The Case for Improving the Quality of Prescription Pharmaceuticals

The incentives to improve the quality of generic drugs are compelling. Generic drugs are as efficient and safe as their branded counterparts, but much less expensive to produce. However, with their reduced production costs come significant challenges with ensuring the safety and efficacy of these drugs.

In the United States, the safety and efficacy of all drugs sold—whether generic or not—is ensured by the Food and Drug Administration (FDA). The FDA’s safety and efficacy standards are maintained through a strong quality management system that is continuously updated and works in close coordination with manufacturers.

However, globally, approximately 80% of active pharmaceutical ingredients and 40% of drug products sold every year are manufactured outside of the United States, primarily in India and China. Manufacturing pharmaceuticals in these countries allows them to be produced at the lowest possible cost. For example, drug manufacturing costs in India are 65% lower than in the United States and 50% lower than in Europe.

Both in the United States and abroad, generic drugs are critical to ensuring that quality medications are available at lower costs. Nevertheless, the incidence of ineffective or unsafe products coming from these new manufacturing hubs is a problem. Some of the reasons for these problems include failure to investigate batch failures, discarding of raw laboratory data, lack of data audit trails, and no investigation of quality related complaints.

As a result, manufacturers are making a variety of quality improvements, including better auditing procedures, staff training, and process and production controls.

Incentivizing these quality improvements is the fact that the FDA is working to standardize the quality of pharmaceutical ingredients and drugs produced across the globe, in an effort to increase the safety of drugs sold in the United States.  As a result of the Safety and Innovation Act of July 2012, the FDA has increased both the domestic and overseas inspections of firms and facilities involved in the manufacture of generic drugs. For manufacturers to compete on the global market, they must work to meet the quality standards set in the United States and Europe.

India is a key contributor to the global generic drug industry. The country is host to more than 120 FDA-approved manufacturing facilities. As a result, the FDA has expanded its regular system of biennial inspections to India, already the norm in the United States.

Policy makers, organizations that provide standardization and training, auditors, civil society, and the drug industry as a whole stand to benefit from quality improvement efforts. The white paper “Improving the Quality of Generic Drugs” lays out a compelling argument for improving quality in the generic pharmaceuticals industry, and offers best practices and guidelines for how to achieve this.

March 20, 2015
Regions/ Countries