Dr. R. Manavalan has completed his B.Pharm from Madurai Medical College, Madurai University with First Rank in University and G.P. Nairs Gold Medal. He has done his M.Pharm from Birla Institute of Tech & Science, Pilani. He achieved his Ph.D from Birla Institute of Tech & Science, Pilani in 1982. He has served as Lecturer and Reader in BITS, Pilani and Professor & Head in Annamalai University. Presently he is Professor & UGC-BSR Faculty and Research Director (PG and Ph.D). He has guided 08 Ph.D scholars and coordinated numerous M. Pharmacy Projects.
Over the last decade, there is an increasing focus on quality clinical trials to be carried out as per ICH guidelines so that the data will be accepted throughout the globe. Clinical pharmacologists, pharmacists trained in pharmacology are standing better chance along with doctors and pathologists to carry out clinical trials. Preformulation studies of the drugs are carried out to design a particular dosage form. These drugs are subject to preclinical studies in animal models to establish its pharmacological activity. With the Preformulation and animal study data, applications are made to regulatory authorities to get the drugs approved as “Investigational New Drugs” (IND). Subsequently clinical studies are carried out with the formulation in human beings at ascertain its safety and efficacy. Simultaneously large scale manufacturing of the formulation is developed with validation protocol. In this topic the following items will be discussed as given in ICH guidelines: i. Objective of clinical trials ii. Test subjects and safe guards iii. Principles of informed consent from human subject iv. Process of New Drug Development and submission for NDA and ANDA for marketing approval v. Clinical trial - Phase I, II and III vi. Pharmacoepidemiology or Post marketing surveillance (Phase IV) vii. Pharmacogenomics application in drug development and rational therapy Using all the above data, submission are made to legal authorities about the formulation as a New Drug. It is called New Drug Application (NDA). The legal authorities after thorough review of the data conduct approval inspection of the manufacturing premises (Pre approval inspection). The whole process takes 10-12 years and costs about 80-100 corers of rupees. It follows post marketing surveillance study where safety and efficacy of the drug is established from the data generated after the use of the drug in the larger population (Pharmacoepidemiological study). Some drugs may fail during the study and may be withdrawn from the market. In the patent era as well as Globalization of trade, technological game already started to develop new formulations and market globally. In this context a common guideline is developed in “International Conference on Harmonization” to perform clinical trial of drugs which are acceptable to all the countries so that the drug can be marketed across the globe. India is becoming an important centre to carry out clinical trials in well established “Contractual Research Organisation” (CRO) Which are approved and accredited by international bodies. Food & Drug administration (FDA) Regulation permits • The acceptance of foreign clinical studies in support of an application for marketing approval of a human drug, product or device if their conditions are met • Drug development process may seem cumbersome and time consuming • Drug of the highest quality finally come on to the market by regulatory authorities to the public India’s attractiveness as a global hub for clinical trials is the result of the major changes in regulatory requirements, the establishment of product patent and the enforcement of Good Clinical Practice (GCP) guidelines. India’s involvement in global GCP trials, which started a decade ago, is rapidly expanding. By 2014, industry will spend around 40 billion us dollar and going to become global hub for clinical trial. Lots of contract research organization with medical infrastructure and large number of experts will emerge. Recent development in Pharmacogenomics will be included in the clinical trials and it is going to dictate rational drug therapy avoiding adverse drug reactions.