Latin America Roundup: Four more Argentinian drugmakers are shuttered

Editor’s note: Latin America Roundup will be put on hiatus following the publication of this edition.

In the aftermath of a scandal in which nearly 100 patients died after receiving bacterially-contaminated fentanyl in hospitals, Argentina’s National Administration of Drugs, Food and Medical Devices (ANMAT) has suspended four more drugmakers over plant inspections that revealed violations.

Last May, ANMAT closed operations at the Buenos-Aires based drugmaker HLB Pharma, after its tainted fentanyl products were found to have killed patients at hospitals across Argentina. HLB’s owners and senior managers were arrested, and a shakeup ensued at ANMAT, which was widely blamed for not having not taken faster action against HLB, a company with a long history of violations.

Gastón Morán became director of ANMAT’s medicines division on 21 August, following the ouster of his predecessor. Morán immediately launched follow-up investigations on manufacturers with unresolved findings from prior ANMAT inspections, according to media reports.

On 28 August the agency ordered a shutdown of Laboratorios Rivero, a maker of intravenous solutions, for irregularities seen in finished products that suggested poor manufacturing practices.

On 5 September, ANMAT halted operations at Sant Gall Friburg, a maker of antibiotic and analgesic drugs, over quality concerns. The action came after an unannounced plant inspection that revealed structural changes that had not been declared to the agency.

On 12 September, the agency ordered production stopped at Aspen, a maker of a wide variety of drugs across specialties that include hematology and oncology. ANMAT also issued a recall notice for lots of one chemotherapy product made by that company.

And on 15 September ANMAT said that it had shut down operations at Filaxis, another maker of chemotherapy drugs, for “critical and major deficiencies” in manufacturing conditions. It also recalled lots of two products made at one Filaxis plant.

Some of the sanctioned drugmakers have long histories as generics producers in Argentina. Sant Gall Friburg was established in 1972, while Laboratorios Rivero was founded in 1932.

ANMAT demands antidiabetic drugs meet bioequivalence standards

Pharmaceutical manufacturers must present evidence of bioavailability and bioequivalence for medications classed as oral hypoglycemic agents, ANMAT announced on 8 September. All studies comparing these generic antidiabetic drugs to their reference products must be completed and submitted within 6 months, the agency said.

Any manufacturer that fails to present bioavailability and bioequivalence evidence for their products will see them suspended from the market “without prior notice,” ANMAT said. There are about 20 oral hypoglycemic agents in use worldwide, and nearly all of them are available in Argentina.

ANMAT’s demands come amid a wave of agency actions aimed at improving manufacturing, traceability, and safety standards for generic medications, according to a 4 September report in the media outlet Infobae.

The agency also revealed that it was implementing new measures for tracing the production and distribution of medicines classed as narcotics and psychotropics, and that it was updating a list of them that had remained unchanged since 2016. These and other recent measures, according to Infobae, reflect a reform process currently underway at ANMAT that was spurred by this year’s fentanyl disaster.

The reform, described in broad terms in July by the country’s health minister but never formally announced, will have ANMAT concentrating its efforts on medicines, food, and medical devices, Infobae reported, “while areas such as the cosmetics industry will move to a more decentralized regulatory framework.” The purpose of the reform, according to the outlet, “is to restore efficiency and public trust in ANMAT.”

Statement (Spanish)

COFEPRIS to work closely with Mexico’s science agency

Mexico’s Federal Commission for the Protection Against health Risks (COFEPRIS) has teamed up with the country’s science and technology agency on a series of initiatives aimed at strengthening Mexico’s pharmaceutical sector and regulatory capacity.

The agreement between COFEPRIS and the Ministry of Science, Humanities, Technology, and Innovation (SECIHTI), announced in a joint statement 11 September, is aimed at supporting interagency collaboration on the development of medicines and devices by Mexican universities and public health research centers. It also seeks to ease their path to commercialization.

Further goals of the agreement include the creation of shared databases, university training to help feed the pipeline of regulators, joint research projects and “public dissemination of research findings applicable to health regulation and production,” the agencies said.

The effort is meant not only to boost Mexico’s medicines and devices sectors but to improve COFEPRIS’s standing among global regulatory agencies. COFEPRIS says it seeks to become a WHO-listed regulatory authority, the highest designation awarded by the World Health Organization.

On 9 September, COFEPRIS also announced that 91 new compliance experts had graduated from its joint program with Mexico City’s School of Public Administration (EAP).

The idea behind the program is to create a uniform body of knowledge for professionals reviewing health services across different states. The hope is to create more uniform review practices throughout Mexico.

Graduates were trained in topics such as law, surgery centers, supplies, and pharmacovigilance, and will continue their training at 15 hospital centers across the country. This is the program’s third graduating class, the agency said.

Statement (Spanish)

Chile adopts WHODrug standards

Chile’s Public Health Institute announced on 15 September that it had adopted WHODrug Global, a dictionary of pharmaceutical products that lists trade names, forms, and active ingredients that is used by regulatory agencies worldwide in pharmacovigilance activities. Standardized terms are considered key in assuring effective identification and dissemination of adverse events associated with drugs, vaccines, and other medical products.

Regulatory agencies must license use of the dictionary from the World Health Organization’s Uppsala Monitoring Center in Sweden. Representatives of the UMC visited Chile on 10 and 11 September to sign the agreement, ISP said in a statement.

Statement (Spanish)

Latin America Roundup: Four more Argentinian drugmakers are shuttered

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