study of regulatory affairs

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Introduction:
The Indian Pharmaceutical Industry today is considered highly progressive industry among India's science-based industries with wide ranging capabilities in the field of drug manufacture and technology. India is considered to be global powerhouse of generic drugs. However, it is now witnessing regulatory challenges like delays in clinical trial approvals, uncertainties over the FDI policy, a uniform code for sales and marketing practices and compulsory licensing (M. Janodia, 2007).
Key Regulatory Challenge: Delay in Clinical trial approvals

India was considered to be the major hub for conducting clinical trials. The relatively low cost of conducting trials and a fast-growing population of 1.2 billion makes India an attractive destination for companies to carry out tests (Devarakonda, 2013). It is already a generic drug-making powerhouse whose exports to Latin America and Africa However, the current scenario shows that there is decline in Indian clinical industry due to recent amendments to regulations (Williams, 2013). Clinical trial approvals were also delayed due to such stringent regulations.
Several issues such as ethical, Quality, Regulatory and Cultural along with improper training and mentoring have caused hurdles in clinical trails and approvals. Delays in permissions and regulatory clearances are resulting in companies taking clinical trials abroad (Devarakonda, 2013). The US Association of Clinical Research Organizations (ACRO) reported that clinical trials of members in India had dropped by more than 60% since 2010 as a result of an inconsistent regulatory environment (Unnikrishnan, 2014).
The stringent rules include intervention of multiple agencies while clearing trials, mandatory registrat...

... middle of paper ...

...ld be one such professional contributing to my home country in establishing a stronger pharmaceutical sector.

Works Cited

Devarakonda, R. (2013). Current clinical trial scenario of India: challenges and solutions. PharmaBioWorld .

M. Janodia, S. J. (2007). Patents Regime in India: Issues, challenges and opportunities in Pharmaceutical Sector. The Internet Journal of Third World Medicine , 7.

Unnikrishnan. (2014). Uncertainty on approvals sees exodus of clinical trials. Retrieved from http://www.livemint.com/Industry/bQu4EtyMUgkAXEuDade3YN/Uncertainty-on-approvals-sees-exodus-of-clinical-trials.html

Williams, 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)

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