Directorate General of Drug Administration
Profile
- Head
- Md Alamgir Hossain
- Role
- Director General
- Annual budget
- —
- Staff
- —
- Established
- 1976
- Legal basis
- Drugs and Cosmetics Act 2023 (Act No. 29 of 18 September 2023), which merged and replaced The Drugs Act 1940 and The Drugs (Control) Ordinance 1982. DGDA established as a separate directorate under the Ministry of Health and Family Welfare in 1976; upgraded to Directorate General on 17 January 2010.
DGDA is navigating three simultaneous pressures: (1) implementing Drug Pricing Method 2026 cost-plus framework across 295 essential medicines with a four-year gradual phase-in; (2) enforcing the 25% essential-drug revenue threshold as a condition for new drug approvals, facing industry pushback; and (3) clearing a 1,000-application drug registration backlog before the TRIPS waiver expires on 24 November 2026 at LDC graduation, with biologics for cancer and autoimmune disease at risk of permanent royalty liability. Bangladesh pharmaceutical exports reached approximately USD 213 million in FY2024-25 across 87 countries.
Recent activity
- 2026-01-08 policy Government expanded the National Essential Medicines List by 135 drugs to 295 total, with price controls now applicable to all 295 items under the Drug Pricing Method 2026 (Allopathic) gazette issued under section 30 of the Drugs and Cosmetics Act 2023. The framework uses a cost-plus benchmarking formula; Internal Reference Pricing applies where seven or more companies manufacture the same molecule (approved MRP must remain within 15% of median benchmark); below that threshold, the lower of internal or international reference price applies. ↗↗↗↗
- 2026-01-08 regulation DGDA mandated that pharmaceutical companies must derive at least 25% of their revenue from essential medicines as a condition for new drug approval. Companies failing to meet the threshold will be barred from seeking registration of new non-essential medicines. ↗↗
- 2026-03-01 policy Dhaka Law Review analysis noted that 2026 reforms revise pricing methodology for the first time in a decade; gradual four-year phase-in of new price ceilings built into Drug Pricing Method 2026 to limit disruption to manufacturers, particularly smaller firms. ↗
- 2026-04-28 appointment Md Alamgir Hossain, an additional secretary from the Ministry of Public Administration, appointed Director General of DGDA via presidential gazette notification, replacing Maj Gen Md Shamim Haider who had served since 22 October 2024. ↗↗
- 2026-05-01 regulation TRIPS patent waiver for LDC-status pharmaceutical manufacturers set to expire 24 November 2026 when Bangladesh graduates from LDC status. DGDA had over 1,000 drug registration applications pending as of early 2026, including 617 applications from approximately 50 firms covering biologics for cancer, rheumatoid arthritis, diabetes, and autoimmune disorders. Government has formally requested a three-year graduation deferment to 2029; registration backlog tied to the Drug Control Committee's failure to convene for over two years. ↗↗↗↗
Provenance & notes
Established year 1976: confirmed by DGDA Info page (dgdagov.info) and Wikipedia -- 1976 is when Drug Administration was recognized as a separate directorate under MoHFW; upgraded to Directorate General on 17 January 2010. Legal basis: Drugs and Cosmetics Act 2023 (Act No. 29, 18 September 2023) replaced both the Drugs Act 1940 and Drugs (Control) Ordinance 1982; confirmed by VDB Loi and DGDA laws page. Parent confirmed as Health Services Division per MoHFW bifurcation order of March 2017 (HSD oversees curative services including DGDA). Current head Md Alamgir Hossain: gazette notification 28 April 2026, confirmed by both TBS News and BSS News; predecessor Maj Gen Md Shamim Haider served since 22 October 2024 (Wikipedia DGDA article). Drug Pricing Method 2026 and 295-item essential medicines list: confirmed independently by TBS News, Dhaka Tribune, BSS News, and Dhaka Law Review. 25% essential-drug threshold: confirmed by TBS News and JustNews BD. TRIPS waiver expiry and registration backlog: confirmed by TBS News, The Daily Star, and BSS News. Pharmaceutical export figure USD 213 million for FY2024-25: from PharmaBossBD citing EPB data. Staff count and standalone DGDA budget not publicly available in any identified primary source. Annual_budget_bdt left null accordingly.
Sources
- https://dgda.gov.bd/
- https://en.wikipedia.org/wiki/Directorate_General_of_Drug_Administration
- https://www.dgdagov.info/index.php/about-dgda/dgda-info
- https://asiaactual.com/bangladesh/bangladesh-directorate-general-of-drug-administration-dgda/
- https://www.tbsnews.net/bangladesh/alamgir-hossain-appointed-drug-administration-dg-1424176
- https://www.bssnews.net/others/382354
- https://www.tbsnews.net/bangladesh/health/govt-issues-new-drug-pricing-method-regulate-essential-medicine-prices-1350641
- https://www.tbsnews.net/bangladesh/health/govt-fix-prices-295-essential-drugs-1329396
- https://www.dhakatribune.com/bangladesh/health/400562/government-expands-essential-medicines-list-sets
- https://www.bssnews.net/news-flash/349320
- https://www.tbsnews.net/economy/industry/pharma-must-sell-25-essential-drugs-new-medicine-approval-govt-mandates-1336141
- https://www.justnewsbd.com/en/health/news/28430
- https://dhakalawreview.org/blog/2026/03/revisiting-essential-medicine-regulations-in-bangladesh-in-the-context-of-2026-reforms-6688
- https://www.tbsnews.net/bangladesh/1000-drug-registrations-stuck-bangladesh-risks-losing-trips-waiver-1224636
- https://www.thedailystar.net/news/bangladesh/news/patent-waiver-till-nov-2026-local-pharmas-may-miss-window-15-costly-drugs-3948576
- https://www.thedailystar.net/business/news/the-end-exemption-3953556
- https://www.bssnews.net/business/381418
- https://vdb-loi.com/bd_publications/the-drug-and-cosmetics-act-2023-act-no-29-dated-18-september-2023-passed-by-the-bangladesh-parliament/
- https://pharmabossbd.com/bangladesh-pharmaceutical-export-market-2025/