title: Safety reporting through a comprehensive and pragmatic pharmcovigilance process for India and emerging markets: an industry perspective.
abstract: BACKGROUND
  Pharmacovigilance (PV) deals with the drug-related adverse reactions ensuring patients' safety. Emerging markets of India, South East Asia (SEA), Russia, Latin America (LA), Middle East and North Africa (MENA) have developed their own PV programs. However, under/manual reporting accompanied with lack of awareness regarding adverse drug reactions (ADRs) are major drawbacks that continue to exist due to lack of co-ordination and disparity in the regulatory approach.
  
  
  METHODS
  Of the 118 studies identified using various databases, 60 were included for the review. The authors discuss the present PV scenario of India, SEA, Russia, LA and MENA, and explain a basic process for uniform PV data input-output across industry, which includes data collection, analysis, processing, causality assessment and data distribution systems.
  
  
  CONCLUSIONS
  As the number of clinical trials conducted are rising in the emerging markets, there is a need to understand and implement a robust PV system, where electronically globalized, evidence based, public health oriented and regulatory compliant PV system is established. This would also improve transparency in system and ensure enhancement in safety data reporting ensuring premature and trouble-free detection of ADRs. It might result in implementing various PV boosting activities, which could yield robust patient safety data from India and emerging markets.
authors: a 1 Wockhardt Limited , Wockhardt Towers, Bandra Kurla Complex, Mumbai, India +91 99 20 168 771 ; sswamy@wockhardt.com.
authors: Shashidhar
authors: S
authors: Swamy
authors: Meenakshi
authors: M
authors: Mourya
authors: Ganesh
authors: G
authors: Kadhe
authors: Amey
authors: A
authors: Mane
authors: Sandesh
authors: S
authors: Sawant
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D003625:Data Collection / Q000379:methods; D004345:Drug Industry / Q000458:organization & administration; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D006801:Humans; D007194:India; D060735:Pharmacovigilance; D011634:Public Health
keywords: adverse drug reactions; pharmacovigilance process; reporting; safety data