Bangladesh manufactures roughly 98 percent of the medicine it consumes. For a country that imported almost everything at independence, that is a remarkable industrial achievement. It also means that domestic drug safety regulation is not a side issue — it is the primary protection for nearly the entire population’s medicine supply.
Here is where those standards stand in 2026, what changed recently, and what remains unfinished.
The Legal Foundation Changed in 2023
For over eighty years, Bangladesh regulated medicine under the Drugs Act 1940 and the Drugs (Control) Ordinance 1982. Both were repealed by the Drugs and Cosmetics Act 2023, passed by parliament in September of that year.
This was not a cosmetic update. The Act made several substantive changes:
GMP became a statutory obligation. The Act defines Good Manufacturing Practice as the manufacturing and quality control practices set out in World Health Organization guidelines, and requires manufacturers to follow them in quality control, production, distribution, supply and storage of drugs. Previously this was largely a licensing expectation; now it is written into law.
Cosmetics came under DGDA. Authority over cosmetics moved from the Bangladesh Standards and Testing Institution to the Directorate General of Drug Administration. Licences and registration certificates are now required to produce, distribute, import or export cosmetics.
Medical devices were formalised. New provisions brought medical and diagnostic devices into the regulatory framework, with marketing authorisation required for market access.
Penalties became severe. The Act provides for life imprisonment for manufacturing, stockpiling or selling contaminated drugs. Selling medicines without a prescription where one is required carries a fine. Operating a drug store without a licence, or selling government-supplied or unapproved imported medicines, carries substantial imprisonment.
Enforcement got a dedicated arm. The DGDA was empowered to establish a Department of Drug Prosecution to pursue violations.
Antibiotic control was addressed. The Act contains provisions aimed at controlling antibiotic use, responding to widespread misuse and the antimicrobial resistance risk that follows.
Who Regulates What
The Directorate General of Drug Administration, under the Health Services Division of the Ministry of Health and Family Welfare, is the sole licensing and regulatory authority for the drug sector. It issues manufacturing and import licences, registers products, inspects facilities, controls quality and enforces drug law.
The Medicine Regulatory Committee must acknowledge or permit a drug registration before the DGDA can register it. There is a narrow emergency exception: during a pandemic or epidemic the DGDA may permit production initially, but must apply for confirmation within 90 days.
The National Drug Control Laboratory performs official testing. Its microbiology laboratory has been accredited by the Bangladesh Accreditation Board under ISO/IEC 17025, later upgraded to the 2017 standard. Its drug wing received ISO/IEC 17025:2017 accreditation from the ANSI National Accreditation Board in 2018. In March 2020 the laboratory achieved WHO prequalification for drug testing.
What a Manufacturer Must Satisfy
For a company to legally make and sell medicine in Bangladesh, several gates apply.
Site licensing. The manufacturing premises must be licensed. The licensing authority may inspect manufacturer premises, and inspection costs are borne by the manufacturer at government-set rates.
Raw material control. Semi-finished drugs and ingredients required for drug manufacture cannot be imported without prior approval of the licensing authority. For registration of raw materials and packaging materials, the Directorate may visit the manufacturing premises to assess whether the applicant follows Good Manufacturing Practice.
Product registration. Each product must be individually registered, with the Medicine Regulatory Committee’s involvement.
Ongoing GMP compliance. Not a one-time hurdle. Facilities are subject to inspection, and GMP status can be lost.
Qualified personnel. The Act specifies qualification requirements for technical staff, including relevant degrees from recognised institutions.
The Safety Risks That Remain Real
Regulation on paper is not the same as safety in practice. Several gaps deserve honest acknowledgement.
Counterfeit and substandard products. Falsified medicine remains a genuine threat, concentrated in high-value products and in informal distribution channels. Counterfeiters target expensive brands because margins are higher, which is why price is a poor proxy for authenticity.
Supply chain storage. A correctly manufactured product degrades if stored in heat, sunlight or damp. Bangladesh’s climate makes cold chain and controlled storage a persistent challenge, particularly in rural distribution and for temperature-sensitive products.
Sale without prescription. Despite legal provisions, purchase of prescription-only medicines — including antibiotics — without a prescription remains common. This is the main driver of antimicrobial resistance risk in the country.
Regulatory capacity. The DGDA operates with staffing and resource constraints relative to the scale of the industry it oversees. It has been progressing toward WHO Maturity Level 3 classification for years but has not yet achieved it, which limits Bangladesh’s participation in global procurement channels for vaccines and constrains some export pathways. A registration backlog has itself become a strategic problem, with large numbers of applications pending.
API dependency. With 80 to 90 percent of active pharmaceutical ingredients imported, incoming material quality control is the sector’s most important single safety control and its most exposed point.
How Patients Can Protect Themselves
You do not have access to inspection reports, but several checks are within reach.
Buy from licensed pharmacies. Informal sellers, street vendors and unlicensed shops are where falsified product concentrates.
Never accept loose tablets. If a pharmacist cuts tablets from a strip and hands them over without the batch number and expiry visible, refuse. That product is unverifiable.
Check five things on the pack: manufacturer name and address, batch number, manufacturing date, expiry date, and an intact seal. All legitimate products have all five.
Look at the printing. Falsified packaging often has slight colour differences, blurred text, spelling errors or misaligned printing. If a familiar product looks subtly different, ask.
Store medicine properly at home. A closed cupboard away from heat and humidity, not a bathroom shelf or a windowsill. Follow refrigeration instructions where given.
Report suspected problems. Tell the pharmacy and the manufacturer, with the batch number. Manufacturers with functioning quality systems log complaints against the batch record and investigate.
Complete prescribed courses. Particularly antibiotics. Stopping when you feel better is one of the most common contributors to resistance.
What Is Changing Next
Three developments will shape the standards environment over the coming period.
LDC graduation. Bangladesh is scheduled to graduate from least developed country status on 24 November 2026, ending the TRIPS pharmaceutical waiver that has allowed local production of patented molecules without licences. The government has requested a three-year deferment to 2029. Either way, patent obligations will arrive, with implications for the availability and price of newer medicines.
Regulatory maturity work. Efforts to reach WHO Maturity Level 3 continue, alongside modernisation of the DGDA’s capacity to register and approve more complex products including biosimilars and jointly developed therapeutics.
Essential medicines and pricing. Expansion of the National Essential Medicines List and greater emphasis on essential medicine portfolio alignment are shaping registration and pricing strategy across the sector.
Domestic API capacity. The API Industrial Park at Gazaria in Munshiganj is intended to reduce import dependency. Progress has been constrained by utility supply, particularly gas, but several manufacturers have established facilities there.
Frequently Asked Questions
Which authority regulates medicine in Bangladesh?
The Directorate General of Drug Administration, under the Ministry of Health and Family Welfare, is the sole licensing and regulatory agency for the drug sector.
What replaced the Drugs Act 1940?
The Drugs and Cosmetics Act 2023, which repealed both the Drugs Act 1940 and the Drugs (Control) Ordinance 1982.
Are cosmetics regulated in Bangladesh?
Yes. Since the 2023 Act, cosmetics fall under DGDA authority, and licences and registration certificates are required to manufacture, distribute, import or export them.
What are the penalties for selling contaminated medicine?
The Act provides for penalties up to life imprisonment for manufacturing, stockpiling or selling contaminated drugs.
How can I report a suspected fake medicine?
Report it to the pharmacy where it was purchased, to the manufacturer with the batch number, and to the DGDA. Keep the packaging.
Is medicine made in Bangladesh safe?
The regulatory framework requires WHO GMP compliance and product registration, and the sector supplies almost the entire domestic market as well as more than 160 export destinations. As anywhere, quality varies between manufacturers, which is why buying registered products from licensed pharmacies matters.
Closing
Bangladesh’s drug safety framework is stronger on paper than at any point in its history. The 2023 Act closed real gaps and raised the cost of non-compliance considerably. What remains is implementation: regulatory capacity, supply chain discipline, prescription enforcement, and the individual quality culture of each manufacturer.
PROMIXCO Pharmaceutical Limited manufactures in its own production unit under a single quality system spanning medicines, toiletries, cosmetics and food and beverage products. Raw materials are tested on arrival, batch records are documented with in-process checks, and finished goods are tested before release.
For quality documentation or to report a product concern with a batch number, contact info@promixcopl.com.
This article is general information about regulation, not medical advice.
