable. That makes them attractive to consumers, but they can do great harm. Some products may contain the wrong ingredients, others may have no or much lower concentrations of active ingredients. They can also contain toxic substances used as a tablet filler, as rat poison, boric acid, chalk or antifreeze.

Some researchers suggest that as much as 42% of the drugs distributed in African countries are counterfeit. The World Health Organization estimates that there are more 1 million annual deaths due to substandard and counterfeit drugs. It has also been reported that about 53% of resistance to malaria drugs in Southeast Asia and sub-Saharan Africa it may be linked to the use of substandard and counterfeit drugs.

There have been attempts to address the problem. WHO, the United Nations Office on Drugs and Crime and Interpol have conducted joint efforts to create policies and implement strategies that member countries can adopt.

Us set out to explore how South Africa is handling the problem of substandard and counterfeit drugs. The answer, sadly, is “not very good.” There are many reasons for this. Mainly, it is due to the absence of a specific policy to combat counterfeit medicines.

This situation needs to be addressed urgently. People need a constant supply of affordable, safe and effective medicines.

Gaps and concerns

South Africa’s pharmaceutical regulatory framework is known to be strict. It is compatible with international standards and much stronger than those of other sub-Saharan African countries. But this framework is not backed by a solid implementation strategy.

For example, we identified the lack of specific policies and regulations against pharmaceutical crimes and anti-counterfeiting as a major obstacle to effective law enforcement. This type of legislation would do two things. First, it would address intellectual property issues to ensure that people cannot copy proprietary drugs. Second, it would provide clear guidance on what areas need monitoring, which stakeholders are responsible, and what action plan is required. This implementation strategy would ensure accountability, improve collaboration and information sharing, and strengthen monitoring and evaluation.

Law 101 of Medicines and Related Substances of 1965 and Law 37 of Counterfeit Products of 1997 summary penalties for forgery. This is a fine of between 5,000 rand (about US $ 326) and 10,000 rand or a prison term of three to ten years. These do not appear to be sufficient deterrents.

Lack of political will

There is also a lack of resources and capacity to implement existing laws.

For example, South Africa needs a designated or national drug regulator-owned pharmaceutical testing laboratory to test ingredients in drugs that are suspected of being deficient and counterfeit. Such a laboratory could also randomly test drugs on the market.

An overloaded criminal justice system, weak penalties, and short prison sentences mean that prosecution rates are low.

Respondents in our study suggested that political will to use state resources in such cases is lacking because pharmaceutical crime is perceived as an intellectual property problem rather than one that focuses on public safety.

Another obstacle to effective prosecutions that respondents identified was the lack of regional coordination in the Southern African Development Community. Prosecutors we interviewed told us that most African criminal justice systems struggled with a lack of resources, transparency, and regional collaboration. This, in turn, contributed to the lack of regional cooperation in the fight against transnational crimes, including counterfeit medicines.

There are various government agencies and law enforcement agencies. But they do not cooperate very well on the issue of counterfeit drugs. This has created gaps in the value chain. It facilitates the proliferation of substandard and counterfeit drugs.

We identified several websites that sell over-the-counter drugs. Most were remotely operated; for example, the domain was registered as coming from South Africa, but the contact details showed other countries such as Denmark and Switzerland. None of these websites had contact details for a responsible pharmacist.

This exposes another loophole in the legislation: Law 101 of Medicines and Related Substances of 1965 is the main piece of legislation that regulates the sale of medicines. But it needs to be modified and updated to address online drug sales.

Going forward

The implications of not having a specific pharmaceutical offense and
The legal framework against counterfeiting is far-reaching. It impedes the government’s ability to prevent the proliferation of substandard and counterfeit drugs and to ensure effective enforcement of the law once counterfeit products have been seized. The implementation of a national anti-counterfeiting policy will enforce a legal mandate with objectives and responsibilities so that all relevant authorities can participate effectively.

Another important strategy is for regulators to engage the public through awareness and education campaigns, as seen in other parts of the continent and internationally.

In other countries such as Ghana, Nigeria, and the United Kingdom, social media platforms have been used to train consumers to identify counterfeit products online. This, as well as the use of mobile authentication systems to check the product
traceability, has greatly reduced counterfeiting.

There is also room for collaboration between private companies and governments. An example is the association between Safe Internet Pharmacy Center, Internet service providers such as Google, Yahoo, and Microsoft, and the United States government to shut down illegal sites and support awareness efforts.The conversation

David R. Katerere, Chair of the Research Platform for Pharmaceutical and Biotechnology Advancement in Africa (PBA2), Tshwane University of Technology

This article is republished from The conversation under a Creative Commons license. Read the Original article.

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