How Countries Can Source Authentic Pharmaceuticals and Avoid Counterfeits

 

How Countries Can Source Authentic Pharmaceuticals and Avoid Counterfeits

In today's global market, ensuring access to safe and effective medications is critical for public health. However, the rise of counterfeit pharmaceuticals poses a serious challenge, especially for countries looking to protect their citizens from potentially harmful or ineffective treatments. As an organization focused on consumer advocacy and safety, CAIR is committed to providing guidance on how countries can locate real, authentic pharmaceuticals on the international market and avoid counterfeit products.

Here are some steps countries can take to ensure the authenticity of pharmaceuticals and identify reliable sources.

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1. Engage with Reputable Global Manufacturers

One of the most important steps is sourcing from well-known and reputable manufacturers. Major pharmaceutical companies, often referred to as “Big Pharma,” have stringent quality control systems in place. These companies include:

• Eli Lilly (USA)
• Novartis (Switzerland)
• Sanofi (France)
• GlaxoSmithKline (GSK) (UK)
• Roche (Switzerland)

These manufacturers comply with international regulatory standards and produce high-quality medications that undergo rigorous testing. When sourcing medicines from international markets, it’s important to prioritize companies with a proven track record and strong reputation in the pharmaceutical industry.

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2. Leverage WHO-Prequalified Manufacturers

The World Health Organization (WHO) maintains a list of prequalified manufacturers whose products meet global standards for safety, quality, and efficacy. This is particularly important for low- and middle-income countries seeking to procure essential medicines.

By using the WHO Prequalification Program, countries can identify manufacturers whose products are approved for distribution, ensuring that the medications purchased are authentic and reliable. This is especially valuable when purchasing medicines in bulk or for public health programs.

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3. Collaborate with International Regulatory Bodies

Countries can strengthen their pharmaceutical procurement processes by working closely with international regulatory bodies such as:

• U.S. Food and Drug Administration (FDA)
• European Medicines Agency (EMA)
• Medicines and Healthcare products Regulatory Agency (MHRA) in the UK

Pharmaceuticals approved by these agencies undergo strict evaluation processes, ensuring that the products meet high standards of safety and effectiveness. By sourcing from manufacturers approved by these agencies, countries can reduce the risk of counterfeit drugs entering their supply chains.

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4. Partner with Global Procurement Organizations

Global procurement organizations such as The Global Fund, Gavi, and UNICEF play a vital role in helping countries source authentic pharmaceuticals. These organizations have established relationships with certified manufacturers and ensure that the medicines procured meet international standards.

Countries can also use regional networks like PAHO’s Strategic Fund (Pan American Health Organization) and the Global Drug Facility (GDF), which focus on procuring safe, high-quality medicines for low- and middle-income countries.

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5. Focus on Good Manufacturing Practices (GMP)

When selecting manufacturers, it is crucial to ensure they follow Good Manufacturing Practices (GMP). GMP is a system that guarantees consistent quality in the production and control of pharmaceuticals. Regulatory agencies like the WHO and FDA enforce these standards to ensure that products are free from contamination, accurately labeled, and produced under controlled conditions.

Countries can request GMP certification from suppliers to confirm that the pharmaceuticals being purchased meet international safety and quality standards.

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6. Conduct Independent Audits and Testing

Even when sourcing from trusted manufacturers, countries should conduct independent audits and lab testing to verify the quality and authenticity of pharmaceuticals. Third-party audits assess compliance with international standards, while lab tests confirm that the medications contain the correct ingredients in the right concentrations.

This additional layer of oversight helps prevent counterfeit products from entering the supply chain and protects the integrity of the healthcare system.

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7. Utilize Trade Agreements and Government-to-Government Partnerships

Some countries negotiate Government-to-Government (G2G) Agreements with pharmaceutical-exporting nations to secure authentic medications. By working directly with governments known for pharmaceutical production, such as India and Switzerland, countries can guarantee the supply of genuine medicines for their populations.

Trade agreements can also include provisions to ensure that only licensed manufacturers and suppliers are involved in the pharmaceutical supply chain.

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8. Be Cautious of Unusually Low Prices

Counterfeit drugs often lure buyers with lower-than-market prices. While affordability is a key factor in many procurement decisions, extremely low prices can be a red flag for counterfeit products. It’s important for countries to avoid deals that seem too good to be true and always verify the authenticity of suppliers.

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9. Monitor International Anti-Counterfeiting Efforts

Organizations like INTERPOL play a significant role in combating counterfeit pharmaceuticals through initiatives like Operation Pangea, which targets illegal online sales of fake medicines. Countries can collaborate with INTERPOL to access intelligence on counterfeit activities and protect their populations from fake products.

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Conclusion

The threat of counterfeit pharmaceuticals is real, but countries can take concrete steps to protect their citizens by sourcing from reputable manufacturers, collaborating with international regulatory bodies, and conducting independent audits. Ensuring access to safe, authentic medicines is critical for public health, and by following these guidelines, countries can safeguard their healthcare systems.

At CAIR, we advocate for strong consumer protection policies and transparent supply chains, so consumers can trust that the medications they use are safe and effective.

For more insights on protecting consumer health, stay connected with CAIR’s updates and research on pharmaceutical safety.

Other Information

Eli Lilly (USA)

Lifestyle Disease Drugs:

• Humalog (Insulin Lispro) – for diabetes.
• Trulicity (dulaglutide) – for Type 2 diabetes.
• Jardiance (empagliflozin) – for diabetes and heart disease (co-marketed with Boehringer Ingelheim).

Antibiotic:

• Vancomycin – used to treat serious infections caused by resistant bacteria like MRSA.

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Novartis (Switzerland)

Lifestyle Disease Drugs:

• Entresto (sacubitril/valsartan) – for heart failure.
• Galvus (vildagliptin) – for Type 2 diabetes.
• Diovan (valsartan) – for high blood pressure.

Antibiotics (via Sandoz):

• Amoxicillin – commonly used for infections like bronchitis and pneumonia.
• Ciprofloxacin – used for bacterial infections like urinary tract infections and respiratory infections.
• Ceftriaxone – broad-spectrum antibiotic for severe infections like sepsis and meningitis.

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Sanofi (France)

Lifestyle Disease Drugs:

• Lantus (insulin glargine) – long-acting insulin for diabetes.
• Toujeo (insulin glargine) – long-acting insulin.
• Amaryl (glimepiride) – for Type 2 diabetes.
• Praluent (alirocumab) – for high cholesterol.

Antibiotics:

• Avelox (moxifloxacin) – for respiratory infections.
• Targocid (teicoplanin) – for severe Gram-positive infections, including MRSA.
• Rifampicin – essential in treating tuberculosis.

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GlaxoSmithKline (GSK) (UK)

Lifestyle Disease Drugs:

• Coreg CR (carvedilol) – for heart failure and hypertension.
• Zebeta (bisoprolol) – for hypertension.
• Avandia (rosiglitazone) – for Type 2 diabetes.

Antibiotics:

• Augmentin (amoxicillin/clavulanic acid) – for respiratory and skin infections.
• Zinnat (cefuroxime) – for respiratory and skin infections.
• Zithromax (azithromycin) – for respiratory infections and sexually transmitted diseases (STDs).

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Roche (Switzerland)

Lifestyle Disease Contributions:

• Accu-Chek – blood glucose monitoring system for diabetes management.

Antibiotics:

• Bactrim (co-trimoxazole) – for urinary tract infections (UTIs) and respiratory infections.