ঔষধ প্রশাসন অধিদফতর কর্তৃক প্রণীত Guidelines on the Evaluation of Biosimilar Products এর খসড়া চূড়ান্ত করা হয়েছে। উক্ত খসড়াটির নিম্নের লিংক-এ আপলোড করা হয়েছে। এই খসড়ার উপর আপনার সুচিন্তিত মতামত ই-মেইল-এ পাঠানোর জন্য অনুরোধ করা হইল।
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
Government of the People's Republic of Bangladesh
Directorate General of Drug Administration
Memo No-DGDA/29-2/09/9570 Date: 14/06/2016
(A) Failure to ensure WHO Current Good Manufacturing Practice (cGMP) and section 15(2) of The DRUG (Control) ORDINANCE, 1982, Drug Manufacturing License of the following 11 pharmaceutical industries has been cancelled.
|SL No||Name of the Company||Address||License No.|
|1||M/S Today Pharma Ltd.||BSCIC I/A, Comilla.||Biological-297 and Non-biological-25|
|2||M/S National Drug Company Ltd.||Dhamrai, Dhaka.||Biological-230 and Non-biological-63|
|3||M/S Sunipun Pharmaceuticals & Chemicals Ltd.||Savar, Dhaka.||Biological-254 and Non-biological-433|
|4||M/S Universal Pharmaceutical Ltd.||Dilalpur, Pabna.||Biological-055 and Non-biological-192|
|5||M/S North Bengal Pharmaceutical Ltd.||Charmuktar, Naogaon.||Biological-172 and Non-biological-415|
|6||M/S Drug Land Ltd.||Siddirgonj, Narayongonj.||Biological-169 and Non-biological-413|
|7||M/S Dolphin Pharmaceutical Ltd.||North Jatrabari, Dhaka.||Biological-173 and Non-biological-95|
|8||M/S Jalpha Laboratories Ltd.||BSCIC I/A, Sylet.||Biological-200 and Non-biological-202|
|9||M/S Rid Pharmaceutical Ltd.||BSCIC I/A, B.Baria||Biological-257 and Non-biological-476|
|10||M/S Remo Camicals Ltd. (Pharma Vision)||Tajgaon, Dhaka||Biological-246 (All Medicine Including) and Medicine included in Non-biological|
|11||M/S Kafma Pharmaceutical Ltd.||BSCIC I/A, Noakhali.||Biological-229 and Non-biological-191|
(B) In the Supreme Court of Bangladesh High Court Division’s writ petition No-6969 of 2016, The Honorable High Court is directed to ensure stop production of all lifesaving drugs and medicine such as antibiotic, steroid, hormone, anticancer drugs etc. of the following 09 (Nine) pharmaceutical industries and Following the direction of the Honorable High Court the production of all products has been stopped.
|1||M/S Globe Laboratories (Pvt.) Ltd.||Tongibari, Munshigonj.|
|2||M/S Medico Pharmaceutical Ltd.||
R.K. Road, Darshana, Rangpur
|3||M/S Aexim Pharmaceutical Ltd.||BSCIC I/A,Mymenshing|
|4||M/S Avert Pharma Ltd.||Savar, Dhaka.|
|5||M/S Bikolpo Pharmaceutical Ltd.||Mirpur. Dhaka.|
|6||M/S Spark Pharmaceutical Ltd.||Charpara, Mymenshing.|
|7||M/S Star Pharmaceutical Ltd.||BSCIC I/A, Barisal.|
|8||M/S Tropical Pharmaceutical Ltd.||Shamoly, Dhaka.|
|9||M/S Skylab Pharmaceutical Ltd.||BSCIC I/A, Comilla|
(C) In the Supreme Court of Bangladesh High Court Division’s writ petition No-6969 of 2016, The Honorable High Court is directed to stop production of antibiotics (Non-penicillin, Penicillin & Cephalosporin group) of the following 14 pharmaceutical industries.
Henceforth, following the direction of the Honorable High Court, the production of all antibiotics (Non-penicillin, Penicillin & Cephalosporin group) of 14 (fourteen) pharmaceutical industries have been stopped.
|SL No||Name of the Company||Address|
|1||M/S PharmiK Laboratories Ltd.||Khulshi, Chittagonj|
|2||M/S Bristol Pharma Ltd.||Konabari, Gazipur.|
|3||M/S Bengal Drugs & Chemicals Works||BSCIC I/A, Comilla.|
|4||M/S Belsen Pharmaceutical Ltd.||Kalampur, Faridpur.|
|5||M/S Indo-bangla Pharmaceutical Ltd.||College Road, Barisal|
|6||M/S Orbit Pharmaceutical Ltd.||Kornofully, Chittagonj.|
|7||M/S Millat Pharmaceutical Ltd.||Postugala, Dhaka.|
|8||M/S Crystal Pharmaceutical Ltd.||South Chartha, Comilla.|
|9||M/S MST Pharma & Healthcare Ltd.||Gazipur Sador, Gazipur.|
|10||M/S Rasa Pharmaceutical Ltd.||Soyadhangara, Sirajgonj|
|11||M/S Save Pharma Ltd.||Cathlic Mission, School Road, Mymensing.|
|12||M/S Ad-din Pharmaceutical Ltd.||BSCIC I/A, Jessore.|
|13||M/S Alkad Laboratories Ltd.||Alamnagor, Rangpur.|
|14||M/S Phoneix Chemical Laboratories (pvt.) Ltd.||Vagdi, Norsingdi.|
Therefore, it is suggested to all to stop purchase of all medicine of above pharmaceutical Industries mentioned in (A) & (B) and stop purchase of all antibiotics of pharmaceutical mentioned in (C).
Major General Md. Mostafizur Rahman
Directorate General of Drug Administration
Licensing Authority (Drugs)
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 conducted a training for DGDA Content Management Team (CMT) on Web Portal Management for two days
DG, Narcotic Control Department has been included as a member in the Drug Control Committee