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International Clinical Trials
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Dr Yati Chugh, Managing Director of Lotus Labs, talks to ICT about the
Indian CRO market and the upcoming ICSE event taking place in Madrid in
October
ICT: The clinical research scene in
India is developing rapidly. What are the attractions of this preferred
outsourcing destination?
Dr Yati Chugh: India currently
stands as one of the highest ranked emerging countries in global
contract research industry and is expected to grow by 20 per cent
compounded annually over the next five years. India has exploited the
potential for clinical research and is building up its capabilities by
attracting various international and domestic pharmaceutical companies.
Apart from taking these initiatives, India offers advantages such as a
hugely diversified population, well-equipped hospitals, Englishspeaking
trained doctors, government initiatives and increased awareness among
various health care professionals regarding ICH-GCP guidelines and cost
effectiveness thus confirming its potential to become a major clinical
research hub.
Indian regulatory guidelines have been
streamlined in recent years. How can the validity and accountability of
trials carried out in India continue to be maintained?
Indian regulatory authorities have been working towards updating the
existing guidelines for some time. This exercise has complemented the
existing Drugs and Cosmetic Act and Rules, Indian GCP and ICH GCP
guidelines. The efforts have helped streamline guidelines in India on
par with international standards. This confirms the commitment towards
improving the quality of data generated compliance to the rules and
regulations for the benefit of the industry. The new guidance documents
include registration of clinical trials, guidance on clinical trial
inspection and draft rules for CRO registration, among others. These
will assist in ensuring the validity, reliability and accountability of
the trials carried out in India. Moreover, many clinical studies
including bioequivalence studies conducted in India are approved by US
FDA and European member states.
How do you think the global pharma industry will change over the next 10 years?
The global pharmaceutical market generates more than $800 billion a year
in revenues and is expected to grow at a five to eight per cent annual
rate through 2014. This growth is likely to add nearly $300 billion in
additional revenue – driving the total market to a staggering $1.1
trillion in 2014. The exponential growth rate throughout this period
reflects the loss of patent protection of leading products in developed
markets as well as strong overall growth in the world’s emerging
markets. At the same time expansion of the pharma market also determines
the growth of the CRO industry. CROs represent the highest growth
segment of the pharmaceutical services industry. The global CRO
industry, which was a $50 million market 30 years ago, was expected to
grow into a $23 billion industry in 2012, with analysts projecting 10-14
per cent growth over the next several years.
As a CRO, Lotus Labs fully understands this fact and has geared up to
capitalise on this opportunity. As in the past, the emphasis on our
quality and time bound services will be our core competencies allowing
us to generate revenues in a competitive market.
ICSE is an international meeting place for decision makers. Are you launching any new products or services at the event?
Although we are not launching any products, we see it as a global
platform to showcase our company’s capabilities, experiences and service
offerings.
What are you hoping to achieve by exhibiting at ICSE this year?
We hope to meet new people and companies with similar interests to
expand our client base as well as using it as a platform to keep in
touch with our existing clients. The event will also be an opportunity
to explore and build-up potential strategic partnerships with interested
CROs of different geographical areas that will help us in developing
our global operations as well as a marketing and branding platform.
Finally, we are hoping to interact with people and understand the
requirements of the untapped markets.
What zones are you looking forward to explore at this year’s event?
We are particularly interested in meeting R&D, formulation and
generic companies as well as exploring organisations involved in
vaccines and nutrition.
Who will be on your stand at ICSE?
We will have business development representatives, project management
representatives and scientific/technical representatives on our stand –
look out for us there! |
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