Coalition of Interested Partners for medicines regulatory affairs meeting

1 November 2021
Statement
Dhaka

Speech By Dr Bardan Jung Rana, WHO Representative to Bangladesh

  • Honorable chair Director General, DGDA, Major General Mohamed Mustafizur Rahman
  • Respected partners
  • Honorable guests, ladies and gentlemen,


I am very pleased to be present here today in the Coalition of Interested partners (CIP) meeting, an important initiative for improving the health sector in Bangladesh, under the Directorate General of Drug Administration (DGDA) with technical support from WHO.

Access to quality, safe and efficacious medicines is essential to achieving health gains and protecting the population from emerging diseases and health hazards. The importance of pharmaceutical products cannot be over-emphasized, and DGDA's role is essential for the nation's health. In Bangladesh, it is a matter of national pride that approximately 98% of the medicines needed are produced locally. Many medicines manufacturers operate in the country, including 269 Allopathic, 206 Ayurvedic, 266 Unani, 32 Herbal and 79 Homeopathic drug manufacturing companies.

DGDA is continually striving towards self-improvement and advancement in its capacity to regulate pharmaceutical products and is committed to achieving maturity level three, according to the WHO criteria for the functionality of national regulatory authorities for medical products. From 2017 to 2020, several self-benchmarking exercises were conducted, resulting in a series of gap analyses of DGDA and the development of a live Institutional Development Plan, which is updated following each round of self-assessment. An informal external benchmarking took place in September 2018 and a formal benchmarking in July 2021, providing in-depth observations to help shape directions in moving towards higher maturity levels.

The commitment of DGDA and the government of Bangladesh to ensuring the quality, safety and efficacy of medical products is clear. These efforts are highly appreciated and fully supported by WHO and development partners such: as Management Sciences for Health and the United States Pharmacopoeial Convention, with financial support from USAID; Better Health Bangladesh project with financial support from FCDO; World Bank and other development partners. The Coalition of Interested Partners includes the partners working closely with DGDA and encourages all development partners to provide mainstream support to strengthen the national capacity for regulating pharmaceutical products.

I take the opportunity to congratulate DGDA on the national control laboratory achieving WHO prequalification, a milestone success for the country. Two Bangladeshi medicines have been prequalified by WHO, gaining access to the UN system and other major procurement agencies in different parts of the world. This boosts confidence in DGDA's capacity to regulate medicines and could promote regulatory cooperation with other countries.

I would also like to acknowledge that DGDA is progressing towards achieving maturity level three, despite a shortage in staff and other necessary resources. As I understand, the recruitment of additional technical and administrative staff is in process. We hope that the government of Bangladesh will gradually equip DGDA with sufficient staffing to perform the full scope of activities required by the national regulatory authority.

The program of this CIP meeting is inspiring. It includes a review of DGDA progress in a hectic time since the last meeting in March 2021, feedback from the WHO external benchmarking team, an overview of the institutional development plan with a discussion on potential contributions from development partners, supporting the critical theme of local production of priority vaccines and promoting regulatory cooperation.  

I would like to congratulate DGDA on the rapid progress being made and convey WHO's appreciation and full support in continuing the work towards compliance with international standards in ensuring quality, safety and efficacy of medical products in Bangladesh. Ultimately, reaching maturity level three could improve access to vaccines at regional and global levels, as Bangladesh has prospects for becoming a significant producer of quality, low-cost vaccines. This will contribute towards seeking Universal Health Coverage and progressing towards the achievement of Sustainable Development Goals.

Thank you.