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The meeting was convened to hold
discussions on the current national
and international scenarios in
vaccine development and its
regulations. The dialogue between
regulator and industry on various
issues, challenges, opportunities
in respect of manufacturing of
priority vaccines including import
of vaccines and regulatory pathways
i.e to promote a legal, regulatory
and administrative framework for
the safety of vaccines at national
and international levels.
While the manufacturers go
through hiccups, the importers
too have to face many issues
including taxes and transportation.
In case of imported products,
these are considered on a case-
by case basis; if trials meet the
requirements of the National
Regulatory Authority (NRA), there
is no insistence on clinical trials
in the country for registration.
The advisory committee that
review the information follow
published guidelines, directed by
a responsible person. External
clinical experts may be asked for
advice on a case-by-case basis. After
licensing, the vaccine manufacturer
should undertake a large post-
marketing surveillance (Phase
IV) to further ensure the safety
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BioVoiceNews | September 2017
of their products. Any complaint
regarding the safety, efficacy, etc
of the licensed vaccine should be
directed to NRA. Once the vaccine
is licensed in the country, it can be
used both by the private as well as
the public sector. Generally, all the
vaccines recommended by Indian
Academy of Paediatrics-Committee
on Immunization (IAP-COI) are
approved by WHO.
The experts have also termed the
inclusion of vaccines in National
List of Essential Medicines (NLEM)
misconstrued besides blaming the
dearth of funding mechanisms for
scale-up and technology access,
several redundancies in current
regulatory pathways and lack of
defined timelines causing undue
delays in new product launches.
As per Pushpa Vijayraghavan,
Director, Sathguru Management
Consultants, “Eliminating
redundancies in the regulatory
process and creating efficiency in
the approval pathway is critical to
ensure that the country realizes
benefits of the current pipeline
of high value vaccines such as
PCV. These are high public health
priorities and delay in approval of
Indian vaccines only extends the
period of dependency on couple