Pharmaceutical research in India

Abstract

The field of pharmaceutical research has expanded worldwide. Many research activities are currently being conducted in developing nations like India because of the higher expense, stringent regulations, complex safety and compensation requirements, and limited population of developed countries. The aim of the study is to assess the current requirements to conduct clinical trial in India and to analyse the advantages, disadvantages, challenges in conducting it. The central drug standard control organisation (CDSCO) official website is used to identify the regulatory requirements, for conducting clinical trials within India. Systematic review was conducted to collect the information on selected requirements. The databases PubMed and Scopus were used for the literature review. Strengths, weakness and challenges encountered in conducting clinical trials with in India were looked into. The process of clinical trial is complicated and bound to meet several requirements for safe conduct. The regulatory authority for approval, inspection and monitoring of clinical trial in India is central drug standard control organisation. The head of the organisation is Drug controller general of India (DCGI). The study identified; application, regulatory fees, ethics approval, registration, insurance, safety reporting, progress reporting as major requirements for conducting clinical trial in India. The sponsor submits the application for clinical trial along with the stipulated fees to the DCGI for review and approval. Depends on the category of the drug undergoing clinical trial the fees to be submitted with the application and timeline for application review changes. The timeline is 90 days for the new drugs, investigational new drugs and drugs already approved outside the India. The decision on application is taken within 30 days if the drug is discovered, manufactured and developed in India. Study approval from the institutional/independent ethics committee is essential before commencement of the study. Registration of the trial in Clinical trial registry of India became mandatory to maintain the transparency of the trial. The other requirement insurance helps the patients in case of any trial related injuries. After initiation it is important to monitor and take feedback in time to time. The safety reporting and progress reporting are to be done for this purpose in specific time intervals. The main advantage of India as a clinical trial hub is the availability of patients which makes recruitment of large number of clinical trial subjects in limited time. The process cost is low compared to developed countries. When the advantages attract overseas pharmaceutical companies and leads to growth of the clinical research organisation in India it is important to consider challenges such as exploitation of the poor diseased patients in unethical clinical trials. In conclusion the frequent updating of clinical trial regulation and strict monitoring of requirements in India may attract more international clinical trials and thereby contributes towards growth within the pharmaceutical sector.