It is important for medical advisors to actively lead the research activities. These could include a protocol and case report form designing, selection of investigators, medical monitoring, Gemcitabine clinical trial development of the study report, and publication, in addition to coordinating with the Drugs Controller General of India during the submission and drug approval process. Medical advisors have a major role in early drug development especially phase IIa studies, basic research, and epidemiological research. This would include both the registration studies as well as the studies as part of global drug development. Pharmacovigilance In India, the pharmaceutical company holding the marketing license for the product has to ensure the responsibility of pharmacovigilance for their marketed products, as specified in Schedule Y.

[4] In this regard, the role of a medical advisor in drug safety is of paramount importance. It not only includes screening of the available information on adverse events for its causality and expectedness, but also includes communication with the reporter or other physicians coordinating with the regulatory authorities, if required. Identifying signals and working to reduce the risk in specific populations, alerting the organization on possible risks and working on remedial actions are other areas of importance in pharmacovigilance. Access to medicines In India, this has come up as a new responsibility especially in diseases with unmet medical needs, and certain neglected or tropical diseases.

The responsibility of a medical advisor is to provide access to specific or institutional requests in line with the norms outlined in the Drugs and Cosmetics Act, liaise with internal stakeholders [Figures ?[Figures11 and ?and2].2]. on quantity and labeling details, and fulfill pharmacovigilance responsibilities. In addition, in the post launch period, a medical advisor has to play a role in designing an access program by which patients may not be deprived of medicines because of high cost alone. As we enter an era of biologics and other specialized treatments in chronic illness, the need for designing and developing such programs is going to increase further. Figure 2 Schematic diagram of pharmaceutical physician’s internal stakeholders As discussed before, the Indian pharmaceutical industry has continued to evolve over the last few years GSK-3 from a product-centric approach to a disease-centric approach to a therapeutic area?Ccentric approach to a patient-centric approach [Figure 3].

Figure sellckchem 3 Evolution of focus of pharmaceutical industries in India FUTURE ROLE The main challenges that the global pharmaceutical industry is facing include shrinking and less productive pipelines, and longer drug development timelines in developed as well as emerging countries.