আজ ০৭ এপ্রিল,২০১৮ বিশ্ব স্বাস্থ্য দিবস।
ঔষধ প্রশাসন অধিদপ্তরের পক্ষ হতে সকলের সুস্বাস্থ্য কামনা করছি। 
সকলের জন্য মানসম্পন্ন, নিরাপদ ও কর্যকর ঔষধ সহজলভ্য করা ঔষধ প্রশাসন অধিদপ্তরের অঙ্গীকার।
 
শুভেচ্ছান্তে
মেজর জেনারেল মো: মোস্তাফিজুর রহমান
মহাপরিচালক
ঔষধ প্রশাসন অধিদপ্তর।

DGDA’s Vision

The DGDA will strive to ensure quality and safe medicines for all.

DGDA’s Mission

  • Safeguard the health of humans and animals by ensuring that medicines and medical devices meet applicable standards of safety, quality, and efficacy
  • Ensure the safety and security of the supply chain for medicines and medical devices
  • Ensure accessibility, including availability and affordability, and rational use of essential medicines
  • Foster a regulatory environment that supports research and innovation, thereby ensuring moving toward global standards for quality production

News:

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 (http://pharmadexbd.org/) 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

What is Pharmadex

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

Mohakhali, Dhaka-1212.

www.dgda.gov.bd

“Notice”

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

Director General

Directorate General of Drug Administration

&

Licensing Authority (Drugs)

Phone: 9880803

E-mail:This email address is being protected from spambots. You need JavaScript enabled to view it.

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

 

Details

 

The Directorate General of Drug Administration under the Ministry of Health & Family Welfare.

The Directorate General of Drug Administration under the Ministry of Health & Family Welfare.

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