involved and lack of harmonization
with international regulatory
agencies besides the price point
pressure. The losses in this high cash
intensive market can be mitigated
by support from government and
international NGOs.
Considering the import duties
on raw materials and of the
cost of production, storage and
distribution the manufacturers
face a grim situation to run their
business profitably. The model of
low cost high volume business has
created margin pressure for some
vaccines to their manufacturers.
The supply chain of the vaccines
has to be strictly monitored
for specific temperature which
adds to the costing woes of the
manufacturer. A shortfall in the
private investments is strongly felt
by the vaccine manufacturers. The
cost of the institutional loans is high
in comparison with the returns. Eliminating redundancies in the
regulatory process
The meek margins realized for
certain vaccines strongly impact
the relapse of funds into their
R&D capabilities. Uncertainty in
demand forecasting for the vaccine
market may affect the profitability
of the manufacturers. Clear
regulatory guidelines are still under
development in India. The success
of the vaccine depends upon the
results of the clinical trials and the
prevailing regulatory guidelines.
With a great potential to emerge as
country’s key industrial contributor,
the vaccine businesses have not
been fully able to evolve due to
regulatory hiccups. However, with
the takeover of the new government
in 2014, the health ministry is
trying to streamline the regulations.
In a step towards that, for the
purpose of charting out a new
regulatory pathway for vaccines,
the Central Drugs Standard Control
Organization (CDSCO) constituted
three core working groups from
within the industry during 2015.
One each for strategy, technical
operations and technical post
approval each with its designated
chairman and member secretary
who will take the things forward
in a time bound manner. The new
initiative was an outcome of the
interaction between the vaccine
manufacturers and importers
in the country with the Drug
Controller General of India (DCGI)
on January 15, 2015 in New Delhi.
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