Bangladesh Pharma Industry: Are we prepared?

1. BANGLADESH PHARMA INDUSTRY: ARE WE PREPARED?
By Shawkat Haider, M Pharm, PhD
shawkathaider@yahoo.com
Bangladesh is an LDC country with a population of 150 million and it has been
reputed only for its vibrant RMG industry which fetches around $10+ billion from
export. NO other industry, although having export potential, could make significant
foothold in overseas markets. The second biggest foreign currency earner is its
foreign remittance, mostly from semi skilled and unskilled labor force in middleeast,
which touches $9 billion in the current fiscal. Pharma industry has good export
prospects, its potential is highly publicized in media, but there are many hurdles and
challenges in its way to become a viable export industry- which should be addressed
immediately. The country has a commendable track record and has achieved almost
self sufficiency in pharmaceuticals production. Currently, at $750-800 million, this
industry has attracted huge public and media attention. Over the years, the sector
has attracted overseas buyers, mostly from unregulated markets, and it has earned
good reputation as a quality drug manufacturer. With recent certifications of top 3-4
pharma facilities by major drug regulatory agencies like UKMHRA, TGA etc, the
sector has reached new heights. Now let's talk about where the industry is right now.
Since the DOHA declaration, six years have elapsed. How far have we progressed in
terms of infrastructure development or competitiveness? After many years of efforts,
the govt. has just allocated land for the proposed central API (active pharma
ingredient) facility. It's commonsense that if you don't have the backward-integrated
API or raw material industry, you cannot be competetive in export markets. India is
competitive in world market because it has vibrant, world class API manufacturing
capabilities. APIs occupy a significant portion of cost of pharma products, and cheap
labor cost is not a huge advantage as it is always publicized by many. With unreliable
power supply, where most of the companies have to rely on captive power
generation, have we done our exercise as to how our margin is eroded due to this?
Where are we now? Sad but true- we are no where near india in terms of skilled
manpower or process capabilities, and there is no visible progress to develop the
skillset or manpower. Isn't it quite a big lapse when the time factor is critical? Again,
the industry is yet to have any bioequivalence testing facility which is mandatory for
product registration in developed markets, and there is mounting pressure from even
semi regulated markets for such compliance. When we talk about billions of dollar,
we mean regulated markets like US and EU, where generic drug industry is growing
fast with increasing pressure from public and legislators and also global economic
downturn. The global generic drug market is now $80 billion, and US is the market
leader with $38 billion whereas India's presence is strong with $9 billion. Unless you
prove that your medicine is equivalent to the originator brand in terms of safety and
efficacy, by conducting bioequivalence testing in human subjects, you cannot make
any foray into the regulated markets like US, EU, Australia etc. The cost of doing
such test is exceedingly high in developed countries ranging from Tk 70-90 lakh per
study; in India it costs around Tk 40 lakh. A central bioequivalence facility in the
country can largely benefit the industry by saving foreign currency, at the same time
this will significantly improve the quality of our medicines. Again the same question
arises- why is the delay in taking action? Couldn't this be done much earlier? By the
time the central API and bioequivalence facilities are ready, there is no clear timeline
though, 2016 is knocking at the door -- the waiver period will expire without any real
benefit to the industry. Having so many advantages, as many experts say, how is

2. the industry equipped to realize them is a million dollar question. When we have
generic drug producers like India and China, we will have to make double the efforts
required to enter any export destination. Is India sleeping? India has over 100 US
FDA-approved pharma plants, the highest number outside the US; and they are
increasingly focused on R&D.
This is pharma industry and India is far ahead of us in terms of know how or scale of
operation to be competitive in export markets. Not only manufacturers from Israel,
India or China, the ever increasing number of generic players are fiercely competing
in the 80 billion dollar generic drug markets. India is not overlooking opportunities
even in African countries where they have already set up plants taking advantage of
LDC status of those countries -- particularly for HIV drugs. Here we don't understand
the issues of TRIPS well and everyone is concerned about hypothetical prospects.
There is no brainstorming where we are now and what would be our competitive
advantages in the export market. Say, for example, we can produce any new
patented drug without the permission of the patent holder till 2016. Fine.. but where
will we get the raw material or API for this formulation? India or China are no longer
allowed to manufacture the new drugs, and we are mostly dependent on them for
our APIs. The only possible way is to produce those APIs in our own country with our
own skills. Do we have that? Although we are producing some of the old and
conventional APIs like amoxicillin, cipro, ranitidine, paracetamol etc on a commercial
scale, we are far from synthesizing the new and patented drugs. So, the question is
capability as well as availability.
To build up the capabilities we must start from the university which is the skill
development workshop, we must improve our education system with practically-
oriented advanced courses having adequate laboratory facilities. There should be
more industry-university alliance and collaborative research between universities at
home and abroad to promote research activities. If we cannot have the degree of
competence developed back in the university level, we cannot compete in any way-
in the long run. This is largely a knowledge based industry- unlike many other
industries such as RMG the cheap labour or conventional wisdom is not enough.