Topic > study of regulatory affairs - 837

Introduction: The Indian pharmaceutical industry today is considered to be a highly progressive industry among the science-based Indian industries with a wide range of capabilities in the field of drug manufacturing and technology. India is considered the world's generic drug powerhouse. However, we are now witnessing regulatory challenges such as delays in clinical trial approvals, uncertainties over foreign direct investment policy, a uniform code for sales and marketing practices, and compulsory licensing (M. Janodia, 2007). Key Regulatory Challenge: Delay in Clinical Trial Approvals India has been considered as the major hub for conducting clinical trials. The relatively low cost of conducting tests and a rapidly growing population of 1.2 billion make India an attractive destination for companies looking to conduct tests (Devarakonda, 2013). It is already a powerhouse in the production of generic drugs whose exports to Latin America and Africa. However, the current scenario shows that there is a decline in the Indian clinical industry due to recent changes in regulations (Williams, 2013). Clinical trial approvals have also been delayed due to such stringent regulations. Various ethical, quality, regulatory and cultural issues along with inadequate training and mentorship have caused barriers in clinical pathways and approvals. Delays in regulatory approvals and clearances lead companies to undertake clinical trials abroad (Devarakonda, 2013). The US Association of Clinical Research Organizations (ACRO) reported that member clinical trials in India have declined by more than 60% since 2010 due to an inconsistent regulatory environment (Unnikrishnan, 2014). Strict rules include multi-agency intervention while clearing trials, mandatory registration… half of the document… I would be one of these professionals who will contribute to my home country in creating a stronger pharmaceutical sector. Works Cited Devarakonda, R. (2013). Current Clinical Trial Scenario in India: Challenges and Solutions. PharmaBioWorld .M. Janodia, S. J. (2007). The patent regime in India: problems, challenges and opportunities in the pharmaceutical sector. The Internet Journal of Third World Medicine, 7.Unnikrishnan. (2014). Uncertainty over approvals leads to an exodus of clinical trials. Retrieved from http://www.livemint.com/Industry/bQu4EtyMUgkAXEuDade3YN/Uncertainty-on-approvals-sees-exodus-of-clinical-trials.htmlWilliams, K. &. (2013). Slow approvals 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)