:quality(85)//cloudfront-us-east-1.images.arcpublishing.com/infobae/KLL3QHZMDJHGLJPWX7JS2W3FLQ.png "Cofepris suspended Psychofarma operations due to irregularities in the production of psychiatric drugs 1")
The Federal Commission for Protection against Health Risks (cofepris) partially suspended the activities of Psicofarma SA de CV after finding irregularities in the production of psychiatric drugs.
Cofepris authorizes the importation of an innovative treatment against blood cancer
Therapy that uses CAR-T cells is considered one of the most effective for treating conditions such as leukemia and lymphoma.
During health control visits, Cofepris detected irregular handling of substances subject to sanitary control. In particular, they detected violation of the health registero, manufacture of drugs without respect for good practices, absence of raw material control books, presence of raw material to manufacture solids while your permit includes injectables, use of test batches as a finished product to be marketed and waste of packaging in garbage bags, which could lead to the sale of counterfeit products.
In addition to the partial suspension, Cofepris provided the raw material and the controlled drugs. The institution analyzes the options so that the product reaches the patients in a timely manner; however, they warned that before will be analyzed and if it does not meet the requirements, it will be discarded.
“Cofepris will subject the products of Psicofarma SA de CV to strict analysis, and if they do not comply with the established standards, the product must be destroyed in accordance with the provisions of national regulations.”
In the letter of conclusions addressed to Psicofarma SA de CV, the institution indicated that the irregularities noted in the document are not a complete list irregularities noted but which are “symptomatic serious manufacturing issues and in the company’s quality management system”.
Sheinbaum warns Santiago Taboada against alleged political persecution: “He who owes nothing, fears nothing”
In addition, the president assured that she does not know if there is a criminal procedure against the member of the PAN, while he maintains that there is persecution because of his intention to go through the headquarters of the capital.
The anomalies were discovered during visits to its factories located in the offices of the mayors of Tlalpan and Azcapotzalco, in Mexico City. According to Cofepris, The irregularities detected go against what is established in two official Mexican standards (NOM-164-SSA1-2015 and NOM-059-SSA1-2015).
Cofepris indicated that with this type of action, it puts the well-being of patients at the center and fulfills its objective of guaranteeing access to safe, effective and quality medicines.
The agency issues constant warnings about the infectiousness of certain drugs, counterfeit drugs, and misleading products.
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“We are loyal to the CJNG; We won’t say anything and no one will knock”, would have been the instruction among the defendants to try to hide the operations of this organization
Among the latest alerts issued by Cofepris, two concern misleading products that promise to effectively treat diabetes and prostate conditions. It is Bye there Prostalif.
consumption of Bye is risky because, like most similar products, may contain ingredients of natural or synthetic origin What in combination with drugs can have harmful effects.
Add to that, is marketed as a dietary supplement, a compound that is not useful in fighting disease. Even if it were, it would pose a risk since it likely contains gymnema and chromium, two ingredients that should not be used in such products.
While Prostalif It promises to eliminate symptoms associated with prostate problems such as feeling of incomplete urine emptying, constant interruption of sleep to get up to urinate (during the night), weak stream and urinary urgency, among others. However, he has a fake health record and it might even contain different ingredients than advertised.
They also do not know if they have the technical and clinical studies that guarantee the quality, safety and effectiveness of the pills, so they warn that they should not be consumed, as it may cause adverse effects on the health.
Added to this the Cofepris has issued an alert on the ineffectiveness of Octralin, a drug used in transplant patients. The institution has urged doctors not to prescribe this product since it has at least 56 reports of therapeutic ineffectiveness due to the low concentration of tacrolimus in the blood and asked people on treatment with this drug consult a specialist to replace it.