setting up Pharma Zones in India
The Drug Controller General of India (DCGI), India’s home
grown equivalent of FDA of the US is setting up a export-import port
office in Bangalore.
According to a DCGI director general Dr Surinder Singh, the
export-import center in Bangalore International Airport will help
pharma makers in Bangalore a hassle-free and dedicated place for export
and import of pharmaceuticals products.
“This is in view to address the long pending demand from the
industry in Bangalore. They wanted an export and import
center at the Bangalore airport. The setting up of this port will save
time for the pharma exporters in Bangalore. The Bangalore International
Airport Limited (BIAL) authorities have also given us space
for a sub-zonal office in Karnataka. Mani Vannan, senior deputy
director of port facility will take over as head and he will be
assisted by two assistant drug inspectors,” Dr Surinder
Singh, Drug Controller General of India, Central Drugs Standard Control
Organization said in Bangalore.
There are four port offices in India at Mumbai, Chennai, Kolkata and
Ghaziabad and two sub-zones at Hyderabad and Ahmedabad, and both of
them are being upgraded as full-fledged zones soon increasing the total
number of zones in India to six.
The federal government also intends to have a sub-zonal office in
Karnataka, where there are a lot of mid and small tier drug companies.
The office will initially function from the Karnataka State Drugs
Control Department and later shift to a permanent facility. A new
sub-zone will also be set up in Baddi, Himachal Pradesh, a tax free
Debashish Panda, joint secretary, drugs, ministry of health and family
welfare, Government of India, said that the zones will facilitate
inspections, license approvals and eventually manage clinical trial
The DCGI is also starting Pharma Zones, which are dedicated
areas for export and import of pharmaceutical products, having cold
storage facility and laboratory for testing samples.
The federal health ministry is setting up an expert panel to hammer out
the details of the proposal at Delhi, Mumbai and Hyderabad airport.
Besides, Pharma Zones will also be set up at sea ports. DCGI is in
discussion with the civil aviation ministry and the port trusts on the
modalities. The Pharma Zones will be in place by March 2010.
The total investment planned for these Pharma Zones is Rs 7 crore,
which will be borne by GMR, the Bangalore-based consortium developing
the Delhi airport and Hyderabad-based GVK group which is developing the
Mumbai airport. Details will be finalized in consultation with them.
The Pharma Zones will have cold storage centers for drugs. The
facilities would be worked out depending on the proposed volume of
medicines handled. It will prevent the possibility of
cross-contamination and drugs will be stored at different temperatures
as prescribed to ensure efficacy.
Dr Surinder said, “This is a part of our Good Distribution
Practices (GDP) and our strategy in making things better and more
centralized. As we move towards the clinical trial audits, we need to
make our presence better. This is also a step towards gearing up the
country with Rs 2.8 lakh crore ($60 billion) worth of drugs going off
patent. We want India to take at least 40 percent of that share. This
will require quality infrastructure, more inspections and
Speaking about its recent move towards making clinical trial registry
mandatory, Dr Surinder added, “We don’t want
Indians to be treated as guinea pigs. Therefore we have made it
mandatory for clinical research organizations to register the trials
through Indian Council of Medical Research (ICMR). We expect
things to become transparent with this initiative we will
know what trials are being conducted in India. We
are also getting our people trained from the FDA for clinical trial
audits. They will learn to audit bioequivalence centers. Clinical trial
auditing will become very important in the coming years. We will
randomly pick up centers for such audits to keep a regular check in the
system and if there is a misconduct or fraud, we will take
Biosolutions to introduce test for H1N1 flu
India’s Ocimum Biosolutions has launched a microarray-based
test (research use only) for the latest version of the H1N1 flu. The
company reported that it has updated its custom chip probes using
sequence information from the latest strain of the swine flu from the
NCBI site. The CDC and US Food and Drug Administration have authorized
the emergency use of an RT-PCR-based molecular diagnostic assay to
identify cases of swine flu in the current outbreak in the US.
Anuradha Acharya, CEO, Ocimum Biosolutions, said
“Our bioinformatics team in India has redesigned the OciChip
array probes to match the latest sequence information available. The
RT-PCR assay and the microarray will quickly identify the H1N1 virus in
patients diagnosed with influenza A as some older tests may not pick up
this new strain.”
The microarray was developed on Ocimum’s custom OciChip array
platform three years ago when the first cases of the avian flu outbreak
occurred. This is now said to have been updated with the latest
sequence information posted last week and the probes have been
redesigned. According to the company, this test will be available for
use after the validation is completed. Ocimum said that it can also
provide an RT-PCR-based molecular diagnostic assay for use in India and
“In a public health emergency like swine flu
outbreak, we want to make sure that we identify the right strain which
is not picked up by current tests. We are ready to work with various
public health labs in India and the region that need help in setting up
these assays. Both these assays can be conducted in a few hours and
avoids the risk of patients with suspected cases infecting others when
they have to wait longer,” added Acharya.
to invest $150 mn in Genome Valley
Swiss bio-pharmaceutical company Lonza said it is investing Rs 713
crore ($150 million) on two major projects in Genome Valley in
BP Acharya, chairman and managing director of Andhra Pradesh Industrial
Infrastructure Corporation, announced the investment during the India
Evening session held at India Pavilion at the international biotech
conference, BIO, in Atlanta, USA.
“This is one of the largest investments in recent times in
the biopharmaceutical sector in India and marks the emergence of India,
in general, and Genome Valley, in particular, as a preferred
destination for global biopharmaceutical companies,” said
“This is an achievement for Bio Asia, the global bio-business
forum, and Genome Valley to draw companies like Lonza to Hyderabad. The
ultimate motive of Bio Asia is knowledge sharing and business
development. We are committed to such developments and hope that we
will be able to strike such chords of success in Bio Asia
2010,” said Dr BS Bajaj, secretary general, Federation of
Asian Biotech Associations.
Lonza’s investment in Hyderabad will be in two phases. During
phase-I, which will be operational from 2011-2013, Lonza will set up
R&D labs which include facilities for tissue/cell isolation,
cell culture and expression techniques, bio services, labs for
biologics and bioinformatics. Lonza will also set up microbiological
application labs and formulation development for microbial control for
injectables. Small-scale multi-purpose manufacturing plant for
biopharmaceuticals and small-scale biotherapeutic media manufacturing
plan are also part of the deal.
In its phase-II expansion which will be operational between 2014 and
2015, Lonza will expand media manufacturing capacity for biotherapeutic
media and build additional R&D lab capacity for biologics and
expanded large-scale manufacturing plant for biopharmaceuticals.
confers Excellence Award on Molecular Connections
Molecular Connections Private Ltd, an Indian life sciences informatics
company, has been conferred with the Excellence Award and Udyog Rattan
Award by the Institute of Economic Studies (IES) at the Conference on
The award was presented to Molecular Connections in appreciation of the
outstanding contribution to the country’s industrial
development in the field of informatics and its exemplary work for
accelerating research and aiding Insilco drug discovery. The company
was also applauded for the quality of talent that it attracts and for
being instrumental in creating a highly knowledgeable talent pool in
informatics industry in India.
After receiving the award Jignesh Bhate, CEO, Molecular Connections,
said, “This award brings the due recognition to Molecular
Connections as a pioneering and focused informatics company. The award
goes to the dedication of my team, who made this
The award was presented at a glorious ceremony in New Delhi on May 4,
2009. The Institute of Economic Studies confers the Udyog Rattan Award
and Award for Excellence every year. IES was established in 1980 by a
group of economists, parliamentarians and industrialists who came
together to study and discuss problems concerning various aspects of
economy and economic development of India and to offer their expert
advice and services.
brings NxG stem cells technology to India
LifeCell International, an Indian stem cell banking service provider
has associated with Harvest Technologies of Germany to bring a next
generation technology, Bone Marrow Aspirate Concentrate (BMAC) system
BMAC is a FDA and CE approved biological technology that accelerates
the body’s natural healing capacity, thereby improving
BMAC System helps in safe and rapid preparation of cell concentrate
from bone marrow. The process takes only about 15 minutes and can be
conducted in the point of care setting.
The system is currently being used clinically in many developed
countries like US and Europe for various medical disciplines. These
applications range from fractures, non-unions, osteonecrosis, cartilage
repair applications and critical limb ischemia (CLI). The system will
soon be applied for cardiovascular regeneration.
establishes office in India
US-based BioReliance, a contract services company, has established a
liaison office in Bangalore, expanding its operations to address
significant growth opportunities in the Indian subcontinent.
BioReliance is said to recognize that India has world-class
biotechnology, pharmaceutical and vaccine companies and is
demonstrating a strong commitment to support their growth.
BioReliance provides contract services in biologics safety testing,
toxicology, viral manufacturing and laboratory animal diagnostic
services to the pharmaceutical and biopharmaceutical industries
“To date, we have served the Indian biopharmaceutical
marketplace through our UK offices. However, at this time when the
Indian biomanufacturing market is growing in experience and reach, it
is clear that having a local presence will be the best way to support
our clients in the future,” said Jarlath Keating, senior
director of sales, Bio Reliance.
bags healthcare awards at Sankalp 2009
Sankalp 2009, India’s social enterprise and investment forum,
announced awards for innovative key entrepreneur ideation in the
healthcare sector. The Sankalp 2009 Emerging Award for Healthcare was
won by Biosense Technologies, an enterprise that is said to be actively
focused on combating anaemia, the cause of 40 percent maternal and
Sankalp 2009 was organized with the aim of creating the first
investment forum for emerging enterprises as well as encourages ideas
that aim to solve pressing issues of the day in a sustainable and
profitable manner. The primary objective of this initiative was to
bring together various stakeholders sharing a common conviction that
capital should be invested to create multiple bottom-line returns
(financial, social and environmental) and not exclusively financial
(profit-maximizing) or social (philanthropic) returns.
“I have participated in many such forums but rarely have I
seen the quality of plans that I saw at Sankalp. I would not be surprised
to see a number of participants who are looking for capital actually
get funding as a result of Sankalp 2009,” said Mohanjit
Jolly, executive director, Draper Fisher Jurvetson and jury chair of
the Sankalp 2009 for the healthcare track.
The jury is said to have consisted of 30 investors across the five
sectors and in addition to the names mentioned above other prominent
investors are Bejul Somaia of LightSpeed Ventures, CK Gopalakrishnan of
NABARD, Kumar Ashish of ICICI Bank, Amit Vikram of Milestone Religaire,
Deepthi Reddy of IFMR Trust etc.