Pharmaceutical regulatory requirements of nonregulated markets

An underdeveloped country is characterized by its chronic and widespread prevalence of poverty and poor economy when compared with the developed nations. Every year around 10 million people in underdeveloped countries die because of communicable diseases that could be prevented and managed in an economically efficient manner. Thus access to medicines is largely regarded as the priority focus for underdeveloped countries and this consequently impacted the regulation of the pharmaceutical market in the underdeveloped countries. The regulations in underdeveloped countries are still evolving to become competent to demonstrate the safety, quality, and efficacy of healthcare products compared to the regulated markets. Consequently, the underdeveloped countries suffer from the ill-fate of using low-quality pharmaceuticals as they are mostly nonregulated. Nonetheless, it is apparent that nonregulated markets require significant attention from the government, nongovernment, social, and other sectors to improvize and enforce measures to address the critical need for regularization of nonregulated markets. In this context, the following contents review the conventional regulations which are currently applied and practiced in the nonregulated markets, the legal barriers to regularize pharmaceuticals, the challenges associated with varying country-specific requirements of export and import of pharmaceuticals, and the unprecedented roles and responsibilities of healthcare, food and drug administration, and other entities. Together this chapter provides an overview of the current regulations and the regularization needs in the nonregulated market.