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Objectives: To assess the relation between the number of clinical trials conducted and respective new drug approvals in India and South Africa.
Design: Construction and analysis of a comprehensive database of completed randomised controlled clinical trials based on clinicaltrials.gov from 1 January 2005 to 31 December 2010 and drug approval data from 2006 until 2013 for India and South Africa.
Setting: USA, the EU, India and South Africa.
Main outcome measures: Percentage of completed randomised clinical trials for an Investigational Medicinal Product (IMP) leading to new drug approval in India and South Africa.
Results: A total of 622 eligible randomised controlled trials were identified as per search criteria for India and South Africa. Clustering them for the same sponsor and the same Investigational New Drug (IND) resulted in 453 eligible trials, that is, 224 for India and 229 for South Africa. The distribution of the market application approvals between the EU/USA as well as India and South Africa revealed that out of clinical trials with the participation of test centres in India and/or South Africa, 39.6% (India) clinical trials and 60.1% (South Africa) clinical trials led to market authorisation in the EU/USA without a New Drug Application (NDA) approval in India or South Africa.
Conclusions: Despite an increase in clinical trial activities, there is a clear gap between the number of trials conducted and market availability of these new drugs in India and South Africa. Drug regulatory authorities, investigators, institutional review boards and patient groups should direct their efforts to ensuring availability of new drugs in the market that have been tested and researched on their population.
Malnutrition, nutritional deficiency, or undernutrition is an imbalanced nutritional status resulting from insufficient intake of nutrients to meet normal physiologic requirements. Malnutrition in childhood has both short-term consequences and long-term consequences on mental and physical health as well as the overall health development of children. Of all regions in the world, the Asia and the Pacific region has achieved the fastest rate of economic growth. There is no evidence that this rapid economic growth translates into a decline in malnutrition of children in Asian countries such as India.
Malnutrition is the condition in which the body does not get the right amount of proteins, vitamins, or other nutrients.1 The global prevalence of malnutrition was reported as 13% in 2015.2 The subregion of South Asia is especially known as a critical area for severe wasted children aged <5 years.3 In India, 38.4% of children aged <3 years are stunted, and 46% are underweight.4 Malnutrition can lead to mortality as well as disabilities and long-term consequences such as cognitive disabilities, less economic productivity, or diseases.
The world health organization defines musculoskeletal disorder (MSD) as “a disorder of muscles, tendons, peripheral vascular system not directly resulting from an acute or instantaneous event.1 Work related MSDs are one of the most important occupational hazards.1 Among many other occupations, dentistry is a highly demanding profession that requires good visual acuity, hearing, depth perception, psychomotor skills, manual dexterity, and ability to maintain occupational postures over long periods.
The medical devices sector helps save lives by providing innovative health care solutions regarding diagnosis, prevention, monitoring, treatment, and alleviation. Medical devices are classified into 1 of 3 categories in the order of increasing risk: Class I, Class II, and Class III.1 Medical devices are distinguished from drugs for regulatory purposes based on mechanism of action. Unlike drugs, medical devices operate via physical or mechanical means and are not dependent on metabolism to accomplish their primary intended effect.
Immunization is the most cost-effective intervention for infectious diseases, which are the major cause of morbidity and mortality worldwide. Vaccines not only protect the individual who is vaccinated but also reduce the burden of infectious vaccine-preventable diseases for the entire community.
1 Adult vaccination is very important given that >25% of mortality is due to infectious diseases.
2 There is a scarcity of information on the vaccination status of young adults and the role of socioeconomic conditions in India.
Diabetes is fast gaining the status of a potential epidemic in India, with >62 million individuals currently diagnosed with the disease.1 India currently faces an uncertain future in relation to the potential burden that diabetes may impose on the country. An estimated US$ 2.2 billion would be needed to sufficiently treat all cases of type 2 diabetes mellitus (T2DM) in India.2 Many interventions can reduce the burden of this disease. However, health care resources are limited; thus, interventions for diabetes treatment should be prioritized.
Hypertension is a serious global public health problem. It accounts for 10% of all deaths in India and is the leading noncommunicable disease.1 Recent studies have shown that the prevalence of hypertension is 25% in urban and 10% in rural people in India.2 It exerts a substantial public health burden on cardiovascular health status and health care systems in India.3 Antihypertensive treatment effectively reduces hypertension-related morbidity and mortality.1 The cost of medications has always been a barrier to effective treatment.
Background: The mission of the pharmacy profession is to improve public health through ensuring safe, effective, and appropriate use of medications. Population health management (PHP) is a process wherein opportunities are identified to improve the quality of health care delivered and thereby, promote better health outcomes for patients.
Rationale: As concept of PHP is extremely important in today’s context, it is helpful to integrate data related to pharmacist in population health management practices. Authors conducted a systematic review of the literature on role of pharmacist in population health management practices. Method: We conducted a systematic review of the literature on literature on role of pharmacist in population health management practices by searching, PubMed Medline database using the following combination of keywords – pharmacist, population health. Truncation was used to ensure retrieval of all possible variations of search terms. The search was limited to articles published between 1st January 2015 and 31st December 2019, human studies and English language.
Results: Initial search resulted in a total of 281 studies, title abstract review to remove irrelevant studies resulted in 256 studies. Yearly trend showed that number of publications are decreasing. Highest number of publications were from Europe (47; 18%) and 29 publications (11%) discussed role of pharmacist in population health management of subjects in the age group of 10 to 20 years. Twenty five publications mentioned health management was done in the community settings. Advice on the lifestyle was mentioned in 242 (96%) and 10 (4%) publications offered advice about drugs during the health management. Pharmacists played important roles in population health management for e.g. as care provider in exploring the challenges faced in clinics for management of Type 2 DM. Pharmacists played an important role in increasing the quality of life of patients.
Discussion: Population health management concept has evolved steadily over the past few decades and is now contributing to the ‘patient care journey’ at all stages. There were 24 (9%) publications from India. Specially designed and implemented Pharm D program would play a major role in Indian health care system in future. This will give an opportunity to pharmacists to work more prominently in Indian health care system.
Conclusion: Authors are of the opinion that this is the first review encompassing the topic of pharmacist and population health management in the global context. It is clear that there is a global trend of moving towards involvement of pharmacist in healthcare management. This enables pharmacists to assume an expanded role and at same time it necessitates reforms in pharmacy education and practice.
The practice, attitude, and knowledge of complementary and alternative medicine in Mumbai, India
(2020)
Background: In the recent times, there has been a resurging interest in the use of complementary and alternative medicine (CAM) in India. The present study was conducted to examine the prevalence of CAM use in Mumbai, the knowledge and attitude regarding CAM regarding its safety and efficacy and the reasons for the use of CAM.
Methods: A cross-sectional study was conducted among the general population of Mumbai and its adjoining regions during January-July 2020. 205 residents participated in the study and were asked to fill a pretested questionnaire. The collected data was analyzed using IBM SPSS version 23.
Results: Out of the 205 responses, 163 (79.51%) agreed to have used CAM at least once in their life. Of these, 108 (52.68%) respondents used Ayurveda and 105 (51.21%) used homeopathy. 60 (36.81%) of the respondents practicing CAM used it for common gastrointestinal (GIT)-related disorder with a 100% recovery rate, 125 (76.67%) for infectious diseases with a 93.6% recovery rate. 99 (60.74%) of the respondents preferring CAM for its safety profile, 68 (41.72%) believed that CAM is time tested and thus is efficacious. An integrative approach was suggested by 118 (57.56%) of all the respondents.
Conclusions: There is a disparity between the high prevalence in the use of CAM and its knowledge. However, a general consensus suggests that CAM is efficacious and is practiced for various indications.