The DGDA will strive to ensure quality and safe medicines for all.
- Ensure accessibility, including availability and affordability, and rational use of essential medicines
- regulatory environment that supports research and innovation, thereby ensuring moving toward global standards for quality production
On May 17, 2017, the Honorable Minister Mohammad Nasim, Member of Parliament (MP), Ministry of Health and Family Welfare (MOHFW), officially launched Pharmadex in Bangladesh at DGDA conference room, Mohakhali, Dhaka. Pharamdex () is a web-based integrated information system that facilitates the submission, review, and evaluation of medicine registration applications and dossiers on the basis of international standards and formats. Minister Mohammed Nasim appreciated the initiative taken by the Director General of Directorate General of Drug Administration (DGDA) to digitalize its regulatory systems and congratulated US Agency for International Development (USAID) and SIAPS for their support in DGDA’s systems strengthening activities.
DGDA, with SIAPS technical assistance, adapted Pharmadex to meet the context of Bangladesh to move toward a more efficient and transparent medicine registration system from the current paper-based process. SIAPS facilitated trainings for DGDA officials and selected pharmaceutical industry representatives to build their capacity to use this tool successfully. SIAPS also supported DGDA in adopting Common Technical Document (CTD) guidelines to make sure that the dossiers submitted to DGDA meet international standards.
At the event, the Director General of DGDA, Major General Mohammad Mustafizur Rahman, presented the highlights of DGDA’s regulatory activities and said that, although Pharmadex is a new concept for Bangladesh, it can help DGDA ensure that manufactured drugs are safe, effective, and of good quality.
The President of the Bangladesh Association of Pharmaceutical Industries (BAPI), Nazmul Hassan, MP, also recognized that a system like Pharmadex, aligned with CTD, is needed for the country. He stressed that pharmaceutical companies would need more training at the initial stage to submit applications online.
Miranda Beckman, Deputy Director, Office of Population, Health, Nutrition, and Education, USAID, mentioned that USAID will work shoulder to shoulder to assist DGDA strengthen its capacity on critical regulatory systems and ensure that sustainable health systems exist in Bangladesh.
Commending DGDA for taking such a momentous step, SIAPS Bangladesh Country Project Director Zahedul Islam hoped that by using Pharmadex, the DGDA would be able to perform their regulatory functions more efficiently and effectively.
A total of 150 participants attended the launching ceremony, including senior officials from the MOHFW, DGDA, and Directorate General of Health Services, representatives of BAPI, the Bangladesh Chemist and Druggist Samity, pharmaceutical manufacturers, USAID, World Health Organization (WHO), Promoting Quality of Medicines (PQM) Program, and other international and national organizations, academia, and media.
The USAID-funded Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program, implemented by Management Sciences for Health (MSH) partnered with the DGDA to improve the efficiency of the country’s medicine registration process and other drug regulatory systems
Way forward to Implement Pharmadex :Key dates
Hands on practice on submission of the applications for pharmaceuticals:
Held on 05 July 2017
Capacity building and UAT training on review and evaluation for DGDA officials:
To be held on 6 and 8 July 2017
Pilot submission of applications starts: Expected time: 15 July 2017
Joint monitoring and feedback: Continued process
There was a meeting of technical subcommittee formed by ADRAC (Adverse Drug Reaction Advisory Committee) along with the ADRM Cell & msh/SIAPS in 21st April 2015 at 10:30am . All the five members of the sub-committee, two members of msh/SIAPS and all ADRM cell members were present in the meeting. Head of the ADRM cell, MD. Golam Kibria(Director, DGDA) inaugurated the session. After inauguration, there was a short presentation from msh/SIAPS about the activities of ADRM cell. Then members assessed Eighty ADR reports. The assessed reports will be uploaded in the vigiflow as soon as possible
SIAPS has been working with the Directorate General of Drug Administration (DGDA) to strengthen its medicines registration and licensing systems. In collaboration with the US Food and Drug Administration and the University of Washington, SIAPS conducted two assessments on pharmacovigilance systems and the national medicines regulatory system in Bangladesh.
To support the process, SIAPS facilitated a two-hour presentation on June 12, 2012, at Ikebana Hall, Lakeshore Hotel. The presentation was made by Andy Stergachis, PhD, Professor of Epidemiology and Global Health/Adjunct Professor of Pharmacy and Director, Global Medicines Program, School of Public Health, University of Washington. The presentation included global and Bangladesh perspectives on pharmacovigilance and regulatory systems, with details and examples of the assessment methodologies and expected assessment outcomes. It was followed by a two day training of data collectors, which was conducted jointly by SIAPS and DGDA. The session was attended by the Senior Secretary Kabir and the Director General of DGDA, Maj. Gen. Md. Abul Kalam Azad.
The following outcomes are expected through these assessments—
- Greater awareness of the importance of strengthening regulatory systems.
- Greater understanding of the current status of pharmacovigilance and post-market surveillance system components and their relationship to regulatory systems.
- Identification of strategies for strengthening these systems.
- Establishment of a baseline of regulatory and pharmacovigilance systems performance.
- Catalyzing evidence-based action plans for the DGDA and other stakeholders.
An Adverse Drug Reaction Monitoring (ADRM) Cell has been established in the Directorate General of Drug Administration (DGDA). The committee is chaired by Mr. A. A. Salim Barami, Director, DGDA; other members include Ms. Nayer Sultana, Deputy Director, DGDA; Dr. Afsana Alamgir Khan, Bacteriologist, Drug Testing Laboratory; Mr. Akhter Hossain, Assistant Director, DGDA; and representatives from the Institute of Epidemiology and Disease Research and SIAPS. Dr. Afsana also acted as the focal person for the ADRM Cell.
The purpose of the ADRM Cell is to ensure the collection and recording of ADR reports in an online system and to analyze and review data to detect any causal relationship or a signal regarding a possible ADR. The ADRM Cell also closely monitors new medicines in the marketplace to look for any new ADRs, issue warnings, identify new indications or changes, and if necessary, advocate for the withdrawal of medicines following the issuance of recommendations by the Adverse Drug Reaction Advisory Committee (ADRAC).
The ADRM Cell assisted in the formation of the ADRAC and supports the issuance of notifications of ADRs by MOHFW. The ADRM Cell facilitates ADRAC meetings and takes necessary actions to bring ADR reports before the Committee to assess any causal relationship and to make recommendations.
With support from SIAPS, the ADRM is now fully active and successfully facilitated the first ADRAC meeting. The updated ADR reporting form was presented and approved at this meeting. This is a key achievement of the ADRM Cell. In addition, 20 public and private hospitals around the country were identified at which the ADR reporting form will be initially introduced. To ensure proper reporting, focal persons from the hospitals have been designated by the hospital directors. They will be trained by the ADRM Cell, with support from SIAPS, to ensure proper reporting and rational use of medicines.
Another achievement of the ADRM Cell is the publication of the pharmacovigilence guideline for Bangladesh. The draft guideline has been finalized and was launched in September. Finally, the ADRM Cell is working to earn membership in the Uppsala Monitoring Centre, the international drug monitoring organization set up by WHO. The ADRM Cell facilitated submission of an application from the DGDA to MOHFW to recognize the ADRM Cell as the national drug monitoring centre for Bangladesh.
The Secretary acknowledged the remarkable accomplishment of the Directorate General of Drug Administration (DGDA) as well as the support provided by SIAPS.
SIAPS initiated support to the DGDA in 2013 to revive dormant committees and cells in the Directorate. As a result, the Adverse Drug Reaction Monitoring (ADRM) Cell has become fully functional, with meetings taking place at regular intervals. When the ADRM Cell took up its responsibilities, it applied to MOHFW on July 22, 2013, requesting recognition as the National Drug Monitoring Centre (NDMC) for Bangladesh. On September 3, 2013, the Ministry issued a notification declaring the ADRM Cell as the NDMC for the country. The DGDA itself is declared as the NDMC, however within the DGDA, the ADRM Cell will play the pivotal role and carry out the appropriate activities. The ADRM Cell is led by Mr. A.A. Salim Barami,Director (current in-charge). The members are Ms.Nayer Sultana, Deputy Director, DGDA; Mr. Akter Hossain, Assistant Director, DGDA; Ms. Afsana Alamgir Khan, Bacteriologist, District Tuberculosis and Leprosy; a representative from the Institute of Epidemiology Disease Control and Research; and a representative from SIAPS. The NDMC is a necessary entity to monitor ADRs, which is an important component of PV. The DGDA is responsible for ensuring medicine safety and quality for the people of Bangladesh. To streamline and clarify the process, it is important that a team of people be designated to carry out the activities, so that they are performed properly and in a systematic manner. This will be done by the NDMC. The NDMC will also collaborate with the WHO International Drug Monitoring Centre, which will further strengthen its capacity. The overall Bangladesh health system will be improved when necessary actions are taken in response to ADR cases, thereby enhancing the provision of quality medicine to the people of the country.
As a follow-up to the launch of the National PV Program, SIAPS conducted a three-day training session (September 2-4, 2013) on PV and regulatory systems for focal persons from each of the 20 selected public and private hospitals and DGDA officials. Training sessions were facilitated by SIAPS representatives from headquarters and Bangladesh; a consultant from Washington University, Dr. Andy Stergachis; senior officials from the DGDA; a professor from Dhaka University; the Expanded Program of Immunization program manager; line director, TB; and the head, Pharmacology Department, Dhaka Medical College and Hospital.
The objectives of the training were to:
- Give an overview on PV practices and support the Operationalization of guidelines and reporting forms for the ADRM Cell, ADRAC, DGDA, and other relevant stakeholders of the PV focal persons.
- Conduct regulatory system training for DGDA staff, committee members, and reviewers on key and emerging regulatory topics, including the quality management system, Good Regulatory Practices (GRP), quality assurance (QA), and Good Manufacturing Practices (GMP)
The topics also included:
- Good PV practices.
- Operationalizing the PV guidelines and the suspected adverse events reporting forms.
- Data quality management.
- Spontaneous reporting of ADR events and other sources of safety information
The PV focal persons are aware of the PV system being established in the country and have been oriented on the ADR reporting format. They also benefited by learning from one another about ADR related activities taking place in their hospitals. The DGDA officials had the opportunity to gain a better understanding of the common technical documents and their importance and use for ensuring GMP, GRP, and QA.
In light of the recent achievements of the ADRM Cell including it being declared as the National Drug Monitoring Centre by the Ministry of Health and Family Welfares (MoHFW), DGDA was awarded an Associate membership from the WHO International Drug Monitoring Centre (WHO-UMC). Consequently, in order to attain the full benefits of WHO-UMC, DGDA with the assistance of SIAPS MSH has succeeded in taking the necessary steps to make Bangladesh become a full member of WHO-UMC.
As of January 2014, Bangladesh has paid the necessary fee that allows its access to VigiBase, a WHO global Individual Case Safety Reports (ICSRs) database, through WHO-UMC web base tool,
VigiFlow as a first step. VigiBase contains more than 8 million case reports of suspected adverse drug reactions submitted by increasing number of members. The second step to attaining a full membership will be to submit ICSRs regularly to the database to create a working relationship. Being a full member of WHO International Drug Monitoring Centre has benefits, such as:
- Access to VigiBase
- Early information about potential safety data
- Access to PV Terminologies and software
- Access to training materials, guidelines, and resources
- Access to international network
Furthermore, the ADE reporting form for Bangladesh has been mapped into the corresponding fields in VigiFlow and reports can now be entered into the account.
A half day program was conducted on to assess the Users Acceptance of the DGDA Website on 03 December, 2013 at the MSH/SIAPS Conference Room. The session was chaired by Maj. Gen. Jahangir Hossain Mollik, Director General, Directorate General of Drug Administration and facilitated by SIAPS technical staff.
The objectives were;
- On –the-Job training for the DGDA officials who will be the main user of the website
- Train the users on the usage of the new included forms and how to input data and information
- Ensure proper reports are generated by including real time data into the formats Ensure acceptance of the site by the DGDA officials
- To demonstrate that the system is fit for use in the business e.g. to ensure that the system satisfies the needs of the business as specified in the functional requirements and provides confidence in its use.
- To identify and expose defects/bug, communicate all known issues to the SIAPS team, and ensure that all issues are addressed in an appropriate manner
- To provide an in-depth knowledge in terms of quality of the system, usage and very importantly, benefits out of it.
The programme started with brief welcome remarks from Mr. Jahangir Hossain Mollik, Director General, DGDA followed by remarks from Dr. Zubayer Hussain, CPD, SIAPS. Once the programme started a brief presentation from starting of the design on the website till the end and how it was produced was shared with the DGDA staffs. The method of the testing was such, that each part/module of the website was first demonstrated and the users were given time to use it themselves and then answer to the questions in the questionnaire. The Feedback questionnaire was developed based on the modules on the website and the questions were raised in accordance of their usage.
The participants provided very concrete feedback and suggestion from the participants after demonstrating the website. Few of them are;
- Update the caption of the web site ‘Directorate General of Drug Administration’. Add ‘DGDA’ at the end
- An entry form is required so that DGDA will be able to include new offices as and when introduced.
- The home page map will be linked with the address database, so that any new office will automatically show on map.
- Dhaka office icon should show in different color. Map pop-up should show Office Name, Address & Phone#. Head office & divisional offices in different color
- The site can contain a discussion board or maybe blog? Need to discuss more to finalize. Some questions – will it be interactive? Question/answer mode? Users need to register before posting questions? Questions will be open for public viewing? Anyone will be able to answer? Or only designated personnel? One on one communication? Requesting for information will be through this channel?
- 3 member team would be formed who will be oriented to handle Content Management System of the site
Taking into considerations all these suggestions and comments an action plan with specific roles and responsibilities has been developed to move forward.