In order to address the increasing demand for pharmacovigilance professionals in the country, the JSS University, Mysore has trained over 60 students for job profiles like Drug Safety Associates in Contract Research Organizations (CROs) and in the Pharmacovigilance Programme of India (PvPI) in the past three years since its inception.

The programme named Post Graduate Diploma in Pharmacovigilance has gained a lot of relevance today as learning and incorporating pharmacovigilance in the routine patient care has become a present day challenge for healthcare professionals in the country.

Informs Dr G Parthasarathi, dean, Faculty of Pharmacy, JSS University, Mysore, "Effective communication of the safety data to the general public is a key challenge which need to be addressed on a war footing. Therefore, the course has been able to encompass areas like pharmacology, pharmacotherapy, drug development, pharmacoepidemiology, literature search and critical evaluation of drug safety data, medical writing and also the regulations and guidelines."

Letter writing, package insert warnings are some of the conventional methods used for communication of pharmacovigilance knowledge. Changing regulatory environment and ever increasing drugs and associated information has necessitated the need for such course.

Certain factors including pharmacovigilance as a science or as a specialty is slowly picking up in the country. Besides this, research and reporting outcomes are limited. There has also been lack of methodological approach and the specialty has been more hospital focussed than community focussed. Single-centered studies has been done versus multiple centres and a lot of research on the subject remains unpublished are some of the key drivers fueling the demand for such courses.

The courses offered by JSS University have been able to sensitise students on the importance of pharmacovigilance, basics of ADRs, risk factors for ADRs, individual case safety reports, pharmacovigilance in clinical development, product quality complaints, product security and medication errors, spontaneous reporting systems and signal detection and management.

Besides, the course also addresses challenges like lack of knowledge and expertise, uneven audience, evolving GVP culture, highly specialised area and very less teaching or learning prospects at UG Level.

For effective pharmacovigilance, there is a need to cover areas like post authorisation studies, benefit-risk assessment, risk management plans, quality assurance and inspections, guidance and legislations and pharmacovigilance in public health programmes.