Dominican pharmaceutical companies accelerate growth through international quality standards

Santo Domingo.- The Dominican Pharmaceutical Industry Association (INFADOMI) has experienced significant growth in recent years. This progress is largely due to the implementation of international good manufacturing practices (GMP) standards, as evidenced by the adoption of WHO Report 32. Now, the industry is taking on the challenge of adhering to the organization’s latest guidelines.

This year, in conjunction with the celebration of Pharmacist Day, the association announced its commitment to advancing the adoption of the standards outlined in WHO Report 37. With this new challenge, the local industry aims to further enhance its national and international reputation. Domestic companies within INFADOMI account for 65% of private sector medication sales in the country.

Additionally, the industry exports up to 15% of its production to markets in Central America and the Caribbean, as well as to the United States, the Netherlands, and Poland.

The previous WHO Report 32 established a foundational standard for GMP, outlining essential principles for quality control in pharmaceuticals. This report includes guidelines for infrastructure, personnel, documentation, production, and quality control. It also introduces key concepts such as qualification and validation, hygiene and sanitation, handling complaints and product recalls, and self-inspection.

INFADOMI has successfully adapted to all these factors, a process that began as an enthusiastic initiative of the organization and was later implemented and overseen by the Directorate General of Medicines, Foods, and Health Products (DIGEMAPS).

The new guidelines in WHO Report 37 represent a significant evolution from the previous report, incorporating advances in technology and emerging practices. These include the management and security of electronic documentation, validation of automated systems, enhanced cleaning procedures and quality control, data integrity, risk management, and specific guidelines for the cold chain.

These improvements ensure that manufacturing processes are robust and reproducible, thereby increasing the quality and safety of medications. The adoption of this report by Dominican pharmaceutical companies will further strengthen their competitive position both domestically, where they already hold 65% of the market, and internationally, as they seek leadership roles in markets such as Central America and the Caribbean.

The Dominican pharmaceutical industry’s commitment to quality and adherence to international standards has allowed for steady growth over the past decade. This progress is reflected in increased exports, sales, fiscal contributions and job creation.

In its ongoing effort to raise quality and safety standards for consumers, INFADOMI urges government actors like DIGEMAPS to strengthen the legal framework and public policies aimed at enhancing the sector. This includes establishing the necessary controls to ensure the quality, safety, and efficacy of imported products from countries with lower regulatory oversight, such as India and China.