Bangladesh

Bangladesh is located in South Asia, bordering the Bay of Bengal to the south and Burma to the southeast. The rest of the country shares a border with India. Bangladesh came into existence in 1971 when Bengali East Pakistan seceded from West Pakistan; approximately 98% of the people remain Bengali.

About a third of the population of Bangladesh—approximately 1.47 million people—falls below the poverty line. Economic development is hampered by a number of factors, not the least of which is that much of the country floods during the monsoon season. Because nearly two-thirds of Bangladeshis are employed in the agricultural sector, the frequent floods pose a major impediment to economic stability and seriously limit access to healthcare.

These factors combined create a continual battle against disease putting young children especially at risk. Diarrheal diseases, for example, cause the death of an estimated three million children a year in developing countries and contribute substantially to malnutrition in surviving children. Diarrheal episodes of longer duration have the greatest effect on these outcomes. Treatment of acute diarrhea with oral rehydration solution (ORS) has become widespread, resulting in reduced mortality from dehydrating diarrheas, but has shown no decrease in the duration of episodes or their consequences.

Zinc supplementation—taking oral zinc sulfate medicine in addition to the standard ORS regimen—was included in the official World Health Organization (WHO)/UNICEF recommended treatment guidelines in 2004 after having been shown to reduce the duration and severity of childhood diarrhea in clinical trials. In 2005, at the request of USAID/Bangladesh Mission and in collaboration with WHO and UNICEF, USP DQI began providing technical assistance to assure the quality of zinc drugs in Bangladesh.

USP DQI staff visited three major pharmaceutical companies in Bangladesh to assess their Good Manufacturing Practices (GMP) status. The assessments were performed to determine whether the sites would be able to produce zinc sulfate according to pharmaceutical monograph standards for use in the region. Two sites should be accredited once construction to upgrade their facilities has been completed; the third site should have no major problems reaching WHO GMP status with further USP DQI technical assistance.