RESUMEN
BACKGROUND: The National Coordination Centre-Pharmacovigilance Programme of India (NCC-PvPI), Indian Pharmacopoeia Commission works under the aegis of Ministry of Health and Family Welfare, Government of India. It promotes patient safety in India and also supports postmarketing surveillance programs. Currently, almost hundred thousand case reports are submitted to NCC-PvPI each year through its 250 ADR Monitoring Centers (AMCs) located across India, and India is the one of the top ten contributor countries under WHO-Uppsala Monitoring Centre since 2012 and start issuing drug safety alerts from March 2016. AIM: This study aims to highlight the drug safety alerts issued by NCC-PvPI from March 2016 to June 2017 and urgent need for further monitoring by adopting targeted spontaneous reporting (TSR) methodology at AMCs and its impact on the NCC's drug safety database, i.e., VigiFlow in India. METHODOLOGY: A retrospective analysis was done for the reported unlisted ADRs by various AMCs to PvPI through VigiFlow, i.e., individual case safety report (ICSR) management system at NCC, where these unlisted drug-ADR combinations considered and issued as drug safety alerts for further reporting these to NCC, if any detected at healthcare settings during routine clinical practice by healthcare professionals. RESULTS: From July 2011 to June 2017, NCC-PvPI was collated 250,787 ICSRs and contributed to WHO international drug safety database, i.e., VigiBase, from these ICSRs; NCC-PvPI was issued 56 drug safety alerts from March 2016 to June 2017. CONCLUSION: In India, spontaneous reporting of ADRs existed since 1998 under passive surveillance method, but there is an urgent need to initiate TSR, which is a complementary method to spontaneous reporting on these drug safety alerts for further regulatory action by Central Drugs Standard Control Organization.
RESUMEN
Cataractous-opacification of the lens is one of the leading causes of blindness in India. The situation can be managed by surgical removal of the cataractous lens. Various pharmacological strategies have been proposed for the prevention and treatment of cataract. Information on possible benefits of putative anticataract agents comes from a variety of approaches, ranging from laboratory experiments, both in vitro and in vivo , to epidemiological studies in patients. This review deals with the various mechanisms, and possible pharmacological interventions for the prevention of cataract. The article also reviews research on potential anticataractous agents, including aldose reductase inhibitors, glutathione boosters, antiglycating agents, vitamins and various drugs from indigenous sources.
