the problem of their storage and
distribution has fallen short of
receiving the attention they
deserve. The complexity of the
problem increases with related
issues such as cold chain,
temperature control, lack of
information, technology and
infrastructure, multi-agency multifunctional fragmented supply
chain, quality and safety.
The supply chain management of
perishable food produce consists
of various processes from
production in farms to delivery to
the distribution outlets or end
consumers. These processes
involve storage and transport
through a chain of intermediaries
like farmers, local traders,
transporters, freight forwarders,
regulatory and port authorities,
warehouse operators, processors,
retailers, etc. and their various
functions, such as transfer of
ownership of commodities,
movement of perishable cargo,
maintenance and preservation of
quantity and quality, payment to
the seller and delivery to the
buyer. It is mainly by
streamlining these functions that
movement of perishable
agriculture products is taken care
of globally. Few of the important
measures setting up a single-point
payment system for all taxes,
either domestic or international
and faster single-window
clearances to prevent delays
leading to decay and loss.
The regulatory scenarios differ
in various aspects across the
world. How do the biopharma
products such as vaccines and
biosimilar drugs pass the
compliance measures in a new
environment?
Biosimilars are biotech drugs that
are made to have quality, safety,
and efficacy comparable to the
“
Vaccines face a tougher
safety standard than
biosimilars due to their likely
toxic effects, especially on
children and people with
immune deficiency. Therefore,
regulatory authorities have
become increasingly vigilant
launching effective surveillance
efforts and pre-licensing trails to
monitor the safety of vaccines.
original product. Biotech processes
and products are complex.
Therefore, the biggest challenges
regulatory agencies across the
world face are about being able to
establish the correlations between
the clinical safety and efficacy of a
biotech product and its product
quality in comparison to the
original drug which is about
striking the balance between
financial benefits and public safety
of having that drug in the market
for consumer use.
Different regions may vary in the
operating analytical methodology
to establish this efficacy and safety,
but by and large they agree on the
need to have a compliance
framework and procedural
guidelines in this regard. For
instance, the European regulatory
authorities already have The
"Guideline on Similar Biological
Medicinal Products" and World
Health Organization (WHO) is also
in the process of issuing guidelines
that provide globally acceptable
principles for licensing
biotherapeutic products similar to
original licensed ones. Similarly, in
the US, the FDA Policy on
Coordinated Framework for
Regulation of Biotechnology
governs review and approval of new
protein products. These guidelines
recommend that a Safety
Specification, Pharmacovigilance
Plan and Critical Process
Parameters (CPP) be submitted at
the time of license application that
outlines the design and
performance of these products for
them to pass through compliance.
Vaccines face a tougher safety
standard than biosimilars due to
their likely toxic effects, especially
on children and people with
immune deficiency. Therefore,
regulatory authorities have
become increasingly vigilant
launching effective surveillance
efforts and pre-licensing trails to
monitor the safety of vaccines.
The WHO is working with 12
countries, including Iran, Tunisia,
Vietnam and India, to develop
methods and tools for vaccinesafety monitoring and reporting
them to a global database.
What are the common issues
faced by the healthcare
companies while moving their
products through supply chain
and customs? How do
companies deal with these?
Healthcare is supposed to be a
highly regulated sector for most
obvious reasons of safety and
wellbeing of the entire population.
The pharma and healthcare
industry world over is influenced
by patent laws, safety policies,
drug regulation, price regulation,
insurance, illegal and corrupt
practices, etc. Hence, regulatory
mechanism plays a crucial role.
While there are similarities
between countries (like the
universal need for shipment
documentation, including
commercial invoice, import
declaration and Bill of Lading,
there are local, specific
requirements that have to be
addressed. In India, for instance,
the drug manufacturers and
exporters not only need to adhere
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