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International Clinical Trials

Shining Light



Misunderstandings and bureaucracy challenges are checking the potential growth of India’s healthcare sector. Yet initiatives to fine tune the regulatory framework and streamline approval processes are boosting the appeal of clinical trials in the subcontinent.

A few years ago, the Indian population encountered a particularly motivational slogan: ‘India shining’. Although the slogan had a political genesis, it had the right cues that infected the common man with positive energy and can perhaps be attributed to fuelling India’s subsequent success in the healthcare sector.

The Indian clinical trial market is buoyant with a forecasted growth rate of 20-25 per cent in the next five years. India currently has around 150 CROs with revenues of $485 million.

Many pharmaceutical companies are choosing to outsource to India to gain increased operational efficiencies, high quality IT and data systems and greater access to patients due to its population of 1.2 billion (see Figure 1). The latter provides advantages in terms of logistics, therapeutic areas, genetics and demographics.

Despite positive growth trends, the full potential of the Indian market is yet to be exploited, creating a need for members of the Indian clinical trial industry to take responsibility for leading opinion and change. While the Indian market was expected to grow to $2 billion by 2011, this has not happened yet as the forces driving this growth were not working in tandem with respect to infrastructure, the regulatory environment, manpower and efficiency.

Challenges Facing the Industry

Currently, a number of misunderstandings surrounding lax laws and regulations, the conduct of illegal trials and improper compensation are affecting the reputation of the industry. While many of these concerns are unfounded, industry associations such as the Association of Clinical Research Organizations (ACRO), Indian Society for Clinical Research (ISCR) and the Association for Better Living and Education (ABLE) have come together to lead the way in standardising and refining regulatory frameworks to eliminate hurdles that can result in signifi cant delays in the completion of clinical research.

India must learn from countries such as Korea, which has invested in infrastructure to ensure clinical research happens in an organised manner and which has established a robust regulatory framework that allows good clinical practice (GCP) compliant trials across the country.

Addressing Regulatory Hurdles

ACRO, ISCR and ABLE have come forward and reached out to the office of Drugs Controller General India (DCGI) and the Ministry of Health (MOH). The approach has been to collectively introduce compliance, and bring in regulations that will protect the interests of the participating subjects as well as to promote the progress of science. This is the most prudent way to bring about improvements and ensure that clinical research is conducted in the right manner.

The entire Indian clinical trials industry advocates adherence to the highest standards, and steps are currently being taken to streamline regulatory processes and overcome hurdles. For example, it has been recognised that the DCGI office, which has the powers to approve and reject trials, has to be invested with authority and resources to improve its effectiveness.

In addition, the DCGI is responsible for approval of licenses of specified categories of drugs and biologics, such as blood and blood products, IV fl uids, vaccines and sera. There is a need to improve efficiencies, as it currently takes six to eight weeks to get an initial response from the DCGI, resulting in significant delays to drug development. The process of handling amendments to an application is also timely as each amendment is considered as a new application. Linking amendments to the original application is recommended to reduce the review time.

Regulatory timelines are also increased as clinical trial applications (CTAs) are reviewed by the DCGI during a 45-day process, followed by an expert panel review taking an additional six weeks. To save time and resources, it is recommended that the expert review period be avoided for clinical trials with key country approvals. In some cases, CTAs are also not being referred to the correct experts and instead should be channelled in an organised manner.

A further method to improve regulatory timelines is to change the order in which certificate of analysis (COA) and stability data are submitted to the DCGI. While currently these data are submitted alongside the original application, it is recommended that they are instead submitted before the initiation of the study, in order to save time.

Steps have also been taken to enhance the clinical research infrastructure in India. The Drugs Technical Advisory Board (DTAB) had made it compulsory for all ethics committees attached with clinical trial organisations to register themselves with the DCGI. This is in line with India’s efforts to build a sound regulatory framework, and it is predicted to help increase transparency in relation to patient recruitment, consent processes and the independence of the ethics committee and its review and decision making process. CRO registration has also been addressed and it is proposed that CROs should be graded as per their capabilities and expertise. In November 2011, the Indian Council of Medical Research (ICMR) put forward a draft guideline to formalise this and it is currently under review.

Ensuring Good Clinical Practice

For many years the Indian market has been engaged in adopting good clinical practice (GCP) to ensure that studies are undertaken and reported in a way that protects the confidentiality of the subjects and provides assurance that data is credible and accurate. In 1996, the International Conference on Harmonisation (ICH) set out to streamline drug development and regulatory processes, increase efficiency of clinical research and ultimately decrease country to country differences in GCP guidelines. Primary participants in the debate included the US, the EU and Japan, while countries such as Canada and Australia were there to observe. Eleven topics in the areas of safety, quality, effcacy and multi-disciplinary were identified as requiring harmonisation.

Following this, the ICMR issued guidelines in 2000 to adapt the existing international GCP guidelines to the Indian context. As outlined by the updated 2008 guideline, the aim was “to elucidate step wise procedures which should be followed by laboratories to strengthen the quality of test results.” By adopting these guidelines, CROs are able to generate “uniformly acceptable and good quality laboratory data” (1).

Indian GCP guidelines were established in 2001 and should be followed when conducting biomedical research in India at all stages of drug development, whether prior or subsequent to product registration in India. The principles behind Indian GCP include the essentiality of the trial in question, ensuring professional competence, taking precautions and minimising risks, following privacy and confidentiality procedures, the non-exploitation of trial subjects and the need for informed consent from trial subjects. The guidelines also strive to ensure accountability and transparency during clinical trials, as well as regulatory compliance.

Conclusion

While GCP procedures are already established to ensure credible data and protect trial subjects, India still has steps to take in terms of streamlining regulatory processes and improving the effectiveness of its infrastructure. Industry associations are working towards these goals and are creating awareness of best practice, working with regulators to educate CROs of new processes to ensure faster approvals of drugs while also maintaining ethical and regulatory compliance.

It is in India’s best interests to tackle existing challenges as the continued growth of the Indian clinical trial market will lead to socio-economic advantages, including providing good employment opportunities for the country’s educated youth and delivering faster cures and earlier diagnoses for local diseases.

Reference

  1. Guidelines for Good Clinical Laboratory Practices (GCLP), Indian Council of Medical Research, New Delhi, 2008

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Apurva Shah is the Founder and Group Managing Director of Veeda Clinical Research. He has an MBA in International Finance & Entrepreneurship from Babson College in Boston, US. Apurva has strong entrepreneurial and organisational skills and as a founder Apurva is responsible for set up and running of Veeda’s operations. Apurva was awarded Entrepreneur of the Year by Bio Spectrum in 2009 and SME CEO of the year by Business India and Yes Bank in 2010. He is the current Chairman of Association of Contract Research Organizations (ACRO), India.

Ashish Kumar Dasgupta is the Vice Chairman of Association of Contract Research Organizations, India, bringing with him over 30 years of experience in clinical research. He was instrumental in drug development activities at Ranbaxy for 15 years, and was one of the Founding Directors of Lambda Therapeutic Research before joining Jubilant Clinsys as COO, working closely with drug discovery and clinical development groups. Ashish’s expertise lies in strategic development, acquisition, integrated business solutions and business development. Bringing in all his experience and expertise under one roof, Ashish has founded Anregen Consulting Pvt Ltd, catering to the pharmaceutical and healthcare sectors.
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Ashish Kumar Dasgupta
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