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Study Of Regulatory Affairs Essay

994 words - 4 pages

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 registration of drug trials, video consent of patients and volunteers, mandatory clearance by ethics committees and mandatory participation of government hospitals, among others (Devarakonda, 2013). Two other reasons that are responsible for the delay in clinical trial approvals are shortage of trained/technical staff and lack of standardization and transparency in Clinical trial approvals, audits, and inspections.
Overcoming the Challenge:

I think this challenge can be addressed by adopting certain changes which will enable the clinical trials to be carried out in India rather than being outsourced abroad. Firstly, the recent amendment to regulations should be addressed even though they are very stringent. They are needed for the mandatory GCP compliance and adverse event reporting. However, I think the ambiguity in the regulations should be clarified, as they look more patient friendly and less sponsor friendly. Once this balance is achieved it would lead to integrity of clinical trials. Timelines for safety adverse events reporting should also be streamlined so that they reduce the ambiguity of regulations. The technical staff at DCGI should be increased as they are understaffed or undertrained. I think further training...

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