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International Clinical Trials

The Global Player

Faced with changing clinical trial regulations in India, Nilesh Vite and Arulsingh Jayaraman of Lambda Therapeutic Research assess an initiative to meet tough global standards

The clinical trials industry in India has exploded over the last few years. While regulation presents challenges, it also creates opportunities. In recent times, India has become a major centre for administering clinical trials, and drug companies have realised the potential for outsourcing trials to this region for fast subject recruitment and major cost savings.

The main attraction is the potential to save time and money, with drug tests requiring only one-third to one-half of the cost and duration that would be involved in Europe or the US. To the extent that it enables Indian pharmaceutical companies to maintain a competitive advantage with respect to clinical trials, regulation could be viewed as the cloud with the silver lining.

Beyond these more immediate industry-specific scenarios, the Indian pharmaceutical companies and the Indian government will need to recognise a broader range of fundamental uncertainties that can exert a major impact on India’s overall competitiveness as a country, as well as its specific competitive position in the pharmaceutical industry over the longer term. Internationallyaligned intellectual property (IP) structure and better clinical research regulations are good indicators for multinationals. This will enable companies to develop growth strategies based on encouraging regulatory developments in India.

Compliance with global good clinical practice (GCP) norms requires a global mindset at every level of the process, whether it be a government official approving applications for clinical trials, or an investigator interacting with a recruited patient or volunteer. From a long-term perspective, the accent has to shift from quantity to quality of work. There are signs that this process is already underway.

BACKGROUND

In the last year, it has been acknowledged that the first challenge is to get all the stakeholders in clinical research on a single platform, talking the same language and on the same wavelength – which means the regulatory authorities as well as those responsible for influencing clinical research as a discipline. In the past, they have rarely been consolidated as a group. This unity is important because a comprehensive national agenda for clinical research is required. At most forums, meetings and conferences, a positive conclusion is asserted – and once we go back to work, the same problems arise. But now the scenario is changing, and government is taking the initiative to meet global standards.


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Nilesh Vite is a Clinical Trial Auditor in quality assurance for Lambda Therapeutic Research, a CRO in Ahmedabad, India. He is responsible for planning and conducting Phase II and III trial audits as well as framing SOPs and their implementation. He also provides training in the QA aspect of clinical trials, defines the QA programmes, measures compliances, analyses audit observations and makes suggestions for improvements to the clinical trial system. Nilesh graduated from Mumbai University, India, with a degree in Chemistry, Drugs and Dyes, and has a Masters in CLinical Research from the University of Chennai, India. He is currently pursuing an MBA in Marketing from the University of Hariyana, India.

Arulsingh Jayaraman has an Masters in Medical Biochemistry from the University of Calicut, India. A Clinical Trial Auditor in quality assurance for Lambda Therapeutic Research, Arulsingh offers support framing SOPs and their implementation, whilst also taking charge of conducting Phase II and III trial audits, analysing audit observations and measuring compliance.

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Nilesh Vite
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Arulsingh Jayaraman
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