Click here to Download - মেয়াদ উত্তীর্ণ ঔষধ ও মেডিকেল ডিভাইসের বিষয়ে গণ শুনানী
a2i প্রকল্পের আওতায় ঔষধ প্রশাসন অধিদপ্তর কর্তৃক প্রণীত web portal এবং mobile apps “Drug Admin” এর মাধ্যমে ঔষধের সঠিকতা যাচাই করুন।Written by Super User
a2i প্রকল্পের আওতায় ঔষধ প্রশাসন অধিদপ্তর কর্তৃক প্রণীত web portal এবং mobile app “Drug Admin” এর মাধ্যমে ঔষধের সঠিকতা যাচাই করুন।
Detailed : download Please click : "Drug Admin"
WHO-এর Medical Product Alert-এর প্রেক্ষতে Zhejiang Huahai, China-এর উৎপাদিত Valsartan নামীয় ঔষধ তৈরীর কাঁচামাল দ্বারা উৎপাদিত ঔষধ জনস্বাস্থ্যর নিরাপত্তার স্বার্থে সরবরাহকৃত ফার্মেসী/প্রতিষ্ঠান হতে প্রত্যাহারের নির্দেশ দেওয়া হয়েছে।Written by Super User
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.