Original Research Article

MICRORNA–RELATED GENE POLYMORPHISMS IN PATIENTS WITH RENAL DISEASE IN BABYLON PROVINCE

RABAB OMRAN, ZAHRAA ISAM, AMMAD HASSAN MAHMOOD, DHULFIQAR AHMED KHALEEL

Journal of Disease and Global Health, Page 53-60

Micro Ribo Nucleic Acids (miRNAs) are endogenous short non-coding ribonucleic acid, its though (miRNAs) were controlled most of the necessary cellular processes by inhibiting gene expression through the post-transcriptional repression of their goal mRNAs. In kidneys, several types of research exhibited, that miRNA are related to nephritic development, homeostasis, and physiological functions. The study aimed to analyze the risk factor of MIR196A2 T>C (rs11614913) among patients with chronic and end-stage renal disease (ESRD).

The blood samples were collected from 100 patients divided into two groups, chronic renal disease (50 samples) and end-stage renal disease (50 samples), who admitted to Merjan Teaching Hospital in Babylon Province, Iraq. Additionally to healthy persons as a control group (50 samples), from February to July 2016. Genotyping of MicroRNA SNPs was performed using a polymerase chain reaction (PCR) technique, followed by Restriction Fragment Length Polymorphism. we tend to determined associate redoubled risk of just about twofold for ESRD and chronic compared to control, Continuous analysis unconcealed that the mutant genotypes of rs11614913 SNP are associated with the lowest overall survival compared with heterozygous and wild genotypes chronic and end-stage renal disease. The results of our study counsel that the variants specifically, rs11614913 of MicroRNA SNP may be concerned in status to chronic and ESRD.

Review Papers

COMPARISON AND COMPILATION OF MARKETING AUTHORIZATION APPLICATION REQUIREMENTS FOR VACCINES IN SAUDI ARABIA AND SINGAPORE

SUHAS SHANKAR JOSHI, V. BALAMURALIDHARA

Journal of Disease and Global Health, Page 1-11

Vaccines contain agents which are often made from the microbe or its surface proteins or its toxins, which are eventually derived from the biological source. Before launching a new vaccine in the market, the rigorous regulatory procedure is required to assess the quality, efficacy and safety of the vaccine. Saudi Arabia registration of vaccine procedure is done under the marketing authorization of Saudi Food and Drug Administration (SFDA). Registration of vaccines guidelines in Singapore is categorized under Therapeutic product registration. NDA (New Drug Application) application must be filed for registering the vaccines in Singapore.

This study was aimed to bring out information about the registration procedures amongst the guidelines from Saudi Arabia and Singapore and concluding from the fact that how these guidelines can be harmonized. The harmonized registration procedure is required to ensure the reachability of the vaccines on time to the global population.

Review Papers

MARKETING AUTHORIZATION APPLICATION REQUIREMENTS FOR VACCINES IN INDIA, EUROPEAN UNION, UNITED STATES

SUHAS SHANKAR JOSHI, V. BALAMURALIDHARA

Journal of Disease and Global Health, Page 12-22

Vaccines contain agents which are often made from the microbe or its surface proteins or its toxins, which are eventually derived from the biological source. Before launching a new vaccine in the market, the rigorous regulatory procedure is required to assess the quality, efficacy and safety of the vaccine. U.S. Food and Drug Administration (FDA) Centre for Biologics Evaluation and Research (CBER) is responsible for regulating vaccines in the United States. European Union (EU) follows five steps to regulate vaccine registration and regulation which are, marketing authorization application (MAA), registration, quality assessment, pharmacovigilance, post-license commitments and license renewals. In the case of India, vaccine registrations are regulated by the Drugs and Cosmetics Act, 1940.

Review Papers

LEGAL ASPECTS OF SPURIOUS DRUGS IN INDIA

S. UMESH, V. BALMURALIDHARA, H. V. RAGHUNANDAN, K. C. SWATHI

Journal of Disease and Global Health, Page 23-36

India is very important in the manufacture of Common Place tablets and 12-25% of the drugs supplied worldwide are contaminated, substandard and counterfeit. As the sector produces powerful pharmaceutical components and finished goods, India along with VP Patrick Luke of the Global Fitness Applications of the US Pharmacopoeia Convention may be the leading individuals for counterfeit medicines in China. In this review article main aim is to provide overview information and to trace the spurious drugs along with the Indian market compare with the US and Europe market. Some legal aspects of maintaining an exceptional Standard of medicines. India made some preventive measures in the nation to fight against the poor quality of drugs, drugs in Indian market compare with the US and Europe market, definitions along with justification for change for not preferred satisfactory drugs, and its declaration procedure. In perspective on above perceptions and information acquired, we may conclude that it might be inferred that, the degree of misleading medications in retail drug store is much underneath the projections made by Central Drugs Standard Control Organisation (CDSCO). CDSCO formulate guidelines, according to which CDSCO classified tablets (non-high quality) are divided into 3 categories. Government attempted some preventive measures to limit the hazard from misleading and inadequate medications. By the comparison of drugs with US and Europe market, drugs in Indian market are safe and need more awareness amongst the public about the safety of medicines.

Review Papers

SPURIOUS DRUGS IN INDIA: COMPARISON WITH EUROPE AND USA, SYSTEMATIC REVIEW

S. UMESH, V. BALMURALIDHARA, K. C. SWATHI, H. V. RAGHUNANDAN

Journal of Disease and Global Health, Page 37-52

India has a bigger problem of spurious and substandard drugs, which result in life threatening issues, financial loss of consumer and manufacturer and loss in trust on health system. In view of the fact that the conversion of credible medication into unsatisfactory medication can cause a number of adverse effects from mild to direct and to severe. To provide information regarding track and trace of  the spurious drugs in India in comparison with United States (USA), and Europe (EU). India is the largest producer to no-exclusive drugs. Also, potentially, 12-25% of all given prescriptions in India are contaminated, unsatisfactory or fake. The Directorate General of Health Administrations, Ministry of Health and Family Welfare, Legislature of India is united to decrease the spurious drugs. Legal foundation is discussed and  Guidelines for making a move on tests of not of standard quality in the light of upgraded punishments under the medications and beautifying agents (revision) act and future investigation plan and the comparison of spurious drugs in India, US and Europe. In   perspective on above perceptions and information acquired compared with US and Europe, we may conclude that, the state medication control associations made 13 rules to minimize the spurious and substandard drugs in India. Central drug standard control organization (CDSCO) done nationwide overview in India in 2017, from the review we come to know 3% sedates in India is unsatisfactory.