Declining enrollment in USA and West European countries has led the pharmaceutical and biotechnology companies to turn towards India and other Asian countries to conduct clinical trials for faster launch of drugs in the market.
It might take somewhere between 10 to 15 years for the drug development process, from pre-clinical to complete phase III clinical trials. Out of which, the phase II and III clinical trials consume almost half of the time. Given this situation, it looks imperative that pharmaceutical and biotechnology companies are ought to look for ways to conduct trials faster and with less spending. However, they have often failed to meet the challenge and hit the market with the drug as planned.
The reasons have been the dropping enrollment for clinical trials in the US and Western Europe and that has led companies to think of alternative places where they can have trial sites, and which can help them enroll more volunteer to conduct trials faster. These companies are looking forward to the countries like India and China as a solution.
It is believed that one of the advantages of conducting clinical trials in areas such as Eastern Europe and Asia is the speed, with which patients can be recruited. As, it is very difficult to get patients to enroll now in the US. Enrollment rates in the Far East, China, Eastern Europe and India are much higher. So, if you needed 200 patients for an oncology trial, your chance of getting them in India within a three-month enrollment period is much higher, whereas it might take you a year or a year and a half in US.
While there have been a number of challenges to conducting these clinical trials, several countries, most notably India, have taken a number of steps to make the process more user-friendly. In 2005, the Indian government increased intellectual property protection on patents, a key change in a country’s enforcement of laws protecting patents and clinical trial data. That made companies a little more comfortable coming to India.
Another legislative change was for sweeping, mandatory global clinical practices for conducting trials. But, one of the most important legislative changes has been the amendment of schedule by the Indian Drugs and Cosmetics Act to comply with the regulations of the International conference on harmonisation. Prior to the amendment, there was a phase-lag rule in effect that barred earlier-phase trials from being conducted in India before being conducted elsewhere in the world. “What that did is, it said, if you’re doing a trial in India, you need to be one trial further advanced in the rest of the world. So if you were doing a phase III trial in Europe, you could do phase III trials in India, but you could not do phase II trials, and that was really to protect the country.” The amendment means companies can include India in global, multi-centre trials in all phases. That allows companies to conduct their clinical trials more quickly and efficiently.
Many pharmaceutical and biotechnology companies are turning to Contract Research Organisations (CROs) like Quintiles and Accenture to take their trials outside the US and Western Europe. Similarly, many of the CROs are specialised now to operate in Indian subcontinent because of local geographical knowledge.
Certainly, India becomes a more obvious choice because this is home to over 16,000 hospitals and 500,000 doctors, making it an ideal country, in which to conduct clinical trials. Whereas, one of the challenges of conducting clinical trials in China is that simply getting a clinical trial application approval can take from seven to 10 months.