Policy hurdles, import syndicates, counterfeits holding back Tk41,000cr medtech market

Infographics: TBS

Bangladesh is now capable of manufacturing almost every essential medical device required for a modern healthcare system. Local industries are producing blood pressure monitors, glucometers, nebulisers, mobility aids, hospital beds, suction machines, rehabilitation tools, ICU and CCU beds, modular operating theatre systems, ventilators, and even some imaging equipment under contract manufacturing arrangements.

Yet hospitals and clinics across the country remain heavily dependent on imports.

Industry insiders estimate the domestic medical device market at around Tk15,000 crore. But despite rising local capacity, Bangladesh spent Tk7,000 crore on imported devices in FY2021 alone, up from over Tk4,000 crore in FY2017, according to National Board of Revenue data.

The disconnect raises a critical question: How did a country that built a $3 billion pharmaceutical industry – meeting 98% of domestic drug demand and exporting to more than 160 countries – fail to replicate this success in medical devices?

While pharmaceuticals have become a national success story, domestic medical device makers meet only 10-15% of national demand. Imports supply the rest, allowing low-cost and substandard products to enter the market due to weak regulatory controls.

Demand, meanwhile, is surging. Rising incomes, a growing middle class, and greater health awareness are driving the sector towards sustained double-digit growth. But the industry's ascent to becoming a manufacturing powerhouse remains stalled – largely because Bangladesh still lacks a modern, comprehensive medical device policy.

Without such a policy, investors hesitate, global manufacturers avoid long-term commitments, and local producers struggle to scale or meet international certification standards.

"The 1982 National Drug Policy transformed Bangladesh's pharmaceutical industry, but no comparable policy exists for medical devices, equipment, or even cosmetics," said Md Abdur Razzaq, founder and managing director of JMI Group, the country's largest medical device manufacturer.

He said in the absence of a strategic roadmap, entrepreneurs remain cautious and the sector stays import-dependent.

Tk15,000cr market growing at 15%

According to the Bangladesh Association for Medical Devices and Surgical Instruments Manufacturers and Exporters, the domestic market is worth around Tk15,000 crore, growing at 15% annually. Nearly 90% of devices – from syringes to imaging and surgical machines – are imported.

If this trajectory holds, the market may reach Tk41,000 crore by 2030, aligning with forecasts presented at the Bangladesh Investment Summit 2025 that project a $23 billion healthcare sector.

"Diagnostic and imaging equipment, surgical instruments, PPE, and IV sets are essential for modern healthcare, yet there is no policy supporting local manufacturing," Razzaq of JMI said.

"Even a 10-year incentive policy – low-interest loans, tax breaks, marketing support – could create a sustainable domestic industry."

He added that a longstanding "import syndicate" has dominated device procurement, stifling local industry growth.

With stronger oversight, Bangladesh could scale production of high-end equipment such as ventilators, dialysis machines, digital X-ray units, ultrasound machines, ECG devices, infusion pumps and monitoring systems, he said.

From saline to sophisticated devices

Bangladesh's medical device journey began in 1995 when Opsonin Saline established the first local plant. JMI Syringes and Medical Devices followed with mass-scale syringe manufacturing in 1999.

Since then, major firms such as Nipro JMI, Libra Infusions, Pran-RFL's Getwell, Incepta Hospicare, Promixco, DBL, Taiwan-Bangla Medical Equipment, Accura Biotechnology and Shefta Medical Industries have expanded the sector.

Local manufacturers now produce diagnostic instruments, imaging devices, surgical tools, PPE, syringes, IV and infusion sets, haemodialysis tubing sets, respiratory care items and critical care consumables.

"JMI Group exports haemodialysis tubing sets to more than 40 countries, while Promixco supplies around 60% of ICU, NICU and CCU beds in Bangladesh," said Mousumi Islam, chairperson of Promixco Group.

Local production has boosted availability of syringes, saline and PPE, but still covers less than 10% of overall demand.

Industry asks for policy support

Incepta entered the medical equipment segment in 2017, focusing on surgical sutures and infusion sets for district-level hospitals.

But few companies venture deeper into the sector due to high capital needs, strict compliance requirements and long payback periods.

Establishing sterile production lines, securing ISO and Director General Drug Administration (DGDA) certifications, maintaining quality standards – all require major investment, yet profit margins remain thin due to cheap illegal imports and heavily price-controlled government tenders, said Mizanur Rahman, head of Incepta Hospicare.

Legal manufacturers also face high VAT and import duties on raw materials, while under-invoiced imports evade such costs. Delayed VAT refunds further strain working capital.

Bangladesh produces hundreds of biomedical engineers annually through institutions such as Buet, Bangladesh Medical University and several private universities. But many leave the country due to limited high-tech opportunities.

Rising costs have also slowed diversification.

"Our saline production continues, but producing other devices with imported raw materials has become too expensive. Smuggled or under-invoiced devices are often sold below our production cost," said Abdur Rahman, managing director of Opsonin Pharma.

Fake imports and health risks

With no strong domestic manufacturing base, rural and semi-urban markets are dominated by small importers and unregistered distributors. Poorly calibrated or counterfeit devices – from BP monitors to diagnostic kits – pose serious public health risks.

In 2022, law enforcement raids in Dhaka uncovered large quantities of expired and counterfeit diagnostic kits with tampered expiry dates, some originally manufactured as far back as 2010.

"Importers face almost no accountability, but domestic producers face dozens of hurdles," said Rahman.

Regulatory hurdles, sector potential

The DGDA regulates imports, exports and production. Several local firms are being vetted for new plant approvals, though high-tech manufacturing has yet to begin.

Professor Md Abu Jafar, director general of DGHS, said consumer safety remains the priority, with urgent imports approved only when products are unavailable locally.

He said Bangladesh still lacks internationally accredited testing laboratories, forcing manufacturers to rely on expensive overseas certifications. High import duties on raw materials reduce competitiveness.

"Regulatory approval timelines remain lengthy, and the shortage of skilled biomedical engineers limits expansion," said Mousumi of Proximco.

New regulatory era, expansion

The Bangladesh Drug and Cosmetics Act 2023 aligns national regulations with the EU MDR, WHO and US FDA standards. Mousumi said this shift signals a maturing production base. Getwell, a Pran-RFL brand, expanded its medical device factory after an initial Tk154 crore investment in 2020.

"Since entering this sector, market response has been very encouraging. We are expanding our product line as demand grows," said Kamruzzaman Kamal, director of marketing at Pran-RFL Group.

Meanwhile, Promixco is expanding into respiratory care, diagnostic accessories and critical care consumables.

JMI Group's export strength in haemodialysis tubing sets shows Bangladesh can compete globally with the right policy support. "We have the technology, manpower and market. What we lack is consistent policy support," Razzaq added.