After successful trials, three local drug makers are set to begin full-fledged commercial production of active pharmaceutical ingredients (APIs) at the BSCIC API Industrial Park at Gazaria in Munshiganj.

Two of the factories, ACME Laboratories and Ibn Sina Pharmaceutical, are currently awaiting regulatory approval, while the third, Healthcare Pharmaceuticals, has recently begun limited-scale commercial production of these essential drug-making raw materials.

"We obtained approval from the Directorate General of Drug Administration (DGDA) and began manufacturing on a limited scale recently," said Muhammad Halimuzzaman, managing director of Healthcare Pharmaceuticals.

He said full-scale commercial production of some items requires permission from the narcotics department, which they are currently awaiting.

The Bangladesh Small and Cottage Industries Corporation (BSCIC) established the industrial park along the Dhaka-Chattogram highway, allocating 42 plots for 21 industrial facilities.

Bangladesh now meets over 97 percent of its domestic demand for pharmaceutical products and exports medicine to more than 151 countries worldwide

So far, four local manufacturers -- ACME Laboratories, Healthcare Pharmaceuticals, Ibn Sina Pharmaceutical and UniMed-UniHealth Fine Chemicals -- have set up factories there.

Commercial production at the park spanning 200 acres was scheduled to begin in April of this year. However, it has yet to be connected to the national gas grid or equipped with a functional common effluent treatment plant (ETP).

"We commenced trial production nearly three months ago and submitted samples to the drug directorate for approval," said Mizanur Rahman Sinha, managing director of ACME Laboratories Ltd.

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Local production of pharma raw materials gaining traction

According to Sinha, ACME has already invested Tk 500 crore to import sophisticated machinery from the United States, Germany, Japan and India to ensure local APIs meet global standards.

He said the ACME unit will be able to produce APIs worth Tk 600 crore annually.

Jasim Uddin, chief financial officer of Ibn Sina Pharmaceutical, said they submitted their samples to the drug directorate in June this year.

"If the DGDA approves, we will proceed with commercial production of APIs. Our plant is fully ready to begin commercial production."

However, Nazmul Hossain, director of UniMed UniHealth Pharmaceuticals Ltd, said current market conditions are unfavourable for commencing commercial production due to high financing costs.

"We will begin commercial production once financing costs come down," he added.

Factories ready, park not

The initiative to establish the API park was taken in 2008, while the BSCIC allocated the plots to drug makers in 2018.

While pharmaceutical giants like Square and Beximco Pharmaceuticals got plots there, they are yet to begin factory construction.

Previously, SM Shafiuzzaman, secretary general of the Bangladesh Association of Pharmaceutical Industries, which represents 265 local drug makers, said most of their members have not set up factories at the park due to the long delay in providing gas connections.

Healthcare Pharmaceuticals Managing Director Halimuzzaman said API manufacturing needs uninterrupted electricity supply, necessitating a gas-run captive power plant.

Diesel-fueled electricity is expensive, ultimately pushing up costs.

Besides, he mentioned potential health hazards and pollution risks associated with pharmaceutical raw material manufacturing without a functional ETP.

Ashraf Uddin Ahmed Khan, the current chairman of the BSCIC, said he was unaware of the latest condition of the API park as he had only recently been appointed to the post.

Sanjoy Kumar Bhowmik, the immediate past chairman of the BSCIC, told The Daily Star that Titas Gas Transmission and Distribution Company assured them of gas connections.

'A worthwhile venture'

The country's pharmaceutical industry has undergone a remarkable transformation in recent decades from a heavily import-dependent sector to one that is nearly self-sufficient.

Bangladesh now meets over 97 percent of its domestic demand for pharmaceutical products and exports medicine to more than 151 countries worldwide.

But the country is still reliant on imported raw materials for around 85 percent of its requirements for both biological and non-biological small molecule APIs, incurring costs of around $1.3 billion annually.

These APIs are mainly sourced from China and India.

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API production falls short

Local pharmaceutical companies cater to the remaining demand, with at least six companies, including Square Pharmaceuticals and Incepta Pharmaceuticals, producing APIs worth more than Tk 2,000 crore annually.

Industry people say at least 50 percent of the country's demand for APIs could be met through local production if more big companies would invest in the sector.

This means the remaining 50 percent would still need to be imported since it is now possible to manufacture only non-biological small molecule APIs locally.

"Still, it is a worthwhile venture as the domestic market for non-biological small molecule APIs is currently worth around Tk 6,500 crore," said Sinha of ACME Laboratories.