Latin America Roundup: Argentina authorities recall fentanyl lots after dozens die

At least 34 people have died after being treated with contaminated fentanyl in Argentina hospitals, and many more have become seriously ill, according to media reports.

The National Administration of Drugs, Foods and Medical Devices (ANMAT) on 27 May announced an urgent recall of three fentanyl product lots from Buenos Aires-based manufacturer HLB Pharma. The recall notice was backed by an order from a criminal court, which has opened an investigation.

Earlier in May, ANMAT issued a recall alert after finding drug-resistant Klebsiella pneumoniae and Ralstonia pickettii in samples of HLB fentanyl obtained from a Buenos Aires hospital, which reported 18 cases of infections. At the time, only one lot of the synthetic opioid products was thought to be affected, and no patients had yet died.

As reports of fatalities began to pour in, ANMAT suspended all activities of not only HLB Pharma but another local firm, Laboratorios Ramallo. Both firms had been subject to ANMAT investigations and enforcement actions since at least 2023. Early this year, the agency sanctioned Ramallo for noncompliance with good manufacturing practices.

According to ANMAT, many products marketed by HLB have been packaged at Ramallo’s facilities, and a 29 May report in El País said that Argentine businessman Ariel García Furfaro, the owner of HLB, is also a part owner of Laboratorios Ramallo.

A criminal investigation is ongoing, as well as an investigation by ANMAT. Experts interviewed by media outlets have expressed concern about ANMAT’s ability to trace and recover the contaminated products, of which 300,000 units were reportedly distributed to hospitals around the country.

The deadly incident is just one of several to hit Latin American manufacturers – and regulatory agencies – in recent months. In Peru, lots of defective saline solutions killed seven this spring, sparking a criminal investigation and the resignation of the country’s top regulator. In Mexico, 17 children died late last year after being treated with contaminated intravenous nutrition products. That case, which also involved a local manufacturer, resulted in the revocation of the company’s operating license and has been referred to prosecutors.

Mexico supercharges efforts to attract clinical trials, investment

The head of Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS) said that officials are striving to reduce the maximum time for approval of clinical trial protocols to under 10 days.

The effort comes as part of a broader plan to reactivate the country’s domestic pharmaceutical industry and, at the same time, make Mexico more attractive to foreign drug companies.

COFEPRIS Chief Armida Zúñiga’s comments were made during a conference 22 May sponsored by FIFARMA, which represents manufacturers across Latin America. They were reported in El Economista.

COFEPRIS has made marked improvements in response times for trial protocols, from an average of 115 days in 2024 to 40 days this year, Zúñiga said.

In her remarks to the conference, Zúñiga credited digitalization, regulatory reliance initiatives, and streamlining of documentation requirements for the improvements. Currently more than 300 protocols await approval from COFEPRIS, she said, and all are expected to be resolved by the end of June. COPFEPRIS has also been working closely of late with the Pan-American Health Organization to improve agency standards overall.

The COFEPRIS efforts support the pharmaceutical provisions of Plan Mexico, a sweeping economic initiative of Mexico President Claudia Sheinbaum. In a news conference 29 May, Sheinbaum and top health officials announced incentives for revitalizing pharmaceutical production in the country, which has diminished in recent decades.

The incentives, which will be formalized by decree, would encourage manufacturing and testing of both generic and patent-protected products, by foreign and local firms alike.

Companies that invest in plants, laboratories or clinical research in Mexico will see their products favored in government mass purchases for the public health system, the officials said.

Statement (Spanish)

Tensions erupt at Honduras agency

Political tensions have roiled relations at Honduras’s Health Regulation Agency (ASRA), pitting some agency employees against its director, Dorian Salinas, and culminating in the temporary takeover of its headquarters by employees on 20 May.

Over the past month employees have lodged a series of complaints, alleging that salaries have not been adjusted since 2021, and that employees loyal to the country’s current president and ruling party have been wrongly fired, according to media reports. They have also accused Salinas of meeting foreign officials outside of official channels, and of allowing alcoholic beverages at agency events in violation of Honduran law.

In audio leaked to media, Salinas could be heard complaining about one government official and accusing the ruling party of placing no-show employees in her agency. Salinas responded with an apologetic video in which she claimed her remarks had been taken out of context and professed “profound respect” for Honduran president Xiomara Castro and her administration. Salinas, who has a doctorate in food science, has led ARSA since 2022, initiating several key reforms and international outreach efforts.

El Salvador seeks to set pharmaceuticals policy

A legislative committee in El Salvador has requested legal changes that would allow the country’s Superintendency of Health Regulation (SRS) to “issue and reform the national pharmaceutical policy,” according to a report in El Mundo.

SRS was formally established in August 2024, when the country’s National Directorate of Medicines (DNM) was dissolved and merged with its food agency into a single entity. The legislature approved its 2025 budget at $23 million.

El Mundo (Spanish)

Latin America Roundup: Argentina authorities recall fentanyl lots after dozens die

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