With soaring clinical trial costs and long development periods, many companies have turned to India to conduct cheaper, faster clinical trials. The potential cost savings of 40 to 60 percent together with a large, ethnically diverse population and an increasing pool of highly skilled English-speaking physicians have made India an increasingly attractive market. Over 160 studies have started recruiting for clinical trials in India as of October 2006 (clinicaltrials.gov), and the market will continue to expand.
India ‘s regulatory environment on clinical trials is relatively relaxed, though there is increasing focus on GCP and ethics standards. Currently, the FDA restricts the number of patients recruited outside the US and Western Europe. Clear regulations on specific issues such as informed consent, quality assurance, and recording of data have not been established.
Despite optimism over India’s cost-effectiveness, intellectual property (IP) protection remains weak in India. Until 2005, India issued patents simply for manufacturing processes of drugs, which commonly led to reverse engineering and copying. However, after changes to the Patents Act in 2005, drugs themselves can now be patented. Adopting ICH regulations to schedule Y of the Indian Drugs and Cosmetics Act was also a major breakthrough, as it allowed companies to include India in international, multi-center trials during all phases. However, strict legislation and enforcement is still lacking compared to the US and Europe, and companies should take care in maintaining due diligence and enforcing contracts.
Regardless of IP issues, many firms are eager to decrease the time spent on drug development, as pre-clinical testing to phase III clinical trials can take up to 10 years in some instances. India’s government has also introduced incentives to attract increased foreign investment such as tax exemptions for in-house R&D. India also plans to create a National Drug Authority (NDA) similar to the US FDA to replace the Central Drug Standards Control Organization (CDSCO). Currently, the CDSCO and State FDA share responsibilities for drug regulation in India, so creating an NDA would allow for more consistent regulation under one body.