(^26) COVER STORY BIOSPECTRUM | SEPTEMBER 2018 | http://www.biospectrumindia.com
future for vaccine research in
India is partially dependent on
new technologies, the companies
need to have the patience for
long term investments
and research and
development”, shares
Dr Krishna Ella, CMD, Bharat Biotech.
This year also saw a strategic deal being signed
between Panacea Biotec and Serum Institute of India
(SII) for a fully liquid six-in-one vaccine. Under the
collaboration, SII will be allowed to make and sell
fully liquid Whole cell Pertussis (wP) and Salk-based
Injectable Polio Vaccine (IPV) based Hexavalent
vaccine (DTwP-HepB-Hib-IPV) developed and
commercialised by Panacea Biotec, touted to be the
first of its kind. Both vaccine companies intend to get
this wP-IPV-based Hexavalent Vaccine introduced
in the government’s National Immunisation
Programme. Other developing countries are also
on the radar through stakeholders, including
governments, the World Health Organisation, the
Global Alliance for Vaccines & Immunisation (GAVI),
the Bill and Melinda Gates Foundation (BMGF) and
other United Nation agencies.
Back in 2017, SII had launched two new vaccine
products - Rotasiil and Rabishield for rotavirus
causing diarrhoea and rabies respectively. The newly
developed Rabishield anti-rabies immunoglobulin
is the world’s first recombinant rabies monoclonal
antibody to prevent Rabies, a fatal disease which is
estimated to cause two deaths every hour in India.
Rabishield has been developed in research partnership
with Massachusetts Medical School, USA. Rotasiil
rotavirus vaccine is the world’s first thermostable
pentavalent Rotavirus vaccine containing the G9
strain to help prevent the spread of rotavirus which
causes diarrhoea mostly in babies. Currently, SII is
working on developing vaccines against pneumonia,
chikungunya and enteric diseases.
“The main challenge the Industry is facing in
vaccine development is capital intensive nature of
development and long gestation period. To sustain
through this along with technological complications
and legal framework, is quite a task. In
fact clinical trial permissions and
protocol is also equally challenging as
technology. For the coming years, new
technologies are required for carrying
out analytical work and testing of
vaccines”, elaborates Dr SD Ravetkar,
Executive Director, Serum
Institute of India.
Joining the league of vaccine R&D,
Sun Pharmaceutical Industries
Ltd has entered into a collaboration with the
International Centre for Genetic Engineering and
Biotechnology (ICGEB), New Delhi to develop a novel
dengue vaccine targeted against all four serotypes
of dengue virus (DENV). Sun Pharma is funding
and supporting further development of the vaccine
candidate while ICGEB will be granting Sun Pharma
exclusive rights and licenses for development and
commercialisation of this vaccine globally. “A major
problem with dengue is that as it has four types --
DENV-1, DENV-2, DENV-3 and DENV-4 and it is
quite possible that a person may get infected with
one type first and later have a secondary infection
with another type. The drug we are working on has
been validated in animals and is ready to undergo
all the mandated safety and toxicity tests as per
existing regulations. It is derived from a plant
called Cissampelos pareira Linn (Cipa). It has been
List of Licensed Human
Vaccine Manufacturers in India
Private Vaccines Manufacturing Units
● Bharat Biotech International Ltd.,
Hyderabad
● Biological-E Ltd., Hyderabad (3 Units)
● Biomed Private Limited, Ghaziabad
● Cadila Health care Ltd, Ahmedabad (2 units)
● Cadila Pharmaceuticals Ltd., Ahmedabad
● Chiron Behring Vaccines Pvt. Ltd. Gujarat
● Dano vaccine & Biological Pvt. Ltd.,
Hyderabad
● Green Signal Bio Pharma Pvt. Ltd. Chennai
● Panacea Biotech Ltd., (2 units)
● Ranbaxy Lab, Bangalore
● Serum Institute of India Ltd., Pune
● Shantha Biotech Ltd., Hyderabad (2 units)
● GSK Asia Pvt Ltd, Nashik (Labelling and
packaging)
● Sanofi Pasteur India Pvt Ltd, Mumbai
(Relabeling & Stickering)
Public Sector Undertaking (PSU)
Vaccines Manufacturing Units
● Bharat Immunological & Biological
Corporation Ltd. (BIBCOL), Bulandshahr
● Haffkine Bio Pharmaceutical Corporation
Ltd., Mumbai
● Human Biological Institute (3 Units)
● HLL Biotech Ltd., Chennai
Govt. Vaccines Manufacturing Units
● BCG Vaccine Laboratory, Chennai
● Central Research Institute (CRI), Kasauli
● Pasteur Institute of India, Coonoor
Source: http://www.cdsco.nic.in
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