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International Clinical Trials

The Road to Madrid



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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Dr Yati Chugh is Managing Director of Lotus Labs. He has 20 years of experience conducting pre-clinical and clinical research, with extensive experience in areas of CNS, CVS, drug metabolism and clinical pharmacology.
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