Posted by:  Dr. Chandrashekhar Potkar

-Clinical Trials Today’s guest author, Dr. Chandrashekhar (Shekhar) Potkar, is the Director of Clinical Research & Regulatory Affairs at Pfizer LTD in Mumbai, India. Over the coming weeks, Dr. Potkar will explore India’s rapid expansion into the clinical trials arena through a series of posts highlighting on one of the hottest topics in the industry today.

Over the last three years, there has been an increase in clinical research activity in India. Rapid expansion of the clinical research activity has lead to number of questions, some with clear answers and others with not so clear answers. This is not necessarily country-specific but perhaps related to the clinical research field itself. As India is poised at a tipping point in this field, we offer a commentary on a range of key topics given below. There have been a number of pointers to this growth, as reflected in...

1. Exponential increase in number of India focused clinical research related conferences organized in the country as well as outside the country
2. Rise in print media coverage of generic as well as specific topics related to clinical trials
3. Increase in number of interviews, features and debates on television channels on this subject
4. Increased number of explorations for establishing clinical research units in India
5. Mushrooming of training institutes offering various clinical research courses ranging from a few hours to a few months and from a certificate to a degree
6. Proliferation of a range of service providers in this field: CROs, SMOs, laboratories offering niche to full service in India as well as global options
7. Roll out of a number of regulatory initiatives, from amendment of regulations, release of guidelines to announcement of proposed initiatives (e.g. establishment of clinical registry, clinical trial inspections etc)
8. Estimated rise in number of clinical trials done in the country in last 3 years
9. Explosion of job opportunities in this field for the trained as well as uninitiated

This commentary aims to provide a balanced perspective on these topics and hopes to clarify some grey areas in this field. Your response, opinions, clarifications, or counterpoints are welcome.

Dr. Potkar, is the Director of Clinical Research & Regulatory Affairs at Pfizer LTD in Mumbai, India and has over 14 years of experience working in the clinical trials industry. He joined Pfizer in 1995 as a Medical Advisor where for over 11 years has collaborated with industry professionals, academia and government in an effort to enhance the clinical research environment in India.  He is also a  founding governing council and faculty member at the Academy for Clinical Excellence (ACE). Dr. Potkar completed both his postgraduate degree in Pharmacology (M.D.) and MBA from Deakin University. He earned a Master's of Science in Clinical Research at George Washington University.