Post Marketing Surveillance: a Real – Life Effectiveness of Essential Medicines in Indian Population

The aim of the work is the need of post marketing surveillance in India. The objective in Postmarketing surveillance is to estimate the strength of the association between adverse events (AEs) and drug exposures that vary over time. In premarketing testing, the numbers and types of patients used to demonstrate a drug’s efficacy and safety are limited compared with the numbers and types of patients who will eventually be prescribed the drug after it is marketed. Although post-marketing surveillance cannot provide knowledge of the safety or efficacy of drugs at the time of their introduction on the market. Post-marketing surveillance of drug therefore play an important role to discover an undesirable effect that might present at risk. This paper provides you the information of importance of PMS, Guidelines in the other countries, SOP of PMS, Analytical methods of PMS with few direct examples, content of PMS as per DCGI Guidelines and information on the benefit and risk of the drugs.