CLINICAL TRIAL IN INDIA: RISE AND FALL

  • Chitral Kulshreshtha Pharmaceutical Regulatory Affairs Group, Dept. of Pharmaceutics, JSS College of Pharmacy, JSS University, S.S Nagar, Mysuru – 570015, Karnataka, India.
  • M P Venkatesh Pharmaceutical Regulatory Affairs Group, Dept. of Pharmaceutics, JSS College of Pharmacy, JSS University, S.S Nagar, Mysuru – 570015, Karnataka, India.
  • K Shrisha Pharmaceutical Regulatory Affairs Group, Dept. of Pharmaceutics, JSS College of Pharmacy, JSS University, S.S Nagar, Mysuru – 570015, Karnataka, India.
  • Pramod T.M. Kumar Pharmaceutical Regulatory Affairs Group, Dept. of Pharmaceutics, JSS College of Pharmacy, JSS University, S.S Nagar, Mysuru – 570015, Karnataka, India.
  • Pramod T.M. Kumar Pharmaceutical Regulatory Affairs Group, Dept. of Pharmaceutics, JSS College of Pharmacy, JSS University, S.S Nagar, Mysuru – 570015, Karnataka, India.

Abstract

Fight with the disease is the ever evolving frontier for human beings. Discovery of new drugs and devices through
clinical research are the armory to help in the fight with the affliction of mankind. Clinical trials, test potential
treatments in human volunteers to see whether they should be approved for wider use in the general population. A
treatment could be a drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy. India stood
as a global hub for clinical trials in past years. Later, the amendments made in Indian regulations paved for the decline
of clinical trials. The aim of this article is to provide the details about the Indian clinical trial application filing
process, the amendments made in its regulations and the challenges faced by Indian clinical trial industry.
 

Keywords: Clinical trial, India, Schedule Y, Good Clinical Practice.

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Author Biographies

Chitral Kulshreshtha, Pharmaceutical Regulatory Affairs Group, Dept. of Pharmaceutics, JSS College of Pharmacy, JSS University, S.S Nagar, Mysuru – 570015, Karnataka, India.

Pharmaceutical Regulatory Affairs Group, Dept. of Pharmaceutics,
JSS College of Pharmacy, JSS University, S.S Nagar, Mysuru – 570015, Karnataka, India.

M P Venkatesh, Pharmaceutical Regulatory Affairs Group, Dept. of Pharmaceutics, JSS College of Pharmacy, JSS University, S.S Nagar, Mysuru – 570015, Karnataka, India.

Pharmaceutical Regulatory Affairs Group, Dept. of Pharmaceutics,
JSS College of Pharmacy, JSS University, S.S Nagar, Mysuru – 570015, Karnataka, India.

K Shrisha, Pharmaceutical Regulatory Affairs Group, Dept. of Pharmaceutics, JSS College of Pharmacy, JSS University, S.S Nagar, Mysuru – 570015, Karnataka, India.

Pharmaceutical Regulatory Affairs Group, Dept. of Pharmaceutics,
JSS College of Pharmacy, JSS University, S.S Nagar, Mysuru – 570015, Karnataka, India.

Pramod T.M. Kumar, Pharmaceutical Regulatory Affairs Group, Dept. of Pharmaceutics, JSS College of Pharmacy, JSS University, S.S Nagar, Mysuru – 570015, Karnataka, India.

Pharmaceutical Regulatory Affairs Group, Dept. of Pharmaceutics,
JSS College of Pharmacy, JSS University, S.S Nagar, Mysuru – 570015, Karnataka, India.

Pramod T.M. Kumar, Pharmaceutical Regulatory Affairs Group, Dept. of Pharmaceutics, JSS College of Pharmacy, JSS University, S.S Nagar, Mysuru – 570015, Karnataka, India.

Pharmaceutical Regulatory Affairs Group, Dept. of Pharmaceutics,
JSS College of Pharmacy, JSS University, S.S Nagar, Mysuru – 570015, Karnataka, India.

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How to Cite
Kulshreshtha, C., M. P. Venkatesh, K. Shrisha, P. T. Kumar, and P. T. Kumar. “CLINICAL TRIAL IN INDIA: RISE AND FALL”. International Journal of Drug Regulatory Affairs, Vol. 3, no. 1, Mar. 2015, pp. 1-13, doi:10.22270/ijdra.v3i1.11.