Safety reporting through a comprehensive and pragmatic pharmcovigilance process for India and emerging markets: an industry perspective

Abstract

Introduction: 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.

Areas covered: 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.

Expert opinion: 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.

Keywords:

• adverse drug reactions
• pharmacovigilance process
• reporting
• safety data

Declaration of interest

Medical writing assistance for this review article was provided by Knowledge Isotopes Pvt. Ltd., Mohali, India, and was funded by Wockhardt Ltd. (Mumbai, India). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Notes

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