Bangladesh aims to achieve World Health Organization Maturity Level 3 (ML-3) certification by the next World Health Assembly in May 2027. The government says the move is necessary to boost investment and open doors to global vaccine exports.
Meeting WHO standards
The country currently operates at Maturity Level 2, which is insufficient for establishing a significant foothold in the international market. Officials say the target involves fulfilling 211 specific indicators related to regulatory capacity and manufacturing compliance.
A workshop on 24 August reviewed the state of the pharmaceutical regulatory system and identified priority actions. The event was chaired by Prime Minister’s Special Assistant on Health Affairs Dr SM Ziauddin Haider. He stated that the government has formed a high-level task force to oversee the work.
The task force includes representatives from the Directorate General of Drug Administration (DGDA), the health ministry, and the WHO. It also features officials from the country’s three vaccine manufacturers: Incepta, Popular Pharmaceuticals, and Healthcare Pharmaceuticals.
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Filling staffing gaps
Regulatory capacity is the primary obstacle to achieving ML-3 status. The DGDA began efforts to reach these standards in 2016, but progress has been hampered by a shortage of skilled personnel. Key units responsible for market authorisation and inspection currently employ only 4 to 6 specialists, while a full team would ideally consist of 20 to 30.
Dr Ziauddin Haider said the government has determined the required manpower and drafted a new organogram. The authorities intend to recruit the necessary personnel very soon to address these gaps.
Despite nearly a decade of work, Bangladesh has not yet secured the certification. However, officials note that the current government has prioritized the issue and instructed agencies to implement activities expeditiously.
Technology and investment
Vaccine production in Bangladesh began in 2011. Three companies currently manufacture around 15 to 16 types of vaccines for human and veterinary use. Incepta exports small quantities of several vaccines to a few African countries.
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Healthcare Pharmaceuticals Chief Executive Officer Muhammad Halimuzzaman said manufacturers must also invest in meeting current Good Manufacturing Practice (cGMP) standards. He noted that the WHO has assessed facilities and identified various shortcomings. To achieve ML-3, companies must increase automation and reduce human intervention in production processes.
Halimuzzaman added that maintaining conventional standards alone will not be sufficient. He said the industry must align with the broader requirements of the global regulatory system.
The government views the certification as a tool to attract new investment, not merely a label for exports. Dr Ziauddin Haider stated that fulfilling the targets will strengthen Bangladesh’s position in the global market and stimulate growth in the broader pharmaceutical sector. The goal is to expand the country’s presence and ensure a positive impact on other medical products.