Unreviewed medicines in Mexico

It is estimated that 700,000 people die every year worldwide from consuming products from the illegal drug market, which are purchased from unauthorized sites, such as flea markets and fake Internet sites.

This is according to Fernando Fon, director of the Regulatory Affairs Commission of the Mexican Association of Pharmaceutical Research Industries (AMIIF), who states that all countries have an illegal drug market, but countries with more robust regulatory systems are the ones that can identify these products early and avoid a risk to the population.

The most affected are those nations that have weak and vulnerable regulatory systems, where counterfeit or illegal medicines arrive through smuggling and theft mechanisms, among others.

It indicates that Mexico is halfway through the regulatory system, but the capacities of the country’s health agency, Cofepris, can be strengthened, as established by the USMCA.

It highlights the importance of robust regulation, since substances that are purchased as medicines and are illegal kill or put people at risk of death.

He stressed that medicines should not be purchased in places that are not legally authorized, such as street markets, because there is a serious health risk.

These types of products lack efficacy, lack all or part of the drug (active ingredient), may be manufactured with unauthorized, contaminated or expired substances, which would generate an undesirable effect (toxic or contain other active ingredients) and even cause death; the packaging or instructions for use may contain incomplete or incorrect information, leading to improper use or abandonment of treatment.

He points out that the rational and correct use of medications requires dialogue with the doctor, and the prescription is unique and individual.

He stressed the importance of all medicines passing through Cofepris before being used in the country. But there are government buyers who do not know how they reach agreements to acquire medicines that are cheaper and no one checks them, since they are not being recognized by the competent authority, and this has caused great concern in the sector.

He stressed that this is a serious problem, since junk or unregistered medicines are entering the country because they are being bought by government officials who are not medical experts.

These junk drugs are being purchased in markets that no one knows regarding, and they even have labels that are not in Spanish, or even in English, but in Sanskrit.

The worst thing is that public sector doctors are giving these drugs because that is what is available, with all the risks that this entails, since there has been no evaluation of these drugs, nor do they have the Cofepris health registration.

Despite this, the public sector is invading the country with these junk medicines, linked to tenders and award codes that do not guarantee the quality, safety and efficacy that all medicines must have to be marketed.

The expert points out that the drugs that are most adulterated or generated are antibiotics, those used to treat hypertension, diabetes and even highly specialized drugs, which require complex processes, are already presented clandestinely, such as oncological drugs. In addition to the surveillance that must be maintained to prevent the entry into the country of drugs without Cofepris registration, the Mexican health agency must be strengthened, since it has three thousand procedures pending, and nearly 60 registrations of new drugs are pending authorization, new treatments and alternatives not available for Mexican patients, which in other countries have been available for years. “Cofepris needs more agile and expeditious processes without violating the technical and scientific rigor of evaluation.”

It is estimated that the health agency takes 900 days to issue a health registration, which should take 60 days. Larry Rubin, executive director of Amiif, says that the most innovative medicine used in Mexico is seven years old, “if your relative wants the latest medicine, the one he or she is receiving is the one that came out on the market seven years ago,” and what they want is for it to reach the hands of Mexicans as soon as possible.

This requires a more agile and efficient health agency that can evaluate and authorize a drug in less time.

She touched on the topic of research, which she sees as a great opportunity for Mexico, since it currently receives 200 million pesos when other Latin American countries, such as Honduras, Colombia and Argentina, receive much more for research development. “Mexico can receive up to 4 billion dollars for research, but regulatory efficiency is needed.”.— IRIS CEBALLOS ALVARADO