Advanced Postgraduate Diploma in Clinical Research & Pharmacovigilance

The drug development industry is changing in a way where innovation and drug safety are not separate from one another. New business models are maturing leading to the development of new generation therapies and to a coexistence of these newer drugs and well known blockbuster treatments from the past.
Pharmacovigilance is now an essential component of the life cycle of almost all healthcare related products. This is because of a demand for safer and more effective drugs and changes in regulations applicable to their research, development and marketing.
Many global companies such as Pfizer, Quintiles, GlaxoSmithkline etc have developed their own pharmacovigilance centres in all major clinical research regions around the world including India. In addition, local drug companies in these regions are also stepping up their work in research and development for both promising new molecules as well as generics. An industry analysis carried out by Frost & Sullivan titled ‘World Pharmacovigilance Markets in Lifesciences’ has found that the while the global pharmacovigilance industry in 2008 was valued at US $1859.9 million it is estimated to touch US $2252.2 million by 2015. This business report also emphasizes the shifting focus of key drug companies towards outsourcing their pharmacovigilance functions to smaller specialized pharmacovigilance service providers. Developing regions such as India, Latin America etc are slowly becoming a hub for pharmacovigilance business.
In November 2004, the Indian ‘Central Drugs Standard Control Organization’ (CDSCO) launched the National Pharmacovigilance Program under the aegis of Directorate General of Health Services and the Union Ministry of Health and Family Welfare which has now been replaced by the Pharmacovigilance Program of India (PvPI) introduced in 2010.