An update on the Pharmacovigilance Programme of India

Pharmacovigilance is a pharmacological science related to the detection, assessment, understanding and prevention of adverse effects, particularly long-term and short-term adverse effects of medicines (WHO-Essential Medicines and Health Products, 2002). It has been observed that a medication that is proven efficacious in large patient population often fails to work in some other patients of different ancestry. Ancestral background of the patients are controlled by genetic factors that influence drug response-drug targets, drug-metabolizing enzymes, drug transporters, and genes indirectly affecting drug action can modulate drug toxicity and contribute to its individual variability (Ma and Lu, 2011). Thus, adverse drug reactions are highly variable in individuals and are major limiting factor in drug therapy and development. For example people with Asian ancestry are at greater risk for serious cutaneous reactions when starting treatment with carbamazepine. Therefore, even though the drug had already been approved in some other country, clinical trial with robust pharmacovigilance monitoring is needed in the population of different race & ethnicity. In India, a formal ADR monitoring system was started in 1986 with 12 regional centers. In 1997, India became the member of WHO Programme for International Drug Monitoring managed by the Uppsala Monitoring Centre (UMC), Sweden. At inception, 6 regional centers were set up in Mumbai, New Delhi, Kolkata, Lucknow, Pondicherry, and Chandigarh for ADR monitoring in the country (Gupta, 2010). Of these 6 centers, only the centers in Mumbai and New Delhi were active and thus spontaneous reporting of ADRs were poor. Therefore, in November 2004, Govt. of India has launched National Pharmacovigilance Programme (NPvP) with an annual grant of US$0.1 million approved for 5 years from World Bank (Gupta, 2010). However, the World Bank funding for this programme was ended in mid-2009 and this programme was temporarily suspended. Recognizing the need for improved ADR monitoring in the country, in July, 2010, under the aegis of Health Ministry, a nationwide revised ADR monitoring programme was launched and PvPI, ADRs are being identified and spontaneously reported by the healthcare professional of Adverse Drug Reaction Monitoring Centres (AMC). These AMCs are set up across the country in medical colleges approved by Medical Council of India (MCI) (Rehan, 2013). These AMCs are responsible for collecting adverse event as per Standard Operating Procedure (SOP), performing follow up if require for the completeness of ADR reports and uploading these reports in net-based software used for ADR reporting called as Vigiflow (Kalaiselvan et …