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: ??

Broad ligament ectopic pregnancy: a dilemma to diagnose

Broad ligament ectopic pregnancy is a rare and serious form of extrauterine pregnancy with a high risk of maternal mortality. There are no specific clinical features. Ultrasonography may help in diagnosis but definitive diagnosis is made only during surgery. A 20-year-old woman with previous 2 abortions presented with acute abdomen. She had no history of amenorrhoea but there was history of two episodes of bleeding in the last month at an interval of 14 days, each episode lasting for two-three days. The last episode of bleeding was 10 days back. Her urine pregnancy test was done and it was positive. There was marked abdominal tenderness with guarding and rigidity. Per vaginal examination revealed marked tenderness in the right fornix and cervical motion tenderness, uterus size could not be assessed due to tenderness.  It was diagnosed as a case of ruptured ectopic pregnancy. Since she was haemodynamically unstable, emergency laparotomy was done. She had a right sided broad ligament ectopic pregnancy which had ruptured. The tissue was completely removed and haemostatic sutures were taken. High index of clinical suspicion, early diagnosis and prompt surgery is the key to management

Comparison of clinical outcomes in clomiphene citrate resistant infertile polycystic ovarian syndrome women after treatment with laparoscopic ovarian drilling (LOD) versus gonadotropins

Background: Infertility is the inability of a sexually active, non-contracepting couple to achieve pregnancy in one year. Objective of present study was to compare the clinical outcome of laparoscopic ovarian drilling with gonadotropin ovulation induction in patients with clomiphene resistant Polycystic Ovarian Syndrome.Methods: Present study was a comparative interventional study conducted at the Institute of Obstetrics and Gynaecology, Sir Ganga Ram Hospital, New Delhi for a period of one and a half year. We enrolled 40 clomiphene citrate resistant infertile PCOS women who were undergoing treatment for infertility, after taking written informed consent. The women were randomly divided into two equal groups: one for LOD (laparoscopic ovarian drilling) (group A) and other for gonadotropins (group B).Results: Out of 20, 16 women (80%) in group A ovulated with clomiphene citrate and 18 women (90%) ovulated in group B. Pregnancy was the second major outcome and 4 women (20%) in group A with clomiphene citrate got pregnant and 9 women (45%) got pregnant in group B.Conclusions: Out of 20, 16 women (80%) in group A ovulated with clomiphene citrate and 18 women (90%) ovulated in group B. Pregnancy was the second major outcome and 4 women (20%) in group A with clomiphene citrate got pregnant and 9 women (45%) got pregnant in group B. The treatment option can be selected and tailored according to the individual needs and desires of the patient

Performance Evaluation of IoT Sensors in Urban Air Quality Monitoring: Insights from the IoT Sensor Performance Test

In this paper, we report on extensive experiments conducted to evaluate Internet of Things (IoT) sensor performance in monitoring urban air quality. As certified sensors showed a considerably reduced air quality measurement error of 4.3% compared to uncalibrated sensors at 8.5%, our results highlight the crucial function of sensor calibration. The performance of sensors was impacted by environmental factors; higher temperatures produced better accuracy (3.6%), while high humidity levels caused sensors to react more quickly (2.3 seconds). The average air quality index (AQI) recorded by inside sensors was 45, but outside sensors reported an AQI of 60. This indicates that the positioning of the sensors had a substantial influence on the air quality data. Additionally, the methods of data transmission were examined, and it was found that Wi-Fi-transmitting sensors had lower latency (0.6 seconds) and data loss (1.8%) than cellular-transmitting sensors. These results emphasize the significance of environmental factors, sensor placement strategy, sensor calibration, and suitable data transmission techniques in maximizing IoT sensor performance for urban air quality monitoring, ultimately leading to more accurate and dependable air quality assessment

Service user experiences of care recommendations from the 2014 NICE guideline for bipolar disorder: a survey

Clinical guidelines for mental health disorders produced by the National Institute of Care Excellence (NICE) emphasise a recovery-based approach clinical care with collaborative decision-making. The aim of the study was to explore service user experience of collaborative decision-making and recovery focussed care in relation to a NICE clinical guideline for bipolar disorder four years after publication. Participants with a clinical diagnosis of bipolar disorder were recruited from adult mental health services in four specialist mental health NHS Trusts through health professional or self-referral following advertisement. An online or written survey was designed with service user input to cover 40 NICE recommendations on recovery based or collaborative care. Participants completed the survey anonymously and independent of any health professional involvement. Of 222 participants, 72 (33.5%) reported to a great extent care was delivered in line with a positive recovery message; 55 (25.5%) reported that not much or no care was recovery based. Only four items (10%) on medication or the offer of crisis services were endorsed as collaborative decision-making with a health professional by >70% service users. Most decision-making in relation to the NICE clinical guideline for bipolar disorder was not delivered collaboratively and only some care was recovery focussed

Assessment of social, demographic determinants and oral hygiene practices in relation to dental caries among the children attending Anganwadis of Hingna, Nagpur

Background: In developing countries, dental caries is the most common disease of the early childhood. Its increased prevalence in younger age group have been predictive of oral health problems in future, affecting oral health and development leading to several morbid conditions of oral and general health. Prevalence and incidence of dental caries is highly influenced by a number of risk factors such as gender, age, socioeconomic status, dietary patterns, and oral hygiene habits. Aim: To assess social, demographic determinants and oral hygiene practices in relation to dental caries among the children attending Anganwadis of Hingna, Nagpur. Materials and Methodology: A cross sectional study in 27 Anganwadis of Hingna, Nagpur was carried out over a period of two months and a total of 324 subjects attending the Anganwadis were enrolled. Social, demographic and oral hygiene practices in relation to dental caries were assessed in the study population. Results: Out of 324 subjects, 206 had dental caries and 38 were found to be malnourished. A significant association was found among age, malnutrition, parent′s educational status, oral hygiene practices, total number of siblings, and dental caries. Conclusion: Anganwadis should be addressed routinely on effective oral and general health promoting strategies which must include education of parents, oral and general health issues, risk factors for dental caries, and malnutrition in children below 5 years of age