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Clinical trials are research studies which are done to know the efficacy, therapeutic use, safety and adverse effect of any drug [1]. These sophisticated experiments are done on human or animals to answer a lot of specific questions like biomedical aspects of drugs like its efficacy in treatment, prevention, mitigation and cure of a disease with proper knowledge of its adverse effects, therapeutic effect. Clinical trials provide very vital information about the safety and efficacy of drugs. It is done once it gets prior permission from the concerned health authority/ ethics committee of that state or nation. Depending upon product size and developmental stage investigators enroll volunteer or patients into small pilot studies and subsequently conduct progressively larger scale comparative studies. Most conducted in developed nations as the cost of clinical trials is too high. Cost of performing clinical trials varies from million dollars to billions of dollars per drug which got approval. But it is a fact that only less than 9 percent of all drugs started in human clinical trial gets approval and termed as approved drugs. The sponsor may be governmental organization, Multinational Pharma Company, Biotech Company or Medical Device Manufacturing Company. The credit for conducting the first modern clinical trial goes to Ronald A. It is estimated that 20-30 % of global clinical trial activities are conducted in developing countries. In India regulation of clinical trials is controlled by the Central Drugs Standard Control Organization (CDSCO), through the Drug Controller General (DCG) which operates under Ministry of Health and Family Welfare (MoH and FW). The importance of drug trials in promoting health services cannot be overemphasized. New drugs and therapies can improve the quality and lifespan of patients. While it is imperative that the number of clinical trials increase, the Government is also trying to ensure that the rights and safety of the subjects are protected and the quality of the trials performed in India improve to international standards. The regulatory guidelines in terms of serious adverse events (SAEs) reporting, informed consent, compensation in case of injury or death in clinical trials have been recently modified. It is essential that now all clinical trials conducted in India should as per the International conference of Harmonization-Good Clinical Practices Guidelines (ICH-GCP) for clinical trials and follow the recently amended Schedule Y of the Drugs and Cosmetics Act [2].

Benefits of Conducting Clinical Trials in Developing Countries like India