201209302148010A

							                  MALADY OF CLINICAL TRIALS IN INDIA

 BALAMURALIDHAR V.*, ANOOP PILLAI S., PRAMODKUMAR T.M., POOJA M.B.
        Pharmaceutical Regulatory Affairs Group, Dept. of Pharmaceutics,
                 J.S.S. College of Pharmacy, J S.S. University,
                       S.S. Nagar, Mysore - 570015, India
                  E-mail: baligowda@gmail.com@ymail.com

ABSTRACT:

       India's medical tourism is proudly declared as an upcoming industry while a disturbing

silence is maintained about clinical trials which was estimated at Rs 1,500 crore in 2010 and

is expected to touch Rs 2,760 crore in 2012. Foreign drug companies have been shifting their

clinical research from developed to developing countries. The present article highlights how

India has emerged as a hotspot for foreign drug companies and the critical success factors

driving the industry. It also provides an insight into the issues relating to the Government

regulations governing clinical trials i.e. Schedule Y, government support initiatives in India to

encourage the clinical trials and the outsourcing opportunities. These drug testing often prove

lethal can be gauged from the fact that there have been 1,725 deaths during clinical trials in

India over the past 4 years. Clinical trials have now emerged as a business opportunity and

lucrative way to make money for researchers. The article opines that Government should

reinvent Schedule Y via amendments that would make the foreign drug companies realize that

    “The safest way to double their money is to fold it over once and put it in the pocket”.