M. C. Gupta

An overview of the pharmacovigilance system in India

Abstract Pharmacovigilance (PV) has witnessed several advancements throughout the world over the past few decades. This review provides an overview of the PV system in India, focusing on the current scenario, its development, the challenges faced, and the interventions suggested for its improvement. The Pharmacovigilance Program of India (PvPI) is playing a major role in gathering drug safety related data and adding it to the WHO database. PvPI fulfills the minimum requirements given by the WHO for any functional national Pharmacovigilance system. The Indian Pharmacopoeia Commission (IPC) is the national coordinating center under PvPI. PV in India relies mainly upon the spontaneous reporting of adverse drug events. The major challenge for PV in India is under-reporting. However, there is an improvement in the number of submitted reports after regular training and awareness programmes, which have been conducted by the IPC. The regular and periodic circulation of the ‘PvPI Newsletter’ by the IPC has also been instrumental in increasing awareness about PV amongst healthcare professionals and patients. The intensification of PV activities in India demands particular attention in health science curricula. Indeed, a change in mindset is necessary for prescribers, patients, regulatory agencies, and pharmaceutical companies.

Effect of Different Doses of Ascorbic Acid on Depression in Mice

Ascorbic acid, commonly known as vitamin C, is a water-soluble antioxidant vitamin and has several therapeutic applications in a wide range of diseases. It is considered as a neuromodulator as it is highly concentrated in the brain and, as such, has a possible therapeutic relevance for the treatment of depression. This study was conducted to investigate the anti-depressant effect of ascorbic acid in forced swimming test (FST) and tail suspension test (TST) and the correlation between the dose and its antidepressant action. 24 male mice were selected and divided into 4 groups. Group I received normal saline. Group II received venlafaxine (0.048mg/g); Group III and Group IV received 0.065mg/g and 0.13 mg/g of ascorbic acid. All animals received drug treatment intraperitonially (i.p.), thirty minutes before the test. The results showed that ascorbic acid at a dose of 0.13mg/g, decreased immobility period and increased swimming as well as climbing, significantly, (p<0.01) in both TST and FST as compared to normal saline treated group. The effect of ascorbic acid, at the dosage of 0.13mg/g, was comparable to that of venlafaxine while at the dose of 0.065mg/g, the effect was lesser than that of the standard group. We concluded that higher dosages of ascorbic acid are effective to produce an antidepressant effect.

Toxic epidermal necrolysis induced by acetaminophen: a case report -

Acetaminophen is a very commonly used analgesic and antipyretic drug across various age groups. Although mild to moderate cutaneous reactions have been reported quite frequently, serious reactions like Stevens –Johnson syndrome and Toxic epidermal necrolysis (TEN) are very rare. We report the case of a 10 year old child who had TEN after ingestion of tablet acetaminophen. This case report highlights the need to be critically aware of this rare and serious adverse effect of this commonly used over the counter drug.