Bangladesh Drug Pricing Deadlock Stalls Hundreds of New Medicines, Threatens Industry Innovation
核心洞察
A regulatory deadlock over drug pricing in Bangladesh has stalled the launch of hundreds of new locally manufactured medicines, including cancer and diabetes therapies, for nearly two years.
The impasse follows a High Court order directing the government to fix prices of all life-saving medicines, after which the DGDA effectively halted price fixation for new products.
Industry leaders warn that pricing constraints and rising production costs are discouraging R&D investment, squeezing smaller manufacturers, and creating a two-tier healthcare system.
A prolonged regulatory deadlock over drug pricing in Bangladesh has brought the launch of hundreds of new locally manufactured medicines to a standstill, leaving investments worth crores of taka stranded and patients without access to newer therapies for cancer, diabetes, chronic kidney disease (搜索), and other serious illnesses.
Nearly two years into the impasse, more than 100 drug manufacturers are waiting for marketing approval and price fixation for thousands of medicines, according to industry estimates. The crisis has drawn urgent calls from pharmaceutical leaders for government intervention to resolve the regulatory bottleneck and clear the backlog of pending applications.
Crisis deepens after court order
Pricing delays had long plagued the approval process, but the crisis intensified after a High Court order last August directed the government to determine the prices of all life-saving medicines. The order followed a writ petition filed by the Consumer Association of Bangladesh (CAB), which urged the court to compel government officials to explain their failure to fix medicine prices under the Drugs and Cosmetics Act, 2023.
Pharmaceutical companies argued that medicine prices should be determined through consultation with manufacturers rather than unilaterally by the government, and subsequently appealed the ruling. Since then, the Directorate General of Drug Administration (搜索) (DGDA) has effectively stopped fixing prices for new medicines.
"Some new medicines had already been facing pricing delays. But after the High Court order, price fixation for virtually all new medicines has come to a halt," said Dr AZM Zakir Hossain, secretary of the Bangladesh Association of Pharmaceutical Industries (搜索) (BAPI) and managing director of Delta Pharma. "Many companies have already manufactured the products, while others are ready to start production. But without price approval, none of these medicines can reach patients."
Hundreds of products remain stuck
The pipeline of stalled products is substantial. Healthcare Pharmaceuticals (搜索) has developed two strengths of the immunotherapy drug Nivoluma (搜索) — 40mg/4mL and 100mg/10mL — a standard treatment for melanoma (搜索) and several advanced cancers including lung, kidney, liver, stomach, and colorectal cancers. The locally manufactured products have yet to reach pharmacy shelves.
Healthcare Pharmaceuticals (搜索) officials report 18 medicines pending, including five cancer treatments for ovarian, breast, pancreatic, and prostate cancers, as well as therapies for blood cancers, chronic kidney disease (搜索)-related anaemia, liver disease, and severe fungal infections.
Renata has approximately 20 products awaiting price fixation, including seven oncology medicines submitted over the past two years. Beximco Pharmaceuticals (搜索) is waiting to launch 25 medicines covering hypertension, diabetes, and pain management. ACI Pharma has 27 medicines pending approval, Opsonin Pharma has 24 products awaiting clearance, while Incepta and Square Pharmaceuticals (搜索) each have 25 to 30 medicines held up in the regulatory process.
Industry estimates suggest the top 20 to 25 pharmaceutical companies each have 20 to 30 products awaiting approval, while dozens of smaller manufacturers face similar backlogs.
"Over the past two years, almost no new medicines have reached the market," said Rabbur Reza, chief operating officer of Beximco Pharmaceuticals (搜索). "More than the industry, it is patients who are suffering because they are being deprived of newer treatment options."
Pricing policy squeezes profitability and innovation
Beyond the immediate regulatory deadlock, industry leaders say years of limited price adjustments have systematically eroded profitability and discouraged investment in research and development.
In a June 30 letter to Health and Family Welfare Minister Sardar Md Sakhawat Husain, BAPI sought an urgent meeting to discuss the challenges facing the sector, citing rising production costs, persistent inflation, foreign currency shortages, and constraints in the pricing regime.
Bangladesh has 258 pharmaceutical manufacturers, but the market has become highly concentrated. Just 20 companies account for about 94 percent of total production, while the remaining 238 produce only 6 percent. Citing data from IQVIA, BAPI said 64 of the top 100 pharmaceutical companies recorded negative growth in 2025.
Abdul Muktadir, chairman and managing director of Incepta Pharmaceuticals (搜索), said the industry's momentum has slowed since 2016 as the drug regulator has become increasingly restrictive in approving prices for new medicines. "If it costs Tk 10 to produce a technologically advanced medicine but the approved price is Tk 8, no company will continue investing in innovation," he said.
Syed S Kaiser Kabir, chief executive officer of Renata, noted that only 32 of the country's top 100 pharmaceutical companies recorded revenue growth, while the rest posted lower sales. "The industry has been going through a series of shocks since 2020," he said, citing the Covid-19 pandemic, the depreciation of the taka, high inflation, and disruptions to global supply chains.
The weaker taka has sharply increased the cost of imported raw materials, but manufacturers have not been able to fully pass on those costs because medicine prices have remained largely unchanged. "If prices cannot reflect production costs, companies will stop making some medicines," Kabir warned, adding that patients could eventually have to rely on more expensive imported medicines as cheaper locally made alternatives disappear.
Even price reductions are on hold
The regulatory paralysis extends in both directions. Nearly a year ago, ACI Pharmaceuticals (搜索) applied to reduce the price of Tirzepatide INN 2.5mg/0.5mL, a widely used injectable treatment for Type 2 diabetes (搜索), along with five other medicines. Despite repeated follow-ups, the applications remain pending.
"Medicine prices fluctuate globally as raw material and import costs change," said Mohammad Mohsin Mia, director of ACI Pharmaceuticals (搜索). "Sometimes companies need to raise prices, while at other times they need to lower them to stay competitive. At the moment, we can do neither."
DGDA cites legal hurdles
DGDA officials acknowledge the problem but say the delay is largely beyond their control. Medicine pricing is governed by Section 30 of the Drugs and Cosmetics Act, 2023, but the pricing mechanism remained inoperative after political change.
The Drug Control Committee, which grants final approval for new medicines, has not met for nearly two years, creating a major regulatory bottleneck. The committee has yet to be fully reconstituted following last year's political transition.
"Our director general has already written to the ministry, and efforts are underway to resolve the matter," said Dr Md Akter Hossain, a DGDA director. He explained that the law requires recommendations from two separate committees before medicine prices can be approved, and while the ministry has formed one committee, work is underway to complete the remaining process.
A DGDA official, speaking on condition of anonymity, said the authorities had made several attempts to reconstitute the committee but failed because the law requires representatives from multiple government agencies and independent experts, making it difficult to bring all parties together for consultation.
LDC graduation looms
The regulatory deadlock comes at a critical time for Bangladesh's pharmaceutical industry, which meets about 98 percent of domestic demand, exports to more than 150 countries, and has become one of the country's most globally competitive sectors.
Rabbur Reza of Beximco Pharma noted that Bangladesh has benefited from the World Trade Organization's intellectual property waiver, which allows local manufacturers to produce certain patented medicines at affordable prices. After the waiver expires with Bangladesh's graduation from least developed country status in 2026, medicines introduced later will require licensing agreements with patent holders, involving royalty payments and higher costs.
While large companies may be able to negotiate such agreements, smaller manufacturers are likely to find it difficult because of limited financial capacity. Reza urged companies to register as many eligible products as possible before the waiver expires.
Kabir of Renata urged the government to temporarily reinstate the pricing mechanism under the 1994 drug pricing policy until a permanent framework is put in place. "Until the government makes a policy decision on how prices will be determined, the DGDA is not fixing prices for newly registered medicines," he said. "Our focus is now on how to survive. When companies are worried about survival, they cannot think about expansion, investment or becoming globally competitive."
Industry executives warned that the prolonged impasse is creating a two-tier healthcare system, where patients who can afford costly imported medicines can access the latest therapies, while most Bangladeshis are left without comparable treatment options.