A Strong Regulator Can Help Mexico Become a Pharmaceutical Hub

Q: What changes has Emcure Pharmaceuticals made to strengthen its position in the Mexican and Central American markets in the past few years?

A: We made significant changes starting in the second half of last year, when we began receiving more marketing authorizations in Mexico, which led to substantial business growth. As a result, we underwent an internal restructuring and plan to increase our participation in the Mexican market. 

We aim to center our strategy on the evolving dynamics of the Mexican healthcare market. Emcure continues to view Mexico as a key market. 

Q: Which therapeutic areas is Emcure prioritizing in Mexico?

A: We are prioritizing the central nervous system and expect to obtain more product registrations. This field shows strong potential. We are also active in areas such as oncology, but the central nervous system represents a new and strategic direction for us.

Q: What are the main challenges in improving access to medicines in Mexico?

A: There are two key issues affecting access to medicines in Mexico. First, the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) has been slow in processing new products, but its new leadership appears to have a more positive and collaborative attitude. We sense a genuine intention to respond more quickly, and it is working more closely with the industry. This is crucial for bringing new treatments to market. Cooperation between COFEPRIS and the industry must increase and the agency must adhere to its legally mandated timelines and operate more efficiently.

The second issue involves the public procurement process for healthcare products, which continues to undergo frequent changes. This creates uncertainty for the industry. We need to work more closely with the government to ensure that patients have access to the treatments they need.

Q: How are recent changes in the regulatory environment expected to affect the healthcare industry in Mexico and abroad?

A: Mexico’s new administration revoked special import permits for products that lacked a local registration. This move, driven by Minister of Health David Kershenobich, was a positive development. However, it is necessary to accelerate the registration process for products that already meet regulatory requirements. 

COFEPRIS is also making efforts to gain mutual recognition of its approvals in other countries, a process that is advancing well in Central and South America as COFEPRIS registrations are highly respected in the region. As a Level IV regulatory agency, COFEPRIS issues comprehensive authorizations that serve not only Mexico but many other countries. This is yet another reason why addressing the backlog is so important. What happens in Mexico has a direct impact on other markets and contributes to Mexico’s leadership in the region.

Q: How would you assess the capabilities of Mexican pharmaceutical talent?

A: Mexico has universities that are producing highly qualified professionals through strong academic programs. Researchers are conducting excellent work. The industry and various associations are also making efforts to nurture talent, as the industry benefits from a strong talent pipeline.

Q: What products will Emcure Pharmaceuticals launch this year, and what challenges are you facing?

A: We aim to launch no fewer than 10 products this year, and we are on track to achieve that goal. We are focusing on specific therapeutic areas, particularly oncology and bone marrow-related treatments, sectors where we aim to become strong players. However, we need greater certainty around procurement processes and payment schedules, which requires continued engagement with the government. Without timely payment and reliable feedback, it becomes difficult for the government to secure the prices it seeks or to obtain the industry response it hopes for through its tenders. Ultimately, it is the patients who benefit from these efforts. If there is no return on investment, companies cannot continue to invest sustainably.

Q: What are Emcure Pharmaceutical’s short-term plans for the region?

A: A sound strategic business plan and clear communication of goals and objectives always yield positive results. Emcure Pharmaceuticals has a strong offer for the Mexican market and aims to keep investing in the country. Plan México, which encourages companies to continue investing in the country, has opened doors for us to do just that. It allows us to keep investing in the market and continue bringing innovative products to patients.

Emcure Pharmaceuticals is an international Indian company engaged in developing, manufacturing, and marketing a broad range of pharmaceutical products.