Clinical Trials in India: A Scientific Approach for New Drug Development

  • Ajay K Sharma Department of Pharmacy, G.S.V.M. Medical College Kanpur, Uttar Pradesh-208002, India
  • Jyoti N Sharma Department of Pharmacy, G.S.V.M. Medical College Kanpur, Uttar Pradesh-208002, India
  • Harish Rajak Department of Pharmacy, S. L. T. Institute of Pharmaceutical Sciences, Guru Ghasidas University, Bilaspur, Chhattisgarh-49500, India
  • Dushyant K Regional Medical Research Centre (Indian Council of Medical Research), Nehru Nagar, Belgaum, Karnataka590 010
  • Rajesh K Joshi Regional Medical Research Centre (Indian Council of Medical Research), Nehru Nagar, Belgaum, Karnataka590 010
  • Vinod K Dixit Department of Pharmacy, Dr. H. S. Gour University, Sagar, Madhya Pradesh-470003, India

Abstract

Clinical Research is an organized research and systematic study conducted on human beings to generate data for discovering or verifying the clinical, pharmacological or adverse effects with the objective of determining safety and efficacy of new drugs. Globally, Clinical research (CR) is becoming a thrust research area as it is essential for development of not only new drugs but also for new formulations, drug delivery systems, dosage regimen, surgical and diagnostic techniques, devices and therapies. India and other developing/under-developed countries have a plethora of poor and uneducated people, multinational companies are targetting these countries for conducting clinical trials of new drugs. Clinical trials in developing countries are exploding. It is estimated that 20-30% of global clinical trial activities are being conducted in developing countries. 

Keywords: Clinical trial, New drug discovery, Regulatory requirements, Current and Future prospects
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How to Cite
Sharma, A. K., J. N. Sharma, H. Rajak, D. K, R. K. Joshi, and V. K. Dixit. “Clinical Trials in India: A Scientific Approach for New Drug Development”. Current Research in Pharmaceutical Sciences, Vol. 3, no. 1, Mar. 2013, pp. 1-6, http://crpsonline.com/index.php/crps/article/view/86.
Section
Review Articles