ABSTRACT
Drug discovery is a long process which usually takes 10–12 years and costs millions of dollars. The features of drug discovery in India are simple and the requisite process is well regulated. After any molecule is discovered in a laboratory by using modern advanced techniques, animal studies for safety and efficacy and clinical trials in human subjects are needed. Clinical trial is a highly technical area intended to establish quality claims and follows internationally accepted standard protocols viz. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP), and other ethical guidelines. Although many new molecules have been discovered in India, because of the improper testing at the regulatory level itself these molecules could not get through investigational new drug application (INDA) properly for approval by the Drugs Controller General of India (DCGI) as new drugs, despite having patents.
