Best FDA Law Lawyers in Bangladesh

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Counsels Law Partners (CLP)
Dhaka, Bangladesh

Founded in 2016
50 people in their team
Bengali
English
Business FDA Law Employer +4 more
About Counsels Law PartnersCounsels Law Partners (CLP) is a full service international law firm with its head office in Dhaka, Bangladesh. Further, it also has branches in Chittagong and Sylhet. It is one of the best reviewed law chambers in Bangladesh. The CLP team is a blend of UK trained...

Founded in 1970
50 people in their team
Bengali
English
SALAMAZIZ is a law chambers primarily based in Dhaka. The law chambers was founded by Mr. Shah Azizur Rahman, Advocate Supreme Court of Bangladesh who had provided legal services to national and international clients since early 1970s. Today the chambers is managed by his daughter Barrister...

Founded in 2014
50 people in their team
Bengali
English
Until 2013, the total number of all kinds of companies in the whole world was about 100 million, but there was no human rights company anywhere. In spite of it is true that human rights are essential for all.People were waiting for such company. Because people would more benefit if they could get...
Rahman's Chambers
Dhaka, Bangladesh

Founded in 2006
50 people in their team
Bengali
English
About Rahman's ChambersRahman’s Chambers was founded by Mr. Mohammed Forrukh Rahman in 2006 following his family tradition that dates back to 1920s all the way to his grandfather, late Mr. Shamsuddin Ahmed.Mr. Ahmed graduated from Calcutta University in 1924, was awarded by Bangladesh Bar Council...
Shawn Novel & Associates
Dhaka, Bangladesh

Founded in 2007
10 people in their team
Bengali
English
About UsShawn Novel & Associates is a reputed law firm committed to providing excellent quality legal services to its clients. At our firm, we understand the needs of our clients and value them in the highest priority. Our expertise and experience are devoted to prompt delivery of professional...
Azad & Company
Dhaka, Bangladesh

Founded in 2009
50 people in their team
Bengali
English
About UsAzad & Company is the best law chamber service company in Dhaka and a  Law Firm comprising of a team of young & energetic legal experts. Being a modern-styled law firm, we always remain technologically updated. Our competent lawyers gathered together with a common concept of...

Founded in 1978
50 people in their team
Bengali
English
About usWhat can be more transparent and efficient than a group of young enthusiastic minds guided by experienced seniors? It makes our team more accountable as we strive to maintain our exceptional record in client satisfaction.We are located at the heart of the capital, in Azimpur and...
Rahman Law Associates

Rahman Law Associates

30 minutes Free Consultation
Dhaka, Bangladesh

Founded in 1978
10 people in their team
English
A Business oriented Leading Law Firm in Bangladesh with expertise In Corporate & Commercial laws, FDI, M&A and Arbitration. The team is comprising of a highly Efficient, Experienced and Effervescent team of professionals, with the goal to provide one stop solution for all your Corporate and...
The Legal Circle
Dhaka, Bangladesh

Founded in 2008
50 people in their team
Bengali
English
The Legal Circle is a firm of barristers, advocates and legal consultants specializing in representing clients in Bangladesh on both domestic and international legal matters. Bringing together a team of experienced lawyers, several of whom have previously worked at leading law firms in Bangladesh...
OGR Legal
Dhaka, Bangladesh

Founded in 2000
50 people in their team
Bengali
English
OGR Legal is a Bangladeshi law firmwith a rare and invaluable grasp of strategic commercial and practical issues. We combine exceptional legal expertise with deep industry knowledge and refreshingly creative thinking, to help clients achieve their goals. We provide with a full law service to...
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About FDA Law in Bangladesh

FDA Law in Bangladesh refers to the set of legal regulations and guidelines overseen by the Directorate General of Drug Administration (DGDA) and the Ministry of Health and Family Welfare, which control the import, export, manufacture, distribution, and sale of drugs, medical devices, and related health products. These rules are guided by seminal acts such as the Drug Act 1940, Drug (Control) Ordinance 1982, and various subsequent rules, policies, and amendments. The key objective is to ensure the safety, efficacy, and quality of medicines and health-related products available in the country, protecting public health against substandard or counterfeit pharmaceuticals.

Why You May Need a Lawyer

There are several instances where legal assistance in FDA Law becomes necessary in Bangladesh. Pharmaceutical companies and medical device importers may require guidance on licensing, regulatory compliance, and product registration processes. Healthcare providers or pharmacies may face legal actions or need advice on proper storage, sale, and advertising of medicines. If you are involved in product recalls, suspected cases of adulteration, or issues with clinical trial approvals, a lawyer can help you navigate complex administrative procedures. Businesses facing inspection, enforcement actions, or litigation over regulatory noncompliance will also benefit from professional legal advice. Finally, individual consumers who have experienced health issues due to unsafe products might seek legal remedies under these laws.

Local Laws Overview

The primary regulatory framework for FDA-related matters in Bangladesh is comprised of several acts and administrative rules. The Drug Act 1940 lays the foundation for the import, manufacture, sale, and distribution of drugs. The Drug (Control) Ordinance 1982 further strengthens oversight on drug safety, controls prices, and prohibits certain advertisements. The Directorate General of Drug Administration (DGDA) is the principal regulator, issuing licenses for import, manufacturing, and sale, while conducting regular market inspections. Laws also regulate market authorization for new drugs, pharmacovigilance, counterfeit and substandard drug penalties, and mandatory product labeling. Clinical trials are subject to ethical and administrative approval, and there are stringent requirements for record-keeping, adverse event reporting, and batch testing. Recent policies have strengthened post-market surveillance and crackdowns on illegal or expired medications.

Frequently Asked Questions

What is the role of the Directorate General of Drug Administration (DGDA) in Bangladesh?

The DGDA is responsible for regulating and controlling all matters related to pharmaceuticals and medical devices, including licensing, inspection, and enforcement of standards for medicines and related products.

Do I need a license to import or manufacture drugs in Bangladesh?

Yes, both importers and manufacturers of drugs must obtain proper licenses from the DGDA and comply with relevant regulations regarding quality, safety, and storage.

How can a pharmaceutical company register a new drug in Bangladesh?

Companies must apply to the DGDA, submitting detailed data on the product’s safety, efficacy, and quality, along with supporting documentation and samples for evaluation.

Are there restrictions on advertising pharmaceuticals in Bangladesh?

Yes, the advertising of prescription medicines directly to the public is prohibited, and any promotional materials require prior approval from the authorities.

What are the penalties for selling counterfeit or adulterated drugs?

Severe penalties including fines, license cancellation, and imprisonment can be imposed on those found guilty of selling counterfeit, adulterated, or unregistered drugs.

How are clinical trials regulated?

All clinical trials must be approved and monitored by the DGDA and relevant ethics committees to ensure the safety of participants and the scientific validity of results.

Can consumers file complaints against drug manufacturers or sellers?

Consumers can lodge formal complaints with the DGDA or the Ministry of Health if they encounter substandard or harmful medicines, prompting an official investigation.

What should I do if my pharmacy is inspected by DGDA officials?

Cooperate fully with inspectors, provide all requested documentation regarding procurement, storage, and sales, and ensure compliance with legal storage and labeling requirements.

Are there special requirements for medical device registration?

Yes, medical devices must also be registered with the DGDA and meet specific safety and performance criteria. Relevant documentation and sometimes local testing are required.

How can a lawyer assist me in FDA Law matters?

A lawyer experienced in FDA Law can help navigate complex licensing, compliance, and regulatory processes; represent you in legal disputes; assist in responding to enforcement actions; and protect your interests in negotiations with regulators.

Additional Resources

For more information and assistance regarding FDA Law in Bangladesh, you may consider the following resources:

  • Directorate General of Drug Administration (DGDA)
  • Ministry of Health and Family Welfare
  • Bangladesh Association of Pharmaceutical Industries (BAPI)
  • Bangladesh Pharma & Healthcare Association
  • World Health Organization (WHO) Bangladesh
  • Local chambers of commerce focused on healthcare and pharmaceuticals
  • Professional legal associations specializing in health and pharmaceutical law

Next Steps

If you think you need legal assistance regarding FDA Law in Bangladesh, start by identifying your specific issue, such as licensing, compliance, or dispute resolution. Then gather all relevant documentation related to your case or business activity. Search for a legal professional or law firm with experience in pharmaceutical and health regulation in Bangladesh. Schedule an initial consultation to discuss your situation, possible solutions, and potential costs involved. Timely legal advice can help you avoid regulatory pitfalls, resolve disputes efficiently, and ensure that you operate within the law.

Lawzana helps you find the best lawyers and law firms in Bangladesh through a curated and pre-screened list of qualified legal professionals. Our platform offers rankings and detailed profiles of attorneys and law firms, allowing you to compare based on practice areas, including FDA Law, experience, and client feedback. Each profile includes a description of the firm's areas of practice, client reviews, team members and partners, year of establishment, spoken languages, office locations, contact information, social media presence, and any published articles or resources. Most firms on our platform speak English and are experienced in both local and international legal matters. Get a quote from top-rated law firms in Bangladesh - quickly, securely, and without unnecessary hassle.

Disclaimer:
The information provided on this page is for general informational purposes only and does not constitute legal advice. While we strive to ensure the accuracy and relevance of the content, legal information may change over time, and interpretations of the law can vary. You should always consult with a qualified legal professional for advice specific to your situation. We disclaim all liability for actions taken or not taken based on the content of this page. If you believe any information is incorrect or outdated, please contact us, and we will review and update it where appropriate.