Role of Pharmacovigilance in India: An overview.

Pharmacovigilance (PV) plays a key role in the healthcare system through assessment, monitoring and discovery of interactions amongst drugs and their effects in human. Pharmaceutical and biotechnological medicines are designed to cure, prevent or treat diseases; however, there are also risks particularly adverse drug reactions (ADRs) can cause serious harm to patients. Thus, for safety medication ADRs monitoring required for each medicine throughout its life cycle, during development of drug such as pre-marketing including early stages of drug design, clinical trials, and post-marketing surveillance. PV is concerns with the detection, assessment, understanding and prevention of ADRs. Pharmacogenetics and pharmacogenomics are an indispensable part of the clinical research. Variation in the human genome is a cause of variable response to drugs and susceptibility to diseases are determined, which is important for early drug discovery to PV. Moreover, PV has traditionally involved in mining spontaneous reports submitted to national surveillance systems. The research focus is shifting toward the use of data generated from platforms outside the conventional framework such as electronic medical records, biomedical literature, and patient-reported data in health forums. The emerging trend in PV is to link premarketing data with human safety information observed in the post-marketing phase. The PV system team obtains valuable additional information, building up the scientific data contained in the original report and making it more informative. This necessitates an utmost requirement for effective regulations of the drug approval process and conscious pre and post approval vigilance of the undesired effects, especially in India. Adverse events reported by PV system potentially benefit to the community due to their proximity to both population and public health practitioners, in terms of language and knowledge, enables easy contact with reporters by electronically. Hence, PV helps to the patients get well and to manage optimally or ideally, avoid illness is a collective responsibility of industry, drug regulators, clinicians and other healthcare professionals to enhance their contribution to public health. This review summarized objectives and methodologies used in PV with critical overview of existing PV in India, challenges to overcome and future prospects with respect to Indian context.

Anti-arthritic and anti-inflammatory activity of combined pioglitazone and prednisolone on adjuvant-induced arthritis.

The aim of the present study was to evaluate the effect of combined treatment of pioglitazone (PGZ) and prednisolone (PDL) on the progression of adjuvant-induced arthritis in rats. Adjuvant arthritis was induced by single intra-dermal injection of 0.1 ml Freund's complete adjuvant (0.05% w/v Mycobacterium butyricum in mineral oil) into foot pads of left hind paws of Wistar rats of either sex. There were six experimental groups: Group I was healthy animals as control, Group II was arthritic animals without drug treatment, Group III was arthritic animals treated with a standard non-steroidal anti-inflammatory drug aspirin (100 mg/kg), Group IV was arthritic animals received PGZ (10 mg/kg) alone, Group V was arthritic animals received PDL (10 mg/kg) alone, and Group VI was arthritic animals treated with a combined suspension of PGZ and PDL (20 mg/kg). Drugs were administered daily orally at day 0 and continued upto 28th day after induction of arthritis. Induction of arthritis significantly increased hind paw volume (HPV), loss of body weight (BW), enhanced tibiotarsal joint thickness (TJT), and increased plasma tumor necrosis factor-alpha (TNF-α) and interleukin (IL)-6 levels. Treatment with aspirin or combined suspension of PGZ and PDL in the arthritic animals produced significant reductions in HPV and TJT, normalized BW, and significantly decreased plasma levels of TNF-α and IL-6. These observations suggest that the combined administration of PGZ and PDL was effective in modulating the inflammatory response and suppress arthritis progression in experimental animal model. These findings may help to improve the treatment of rheumatoid arthritis.

Association between the ionotropic glutamate receptor kainate3 (GRIK3) Ser310Ala polymorphism and schizophrenia in the Indian population.

Various studies have been done to check the status of glutamate receptor gene in the pathogenesis of schizophrenia. The T928G (Ser310Ala) polymorphism of ionotropic glutamate receptor kainate 3 gene (GRIK3) and its positive association with schizophrenia was reported in Caucasians, whereas no association of this polymorphism with schizophrenia was shown in two other populations, Chinese and Japanese. However, no literature is available regarding the prevalence of this polymorphism and its association with schizophrenia in the Indian population. As genetic susceptibility profiles in India are often different from those of white Caucasians or Orientals, we investigated the status of Ser310Ala polymorphism of GRIK3 in 100 schizophrenic patients and 100 healthy controls in the Indian population by the PCR-RFLP (restriction fragment length polymorphism) method. A statistically significant difference in the genotype and allelic distributions (P<0.000001 and P=0.01, respectively) of Ser310Ala polymorphism was found in schizophrenics than in control, considering Ala-allele as being associated with the disease (OR=1.7, 95% CI=1.137-2.540). Our study suggests a potential role for GRIK3 for susceptibility to schizophrenia in Indian population.