Fake GMP Compliance: A Big Problem for Regulators and the Pharmaceutical Industry
Medicines For Africa | mfa | 14 may 2025
Fake GMP Compliance: A Big Problem for Regulators and the Pharmaceutical Industry
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medicines for africa (mfa)
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May 14, 2025
The pharmaceutical industry is grounded in the promise that every medicine reaching a patient has been manufactured under strict, controlled conditions to ensure safety, quality, and effectiveness. But across the global supply chain, a troubling phenomenon known as “fake compliance” threatens this foundation. Fake compliance refers to the practice where pharmaceutical manufacturers deliberately misrepresent or manipulate their adherence to Good Manufacturing Practices (GMP) in order to pass inspections. These companies invest more in appearing compliant than in actually meeting GMP standards. Facilities may clean up operations days before a scheduled inspection, temporarily fix equipment, or coach staff to deliver scripted responses. Documentation — a cornerstone of GMP inspections — can be fabricated or selectively edited to give the impression of control where none exists.
Rather than embedding GMP principles into their daily workflows, some manufacturers invest in staging compliance. Facilities are cleaned and reorganized before scheduled inspections, documents are selectively fabricated or edited, and employees are coached to give rehearsed responses. In many cases, specific production lines or batches are prepared only for inspection purposes, while the majority of products continue to be manufactured using substandard methods. During audits, inspectors find polished documentation and gleaming facilities that give the appearance of compliance during inspections while cutting corners in day-to-day operations.
This illusion undermines regulatory systems, especially those relying heavily on paper trails rather than real-time observation or data-driven oversight. The result is the release of substandard or falsified medicines into the market, exposing patients to ineffective or even harmful products. In LMICs, where patients already face access barriers, such deception adds an additional layer of risk and erodes confidence in healthcare systems. When regulators rely heavily on documentation and infrequent visits, such practices often go undetected, leaving patient safety at risk. The problem is further compounded in LMICs, where inspection agencies often lack the resources, training, or legal authority to conduct thorough, surprise-based audits. The US FDA recently announced that it will be conducting more surprise inspection in line with how it inspects domestic manufacturers.
The scale of this issue have become increasingly clearer with the challenges reported in countries like India and China. India and China are two of the world’s largest pharmaceutical producers, quite central to the global pharmaceutical supply chain. India supplies over 20% of the world’s generic drugs, while China dominates the production of active pharmaceutical ingredients (APIs). However, both countries have faced repeated scrutiny for fake compliance and regulatory breaches. They have been at the center of repeated allegations of regulatory evasion and fake compliance.
In India, several high-profile cases have revealed systemic manipulation of GMP standards. A 2023 investigation into Indian pharmaceutical exports uncovered numerous instances where companies produced different batches for export compared to those tested by inspectors. In India, a string of incidents in recent years revealed how some manufacturers produce substandard medicines for export markets in Africa and Asia while showing higher quality batches to inspectors. Facilities often performed well during scheduled inspections but failed unannounced visits or foreign audits, including those by the U.S. FDA. Poor-quality cough syrups linked to deaths in The Gambia and Uzbekistan in 2022–2023 further exposed the consequences of regulatory evasion. Investigations into these particular fatal pediatric cough syrup in The Gambia and Uzbekistan brought international attention to the dangers of unchecked manufacturing practices. Facilities involved were often able to pass inspections in India but failed more rigorous or unannounced inspections by foreign agencies such as the U.S. FDA.
In China, while the government has strengthened its regulatory framework in response to past scandals, the challenge of enforcing compliance remains. China made substantial reforms post-2008 (following the melamine scandal), but it continues to struggle with local enforcement. Some manufacturers manipulate data or run “shadow facilities” that operate without proper oversight. Some companies operate parallel, unlicensed production sites or alter production records to meet inspection criteria. These patterns of deception often go unchecked when exported products are sent to countries with limited inspection resources. LMIC regulators may rely on documentation or foreign certifications that do not reflect the true state of manufacturing practices, leaving their populations vulnerable. Even though Chinese regulators have ramped up penalties and conducted more inspections, fake compliance persists. The demand for cheap pharmaceuticals continue to incentivize deceptive practices. The challenge is magnified for LMICs that import large volumes of medicines from these countries. Limited capacity for independent inspections means regulators must often rely on foreign certificates or paper-based documentation that may not reflect the true quality of the product.
To protect public health, regulators in Africa and other LMICs must adopt proactive measures to counter fake compliance and close the gaps that manufacturers exploit. One critical step is to shift from scheduled to unannounced inspections, particularly for manufacturers flagged as high-risk. Surprise audits give a more accurate reflection of routine operations and reduce the ability to stage compliance. Investing in the training and upskilling of inspectors is equally essential. GMP inspections require not just technical knowledge but investigative skill—understanding how to detect subtle inconsistencies in documents, interview plant personnel effectively, and identify telltale signs of manipulation.
Digital technologies also offer promising tools. Systems that enable real-time monitoring of production parameters, electronic batch records, and even surveillance of manufacturing zones can provide regulators with more reliable insights than paper-based logs. In parallel, regulators should build internal mechanisms that encourage whistleblowing. Employees are often the first to witness unethical practices. Providing safe, confidential channels for reporting can offer crucial leads. Finally, regional cooperation for instance under the African Medicines Agency can significantly enhance inspection outcomes. Joint inspections and harmonized regulatory frameworks, as seen in the African Medicines Regulatory Harmonization initiative, not only pool limited resources but also raise the stakes for noncompliant manufacturers, who ideally should face exclusion from African markets.
Fake compliance is more than a regulatory failure. It’s a silent threat to public health in Africa and the world. Medicines that look legitimate but are produced without adherence to GMP standards put patients at risk, weaken health systems, and contribute to antimicrobial resistance. In a highly globalized pharmaceutical industry, the impact of deceptive practices in one region can ripple across continents. The need for vigilant, transparent, and adaptive regulatory systems is an urgent challenge. Staying ahead of fake compliance is not just a technical challenge for LMICs. It is a matter of life and death.