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Argentina's Drug Oversight Lacks Inspections for One in Five Labs
🇦🇷 Argentina /Crime & Justice

Argentina's Drug Oversight Lacks Inspections for One in Five Labs

From La Nación · () Spanish

Translated from Spanish, summarized and contextualized by DistantNews.

At a glance

News Named sources Outcome reported
  • A government audit revealed that 21.7% of pharmaceutical laboratories in Argentina have not been inspected in over five years.
  • The audit, prompted by a contaminated fentanyl case, also found that reports of quality deviations can remain unresolved for over 600 days.
  • The findings highlight significant gaps in the oversight of medication production and safety in Argentina.

Argentina's oversight of the medicines its citizens consume is riddled with critical deficiencies, according to an official report. Over five years, nearly a quarter of the country's authorized pharmaceutical laboratories have not undergone a thorough inspection to verify their manufacturing practices.

The deficiency of inspections are not an isolated fact, but rather coexists with an administrative inertia that allows reports of quality deviations to remain archived, without effective resolution or safety measures, for periods that reach over 600 days.

— SIGEN ReportThe report highlights systemic issues within Argentina's drug regulatory body.

The audit, conducted by the General Audit Office (SIGEN) following a contaminated fentanyl case that led to at least 90 deaths, also uncovered administrative inertia. Reports detailing quality deviations can languish unresolved for over 600 days, with no effective safety measures implemented.

The lack of control and state response in the fentanyl case was not an exception.

— SIGEN ReportThis quote emphasizes that the issues found are systemic and not isolated incidents.

The report, obtained by La Nación, was requested by Judge Ernesto Kreplak, who is investigating the fentanyl deaths. The primary suspect in that case is Ariel García Furfaro, owner of HLB Pharma and Ramallo laboratories and the drug distributor Alfarma.

Good Manufacturing Practices (GMP) are the set of rules that guarantee that a medicine is produced, packaged, and controlled uniformly, with the purity, potency, and stability that its label promises.

— ANMAT RegulationThis defines the standard that laboratories are supposed to meet.

SIGEN's conclusions suggest that the lack of state control and response in the fentanyl case was not an isolated incident. The audit covered the National Administration of Medicines, Foods, and Medical Technology (ANMAT), the agency responsible for controlling medication quality. While Good Manufacturing Practices (GMP) are regulated, the current rules do not mandate a minimum inspection frequency, leaving a significant portion of laboratories unchecked for extended periods.

the same provision does not set any mandatory deadline for carrying out these inspections. There is no minimum written periodicity.

— SIGEN ReportThis points out a critical flaw in the regulatory framework.
DistantNews Editorial

Originally published by La Nación in Spanish. Translated, summarized, and contextualized by our editorial team with added local perspective. Read our editorial standards.

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