Where are the clinical trials conducted?

Are done usually in hospitals in India. Most of the hospitals conduct clinical trials, if they have doctors interested in this activity. Large private hospitals and clinics too perform this work.

What is the status of intellectual property (IP) protection?

India used to recognize only process patents. However, in 2005 by virtue of WTO rules, India now recognizes product patents. Product patent protection alleviates some of the IP concerns our customers have in conducting clinical research in India.

What is India’s top regulatory authority for clinical trials and medical device development?

India's Top Regulatory Organization Central Drugs Standard Control Organisation (CDSCO) and authority is the Drug Controller General India (DCGI).

What phases of the clinical trial process does PLS provide services for?

PLS is currently focused on phase III and phase IV because we identify maximum cost advantages for you in those phases. However, as we grow plans to support other phases are on the horizon.

On average how much cost saving can we get by partnering with PLS?

Trials for a standard drug in the United States can cost in excess of $150 million. A similar drug could be tested in India at a 60 percent reduction. In addition to providing these superior cost advantages, we aim to surpass global clinical trials standards while not compromising on ethical issues.

Why can PLS recruit patients more effectively?

India's wide population base of over one billion gives a great cross-section of many diseases and without much exposure to drugs. For instance, 30 million people in India have heart diseases, 25 million have type-II diabetes and 10 million suffer psychiatric disorders.

What is PLS's future growth potential?

According to a 2003 study by Connecticut-based Business Communications Co (BCC), US-based spending on clinical trials is growing at 12% per year - and should generate $26.5 billion by 2007. Clinical trials in India in 2002 generated $70 million in revenues. Global consultancy McKinsey & Co estimates that by 2010, global pharma majors will spend around $1-1.5 billion for drug trials in India alone. The future is extremely bright if we continue to increase our market share.

In terms of infrastructure what is the competitive advantage that PLS offers?
With 700,000 specialty hospital beds, 221 medical colleges and skilled English-speaking medical personnel in India, PLS can and will continue to provide affordable and exceptional infrastructure and people.

Unethical and even illegal clinical trials have been reported in India, what is PLS’s stand?

A spate of unfortunate events over the past few years has brought to the forefront the rampant practice of conducting unethical and even illegal clinical trials in India. PLS is committed to compassion towards patients. We strongly condemn unethical clinical trials and we ensure that through our training, SOPs, inspections, and adherence to GCP. With medical insurance programs like Medicare inaccessible to most of the Indian population, we also see us saving the lives of people who can’t afford healthcare.