With an increasing number of people needing access to medicines in low- and middle-income countries, the importance of regulation and ensuring reliable surveillance systems are crucial to guaranteeing all medicines and commodities provided to patients are safe, effective and meet approved quality standards. However, few low- and middle- income countries benefit from having adequate pharmaceutical regulatory functions including licensing of premises, inspection of manufacturers and distributors, and monitoring the quality of drugs.
To address gaps and develop strategies for building regulatory capacity and improving the system in Bangladesh, the Directorate General of Drug Administration (DGDA) with support from the SIAPS Program conducted a comprehensive assessment of the national medicines regulatory system which was funded by USAID and the US Food and Drug Administration (FDA).
The assessment, conducted from June–November 2012, showed that parts of the laws and regulations are currently outdated or are not in convergence with pharmaceutical legislations from other countries. The DGDA is also severely understaffed to fulfill its mandate and support the local industry, given the rapidly growing pharmaceutical market, large number of registered products, and large population size.
It also revealed that an absence of an electronic system to maintain an updated register. Such drawbacks have led to an ineffective supervisory system in which substandard or lack of medicines and commodities have become a part of the health system.
During a three-day workshop in November 2012 held in Dhaka where the results and findings of the assessment were discussed and circulated, the DGDA designed and prioritized two separate action plans.
“We need to introduce an automated drug registration system as early as possible to reduce the lead time in drug registration process and we also need to take initiative to attain a harmonized global standard in drug regulation,” Mr. Ruhul Amin, Deputy Director of the DGDA said. “We believe that SIAPS should play an instrumental role in our country’s drug registration system advancement.”
The workshop, held in collaboration with SIAPS’ partner, the University of Washington’s Global Medicines Program, was attended by Mr. Md. Humayun Kabir, Bangladesh’s Senior Secretary of Ministry of Health and Family Welfare and the Major General Md. Jahangir Hossain Mollik, Director General of the Directorate General of Drug Administration (DGDA) along with several staff from the DGDA.
The concept of pharmacovigilance is “relatively new in our country and we should revitalize the current Adverse Drug Reaction Monitoring Cell and also explore stakeholders’ support in explaining to physicians their role in minimizing adverse drug reaction,” added Mr. Salim Barami, DGDA Director.
With support from SIAPS, the DGDA has reintroduce and restructured the National Adverse Drug Reaction Monitoring (ADRM) cell ensuring the public’s health, safety and access to quality medicines and commodities are safeguarded. SIAPS is also currently assisting the DGDA in updating and enhancing their website for better public access to vital information from the administration.