Pharmaceutical Company Registration in Bangladesh 2026: DGDA Licences, Product Registration, Pricing and LDC Graduation

Pharmaceutical company registration Bangladesh: the 2026 framework

Pharmaceutical company registration Bangladesh law requires is not one filing but a chain of approvals. A company incorporated with the Registrar of Joint Stock Companies is only the first link. Under the Drugs and Cosmetics Act 2023, nobody may manufacture, sell, store, distribute or display a medicine without a licence from the Directorate General of Drug Administration (DGDA), no new manufacturing project may begin without the regulator's prior approval, and no product may reach the market until it is registered and holds a marketing authorisation.[1]

This guide follows that chain in the order an investor meets it: the company and its ownership, DGDA project approval, the manufacturing licence, product registration, import and wholesale licences, the API Industrial Park, pricing controls and the effect of LDC graduation on pharmaceutical patents. It also records what changed in 2026, when the elected government reversed the interim government's essential medicines and pricing reforms and Bangladesh awaited a United Nations decision on deferring graduation.

Summary: A pharmaceutical business in Bangladesh needs a company, DGDA approval of its project before construction, a two-year manufacturing or sale licence, and a five-year registration and marketing authorisation for every product. Imports of finished drugs, raw materials and packaging each need separate DGDA approval. Prices of listed and imported medicines can be fixed by the government, and the patent exemption for medicines lasts only while Bangladesh remains a least developed country.

Key point: The Drugs and Cosmetics Act 2023 repealed the Drugs Act 1940 and the Drugs (Control) Ordinance 1982, but section 82 keeps existing licences, registrations, rules and orders alive until they are replaced. In practice, applications still run on the old procedural rules and DGDA guidelines, while the new Act sets the duties, the time limits and much heavier penalties.[2]

At a glance

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Table of Contents

How pharmaceutical company registration Bangladesh works in 2026

The legal framework has three layers. Corporate law decides who owns and runs the business. Investment law decides how foreign money enters and leaves. Drug regulation, now consolidated in the Drugs and Cosmetics Act 2023, decides whether the business may make, import or sell a single tablet. The 2023 Act (Act No. 29 of 2023) was published in the Gazette on 18 September 2023 and took effect immediately.[1] Section 3 gives it overriding effect over any inconsistent law.[1]

What the 2023 Act regulates

The definition of "drug" in section 2 is wide. It covers vaccines and biologicals, medical devices, Unani, Ayurvedic, herbal and homeopathic preparations, dietary and nutritional supplements, and anything the government declares a drug by gazette notification.[1] Cosmetics, previously outside drug regulation, now need their own licence and registration under sections 31 and 32.[1] A business that thinks of itself as a nutraceutical, device or personal-care company may therefore still sit inside the DGDA's licensing net.

Who regulates what

The Director General of Drug Administration is the licensing authority. The government may constitute a Drug Control Committee by notification under section 12, and section 22 allows registration of a medicine only on that committee's recommendation. A National Drug Advisory Council under section 13 advises on national drug policy, domestic production and imports, and publishes an essential drugs list that must be updated every two years.[1] The bodies a new entrant will deal with are set out below.

The narcotics regime is separate. Products containing controlled substances also need authorisation from the Department of Narcotics Control, which our guide to drug laws in Bangladesh covers together with the offence and Drug Court provisions of the 2023 Act.

Company formation for a pharmaceutical business

Section 2 of the 2023 Act defines "company" as a company registered under the Companies Act 1994.[1] Every licence application is therefore made by an incorporated entity, and most manufacturers use a private limited company. The incorporation steps, name clearance, share capital and filings are covered in our guide to company registration in Bangladesh; this section deals only with the choices that matter for pharmaceutical company registration Bangladesh regulators will later scrutinise.

Drafting the constitution for a regulated business

The objects clause should expressly cover manufacture, import, export, wholesale and distribution of medicines, active pharmaceutical ingredients (APIs), devices and cosmetics, as relevant. Directors and senior officers matter more than in an ordinary company: section 57 of the 2023 Act deems owners, directors, managers, secretaries and officers directly connected with an offence liable unless they prove lack of knowledge and reasonable efforts to prevent it.[2] Board composition, delegations and compliance reporting should be designed with that exposure in mind from the start.

Foreign ownership and BIDA registration

BIDA states that 100% foreign ownership is permitted in the majority of sectors, and pharmaceutical manufacturing does not appear on its lists of reserved or controlled sectors.[5] [6] Industrial projects register online through BIDA's One-Stop Service, with fees between Tk 5,000 and Tk 100,000 depending on investment size, plus VAT.[5] BIDA registration also supports work permits, dividend remittance and approvals for royalty and technical fees, which need BIDA's prior approval where they exceed 6% in a year.[5] For the investment route in detail, see our guide to BIDA and BEPZA investment approvals.

The National Drug Policy test for multinationals

Corporate freedom to own 100% does not end the inquiry. The National Drug Policy 2016 allows a multinational to set up a company to manufacture in Bangladesh only if it has at least three original research products registered in at least two of the reference countries: the USA, UK, Germany, France, Switzerland, Japan and Australia.[3] A foreign group without a local plant may instead manufacture through a licence agreement with a licensed local manufacturer, or through contract or loan-licence manufacturing for export only.[3] Section 20 of the 2023 Act now puts those routes into statute.[1] A joint venture with a Bangladeshi manufacturer is often the fastest path; our joint venture guide covers the governance terms.

DGDA project approval: the first regulatory step in pharmaceutical company registration Bangladesh

The second proviso to section 14(1) prohibits starting any new drug manufacturing project, or expanding an existing one, without the licensing authority's prior approval.[1] Evaluating proposals for new projects is a long-standing DGDA function, and the approval comes before land development and construction, not after. A sponsor that builds first and applies later risks a design the regulator will not accept.

What the project proposal must show

DGDA does not publish a single statutory form for the project stage, and requirements are updated by guideline. In practice the proposal sets out the promoters and their technical qualifications, the investment and its funding, the land and site, the planned dosage forms and products, the machinery and quality-control equipment, and the layout of the plant. It must be consistent with section 17, which requires manufacturers to follow the World Health Organization's Good Practices (GxP) guidelines on manufacture, quality control, distribution, supply and storage.[1] Layout, segregation of product lines and utilities are therefore reviewed against GMP from the outset.

Site, environment and factory approvals

Pharmaceutical plants also need approvals outside the DGDA: environmental clearance from the Department of Environment, a factory licence, fire safety approval, trade licence and utility connections. These run in parallel with the DGDA process, and gaps in one can stall another. Our guides to environmental impact assessment and the factory licence explain those regimes. For projects inside economic zones or industrial parks, see our industrial parks and manufacturing facilities practice.

The DGDA manufacturing licence

Section 14(1) is the core prohibition: no person may manufacture, sell, store, distribute or display for sale any drug without a licence, or in breach of its conditions.[1] The first proviso exempts small-scale production for research, analysis or medical study, subject to prescribed conditions. Eligibility, applications, fees and conditions are left to rules, and the government may revise fees by gazette notification.[2] Until new rules are made, procedures and fees continue under the instruments saved by section 82.

Inspection, GMP and qualified persons

Before granting or renewing a licence, the licensing authority may inspect the premises and may license only premises it finds suitable.[1] Staffing is a statutory condition. Section 44 prohibits manufacture of allopathic medicines except under the direct supervision of two qualified persons: a pharmacist, and a holder of an honours or postgraduate degree in a listed discipline such as chemistry, biochemistry, microbiology, pharmacology, pharmacy, medicine, genetic engineering or chemical engineering.[2] Unani, Ayurvedic, homeopathic and herbal manufacturers need two qualified persons with their own prescribed qualifications. Section 46 requires up-to-date details of all qualified persons to be supplied to the licensing authority.[2]

Validity, renewal, suspension and appeal

A licence is valid for two years from issue and is renewable; the renewal application must be filed no more than 90 days before expiry.[1] Under section 18 the licensing authority may cancel or suspend a licence for breach of the Act, rules or conditions, failure to follow GMP, false or concealed information, use of the licence for other purposes, unapproved structural changes that may affect quality, or failure to meet prescribed conditions. A show-cause notice must come first, but on an unsatisfactory reply production can be stopped immediately.[2] Section 19 allows an application for reconsideration to the licensing authority, or an appeal to the government, within 30 working days, and the decision is final.[1]

Licence, contract and toll manufacturing

Section 20 sets out three arrangements. A foreign manufacturer may produce in Bangladesh under a licence agreement with a licensed local manufacturer, but only if its research-based product is registered under the same trade name in a country on the section 41(3) list. A local manufacturer may make products under a written contract with a manufacturer of the same system of medicine.

A foreign company without a Bangladeshi factory may use contract manufacturing or a loan licence for export only, and the products may never be marketed locally. The licensing authority may impose conditions, and may withdraw approval to protect public health.[1] Section 21 lets it require changes to a licence agreement it considers contrary to the national interest, on pain of cancellation.[1]

Product registration and marketing authorisation in pharmaceutical company registration Bangladesh

A licensed factory still cannot sell anything until product registration is complete for each item. Section 22 prohibits manufacturing, importing, exporting, selling, distributing, storing or displaying any unregistered drug, and requires a marketing authorisation before distribution or sale.[1] For many investors, product registration is the longest stage of pharmaceutical company registration Bangladesh imposes, because each dosage form and strength is assessed separately.

The Drug Control Committee

The licensing authority may register a medicine only on the Drug Control Committee's recommendation. In an emergency it may register first, but must place the product before the committee within 90 days.[1] Under section 28 the committee evaluates new drugs for safety, efficacy and usefulness. A "new drug" includes an active ingredient not previously registered or recommended, a new strength or dosage form, and a new fixed-dose combination.[1] The National Drug Policy 2016 generally discourages combination allopathic products unless they are essential.[3]

The CTD dossier

DGDA's 2017 guideline adopts the ICH Common Technical Document for registration, implementing Modules 1 to 3; Module 4 is generally not applicable to locally made generics and Module 5 is deferred, though clinical or bioequivalence data may be required.[4] Module 1 requires an application printed from the Pharmadex online system, proof of payment, labels and inserts, details of the quality control and production managers, GMP evidence with inspection reports and certificates dated within the last two years, the CV of a pharmacovigilance person, and the proposed maximum retail price with cost per dose, day and course.[4] Section 22 itself allows DGDA to demand clinical trial or bioequivalence data and anti-counterfeit identification for specified products.[2]

Brand names, validity and cancellation

Brand and generic names must be approved, and where the same brand is used by more than one company, ownership goes to the company that registered it first.[1] That rule makes early product registration and parallel trademark clearance important; see our guide to trademark law in Bangladesh. Registration lasts five years and is renewable within the same 90-day window, and the marketing authorisation stays valid for as long as the registration.[1] On the committee's recommendation, or where a product is substandard, counterfeit, adulterated, misbranded or made without adequate facilities, registration may be cancelled or suspended and the product recalled under sections 25 and 26.[1] DGDA must publish the list of registered drugs on its website.[1]

Import licences for finished drugs, APIs and packaging

Bangladesh produces most of its finished medicines locally but imports most of its raw materials. Industry figures put local supply at 98% of national demand, with API imports estimated at $1.2 billion a year.[14] Import controls therefore bite at two points: finished products and inputs.

Importing finished medicines

Section 41 prohibits importing any drug without a licence or outside its conditions, and importing even a registered drug without the licensing authority's prior approval. No imported drug may be registered or licensed unless it is registered under the same brand name in the countries on a list the government publishes from time to time.[2] The National Drug Policy 2016 names those countries as the USA, UK, Germany, France, Switzerland, Japan and Australia, and requires valid GMP certificates.[3] DGDA may inspect the foreign manufacturer's plant to verify GMP, at the manufacturer's cost. Small quantities for testing, research or personal use, and imports to meet a national emergency, are exempt.[2]

Module 1 of the dossier also asks importers for the foreign registration status and the local agent.[4] For an importer, pharmaceutical company registration Bangladesh rules therefore turn on the foreign principal's registrations as much as on its own licence.

Importing APIs and packaging materials

Section 42 requires the licensing authority's prior approval to source or import raw materials or packaging materials for registered drugs, and to import semi-finished drugs or other necessary components. DGDA may inspect the foreign source to verify GMP, again at the manufacturer's expense.[2] In practice, manufacturers obtain approval of the materials they intend to import before opening letters of credit. Customs classification, duties and documentation are covered in our customs and trade compliance practice.

Export licences and export registration

Section 43 bars exporting any drug without a DGDA licence, and allows DGDA to register a product for export alone.[2] The National Drug Policy 2016 permits export registration to meet an importing country's demand, except for drugs considered harmful.[3] Bangladesh exported pharmaceuticals worth $213 million to more than 160 countries in fiscal year 2024-25.[14]

Wholesale and retail drug licences

Distribution needs its own licence. The section 14 prohibition covers selling, storing, distributing and displaying for sale, so a distributor, depot, wholesaler or retail pharmacy needs a DGDA licence just as a factory does. Section 14(2) prohibits online or web-based sale without a licence, and section 14(3) prohibits hoarding to create an artificial shortage.[1] Selling, storing or distributing without a licence carries up to five years' imprisonment or a fine of up to Tk 5 lakh, or both.[2]

Supervision rules differ by level. Under section 45, a retailer may sell allopathic medicines only under the personal supervision of a pharmacist, a diploma pharmacist (Bangladesh Pharmacy Council grade B) or a pharmacy technician (grade C), with parallel rules for Unani, Ayurvedic, herbal and homeopathic medicines. Section 45(4) removes the supervision requirement for wholesale sale.[2] Section 40 bars sale of government medicines, expired or banned drugs and physician samples, and sale of antibiotics or other non-OTC medicines without a registered physician's prescription.[2] A foreign manufacturer that imports through a local distributor should make that distributor's licences, storage and recall duties express terms of the distribution agreement.

The API Industrial Park and API incentives

The government's answer to import dependence is local API production. The Active Pharmaceutical Ingredients and Laboratory Reagents Production and Export Policy 2018 offers tax holidays tied to the number of API molecules produced, with an extended holiday for 2023 to 2032 for producers that make API molecules locally; a 20% export subsidy on APIs; and relief from advance income tax on certain chemical imports. BIDA lists conditions including paid-up capital of at least Tk 2 million at the start of commercial production and reinvestment of 30% of the exempted amount within a year.[7] Confirm current eligibility with the National Board of Revenue before modelling these benefits, because fiscal incentives are amended by each Finance Act.

The park at Gazaria

The API Industrial Park sits on 200 acres at Gazaria in Munshiganj, about 50 km from Dhaka on the Dhaka-Chattogram highway. It was approved in 2008 with 42 plots, and 26 plots have been allocated to pharmaceutical companies.[8] In January 2026 The Daily Star reported that no factory was operating there: the park had no gas connection, Titas Gas gave no timeline, and a central effluent treatment plant built for about Tk 80 crore had never been used.[8] An API investor should treat energy supply, effluent treatment and lease terms as conditions precedent, not assumptions.

Medicine pricing controls in 2026

Price control is a permanent feature of the market. Section 30 of the 2023 Act allows the government, by gazette notification, to fix the maximum retail price of listed drugs and of imported drugs, to publish the list, and to fix the maximum sale price of domestic raw materials used in manufacture. Selling above a fixed price is prohibited.[1] Every registration dossier proposes a maximum retail price for DGDA's review.[4]

The 2026 reforms and their reversal

Since 1994 the government has directly fixed prices for 117 essential medicines, with others priced on manufacturers' proposals.[9] In January 2026 the interim government's advisory council expanded the essential list to 295 medicines, to be price-fixed over four years, required at least a quarter of each company's production to be essential drugs, and capped price variation between companies for non-essential drugs at 15%.[9]

In August 2026 the elected government's Cabinet scrapped the Essential Medicines List 2026 and the Drug Pricing Method 2026, restoring the 1994 list of 117 medicines. The stated reason was that the National Drug Advisory Council had not been consulted as the 2023 Act requires. The council was formed on 29 June 2026, and a writ petition on the policies is pending before the High Court Division.[10]

Planning around price control

The Health Secretary has said a new essential medicines list will be prepared and a new committee will recommend price changes.[10] Section 13 requires the list to be updated every two years.[1] A business plan should therefore model three scenarios: the 1994 list, a list of around 295, and an intermediate outcome. Portfolio mix, the share of essential products and the time to reach a viable price on new launches all depend on which one emerges.

LDC graduation, the TRIPS waiver and pharmaceutical patents

The Bangladeshi generics model rests on an exemption. The WTO TRIPS Council's 2015 decision allows least developed countries not to protect pharmaceutical patents until 1 January 2033, or until the country ceases to be an LDC if that is earlier.[11] Section 6(2) of the Patent Act 2023 keeps pharmaceutical and agrochemical products outside patent protection while that exemption lasts, and lets the government extend or reduce the period by gazette notification.[12] Graduation, not 2033, is therefore the operative deadline.

Where LDC graduation stands

Bangladesh was scheduled to graduate in November 2026. In July 2026 ECOSOC agreed to recommend a three-year extension for Bangladesh and Nepal, and officials expect the General Assembly to decide in October or early November 2026, moving graduation to November 2029.[13] At the date of this update no General Assembly resolution had been reported. If the deferral is adopted, the pharmaceutical exemption should run until graduation in 2029; if it is not, it falls away on graduation in 2026. The trade side of graduation is analysed in our guides to the WTO impact on Bangladesh trade and Bangladesh trade agreements.

What LDC graduation changes for a pharmaceutical business

About 20% of drugs made in Bangladesh are estimated to be still under patent elsewhere.[14] After graduation those products become exposed to patent claims, and new molecules can be patented locally. The Patent Act keeps compulsory licensing (section 36), compulsory licences for export of patented pharmaceutical products to countries with insufficient manufacturing capacity (section 39) and government use (section 40).[12] Local manufacturers should run freedom-to-operate reviews on pipeline products; originators should keep Bangladesh in their filing plans. Filing strategy is covered in our guides to patent registration in Bangladesh and intellectual property law in Bangladesh.

Compliance after licensing

The 2023 Act backs its licensing scheme with criminal penalties. Manufacture without a licence, unregistered or misbranded medicines and unlicensed imports carry up to ten years' imprisonment or a fine of up to Tk 10 lakh, or both, and counterfeit or adulterated medicines carry up to life imprisonment.[2] Advertising that makes therapeutic claims without the licensing authority's prior approval is prohibited by section 71(1), and section 72 bars a physician from prescribing an unregistered drug.[2] Contract research organisations need approval of their organisation and each protocol under section 65, and section 66 makes pharmacovigilance reporting mandatory.[2] The full offence table and Drug Court procedure are in our drug laws guide.

The licences at a glance

The table summarises the main approvals in pharmaceutical company registration Bangladesh.

Step-by-step: from incorporation to first sale

Some stages run in parallel, but DGDA project approval should always precede construction, and product registration must precede any sale.

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Mistakes to avoid in pharmaceutical company registration Bangladesh

• Building before project approval. Section 14 requires prior approval of a new project or expansion; a plant designed without DGDA input may need costly rework.[1]
• Assuming 100% ownership means free market access. The National Drug Policy 2016 conditions on multinationals and the export-only rule for contract manufacturing still apply.[3]
• Treating product registration as a formality. Each product needs Drug Control Committee recommendation and a complete CTD dossier, and incomplete dossiers are the main cause of delay.[4]
• Losing a brand to an earlier registrant. Brand ownership goes to the first company to register, so clear and file early.[1]
• Opening letters of credit before DGDA import approval. Raw materials, packaging and finished drugs each need prior approval under sections 41 and 42.[2]
• Missing the renewal window. Licences and registrations must be renewed by application filed within 90 days before expiry.[1]
• Ignoring the LDC clock. The pharmaceutical patent exemption ends on LDC graduation; plan for 2029, and have a plan if it is 2026.[11] [13]

What to watch in late 2026 and 2027

Four developments will shape pharmaceutical company registration Bangladesh in the next year. First, the General Assembly's decision on LDC graduation, expected by November 2026, which fixes when the patent exemption ends.[13] Second, a new essential medicines list and pricing method prepared with the National Drug Advisory Council, and the outcome of the pending writ.[10] Third, rules under section 76 of the 2023 Act that will replace the saved procedures on licence eligibility, applications and fees, and the cosmetics rules that start the six-month window for existing cosmetics businesses under section 33.[1] [2] Fourth, whether gas reaches the API Industrial Park.[8]

TRW advises manufacturers, importers and investors on each stage. For corporate structuring see our corporate and commercial advisory practice; for foreign groups entering the market, our foreign company establishment practice and our guide to foreign company registration in Bangladesh.

Frequently asked questions

What licences are needed for pharmaceutical company registration Bangladesh?

At minimum: incorporation under the Companies Act 1994, DGDA approval of the project, a DGDA manufacturing licence, registration and a marketing authorisation for each product, and import approvals for raw materials and packaging. BIDA registration, environmental clearance, a factory licence and a trade licence run alongside.[1] [2]

Which law governs pharmaceutical companies in Bangladesh?

The Drugs and Cosmetics Act 2023 (Act No. 29 of 2023), which repealed the Drugs Act 1940 and the Drugs (Control) Ordinance 1982. Rules, orders, licences and registrations under the old laws continue under section 82 until replaced.[1] [2]

How long is a DGDA manufacturing licence valid?

Two years from issue. It is renewable, and the renewal application must be filed no more than 90 days before expiry.[1]

How long does a drug registration last in Bangladesh?

Five years, renewable on application within 90 days before expiry. The marketing authorisation remains valid for as long as the registration.[1]

Can a foreign company own 100% of a pharmaceutical company in Bangladesh?

BIDA permits 100% foreign ownership in most sectors, and pharmaceuticals are not on its reserved or controlled lists. The National Drug Policy 2016 adds that a multinational may set up local manufacturing only if it has at least three original research products registered in at least two reference countries.[5] [6] [3]

Can a foreign company manufacture in Bangladesh without its own factory?

Yes, in two ways. It may license a local manufacturer if its product is registered under the same trade name in a listed reference country, or it may use contract manufacturing or a loan licence, but only for export; those products cannot be sold locally.[1]

Can finished medicines be imported into Bangladesh?

Only with a DGDA licence, product registration and prior approval for each import. The product must be registered under the same brand in the reference countries the government lists, which the National Drug Policy 2016 names as the USA, UK, Germany, France, Switzerland, Japan and Australia.[2] [3]

Who fixes medicine prices in Bangladesh?

The government may fix maximum retail prices for listed and imported drugs under section 30. After the August 2026 Cabinet decision, direct price-fixing again covers the 1994 list of 117 essential medicines, while a new list is prepared.[1] [10]

What happens to pharmaceutical patents when Bangladesh leaves the LDC category?

The TRIPS exemption for medicines ends on graduation, and section 6(2) of the Patent Act 2023 stops excluding pharmaceutical products. If the proposed three-year deferral is adopted, graduation moves to November 2029.[11] [12] [13]

Is the API Industrial Park operational?

Not fully. In January 2026 it was reported that no factory was operating because the park had no gas connection, although roads, drainage and a substation were in place.[8]