26 September 2023

MEXICO: Regulator releases suspect medicines

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Mexico’s health regulator has authorised the release of 653,000 boxes of medication for mental health disorders, after originally holding them back over concerns of irregularities in the production process.

The Federal Commission for the Protection Against Health Risks (Cofepris) said the 10.4 million doses of imipramine, lorazepam, lozam and talpramin were released partly to meet a shortage of psychiatric medication.

Cofepris said the drugs, produced by Psicofarma, Mexico’s largest supplier of psychiatric drugs, were now deemed safe for use on the domestic market.

In November 2022, a Cofepris inspection of the Psicofarma laboratories found several failures in the company’s control of psychoactive substances, including cross-contamination and unsterile packaging procedures.

As a result, activity at two Psicofarma laboratories was suspended and millions of boxes of medication were seized for technical analysis, to ensure they were safe for human consumption.

In total, nearly 10.5 million boxes of seized medication have now been authorised for use.

The Psicofarma debacle has only compounded existing issues in Mexico’s pharmaceutical supply, with production of nervous system medicines dropping by 17 per cent; cancer drugs by 12.3 per cent, and rheumatology drugs 21.5 per cent.

Experts say the shortages are due partly to delays in Cofepris’ licensing and approval of imported precursors and finished products.

Mental health disorders saw a sharp rise due to the COVID-19 pandemic, and the shortages have caused severe issues for patients, many of whom have found themselves unable to access essential medications.

Cofepris insists it is working to resolve the crisis, including by supporting Psicofarma in complying with regulations and by authorising new permits to import precursors for psychiatric drugs.

Mexico City, 30 May 2023

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