The topic of generic drugs in Mexico generates a lot of debate. It is appreciated to mention 25% discounts in the pharmacy chain Farmacias Similares on Mondays, and immediately present comments about «weak drugs» and «dubious quality». This stereotype is persistent. You, of course, have the opportunity to not trust Mexican medicine and Mexican medicines, but if you already live here, you need to know the following.
Years ago, criticism of Mexican medicines actually had merit. At least until 2010. But then the health care law was reformed.
Before the legal reform, all drugs produced and sold in Mexico were divided into 3 categories:
- de patente — original (patented) drug,
- generic intercambiable — a generic that has proven complete interchangeability with the original,
- similares — a drug with the same active ingredient, but without confirmed bioequivalence.
(Bioequivalence is proof that the generic drug is absorbed into the body and acts in the same way as the original drug, providing a comparable concentration of the active substance in the blood.)
It was the third category that caused the most mistrust. Many drugs sold in pharmacies in the «similares» format did not undergo strict bioequivalence tests, which became the reason for criticism.
The situation changed with the reform of Mexico's General Health Law (Ley General de Salud) in 2004. The law established that, starting in 2010, all drugs sold in Mexico are required to undergo bioequivalence testing. The third category of drugs was abolished. This was a turning point for the pharmaceutical market.
Since then, generics offered in pharmacies in Mexico must meet the same standards of quality, dosage and effectiveness as the original drugs. In particular, to comply with the new law, the pharmacy chain Farmacias Similares tested all of its drugs, and the cost of each test ranged from 50,000 to 90,000 US dollars. The company has its own pharmaceutical facilities and produces significant volumes of drugs under its own trade names, occupying more than 70% of the generic drug market in Mexico, for this reason there could be more claims against it than others.
Registration and control of medicinal products is carried out by the Federal Commission for Protection against Sanitary Risks (COFEPRIS). It is this government body that ensures that drugs on sale comply with legal requirements.
According to the regulator, it does not matter whether the drug was purchased from Farmacias Similares, Farmacias del Ahorro or Walmart. If we are talking about a registered generic, it has passed mandatory tests. Differences may relate to appearance — color of tablet, shape or packaging, — but not composition and effectiveness.
Additionally, the Prosecutor's Office for Consumer Protection (PROFECO) is responsible for the protection of consumer rights, which in addition participates in market control and regularly publishes reports on the pharmaceutical market.
Skepticism about Mexican generics has a lot to do with past experience and a general distrust of «cheap» goods. The price of generics can be significantly lower than the originals, which is psychologically perceived as a sign of worse quality. At the same time, the reduction in cost is not due to savings on the active substance, but to the absence of development costs and, above all, marketing, which have already been incurred by the manufacturer of the original drug.
Today, generics in Mexico undergo mandatory testing for bioequivalence and are registered by the state regulator. Of course, this does not mean that the market is perfect. But the claim that generics are «weaker» or «poor quality», has no solid foundation. Question of trust — This is largely a matter of budget and general attitude towards cheap goods.
We talked about pharmacies in Mexico in thispublications.