Govt aims to fulfil WHO vaccine industry requirements by May 2027 to boost investment, export

Infographic: TBS

Highlights

• Human resources remain biggest challenge for ML-3 accreditation
• Automation and stronger technical capacity needed
• Govt forms a high-level task force to meet WHO requirements
• New organogram drafted to address staffing shortage
• ML-3 accreditation could boost Bangladesh's access to global vaccine markets
• Incepta, Popular and Healthcare produce vaccines since 2011

Despite nearly a decade of efforts, Bangladesh has yet to secure the World Health Organization's (WHO) Maturity Level 3 (ML-3) certification and has therefore been unable to establish a significant foothold in the global vaccine market. The country now aims to achieve ML-3 before the WHO World Health Assembly in May 2027. 

The government has taken several initiatives to that end, including forming a task force and strengthening human-resource capacity.

A workshop was held on 24 August at the initiative of the Prime Minister's Office to work towards achieving Maturity Level 3 in the country's medicines and vaccine regulatory system in line with WHO's global standards. 

The workshop reviewed the current capacity of Bangladesh's vaccine and pharmaceutical regulatory system, identified existing challenges and discussed priority actions to accelerate progress.

The workshop was chaired by Prime Minister's Special Assistant on Health Affairs Dr SM Ziauddin Haider.

Ziauddin Haider told The Business Standard that ML-3 is primarily related to strengthening a country's medicines regulatory system, particularly the capacity of the Directorate General of Drug Administration (DGDA). It ensures that vaccines manufactured in the country are produced and regulated in compliance with all standards set by the WHO.

"We are currently at Maturity Level 2. In 2021, the WHO launched a formal mission to assess Bangladesh's capacity. Based on that assessment, we were given a target of fulfilling 211 indicators," Dr Ziauddin Haider said.

To fulfil these indicators, the government has formed a high-level task force chaired by Ziauddin Haider. The task force includes representatives from the WHO, DGDA, the health ministry and several other relevant ministries, as well as representatives from the country's three vaccine manufacturers – Incepta, Healthcare and Popular Pharmaceuticals.

Ziauddin Haider said the prime minister has attached importance to the issue and instructed the authorities to implement all activities expeditiously.

"The task force has already started working. We hope to achieve ML-3 before the next World Health Assembly in May 2027," he said.

Fresh move to address manpower shortage
The Directorate General of Drug Administration began working towards achieving ML-3 in 2016. The biggest challenge in developing this capacity in Bangladesh is human resources.

While key units such as market authorisation and inspection should ideally have 20-30 skilled specialists, they currently have only 4-6. The shortage of regulatory scientists, training, international experience and strong technical teams has slowed progress for years. The current government, however, has taken initiatives to address the problem.
Ziauddin said the required manpower has already been determined and a new organogram has been drafted.

"Proposals have been made for all the required positions. We hope that, by recruiting the necessary personnel very soon, we will be able to meet the human-resource targets," he said.

The WHO office in Dhaka is also providing regular technical assistance to the DGDA.

Vaccine production began in Bangladesh in 2011. Currently, three pharmaceutical companies – Incepta, Popular and Healthcare – manufacture around 15-16 types of vaccines for human and veterinary use. Of these, Incepta exports small quantities of several vaccines to a few African countries.

Industry must also ensure international standards
Alongside government efforts, vaccine manufacturers in Bangladesh will need to invest in meeting the WHO's current Good Manufacturing Practice (cGMP) standards and strengthen their technological capabilities to achieve ML-3, said Muhammad Halimuzzaman, Chief Executive Officer of Healthcare Pharmaceuticals Limited.

Halimuzzaman told The Business Standard that all three vaccine manufacturers in Bangladesh will have to meet WHO standards. The WHO will inspect their manufacturing facilities to verify whether their production systems are being operated according to international standards.

He added that the WHO has already assessed the capabilities and inspected the facilities of the companies and identified various shortcomings. The companies have also been informed about how those gaps need to be addressed and within what timeframe.

Halimuzzaman said maintaining conventional Good Manufacturing Practice standards alone would not be sufficient to achieve ML-3. Manufacturers must comply with other requirements. Increasing automation in production processes and reducing human intervention are also important components of meeting international standards.

Investment expected to rise alongside vaccine exports
Ziauddin Haider said the primary objective of achieving ML-3 is not simply to export vaccines, but to strengthen Bangladesh's position in the global vaccine market and attract new investment.

"Our goal is to expand our presence in the global vaccine market and attract more investment in vaccine manufacturing. This will also have a positive impact on other pharmaceutical products," he said.

Halimuzzaman echoed that achieving ML-3 would help increase investment in vaccine manufacturing in Bangladesh. 

"As the government has attached importance to the issue, we are hopeful that Bangladesh will be able to fulfil all the targets and achieve ML-3 by 2027," he said.