The Importance of Generic Medicines in Mexico

India’s pharmaceutical industry has achieved remarkable success in developing its drug manufacturing capabilities. For instance, 4 of the 10 largest generic drug producers worldwide are based in India. The country is not only self-sufficient but has also become the world’s pharmaceutical manufacturing hub, supplying nearly 19% of the global drug volume. 
India is now designing strategies to benefit from nearshoring, and the United States is beginning to view it as a viable alternative to Chinese pharmaceuticals. Prime Minister Modi has emphasized the substantial investments being made to further enhance India’s pharmaceutical production capacity.

In Mexico, 8 out of every 10 medicines are generics. Notable Indian companies operating in Mexico include Micro Pharmaceuticals México, S. de R.L. de C.V., a leader in ophthalmological products, and Accord Farma.

According to the National Council for the Evaluation of Social Development Policy (CONEVAL), a decentralized public agency, 50.4 million people in Mexico currently lack access to healthcare services, a figure that has doubled since 2018. Out-of-pocket healthcare expenses have also increased, driven by shortages of medicines in the public health sector. For many Mexicans with chronic degenerative conditions, the affordability of generic medicines offers critical relief. 

However, researchers at UNAM have recently pointed out that there is a lack of public policies and protocols to ensure the safety, efficacy, and affordability of generics for low-income families. There is a pressing need for comprehensive policies to build a market of innovative and generic medicines that are safe, effective, and accessible, according to Pilar Hernández, professor at the Institute of Legal Research. “Only 5% of clinical trials or studies to test drugs are conducted in Latin America,” says Hernández. A great deal of work remains to be done in fostering innovation in the region.

On the regulatory front, NOM-177 establishes the tests and procedures required to demonstrate whether a drug is interchangeable. Mexican law allows authorized third parties, companies independent of laboratories, to conduct bioequivalence and biocomparability tests for generics. These tests must be validated and audited by COFEPRIS, which currently lacks sufficient personnel and equipment to carry out the necessary studies. Until September 2023, NOM-177 required that reliability tests be conducted within Mexico to confirm their effectiveness for the Mexican population. However, the regulation has since been amended to accept tests conducted in the country of origin.

The latest National Health and Nutrition Survey found that, of every 100 patients seeking medical consultation, more than 40% were treated at pharmacy-affiliated clinics, where generic medicines are predominantly dispensed. According to ANAFARMEX A.C., more than 10 million consultations are held in these clinics each month.

Zoé Robledo, director general of the Mexican Social Security Institute (IMSS), highlighted the significant progress made in addressing the long-standing issue of medicine supply, including generics. "As a key indicator," he noted, "more than 95% of prescriptions — now over 500,000 daily — are being filled at the Institute." He added that IMSS-Bienestar is on track to match the standard of the regular IMSS, which will help resolve these ongoing issues.

Alejandro Svarch, head of the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), has emphasized that the government must support an industrial pharmaceutical policy that guarantees the production of safe, effective, high-quality, and accessible medicines for all.

In Mexico, the most frequently prescribed active pharmaceutical ingredients include:
- Ibuprofen
- Amoxicillin with Clavulanic Acid
- Paracetamol
- Ceftriaxone
- Azithromycin
- Clonazepam

General practitioners, who represent over 49% of healthcare professionals, are the main prescribers of these generics.

To conclude, I would like to outline the regional demand for generic medicines in Mexico. The largest market is in Mexico City and its surrounding areas (State of Mexico, Puebla, Hidalgo, Tlaxcala, and Morelos), due to their high population density and close proximity to the capital. This results in the largest private market with the highest purchasing power. Jalisco ranks second, followed by Nuevo Leon, due to their geographic and economic significance.