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Tuesday, March 16, 2010

[ALOCHONA] We welcome BD Govt to adopt policy of strick GMP Audits to manufacture Quality Medicines




Newly empowered Directorate General of Drug Administration (DGDA) will go for a massive expansion mainly to combat manufacturing and marketing of substandard and spurious medicines across the country.

Pharmaceutical companies have welcomed the move, as such drugs eat away business competitiveness of compliant makers.

The drug administrator will recruit around 1,000 inspectors and superintendents in phases to enforce constant vigilance against adulteration and malpractices, a senior DGDA official said.

"The DGDA will recruit around 150 officials in the first phase to fill the district-level vacancies," Dr Zakia Begum, a deputy director of the DGDA, said yesterday.

The DGDA officials, equipped and supported by testing agencies, will frequently visit pharmaceutical plants and drug markets to check quality of products, Zakia said.

The government on January 17 gave more empowerment to the drug administrator by turning it into Directorate General of Drug Administration from Directorate of Drug Administration (DDA).

The under-stuffed DDA had to inspect around 300 pharmaceutical plants, issue drug licences, register imports of raw materials, and check product quality and prices at market level.

The DGDA has recently finalised its organogram and got a government go-ahead to recruit the officials and provide them with modern facilities.

Mahmud Hassan, business development officer of Eskayef Bangladesh Ltd, said local pharmaceutical businesses will now become more competitive.

"You can't sustain with reputation in a market, which is uneven for different players. If a company can do business providing substandard materials with inadequate monitoring, the reputation of the sector must be in trouble," Hassan said.

The expansion and modernisation of DGDF will help boost the sector and make it more competitive, he added.

MA Kalam, chairman of Chemico Laboratories Ltd, said the new steps of the drug administrator will help identify and eliminate the grey pharma market of the country.

jasim@thedailystar.net


----- Forwarded Message ----
From: M. M. Chowdhury (Mithu) <cgmpservices@yahoo.com>
To: cgmpservices@yahoo.com
Sent: Fri, March 5, 2010 2:55:18 PM
Subject: Calling BD Govt to implement strick GMP rules to drug manufactures to save lives

   Dear my country men and women,
 
I urge current Govt and Pharmaceutical companies in Bangladesh to strength the Good Manufacturing Practices (GMP) in Bangladesh to save lives.  People are suffering in Bangladesh due to the ineffective and low potent drugs where majority drugs are manufactured by the Bangladeshi Pharmaceutical companies.  Most of them lack in GMP and Quality Management System (QMS).  This is a huge issue for Bangladesh to save lives if any concrete steps are not taken immediately.
 
I propose three steps program for the Current Govt in Bangladesh:
 
1) Train the Health Inspectors as per USFDA and put strict law to prevent adulterated drugs in the market.  Since we are digitalizing the whole country with  better communication and using new IT technologies,  we may be missing the basic urgency to save lives in Bangladesh without implementing strict GMP regulations in Bangladesh.  There are lots of NRB and their companies can help Bangladesh to move forward in this sector.
 
2) Provide incentives to the Bangladeshi Pharmaceutical companies to implement strict GMP and QMS to help manufacturing quality drugs.
 
3) Make people and owners accountable who make and sale adulterated drugs in the markets.
 
I hope my proposal would saves lives in Bangladesh in future if current Govt implement the above steps immediately.  We are here to help the current Govt and will answer their call.  We have lots NRB in USA and other countries who can contribute to Bangladesh in this issue and I am sure people with good heart would come forward to help the Bangladesh Govt to saves lives from using adulterate and low potent drugs in Bangladesh.
 
No Bangladeshi Pharmaceuticals Plant has been certified by USFDA due to not meeting the strict GMP regulations and laws.  Some companies are making progress but it is not enough.
 
Regards,
M M Chowdhury, Chemical Engineer
GxP, Validation, Audits & Compliance Expert.



From: M. M. Chowdhury (Mithu) <cgmpservices@yahoo.com>
To: cgmpservices@yahoo.com
Cc: z.hussain@globalstrategyexchange.com
Sent: Fri, January 15, 2010 4:21:11 PM
Subject: [BDBusiness] Pharma Contract Manufacturing Seminar in Dhaka, Bangladesh: March 21-22, 2010

 

Please register http://globalstrate gyexchange. com/ to book your seat.
 

Contract Manufacturing Seminar for the Pharmaceuticals & Biotech Companies in Dhaka, Bangladesh: March 21-22, 2010

Contract Manufacturing for Pharmaceuticals & Biotech Companies:

In an ever turbulant economy pharmaceuticals and biotech companies are being influenced by the financial and operational benefits of outsourcing further aspects of their manufacturing process. As a result of this it is important for a company to mitigate risks while maximizing profit and production. At our contract manufacturing for pharmaceuticals and biotech conference, we have Gathered many high level industry experts to provide insights and unique solutions for the most common challenges faced in this industry. Our sessions and workshop will assist your organization to be ready to capture the market of CMO. By attending this conference, you will hear industry specific case studies and example addressing:

Analyzing the CMO market: Indispensable tools for choosing a preferred CMO.
Due diligence in the emerging markets.
Execution of multiple outsourcing projects.
Maximizing Innovation: Addressing the importance of small biotech's and start-ups
influencing the ability to sustain validation and process compliance - Post CMO collaboration.
Monitoring and ensuring the quality of outsourced manufactured packaging
And much more including over 4+ hours of sheduled netwoking, insightful interactive panel discussions and a series of interactive workshops.

Venue : Dhaka Sheraton Hotel
Dhaka, Bangladesh.
Date : 21-22 March; 2010.

Guest Speaker:

Mr. M M Chowdhury, CEO of Amreteck Pharma LLC, USA (www.amreteckpharma. com) is a guest speaker at the seminar and will cover few topics regarding Quality. We encourage you to register to this seminar to gain knowledge and prospect of the Pharma contract manufacturing business in Asia.



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