It might take somewhere between 10 and 15 years for the drug development process to proceed from pre-clinical trials to completed phase III clinical trials. From these aforementioned trials, the phase II and III clinical trials account for almost 50 percent of the time and resources of the combined pool of studies. Given this situation, it looks imperative that pharmaceutical and biotechnology companies ought to look for ways to conduct trials faster and cheaper. Unfortunately, most clinical trials still take far too long and cost way too much.
The reasons for this have been the dropping enrollment rates for clinical trials in the US and Western Europe and that has led pharmaceutical companies to think of alternative strategies and choose more exotic locations where they can have trial sites with research naive study participants and hopefully enroll more volunteers in order to complete these trials at faster rates while spending less money to do so. India very quickly became one of these “exotic” destinations for pharmaceutical companies and CRO’s to outsource their trials to. The reasons for India being the premiere destination for outsourced clinical trials will be analyzed below.
A vast, unwieldy population, a plethora of diseases, and rampant poverty: this was the picture India presented to the outside world until only very recently. But these days the fact that India has the largest pool of patients suffering from cancer, diabetes and other maladies has given India a new moniker: the global hub of outsourced clinical trials.
It is believed that one of the advantages of conducting clinical trials in areas such as Eastern Europe and Asia is the speed at which patients can be recruited; as it is very difficult to get research naive patients to enroll in trials in the United States. Enrollment rates in the Far East and China and Eastern Europe and India are much faster. So, if a drug company needed 200 patients for an oncology trial, its chance of getting them in India within a three-month enrollment period is much higher, whereas it might take them a year or more in the US.
India has capitalized on 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 highly diverse population, well-equipped hospitals, English speaking doctors, government initiatives and increased awareness among various healthcare professionals regarding ICH-GCP guidelines, and finally, cost effectiveness, thus creating its potential to become a major clinical research destination for years to come. Notice however that we did indeed say potential, as we cover certain key obstacles that may push drugmakers to begin outsourcing their trials in places other than India. First, lets focus on some of the catalysts of clinical research in India.
Indian regulatory authorities have been working towards updating their existing guidelines for some time. This has resulted in the existing Drugs and Cosmetic Act and Rules, Indian GCP and ICH GCP guidelines. The efforts have helped streamline guidelines in India and put them on par with international standards. This confirms the commitment towards improving the quality of data generated as well as strengthening compliance to the rules and regulations for the benefit of the industry.
Some of the new guidance documents include registration of clinical trials, guidance on clinical trial inspection and draft rules for CRO (Clinical Research Organization) 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, European member states, and equivalent regulatory authorities.
The pace for drug trials in the country is so fast that the Clinical Data Interchange Standards Consortium (CDISC), a U.S. non-profit organization committed to the development of clinical research organizations’ standards the world over, is looking at setting up its chapter in India.
CDISC is an open, multidisciplinary, organization committed to the development of industry standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development. The mission of CDISC is to lead the development of global, vendor-neutral, platform independent standards to improve data quality and accelerate product development in the industry. Even as the clinical outsourcing boom is beginning to explode, the Indian government is all set to further boost it. Officials in the health ministry said that the government might now consider giving permissions for pharmaceutical companies to conduct simultaneous trials in India and overseas.
Almost all of the top names in the pharmaceutical industry have zeroed-in on India, setting up clinical trial facilities in major cities, especially Hyderabad and Ahmedabad. Global consultancy McKinsey & Co estimated that by 2010, global pharma companies would spend around $1-1.5 billion just for drug trials in the country. Dr Vishwanath Reddy, a pharmaceutical consultant based in Hyderabad, is getting a steady stream of visitors. He says he gets at least one business call a week from a foreign company eager to set up clinical trials at his facility in India. Big Pharma is attracted to India by the facilities that India offers for pharma companies, their product developments and trials. The biggest advantages many look at are, of course, “India’s huge population of more than one billion, as well as the obvious cheaper costs,” Dr Reddy points out. Trials for a standard drug in the United States can cost about $150 million. A similar drug could be tested in India at a 60 percent reduction of that staggering cost. India currently stands as one of the highest ranked emerging countries in the global contract research industry, and it is expected to grow by 20 percent compounded annually over the next five years.
The global pharmaceutical market generates more than $800 billion a year in revenues and is expected to grow at a five to eight percent 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. CRO’s 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. Whether India plays a part in this growth remains to be seen.