Drug pricing deadlock stalls hundreds of new medicines, strands investment

Infographic: TBS

A regulatory deadlock over drug pricing has stalled the launch of new locally manufactured medicines, including life-saving therapies, dealing a blow to both patient care and one of Bangladesh's most successful manufacturing sectors.

Nearly two years into the impasse, pharmaceutical companies say investments worth crores of taka in product development, manufacturing and regulatory compliance remain stranded, while patients continue to be denied access to newer treatments.

The crisis has left more than 100 drug manufacturers waiting for marketing approval and price fixation for thousands of medicines, according to industry estimates.

The delayed products include treatments for cancer, diabetes, chronic kidney disease, asthma, infertility, fungal infections and several other serious illnesses, they said.

Healthcare Pharmaceuticals illustrates the scale of the problem.

The company has developed two strengths of the immunotherapy drug Nivoluma – 40mg/4mL and 100mg/10mL – for the domestic market. It is a standard treatment for melanoma and several advanced cancers, including lung, kidney, liver, stomach and colorectal cancers.

However, the locally manufactured products have yet to reach pharmacy shelves because the Directorate General of Drug Administration (DGDA) has neither fixed their prices nor granted final marketing approval.

Industry executives said the prolonged delay is tying up large investments, slowing innovation and preventing patients from accessing newer therapies that are already available in many parts of the world.

This is no longer just an industry issue; it has become a patient-care issue, several pharmaceutical executives told The Business Standard, urging the government to resolve the regulatory impasse and clear the backlog of pending applications.

Crisis intensifies following court order

Pricing delays had long plagued the approval process, but the crisis deepened after a High Court order last August directed the government to determine the prices of all life-saving medicines following a writ petition filed by the Consumer Association of Bangladesh (CAB).

The CAB urged the High Court to order the government officials to explain why they had failed to fix the prices of all medicines under the Drugs and Cosmetics Act, 2023.

However, 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 DGDA has effectively stopped fixing prices for new medicines. Without a government-approved price, a company cannot legally market a product, pharmaceutical companies say.

"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 (BAPI).

"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," said Zakir, who is also managing director of Delta Pharma.

Industry estimates suggest top 20 to 25 pharmaceutical companies each have 20 to 30 products awaiting approval, while dozens of smaller manufacturers face similar backlogs.

The pipeline includes medicines for major depressive disorder, advanced cancers, chronic asthma, liver fibrosis, sickle cell anaemia, infertility, chronic kidney disease, and severe fungal infections.

"Over the past two years, almost no new medicines have reached the market," said Rabbur Reza, chief operating officer of Beximco Pharmaceuticals. "More than the industry, it is patients who are suffering because they are being deprived of newer treatment options."

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.

Hundreds of products remain stuck

Officials at leading pharmaceutical companies say dozens of life-saving medicines remain stuck awaiting price approval.

Healthcare Pharmaceuticals officials said they have 18 medicines pending, including five cancer treatments for ovarian, breast, pancreatic and prostate cancers, as well as for blood cancers, chronic kidney disease-related anaemia, liver disease and severe fungal infections.

Renata has around 20 products awaiting price fixation, including seven oncology medicines submitted over the past two years. Beximco Pharmaceuticals is waiting to launch 25 medicines covering hypertension, diabetes and pain management.

ACI Pharma has 27 medicines pending approval, including treatments for cancer, diabetes and asthma. Opsonin Pharma has 24 products awaiting clearance, while Incepta and Square Pharmaceuticals each have 25 to 30 medicines held up in the regulatory process.

Syed S Kaiser Kabir, chief executive officer of Renata, said companies remain uncertain about how the government plans to implement the new pricing framework.

"Until the government makes a policy decision on how prices will be determined, the DGDA is not fixing prices for newly registered medicines," he told The Business Standard.

He added, "Our focus is now on how to survive. When companies are worried about survival, they cannot think about expansion, investment or becoming globally competitive."

Kabir urged the government to temporarily reinstate the pricing mechanism under the 1994 drug pricing policy until a permanent framework is put in place.

Even price reductions are on hold

Nearly a year ago, ACI Pharmaceuticals applied to reduce the price of Tirzepatide INN 2.5mg/0.5mL, a widely used injectable treatment for Type 2 diabetes, along with five other medicines. Despite repeated follow-ups, the applications remain pending.

As international prices of several medicines have fallen, local manufacturers say they have been unable to pass on the reductions because the current pricing framework does not permit price revisions without regulatory approval.

"Medicine prices fluctuate globally as raw material and import costs change," said Mohammad Mohsin Mia, director of ACI Pharmaceuticals. "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. 

They say 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 AkterHossain, a DGDA director.

He said the law requires recommendations from two separate committees before medicine prices can be approved. The ministry has already formed one committee, while work is underway to complete the remaining process.

A DGDA official, requesting 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 of them together for consultation.

The regulatory deadlock comes at a critical time for Bangladesh's pharmaceutical industry, which meets about 98% of domestic demand, exports to more than 150 countries and has become one of the country's most globally competitive sectors.

Industry leaders argue that regulatory certainty has become more important than ever. With Bangladesh preparing for graduation from least developed country status in 2026 when many intellectual property flexibilities for generic medicines will gradually disappear.