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Journal International Journal of Drug Regulatory Affairs

133 articles
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Mal Dipak Kumar, Samrat Chakraborty, Biswajit Mukherjee
International Journal of Drug Regulatory Affairs, Volume 2, pp 1-13; doi:10.22270/ijdra.v2i4.10

Abstract:India is emerging as a global outsourcing power house in almost all fields including Drugs and Pharmaceutical sector.Now it becomes a hub to conduct clinical trials and contract researches. Pharmaceutical industry currently opts fortotal quality management as primary criteria to prevent sub-standard products which do not fall under officialspecifications. However, there are many areas where immediate regulatory measures are desired. Central DrugsStandard Control organization (CDSCO) is the prime regulatory authority for the purpose of enforcement accordingto the Drugs and Cosmetic Act 1940 and Rules 1945, with its amendments. There is no established system formonitoring the Physician’s samples as it generally moves from medical representatives to patients via medicalprofessionals. Fixed dose combinations are approved by Drug Controller General of India without proper doseschedule and indications. Metered dose inhaler is presented without dose counter, so that user cannot read how manydoses remain. The capacity of CDSCO/the licensing authority/ controlling authority at both national and state levelneed to be matched with Pharmaceutical Industry in term of man power, infrastructure and training to provide safeand effective drugs to the patients. In the present review, those areas have been highlighted along with some possiblesolutions such as more stringency and uniformity in drug regulatory policies, use of software to identify duplicate andmisbranded medicines, speedy functioning of drug regulatory authorities etc.
Darab Singh Underwal, Sushma Pandey, Deepak Gupta
International Journal of Drug Regulatory Affairs, Volume 6, pp 92-99; doi:10.22270/ijdra.v6i2.256

Abstract:Backgrounds: Elevated body triglycerides have been implicated as a risk factor of ischemic heart disease (IHD).Objectives: To study the association of serum triglyceride with ischemic heart disease and to assess the relationship of serum triglyceride with other established conventional risk factors.Methods: A cross sectional case-control study of 75 cases of IHD and 75 controls without having any evidence of IHD/CHD between age group 30-70 years. Serum triglyceride levels were estimated by using Colorimetric Method and other risk factors by enzymatic methods.Results: Mean serum triglyceride (263.674 ± 89.029mg/dl) was significantly higher in cases than controls (98.833 ± 62.682mg/dl). Amongst the patients of IHD, significantly higher level of Serum triglyceride was found in diabetics (340.63±90.78mg/dl) than non-diabetics (225.19±58.30mg/dl), male elderly (>60years of age) smokers (304.20±88.60mg/dl) compared to non smoker (206.37±48.88mg/dl), elderly male with high (>150mg/dl) LDL (323.48±86.73mg/dl) compared to patients with normal (40mg/dl) VLDL had significantly higher serum triglyceride (326.49±77.95mg/dl) compared to male patients with normal (200mg/dl) may provide a cost effective tool for predicting an impending ischemic heart disease especially in diabetic patients, male elderly smokers, elderly males with high LDL, male patients of ischemic heart disease with high VLDL level.
Pooja Nemichand Jain, Meera H. Rathod, Vineet C. Jain, Vijayendraswamy S. M.
International Journal of Drug Regulatory Affairs, Volume 6, pp 22-29; doi:10.22270/ijdra.v6i2.232

Abstract:There is growing recognition of the potential role for nutraceuticals and dietary supplements in helping to reduce health risks and improve health quality. Pharmaceutical and nutritional companies are aware of the monetary success taking advantage of the nutraceuticals and dietary supplements. Nutraceuticals has proven health benefits and their Consumption will keep disease at bay and allow humans to maintain an overall good health. Functional foods and internationally products represent a value added growth opportunity both domestically and internationally. Development of better characterized and research proven products will help enhance consumer confidence in nutraceutical and functional food products in the world. Regulatory aspects of such products were in a state of confusion in 20th century. Till date the regulations are not harmonized for the globe and change from country to country. But now it is clearly understood that the regulations for clinical evidence and safety of such products cannot be less stringent than rules for modern medicines and thus the science of nutraceutical is progressing. The global nutraceutical market will reach $285.0 billion by 2021 from $198.7 billion in 2016 at CAGR of 7.5% from 2016-2021. The present research has been devoted towards better understanding of the nutraceuticals and its regulation in India and USA.
Bayya Subba Rao, Anuroop Raveendran, Ratnakar Baki, Adithya Jinuka
International Journal of Drug Regulatory Affairs, Volume 6, pp 30-34; doi:10.22270/ijdra.v6i2.233

Abstract:In the current study, a fundamental approach is used to establish operation procedure, for a hand operated double cone blender. Initially, assuming for a potent drug, where in, the strength of the drug is very less in the final dosage form, a one percent concentration of potassium permanganate with respect to final one kilogram of blended powder using starch as diluent was planned. With a kind of geometric progression method, at a rate of 10 rotations per minute, the final outcome of the uniform distribution of the potassium permanganate was found to be for at least for fourteen hours of rotations, leading to concentration range of potassium permanganate 0.08 ± 0.025 mg per mg of final blended powder.
Garima Kshatriya, Dilip G. Maheshwari
International Journal of Drug Regulatory Affairs, Volume 6, pp 1-7; doi:10.22270/ijdra.v6i2.227

Abstract:Drug Development Tools are methods, materials, or measures that have the potential to facilitate drug development. USFDA has specified three major drug development tools and has also given the guidelines recommending their qualification which would expedite the drug development process. This qualification would ensure better understanding of drug targets and long term safety outcomes. Regulatory authorities of Europe, Japan & India have also focused on developing a formal qualification process of drug development tools though most of it follows USFDA.
Shailaja Pashikanti, Sowmya A.N.V.L, Jyothi Sri Durga V
International Journal of Drug Regulatory Affairs, Volume 6, pp 85-91; doi:10.22270/ijdra.v6i2.253

Abstract:Vaccination is one among the foremost cost-efficient health interventions out available, saving a lot of individuals from illness, incapacity, and death annually. No alternative countermeasures are effective in reducing or eliminating the prevalence of infectious diseases reminiscent of measles, mumps, rubella, smallpox, and diphtheria. Vaccines are products of biological origin that exhibit some inherent variability. They are characterized by advanced manufacturing processes and are administered to a huge number of healthy youngsters, adolescents, and adults. Their quality cannot be assessed by testing the ultimate product alone. The vaccine industry is highly regulated. Vaccines development maybe an advanced and long method. Before a new vaccine is approved for release into the market, a rigorous restrictive procedure to assess quality, effectiveness, and safety should be undertaken. The Office of Vaccines Research and Review (OVRR) at the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA) are responsible for the regulation of Vaccines. Current authority for the regulation of vaccines is in Section 351(a) of the Public Health Service Act (PHS). Throughout the lifecycle of development, from preclinical studies to licensure, vaccines are subjected to rigorous testing and oversight. Manufacturers should adhere to good manufacturing practices and management procedures to make sure the quality of vaccines.
Juhi Ashwinbhai Randeria, Ronak Dedania, Zarna Dedania, Vineet Jain, Meghna Danej
International Journal of Drug Regulatory Affairs, Volume 6, pp 14-21; doi:10.22270/ijdra.v6i2.231

Abstract:Africa is world’s second fastest growing pharmaceutical market. The CGAR of African Pharmaceutical market is 10.6%. African people suffer from numerous diseases. The local pharmaceutical market is weak and insufficient to meet the demand of such diseased condition and so Africa relies heavily on externally developed and procured drugs. This combination of economic strength and prevalence of diseases is already driving a demand for medicines across Africa. The objective of this study is to delve in various parameters required for registration for externally developed pharmaceutical product African countries. A dossier containing detailed information about the drug and results of the studies carried out in its development process has to be submitted to the regulating bodies for getting market authorization. CTD is critical for dossier submissions. A comparative study will help the sponsor to file the dossier in many countries simultaneously; which can save time and money. Thus knowledge of guideline specific for individual country becomes important to determine the most stringent member, which shall ease approval process in other target countries in the region.
Swati Gupta, Harvinder Popli
International Journal of Drug Regulatory Affairs, Volume 6, pp 72-84; doi:10.22270/ijdra.v6i2.246

Abstract:Blood and blood products are precious commodity which gives life to another person. Though we have immense discoveries and invention in science and technology, yet we cannot make blood hence, human blood has no substitute. The availability of safe blood and blood products is essential for diverse modern healthcare services including some surgeries, treatments for cancer, chronic medical conditions, trauma care, organ transplantation, and childbirths that ultimately improve life for millions of patients who are need of transfusion annually. We do not have yet well-defined and stringent regulatory framework for blood products regulation. Frailty may arise from the inability of governments to enforce laws, regulations, and policies and personnel who may not aware or cannot follow quality assurance and/ or good manufacturing practices. While the health sector in developed nation has made outstanding accomplishments in the past few decades. The study sheds on the overview of blood transfusion system in India and other developed nations. There were a mix of methodologies, including literature review (government documents), interviews with key officials in Indian Red Cross Society and analysis of data was used. Results of analysis showed that there are several areas that need to be addressed as it potentially affect the timely availability of safe blood products, which calls for strengthening the planning and monitoring of blood transfusion services.
Jyothshna Devi Katamreddy, Prathyusha Jeeva
International Journal of Drug Regulatory Affairs, Volume 6, pp 59-66; doi:10.22270/ijdra.v6i2.244

Abstract:The review article is only for brief idea about the Marketing Authorization Transfers in few of ASEAN region. Whatever the data here I have been provided is according to my knowledge and study depends on healthy authorities/regulatory authorities sometimes requirements also may change. A Marketing Authorization Transfer is may be necessary to a company selling their product rights to another company it’s like acquisition. In Order to transfer any kind of Pharmaceutical Products in ASEAN region from one MAH to other MAH that particular product must have a Marketing Authorization Transfer issued by the competent health/Regulatory Authority. This MAT is issued to a legal entity called MAT. It is a procedure by which the MA is transferred from the Old MAH to New MAH which is a different legal entity. The MA holder is completing responsibility for the life of the pharmaceutical product including all technical development and further alterations. The MAT process outcomes in the original MAH rights and responsibilities concerning the specific pharmaceutical product to be transferred to the New MAH on a specific date on which the transfer is stimulated. According to dossier all the parameters would be present. The expiry date is same and therefore, if applicable, the date by which it has to be renewed in order to remain legal. If any obligations are applicable (post authorization): PSUR, follow-up measures and special commitments.
Meera Hasmukhbhai Rathod, Pooja N. Jain, Vineet C. Jain, Swamy Vijyendra S. M.
International Journal of Drug Regulatory Affairs, Volume 6, pp 35-40; doi:10.22270/ijdra.v6i2.235

Abstract:South East Asian pharmaceutical market is growing rapidly. In Asian country, The regulatory environment is similar among all countries. But still requirements and process of registration is varying among countries of Asian region. Although ACTD is harmonized for all ten countries but still every country differ in some of the local requirements such as administrative, technical, clinical and non clinical documents. Among this country Myanmar systematically regulate the manufacture, import, export, storage, distribution and sale of drugs. Aim of the present study is To discuss emerging challenges and requirements posed by compulsory licensing for drugs in diseases such as cancer. In this article we have observed documents requires for registration of Mercaptopurine drug belonging to anti – cancer category in Myanmar. Documents like batch manufacturing record, process validation records, stability study which include long term and accelerated stability studies as per zone specification of Myanmar, packing requirements for anti – cancer drug and certificate for product permission required for registration, which has covered all aspects from manufacturing to its packing and registration. This article will give the easy understanding on the drug registration requirements for anti – cancer drug such as Mercaptopurine in Myanmar.
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