Globalization of Regulatory affairs in Healthcare Industry

Globalization is a term that defines exchange of goods and services between the countries which has a positive impact on economic transactionsacross national borders. Healthcare services are also influenced by globalization. Every country has its own regulatory agency which is responsiblefor its public health, health care systems, and financial resources. As the demand for safe food and medical products is increasing, the responsibility ofthe regulatory agencies is also increasing. They ensure the purity and efficacy of the medical products to protect their citizens. The paper will discussglobalization from the point of view of Food and Drug Administration, European Medicines Agency, Pharmaceuticals and Medical Devices Agency, andCentral Drugs Standard Control Organization and will also discuss the impact of globalization on developing countries such as India, China, Brazil, andSouth Africa. The paper will also deal with the importance of the International Conference on Harmonization which has played a key role in bringingdifferent regulatory agencies of the world to achieve the common goal of promoting globalization in healthcare.Keywords: ??

A comparative study of Kigelia pinnata fruit extracts in terms of antimutagenic potential and antimicrobial efficacy against antibiotic-resistant microbial strains

224-233In recent years, antibiotic-resistant microbes have become a serious concern which needs proper attention either to solve the problem or to find out the solution to treat it. In this study, antibiotic resistant strains of Pseudomonas, Enterococcus, and Escherichia coli (E. coli) were used to assess the antimicrobial potential of Kigelia pinnata fruit extract. Further, antimutagenic potential of Kigelia pinnata fruit extract was also assessed by Ames assay using Salmonella typhimurium strain TA 98 and TA 100. In antimicrobial assay, only chloroform, ethanol and hexane extract was found to produce clear zone diameter between 1.08±0.1 to 2.1±0.2 mm. Results of minimum inhibitory concentration revealed the effectiveness of chloroform extract on Pseudomonas, Enterococcus and E.coli at 1.8 mg/mL concentration. However, better antimicrobial activity was found with ethanol extracts at 2.1x10-2 mg/mL concentration revealing the effectiveness of the low dose of ethanol in killing the antimicrobial resistant strains. In the time-kill test method, chloroform extract of K. pinnata was found to be most effective in reducing 98-99% test microbial population at both dilutions in 30 min. Antimutagenicity test showed the equal potential of chloroform and ethanol extracted Kigelia fruit sample in reducing the number of revertants. Kigelia fruit extract (1000 μL) dose can reduce the mutagens at 5 μg/plate level but not at 10 μg/plate dose level. Further research will open the new scope in the field of development of herbal antimicrobials and antimutagenic compound for treating antibiotic-resistant microbes and cancer

Open Access Extracts from Acacia catechu suppress HIV-1 replication by inhibiting the activities of the viral

Background: Acacia catechu (Mimosa family) stem bark extracts have been used traditionally as a dietary supplement as well as a folk medicine given its reported anti-inflammatory, immunomodulatory, hepatoprotective, antioxidant, anti-microbial and anti-tumor activities. The present study was undertaken to evaluate the anti-HIV-1 activity of the extracts from stem bark of A. catechu. Methods: The aqueous and 50 % ethanolic extracts of A. catechu stem bark were prepared and 50 % ethanolic extract was further fractioned by successively partitioning with petroleum ether, chloroform and n-butanol. All the extracts and fractions were evaluated for cytotoxicity and anti-HIV-1 activity using different in vitro assays. The active n-butanol fraction was evaluated for its inhibition against HIV-1 reverse transcriptase, integrase, protease, pro-viral genome integration and viral Tat protein mediated transactivation. The effect of n-butanol fraction on the induction of pro-inflammatory cytokines secretion in Vk2/E6E7 cells and transepithelial resistance in Caco-2 and HEC-1A cells was investigated. Results: The aqueous and 50 % ethanolic extracts of A. catechu showed IC50 values of 1.8 ± 0.18 μg/ml and 3.6 ± 0.31 μg/ml, respectively in cell-free virus based assay using TZM-bl cells and HIV-1NL4.3 (X-4 tropic). In the above assay, n-butanol fraction exhibited anti-HIV-1 activity with an IC50 of 1.7 ± 0.12 μg/ml. The n-butanol fractio

A comparative study of Kigelia pinnata fruit extracts in terms of antimutagenic potential and antimicrobial efficacy against antibiotic-resistant microbial strains

In recent years, antibiotic-resistant microbes have become a serious concern which needs proper attention either to solve the problem or to find out the solution to treat it. In this study, antibiotic resistant strains of Pseudomonas, Enterococcus, and Escherichia coli (E. coli) were used to assess the antimicrobial potential of Kigelia pinnata fruit extract. Further, antimutagenic potential of Kigelia pinnata fruit extract was also assessed by Ames assay using Salmonella typhimurium strain TA 98 and TA 100. In antimicrobial assay, only chloroform, ethanol and hexane extract was found to produce clear zone diameter between 1.08±0.1 to 2.1±0.2 mm. Results of minimum inhibitory concentration revealed the effectiveness of chloroform extract on Pseudomonas, Enterococcus and E.coli at 1.8 mg/mL concentration. However, better antimicrobial activity was found with ethanol extracts at 2.1x10-2 mg/mL concentration revealing the effectiveness of the low dose of ethanol in killing the antimicrobial resistant strains. In the time-kill test method, chloroform extract of K. pinnata was found to be most effective in reducing 98-99% test microbial population at both dilutions in 30 min. Antimutagenicity test showed the equal potential of chloroform and ethanol extracted Kigelia fruit sample in reducing the number of revertants. Kigelia fruit extract (1000 μL) dose can reduce the mutagens at 5 μg/plate level but not at 10 μg/plate dose level. Further research will open the new scope in the field of development of herbal antimicrobials and antimutagenic compound for treating antibiotic-resistant microbes and cancer

Incidence of gall stone formation in acromegalic patients on octreotide therapy

Objective: Octreotide, a long-acting synthetic somatostatin analog, has been widely used for ac-romegalic patients. Gastrointestinal (GI) side effects and gall stones are predominant side effects. We report incidence of gall stones in our cohort of acromegalic patients treated with octreotide therapy. Design: Retrospective case observational study. Setting: Endocrinology Unit, Dr. Ram Manohar Lohia, Hospital, New Delhi. Materials and Methods: Patients of acromegaly on primary or secondary octreotide therapy. Intervention: Patients were enquired regarding complaints related to the GI system and their medical records were reviewed. Ultrasound films at various intervals while on octerotide therapy were evaluated by the radiologist for presence of sludge and development of gall stones. Results: Of seven patients, five developed gallstones and sludge was seen in three patients at intervals ranging from 11 to 36 months postoctreotide initiation. Conclusion: A high incidence of gall stone formation in the present study as compared to the West was noted, the reasons for which are not clear

Persistence of histoplasma in adrenals 7 years after antifungal therapy

Adrenal histoplasmosis is an uncommon cause for adrenal insufficiency. The duration of treatment for adrenal histoplasmosis is not clear. Existing treatment regimens advocate antifungals given for periods ranging from 6 months to 2 years. We report here a rare case who showed persistence of histoplasma in adrenal biopsy 7 years after being initially treated with itraconazole for 9 months. This calls for a prolonged therapy with regular review of adrenal morphology and histology in these patients

Effect of octreotide on endometriosis in acromegaly: Case report with review of literature

Objective: To study the effect of octreotide therapy on endometriotic lesions in a patient with coexisting endometriosis and acromegaly. Intervention: Patient: A 34-year-old female was diagnosed with acromegaly and coexisting endometriosis. Post-surgical resection of the tumor, patient was initiated on octreotide therapy. Results: There was improvement in menstrual bleeding as IGF1 levels decreased with Octreotide therapy. Resolution of the endometriotic lesions was observed during follow up. Conclusion: In this unusual case, the treatment of acromegaly concurred with regression in the endometriotic lesions. Causal or incidental association cannot be inferred from the present case

Electrostrictive Effect in Cancer Cell Reflected in Capacitance Relaxation Phenomena

The present paper has focus on the composite dielectric property of the cancer cell on concomitant with the capacitance relaxation phenomena. In this respect it has been found from MAT lab simulation the electrostrictive process in cancer cell is a complex one for which the electrostatic surfaces surrounding the cell changes with the incremental changes in the capacitance present in the capacitance relaxation curve. From these incremental changes in capacitance it is also possible to find out the electrostrictive energy of the cancer cell. It is interesting to note that the electrostrictive energy corresponding to the cell incremental changes in the capacitance is more in the first order system than that present in the second order system representing the equivalent configuration of the composite dielectric associated with the cell membrane. This is due the fact that during the process DNA synthesis and cell division the change in capacitance of the membrane for the first order system is relatively slow

Extracts from Acacia catechu suppress HIV-1 replication by inhibiting the activities of the viral protease and Tat

BACKGROUND: Acacia catechu (Mimosa family) stem bark extracts have been used traditionally as a dietary supplement as well as a folk medicine given its reported anti-inflammatory, immunomodulatory, hepatoprotective, antioxidant, anti-microbial and anti-tumor activities. The present study was undertaken to evaluate the anti-HIV-1 activity of the extracts from stem bark of A. catechu. METHODS: The aqueous and 50% ethanolic extracts of A. catechu stem bark were prepared and 50% ethanolic extract was further fractioned by successively partitioning with petroleum ether, chloroform and n-butanol. All the extracts and fractions were evaluated for cytotoxicity and anti-HIV-1 activity using different in vitro assays. The active n-butanol fraction was evaluated for its inhibition against HIV-1 reverse transcriptase, integrase, protease, pro-viral genome integration and viral Tat protein mediated transactivation. The effect of n-butanol fraction on the induction of pro-inflammatory cytokines secretion in Vk2/E6E7 cells and transepithelial resistance in Caco-2 and HEC-1A cells was investigated. RESULTS: The aqueous and 50% ethanolic extracts of A. catechu showed IC(50) values of 1.8 ± 0.18 μg/ml and 3.6 ± 0.31 μg/ml, respectively in cell-free virus based assay using TZM-bl cells and HIV-1(NL4.3) (X-4 tropic). In the above assay, n-butanol fraction exhibited anti-HIV-1 activity with an IC(50) of 1.7 ± 0.12 μg/ml. The n-butanol fraction showed a dose-dependent inhibition against HIV-1(NL4.3) infection of the peripheral blood lymphocytes and against HIV-1(BaL)(R-5-tropic) as well as two different primary viral isolates of HIV-1 infection of TZM-bl cells. The n-butanol fraction demonstrates a potent inhibitory activity against the viral protease (IC(50) = 12.9 μg/ml), but not reverse transcriptase or integrase. Further, in Alu-PCR no effect on viral integration was observed. The n-butanol fraction interfered with the Tat-mediated Long Terminal Repeat transactivation in TZM-bl cells, mRNA quantitation (qRT-PCR) and electrophoretic mobility shift assay (EMSA). The n-butanol fraction did not cause an enhanced secretion of pro-inflammatory cytokines in Vk2/E6E7 cells. Additionally, no adverse effects were observed to the monolayer formed by the Caco-2 and HEC-1A epithelial cells. CONCLUSIONS: The results presented here show a potential anti-HIV-1 activity of A. catechu mediated by the inhibition of the functions of the viral protein and Tat