• 9 June 2009
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DCGI 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 manufacturing location.
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 audits.
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 audits.”
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 actions.”

Ocimum 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 Asia.
“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.

Lonza 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 Hyderabad.
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 Acharya.
“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.

IES 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 Economic Development.
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 happen.” 
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.

LifeCell 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 to India.
BMAC is a FDA and CE approved biological technology that accelerates the body’s natural healing capacity, thereby improving surgical outcomes.
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.

BioReliance 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 worldwide.
“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.

Biosense 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 infant mortality.
 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.

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