Factories at API park still unable to start production

Makers of active pharmaceutical ingredients (API) at the API Industrial Park in Gazaria of Munshiganj have fallen into uncertainty as bureaucratic complexities and the lack of gas connections are preventing them from starting production.

Investors of API industries now need to secure a number of certifications before starting commercial production due to the enactment of the Drugs and Cosmetics Act, 2023.

Earlier, API manufacturers would only need a licence from the Directorate General of Drug Administration (DGDA).

But now, they also need permission from the Department of Narcotics, the Department of Explosives and the Ministry of Commerce before commissioning their units, which is a time-consuming process.

As such, the pharmaceutical sector will face challenges related to patent law after Bangladesh graduates from the UN's list of least developed countries (LDC) in 2026, according to industry people.

Investors of API industries now need to secure a number of certifications before starting commercial production due to the enactment of the Drugs and Cosmetics Act, 2023

Acme Laboratories, Healthcare Pharmaceuticals, and Ibn Sina Pharmaceutical Industry have already set up plants at the industrial park, but the bureaucratic tangles and lack of gas are preventing them from going into trial production.

"The facility was all set to begin production but suddenly fell in trouble due to the lack of gas connection and bureaucratic complexities, namely the enactment of the Drugs and Cosmetics Act, 2023," said Muhammad Halimuzzaman, deputy managing director of Healthcare Pharmaceuticals Ltd.

"Earlier, we would need only one permission from the DGDA, but now we need permission from various government bodies, which takes at least six months to collect," he added.

According to Halimuzzaman, the narcotics department seeks a number of documents before providing a clearance certificate.

With this backdrop, API manufacturers are having to unnecessarily spend more time and money.

"We already invested about Tk 300 crore for setting up the API manufacturing plant through bank financing," he said.

SM Shafiuzzaman, secretary general of the Bangladesh Association of Pharmaceutical Industries, which represents 265 local drug makers, said the overall pharmaceuticals sector will face challenges during the LDC transition period due to the delayed commissioning of API industries.

He added that the API industries are helpless at the moment as the government is still unable to provide gas connections at the API industrial park.

Sheikh Maksudur Rahman, director of ACME Laboratories, said both the API and pharmaceuticals sectors need alcohol products like methanol as raw materials, which need extra permission from the narcotics department to import.

"So, investors who set up API manufacturing facilities spending crores of taka are facing severe bureaucratic problems," he said.

Besides, the central effluent treatment plant at the API park is yet to launch due to the lack of gas, Rahman added.

Syed Shahidul Islam, the preceding project director, said physical development of the API park has been completed and 27 companies were handed plots for setting up factories.

According to him, all utility connections, sans gas, are available in the area.

He also said an application has been submitted to the Titas Gas Transmission and Distribution Company Limited to provide gas to the API park, but there has been no progress in this regard.

Md Lutful Hyder Masum, general manager (corporate division) and company secretary of Titas Gas, acknowledged that they received the application but said nothing can be done for now due to the lack of sufficient gas supply.

However, he said they will be able to provide connections within the next one-and-a-half years as the government has signed an agreement with different international gas suppliers to this end.

Monjurul Alam, chief executive officer at Beacon Pharmaceuticals Limited, said the country is still unable to utilise its potential for API manufacturing despite the implementation of the API park.

According to him, API manufactures are keen to develop their own APIs to avoid patent laws after Bangladesh's LDC graduation.

"As we do not have enough time, we need faster permission from relevant government bodies," he said citing how the pharmaceuticals sector will otherwise face a lot of challenges.

Alam also said Beacon realised the problem in advance and that is why they are yet to start setting up a plant at the API park.

"We badly need government support to avoid challenges during the post-graduation period," he added.