Bangladesh's vaccine export dreams on hold over WHO certification

Highlights:

• Bangladesh still lacks WHO ML-3 certification needed for vaccine exports
• DGDA faces major gaps in capacity, staffing, and regulatory systems
• ML-3 could unlock $50 million in vaccine exports
• Only Incepta exports small amounts; wider exports remain blocked
• WHO identified deficiencies; DGDA must complete CAPA and seek re-audit
• Industry urges rapid action as delays hurt post-2026 export prospects

Nearly a decade on, Bangladesh remains grounded in the global vaccine race as its Directorate General of Drug Administration (DGDA) has yet to secure the World Health Organization's Maturity Level-3 (ML-3) certification — a key requirement for pre-qualification and large-scale export of locally produced vaccines.

WHO evaluates nine key areas for ML-3, including vaccine registration, clinical trials, market surveillance and control, knowledge management, quality maintenance, testing, legal authority, logistics support, and human resources. Despite progress, DGDA still has gaps in the regulatory framework, oversight capacity, scientific assessment, quality assurance, and integrated system activities.

Pharma industry experts say achieving ML-3 could unlock up to $50 million in vaccine exports over the next five years, while creating new investment and employment opportunities. 

Starting work in 2016, the DGDA has made progress across WHO-evaluated areas, but certification remains out of reach, leaving Bangladesh largely excluded from global vaccine markets and facing major challenges after its 2026 LDC graduation.

Vaccine production in Bangladesh began in 2011, and three pharmaceutical companies – Incepta, Popular, and Healthcare – produce 15-16 types of human and animal vaccines. Among them, only Incepta exports small quantities to a few African countries. 

Widescale exports remain blocked without ML-3 certification, which signifies that a country's drug regulatory authority is robust, effectively managed, and internationally acknowledged.

A recent inter-ministerial committee report, seen by TBS, has also urged the DGDA to accelerate efforts to secure the certification and to consider alternative incentives for pharmaceutical exports as a replacement for cash support after the LDC graduation.

Infograph: TBS

"Without this certification, WHO does not accept pre-qualification applications from Bangladeshi vaccine manufacturers, preventing them from exporting vaccines to more highly regulated countries," the report mentioned.

A former DGDA official, on condition of anonymity, told TBS, "Achieving ML-3 should be a top priority for Bangladesh, as it would elevate the country's pharmaceutical and vaccine industry to a new level of global acceptance." 

"However, achieving it is by no means an easy target as it measures a country's ability to scientifically evaluate and regulate the quality of medicines, vaccines, and medical products, based on the same standards used by regulatory scientists in developed countries," he added.

Experts said that ML-3 is more than a certificate – it is a mark of trust. In October 2025, Ethiopia became the ninth country in Africa to achieve ML-3. Last December 2024, Senegal and Rwanda achieved this. This milestone highlights their strong commitment to ensuring safe, effective, and high-quality medical products for their populations.

As of late 2025, fewer than 70 countries worldwide have achieved ML-3 status for their national drug regulatory authorities in any capacity. India's vaccine regulatory systems (NRA and affiliated institutions) secured the certification in October 2024, earning top marks in several functions.

Abdul Muktadir, president of the Bangladesh Association of Pharmaceutical Industries (BAPI), said that to secure global export approvals, the DGDA must conduct rigorous oversight, inspect facilities, and ensure vaccines meet international standards. While local companies maintain high production standards, the DGDA has yet to achieve the required regulatory maturity.

He told TBS that the WHO has already pointed out gaps in DGDA's performance, highlighting the need for improvements in some areas.

DGDA's gaps in meeting ML-3 standards

The DGDA began work on achieving ML-3 certification in 2016. Officials said the biggest hurdle in achieving ML-3 in Bangladesh is human resources. Key units like Market Authorisation or Inspection, which ideally should have 20-30 skilled experts, currently have only 4-6. The long-standing shortage of regulatory scientists, training, international experience, and a strong technical team has slowed progress.

Additionally, gaps in laws, infrastructure, analytical capacity, and modern lab facilities have lowered scores in many functions. While Bangladesh has achieved 85-95% progress in some of the nine WHO-defined functions, a few remain at Level-1 or Level-2. ML-3 certification cannot be obtained until all functions reach at least Level-2, they said.

"Unless the DGDA makes substantial progress, Bangladesh cannot achieve ML-3 certification. To meet this goal, the health ministry could establish a dedicated monitoring cell and set a clear timeline to obtain WHO approval," said BAPI President Muktadir.

What DGDA officials say

Sources at the DGDA said that since March 2016, the agency has been taking steps to review its systems and build capacity according to WHO standards. Several initiatives were undertaken, including legal amendments, drafting guidelines, and improving human resources and infrastructure. 

In 2021, a WHO expert team conducted an assessment based on nine regular functions and provided several key observations. Guidance was given to implement CAPA (Corrective and Preventive Actions) to address these gaps.

A former DGDA official said that while some CAPA measures have been implemented, gaps remain. The DGDA must complete them and formally invite the WHO for re-evaluation, where a new team will assess progress and readiness for ML-3 certification. The official added that delays could create major barriers for Bangladeshi vaccine exporters.

When asked, DGDA spokesperson Akter Hossain acknowledged some limitations due to government constraints and resource shortages, but said significant progress has been made.

"The agency is following WHO-standard procedures, implementing necessary laws, and allocating sufficient personnel," he said.

However, Akter Hossain could not confirm whether a formal letter has been sent to WHO for a re-audit or when a WHO team might visit next.

Industry leaders urge quick action

Pharma industry leaders have urged immediate steps to achieve ML-3, saying that despite producing large quantities of vaccines, Bangladesh cannot export them, and even a month's delay would be detrimental.

Md Zakir Hossain, secretary general of BAPI, told TBS, "Each batch of vaccines produced in Bangladesh must undergo separate testing and certification before it can enter international markets. For this, local laboratories need to meet global standards. Bangladesh must therefore achieve ML-3 promptly."

"Once the DGDA's labs are internationally accredited, WHO will recognise Bangladesh's certification globally, allowing vaccines to be tested, certified, and exported directly from domestic labs," he added.

Country's pharma industry at a glance

Incepta Pharmaceuticals, Popular Pharmaceuticals, and Healthcare Pharmaceuticals produce vaccines in Bangladesh. Incepta Pharmaceuticals began domestic vaccine production in 2011 and manufactures 16 important vaccines, including those for pneumonia, cervical cancer, and rabies. The company also produces 13 types of animal vaccines.

Additionally, Essential Drugs Company Limited (EDCL) is set to establish the country's first vaccine plant in Munshiganj at Tk3,115 crore. By 2027, the facility plans to produce 15 vaccines, including HPV (Human Papillomavirus), JE (Japanese Encephalitis), TCV (Typhoid Conjugate Vaccine), MCV (Meningococcal Vaccine), bOPV-10 (Bivalent Oral Polio Vaccine), TD-10 (Tetanus and Diphtheria)/TT, cholera, and influenza vaccines. 

The government aims to meet domestic demand and export surplus vaccines internationally.

Key challenges in pharma export

Lack of clinical trial facilities: The inter-ministerial committee report noted that Bangladesh still lacks the capacity to conduct USFDA/EU-approved bioequivalence or clinical trials. As a result, domestic companies must send these tests to neighbouring countries, which is time-consuming and costly. Experts believe that establishing an internationally accredited CRO (Contract Research Organisation) in the country would facilitate exports.

However, DGDA sources said that 17-18 CROs are currently operating in Bangladesh, and capabilities for important studies like bioequivalence have already been developed, primarily by the private sector.

API Park progress is slower: The API Park, a specialised industrial zone dedicated to producing Active Pharmaceutical Ingredients (APIs), started in 2008 in Gozaria, Munshiganj, and is still not fully operational. 

Due to irregular gas supply, companies setting up factories there cannot begin production. Industry analysts say that without reliable utility services, API production will never gain momentum.

NDTL must enable API testing: Although Bangladesh's National Drug Testing Laboratory (NDTL) is WHO-certified, it currently does not test API samples. Consequently, local API producers must send samples abroad for testing. The industry association and the inter-ministerial committee believe that if NDTL develops API testing capabilities, it would significantly reduce costs, lower import dependency, simplify the export process, and increase customer confidence.

Ensuring GMP and cGMP to boost export capacity: While domestic pharmaceutical companies maintain high production standards, global competition is increasing. Experts note that fully ensuring Good Manufacturing Practices (GMP) and current GMP (cGMP) will greatly enhance export potential.