Introduction: Indian pharmaceutical industry today is considered a very progressive industry among Indian science-based industries with extensive capabilities in the field of drug manufacturing and technology . India is considered the global powerhouse in generic medicines. However, the country now faces regulatory challenges such as delays in approval of clinical trials, uncertainties regarding FDI policy, uniform code for sales and marketing practices and compulsory licensing (Mr. Janodia, 2007). Key regulatory challenge: the delay in clinical trial approvals. considered the major hub for conducting clinical trials. The relatively low cost of testing and a rapidly growing population of 1.2 billion make India an attractive destination for companies wishing to conduct testing (Devarakonda, 2013). It is already a generic drug manufacturing powerhouse with exports to Latin America and Africa. However, the current scenario shows a decline in the Indian clinical industry due to recent regulatory changes (Williams, 2013). Clinical trial approvals have also been delayed due to such strict regulations. Several issues such as ethics, quality, regulation and culture, as well as inadequate training and mentoring, have led to obstacles in clinical trials and approvals. Delays in regulatory approvals and approvals lead companies to conduct clinical trials abroad (Devarakonda, 2013). The American Association of Clinical Research Organizations (ACRO) reported that clinical trials conducted by its members in India had fallen by more than 60% since 2010 due to an inconsistent regulatory environment (Unnikrishnan, 2014). Strict rules include involvement of multiple agencies while ongoing testing, mandatory registration... middle of paper ...... I will be one of those professionals who will contribute to my home country by establishing a sector pharmaceutical stronger. Works Cited Devarakonda, R. (2013). Current scenario of clinical trials in India: challenges and solutions. PharmaBioWorld.M. Janodia, S.J. (2007). Patent regime in India: issues, challenges and opportunities in the pharmaceutical sector. The Internet Journal of Third World Medicine, 7.Unnikrishnan. (2014). Uncertainty over approvals is driving an exodus from clinical trials. Retrieved from http://www.livemint.com/Industry/bQu4EtyMUgkAXEuDade3YN/Uncertainty-on-approvals-sees-exodus-of-clinical-trials.htmlWilliams, K. &. (2013). Slow approvals have put India. Retrieved from Retrieved from http://www.voisinconsulting.com/IMG/pdf/current_ct_scenario_of_india.pdf (Ram, The India Challenge for Clinical Research, 2013) (Ram, The India Challenge for Clinical Research, 2013)