Feasibility of Active Pharmaceutical Ingredient (API) industry by Imrul Sadat,

http://imrulsadat1.blogspot.com

Bangladesh having 16 crore population. Pharmaceutical industry is second largest industry in

our country But 90% API is imported. As linkage industry API having fesaibility.

The Active Pharmaceutical Ingredient (API) is the part of any drug that produces its effects.
Some drugs, such as combination therapies, have multiple active ingredients to treat different
symptoms or act in different ways.Production of APIs has traditionally been done by the
pharmaceutical companies themselves in their home countries. But in recent years many
corporations have opted to send manufacturing overseas to cut costs.This has caused significant
changes to how these drugs are regulated, with more rigorous guidelines and inspections put into
place.

Components of Medications

All drugs are made up of two core components: the API, which is the central ingredient, and the
excipient, the substance inside the drug that helps deliver the medication to your system.
Excipients are chemically inactive substances, such as mineral oil.

For instance, if you have a headache, acetaminophen is the active ingredient, while the liquid in
the capsule or the bulk of a pill is the excipient.

Strength of APIs

Manufacturers use certain standards to determine how strong the API is in each drug. However,
the standard can vary widely from one brand to another. One brand might use one test, another a
different one.

Top API Manufacturers

The leading manufacturer of APIs is TEVA Pharmaceuticals. With over 300 API products, they
have the industry's largest portfolio.

Another leading manufacturer is Dr. Reddy's, with more than 60 APIs in use today.

Where are APIs Made?

While many pharmaceutical companies are located in the United States and England, most API
manufacturers are overseas. The largest are located in Asia, particularly in India and China.
More and more companies are turning to outsourcing to API manufacturers like Dr. Reddy's to
cut costs on expensive equipment, employees, and infrastructure.
Notably, AstraZeneca Pharmaceuticals used to operate several manufacturing centers in the
United States. Now, just 15 percent of their APIs are created in the U.S. and there are plans to
end that small percentage and outsource all manufacturing overseas.

Regulations

The quality of APIs has a significant effect on the efficacy and safety of medications. Poorly
manufactured or compromised APIs have been connected to serious issues, such as illnesses and
even death.

Even in the case of outsourcing, APIs are subject to stringent regulations and oversight from the
country they are shipped to. For example, APIs produced overseas for use in drugs produced in
America still go through an inspection by the U.S. Food & Drug Administration.

As evidenced by the creation of APIs, the pharmaceutical industry is rapidly changing.

Companies no longer handle every step of the drug-making process, from creating the API to
building the capsule. In order to cut down on expenses and increase profits, companies have
begun outsourcing the creation of APIs to foreign manufacturers based in Asia. While this has
helped their bottom line, there is continued concern about the quality of these APIs produced
overseas.

In response, governing bodies responsible for patient safety, such as the FDA, have instituted
intense screenings to ensure medication quality and prevent defects. Violating any of these
established standards can result in fines or very expensive recalls for the pharmaceutical
companies behind these manufacturers.

The Active Pharmaceutical Ingredients (API) industrial park is finally taking shape nearly a
decade after the scheme was taken up with the view to facilitating a steady supply of raw
materials of drugs to reduce import dependency.

Recently, the developer of the park, Bangladesh Small and Cottage Industries Corporation, has
asked the 27 pharmaceutical companies -- which include Square, Incepta, Globe, Opsonin,
Beximco and Eskayef Bangladesh -- to complete all procedures and take possession of the 41
plots allotted to them in August.

“We will complete all procedures to take possession by this month,” said SM Shafiuzzaman,
secretary general of the Bangladesh Association of Pharmaceutical Industries.

The companies will start construction of their plants once taking handover of the plots.

“We hope that some of us will start operation by 2019.”

The initiative to build the API Park by the Dhaka-Chittagong Highway under Gazaria upazila of
Munshiganj for Tk 213 crore was taken in January 2008.

Originally supposed to be complete within five years, the construction of the complex was
delayed for land acquisition and addition of new components to the project.

As a result, the project cost was revised upwards twice to Tk 332 crore, up 56 percent from
original estimate.

It has been revised up again to Tk 364 crore based on recommendation from the planning
ministry in June this year, said Abdul Bashet, project director of the industrial park.

But the final cost of the project is expected to rise when it is close to completion, according to
the BSCIC.

Of the cost, Tk 80 crore will be needed for the effluent treatment Plant to be set up by BAPI, he
said.

The cost has increased for incorporation of the construction of a 2,000-metre pipe to discharge
treated water to Meghna River and a road, Bashet said, adding that they have sought an extension
for the project's completion by another two years.

The industrial park is now expected to be complete in June 2020.

As of now, land acquisition and development, construction of other roads and power substation
have been completed. “Now we have to ensure gas connection.”

The establishment of the transmission line is delayed as Titas is demanding Tk 5.5 crore to set up
connection, whereas Tk 3.5 crore is earmarked for the purpose. All companies save for one has
made advance payment for leasing the plots for 99 years.

The government is offering each acre of land for Tk 2.9 crore and entrepreneurs will have to pay
the total in instalments over a ten-year period at 10 percent interest, he added.

The drug makers who have got plots will get 180 days to submit their factory layout plans, which
the BSCIC will have to approve in one month.

“Then the construction works will begin,” he said, adding that 22,000 new jobs would be created
through establishment of plants at the enclave. “This will reduce API imports,” Bashet added.

Several local firms such as Globe, Beximco, Square and Eskayef Bangladesh manufacture some
APIs, and their production will increase gradually.

Yet domestic production is not enough to meet the demands of the pharmaceuticals industry,
which manufactures about 8,000 generic drugs.

And more than 90 percent of the Tk 4,700 crore worth of raw materials are imported every year,
according to a recent study by LR Global, an asset management firm.
As a result, the industry is vulnerable to external shocks, the report said, adding that local
companies would be able to source at least half of their raw materials once the activities of the
park start.

The park can open up the international API market to Bangladesh, said the report, which
forecasts that Bangladesh's pharmaceutical sector can grow at 15 percent for the next five years
riding on the expanded domestic market as well as new export frontiers. Greater affluence
among the poorest socio-economic group and a shift in disease profile are expected to drive the
growth of healthcare expenditure in Bangladesh, it said, citing the rise of non-communicable
diseases and a gradual move from acute to chronic diseases.

Presently, Bangladesh's pharmaceutical industry meets 98 percent of the local demand and
exports to 151 countries.

In fiscal 2015-16, total drug sales stood at Tk 15,600 crore, according to the report.

Pharmaceutical export rose 9 percent year-on-year to $89 million in fiscal 2016-17, according to
the Export Promotion Bureau.