World Monitor Mag, Industrial Overview WM_November_2018_WEB_Version | Page 36

EXPERT OPINION
will be implemented next year. We hope
that the new laboratory complex will also
become a unique object for Kazakhstan,
because it is initially designed to meet the
requirements of good laboratory practice.
Pharmacists have standards for GDP,
GMP, GLP, even good agricultural practices
for collecting medicinal raw materials,
which have not yet been implemented in
Kazakhstan. This project will take us even
a step higher in terms of competitiveness
and export potential.
The investment program is developing
and gaining momentum in response
to market demand, modern realities.
Because of our leading positions in the
market, we can use opportunities for
further development, increase export
potential, implement innovative ideas and
solutions in production.
Let me remind you that in addition to
production sites, we have a modern
warehouse complex that meets the
standards of good distribution practices.
Our factory is the most “’smart’ from
the point of view of digitalization.
We are the only farm enterprise in
Kazakhstan who participated in the
pilot project ‘Model Digital Factories’,
implemented within the state programs
‘Digital Kazakhstan’, ‘Industry 4.0.’. We
underwent a rather complicated and
serious audit of the German Fraunhofer
Institute, commissioned by the Ministry
for Investment and Development, the
Ministry of National Economy and the
administrators of the Digital Kazakhstan
project. The company’s level of
digitalization was determined to be at a
fairly high level. Only seven manufacturing
enterprises participated in the pilot
project. I think that we are comparable
to the giants of heavy engineering, given
that their ‘digit’ level of penetration is
much higher than that assumed in the
pharmaceutical industry. That is, we
secured leadership in automation. A
separate investment aspect, which is
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not included in the previously announced
figures - these are our digital projects.
This is our present and our future.
Biotechnology is a complex and multi-
step process. You mentioned generics
and biosimilars. Please tell us about
their role in modern medicine.
We talked about the fact that SANTO
is both a domestic manufacturer and
a supplier of generics, including from
the sites of our investor - Polpharma
Group. Generics is a non-patent version
of the original drug product, in which
patent protection is completed, and
manufacturers have the opportunity
to reproduce this drug that meets the
requirements for quality, efficacy and
safety. As you know, pharmaceuticals is
a highly regulated industry, respectively,
all generic drugs comply with the
requirements of the national regulator.
In turn, the national regulator justifies
its requirements, referring to the British,
European Pharmacopoeia. Thus, generic
drugs meet the requirements for quality.
The professional level of the domestic
regulator, expert body – the National
Centre of Examination – is very high.
Recently, they successfully passed
the qualifications of the World Health
Organization, that is, a kind of audit of an
expert body in the field of pharmaceutics.
Kazakhstan has established itself as a
country with good regulatory practice.
According to the data of the National
Centre of Expertise, generic products
that enter the country's markets comply
with international, European quality
requirements. The regulatory requirements
in force in Kazakhstan correspond to those
in the EU. Concerning us, as a domestic
producer, there are higher requirements
for the release of products to the market
than for foreign importing companies. For
us testing is obligatory in laboratories. If,
for example, generic products supplied
from countries of the ICH region (countries
with high regulatory practices, such as the
EU, the USA, Japan, Canada) do not have
to undergo laboratory tests during drug
registration, then domestic manufacturers
confirm the quality of the generic with
laboratory testing. This is about domestic
generics versus imported ones.
We believe that, on the one hand, it
puts domestic producers in unequal
conditions, because the ICH countries
do not check, and domestic producers
check. This puts an extra burden on us.
On the other hand, for us it is another
opportunity to prove that domestic
generics meet the same requirements.
This should dispel the myth that our
generics, in particular, produced by
SANTO, are somehow different from
foreign ones. There are many myths,
some of them are based on associations
with crisis periods in the 90s and early
2000s. Today, because of the investor
and the potential that our plant has, we
have created an innovative and modern
production site. It’s not so easy to get
rid of old myths, but we continue to
work on it.
In addition, we play an important role as
a leader – supplier of generics in terms
of national security in the healthcare
system. If you look at the list of our drugs,
it becomes clear that basic medicines,
which are in our portfolio, are classified
as vital. In Kazakhstan, formally, there
is no definition of ‘life-saving drugs’,
but those drugs that are included in
the National Formulary actually reflect
the concept of ‘life-saving drugs’.
Our drugs, as well as others from the
National Formulary, are the basis for
the treatment of diseases in both
hospital and polyclinic or outpatient
settings. This characterizes our role as
a pillar of safety and reliability as a drug
supplier in the country. Generics in our
portfolio are presented from different
generations, which means it can be
basic drugs or drugs with a well-studied