Mexico’s health regulator has authorized the release of 653,000 boxes of medication for mental health disorders, which authorities have held back ever since an inspection In November at the labs where they were made detected multiple 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. The doses are only authorized for sale on the domestic market, Cofepris said.
The medications were all produced by Psicofarma, Mexico’s largest supplier of psychiatric drugs.
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 were suspended and millions of boxes of medication were seized for technical analysis, to ensure they were safe for human consumption.
This is the fourth batch of government-seized medications to be released. Nearly 1.5 million boxes of clonazepam, methylphenidate, lithium and methylphenidate were released on May 12, followed by more than 7 million boxes of clonazepam and methylphenidate, before a further shipment of more than a million amitriptyline, clozapine, alprazolam, zolpidem and diazepam.
In total, nearly 10.5 million boxes of seized medication have now been authorized for the national market. Cofepris said in its statement that Psicofarma assumes responsibility for any marketing of the medicines in question..
The Psicofarma debacle has only compounded existing issues in Mexico’s pharmaceutical supply. Between the first two months of 2022 and the same period of 2023, production of nervous system medicines dropped 17%. Cancer drugs production dropped 12.3%, and rheumatology drugs 21.5%.
Experts say the shortages are due partly to delays in Cofepris’ licensing and approval of imported precursors and finished products.
“If there are delays at every stage… it will push back the ability to have a product both in the public and the private sector, and this has affected all laboratories,” Enrique Martínez, general director of the pharmaceutical consulting firm INEFAM, told the newspaper El Financiero.
Drugs that are in particularly short supply in Mexico include ADHD medication Tradea; antidepressants Adepsique and Anapsique; anxiety medication Kriadex; opioid Methadone; and schizophrenia drugs Clopsine and Clozapine, among others.
The shortages have caused severe issues for patients, many of whom have found themselves unable to access essential medications. To make matters worse, the crisis has coincided with a doubling in demand for psychiatric drugs, as the effects of the COVID-19 pandemic aggravated many mental health conditions such as depression and anxiety.
Many patients reported consequences such as manic episodes, nausea or suicidal thoughts from being forced to stop their regular medication, which has driven some to look for relief on the black market.
“They are putting our lives at risk; they don’t take us seriously,” one woman with bipolar disorder, who gave her name as Melisa, told El País.
Cofepris insists that it is working to resolve the crisis, including by supporting Psicofarma in complying with regulations and by authorizing new permits to import precursors for psychiatric drugs.
“Cofepris is … building a regulatory path to promote advances in access to psychiatric care medications, [by] providing transparent support to the company [so it can] present the required documentation and tests, [and by] addressing the high-priority keys to supply to the public and private sectors.” the regulator said in a statement.