Until recent years, clinical trials have been conducted primarily in the US and in Europe, due to higher health standards and overall standard of care for patients. However, more and more pharmaceutical companies and contract research organizations (CROs) are being pressured to reduce timelines and costs. Up until about a decade ago, India was low on the clinical trial radar because of lack of a global presence by big pharma and CROs.
This has all changed in recent years. With a population of over 1 billion people, India has one of the largest populations in the world. That being said, India has one of the largest available patient populations in cancer, diabetes, and other common diseases and disorders common to the country. This has lead clinical research industry leaders to create a presence in the country and have made it an important piece of the global clinical market.
As an emerging clinical research market, there are many advantages to including India in global clinical trials including lower overall costs, high standard of care, and an improved regulatory environment.
In the US, clinical trials can costs over $100 million from discovery to market, over a period of 10 to 15 years. The same drug can be developed in India at a much lower cost, sometimes more than 50% lower. With such a large population and increased number of patients without regular healthcare, patient recruitment can be up to 3 times faster than trials run in Western countries. These cost savings are a product of lower cost of staffing and overall operations.
But lower cost of staffing and operations do not mean a lowered standard of care. For over a decade Indian GCP guidelines have been in line with global regulatory standards. English is spoken throughout the medical community, making adherence to ICH GCP and GLP more transparent. More and more medical and scientific professionals are participating in research in India because worldwide competent authorities (e.g. FDA and EMA) agree that regulatory standards and guidelines in India are suitable. Furthermore, as of 15 June 2009, all clinical trials conducted in India must be registered on the Indian Clinical Trials Registry, which will soon be linked to the International Clinical Trials Registry.
But like with any clinical program, regulatory timelines and approval can make or break your program. As the global market for running clinical trials in India continues to grow, India’s regulatory body, the Drug Control General India (DCGI), is facing increased numbers of clinical trial application submissions. Theoretically the approval process should take 14 weeks. However these timelines are often increased due to lack of available agency staffing. Fortunately, regulatory authorities are actively improving the problem by proactively seeking additional, experienced staff to assist with the increased workload. As India’s clinical presence is recognized, the regulatory environment has become a viable resource in global clinical research.
With increased regulatory standards and adherence to global ICH GCP and GLP standards, low costs, fast patient recruitment, and a research industry worth billions of dollars, India truly is the next up and coming location to conduct clinical trials.
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