International Journal of Drug Regulatory Affairs <p align="justify">IJDRA is a broad-spectrum, open-access &amp; peer-reviewed International Pharmaceutical Journal circulated electronically via the World Wide Web. It is the First Journal on Drug Regulatory Affairs in India. It covers the subjects-Regulatory Affairs, Intellectual Property Rights and Pharmaceutical Development and intended to be of interest to a broad audience of pharmaceutical professionals. IJDRA now ideally placed to serve the needs of their Readers and professionals related to pharmaceutical field.</p> Swedish Scientific Publications en-US International Journal of Drug Regulatory Affairs 2321-7162 <div align="justify"> <p>The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published. We therefore ask you to complete and return this form, retaining a copy for your records. Your cooperation is essential and appreciated. 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However, this agreement will be null and void if the manuscript is not published in the IJDRA.</p> <p><strong>Download link for <a href=""><em>COPYRIGHT FORM</em></a></strong></p> <h3>Rights of Authors:</h3> <p>The International Journal of Drug Regulatory affairs. recognize the retention of the following:</p> <ul> <li>Patent and trademark rights and rights to any process or procedure described in the article.</li> <li>The right to photocopy or make single electronic copies of the article for their own personal use, including for their own classroom use, or for the personal use of colleagues, provided the copies are not offered for sale and are not distributed in a systematic way outside of their employing institution (e.g. via an e-mail list or public file server). 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The signing author shall bear the responsibility for designating the co-author(s) and must inform the IJDRA of any changes in authorship.</li> <li>If copyright is held by the employer, then the employer or an authorized representative of the employer must sign. If the author signs, it is understood that this is with the authorization of the employer and the employer’s acceptance of the terms of the transfer.</li> </ul> <p><strong>Warranties:</strong></p> <p>The author(s) warrant(s) that the article is the author’s original work and has not been published before. The author(s) warrant(s) that the article contains no libelous or other unlawful statements, and does not infringe on the rights of others. If excerpts from copyrighted works are included, the author(s) has (have) obtained or will obtain written permission from the copyright owners and will credit the source in the article.</p> <p><strong>Preprints:</strong> The author(s) must agree that if a prior version of this work (normally a preprint) has been posted to an electronic public server, they will not update and/or replace the prior version in order to make it identical in content to the final published version.</p> </div> A Comprehensive and Comparative study of qualification process for Drug Development tools in US, Europe, Japan and India. <p>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 &amp; India have also focused on developing a formal qualification process of drug development tools though most of it follows USFDA.</p> Garima Kshatriya Dilip G. Maheshwari ##submission.copyrightStatement## 2018-06-15 2018-06-15 6 2 1 7 10.22270/ijdra.v6i2.227 Differentiation between the Regulatory paths placed on Mouthwashes in the US and EU <p>Regulating oral rinses has been and still is a topic of debate and confusion. Oral rinses are products that are mainly used for cleaning, perfuming and changing the appearance of the teeth, which in turn improves the individual’s external appearance. Adding medicinal ingredients to these rinses, it can then be used for the elimination and/or prevention of some oral diseases, an example being gingivitis. The United States Food and Drug Administration placed guidelines which state that mouthwashes with possible therapeutic properties should be registered as drugs rather than cosmetics. Meanwhile, on a different continent, Germany along with the other members of the European Union decided not to categorize mouthwashes as drugs, but rather as cosmetics, using its sole purpose of cleaning and beautifying the teeth as the excuse. The following research will thoroughly differentiate between the diverse regulatory systems forced upon mouthwashes across the two countries—the United States and Germany.</p> Philip Saddik John Pappan ##submission.copyrightStatement## 2018-06-15 2018-06-15 6 2 8 13 10.22270/ijdra.v6i2.229 Regulatory requirements for Dossier submission in African Countries (Kenya, Uganda, and Tanzania) - A Review <p>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.</p> Juhi Ashwinbhai Randeria Ronak Dedania Zarna Dedania Vineet Jain Meghna Danej ##submission.copyrightStatement## 2018-06-15 2018-06-15 6 2 14 21 10.22270/ijdra.v6i2.231 Current Regulatory requirements for Registration of Nutraceuticals in India and USA <p>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 20<sup>th</sup> 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&nbsp;progressing. The global nutraceutical market will reach $285.0 billion by <strong>2021</strong> from $<strong>198.7</strong> billion in 2016 at CAGR of <strong>7.5% </strong>from 2016-2021. The present research has been devoted towards better understanding of the nutraceuticals and its regulation in India and USA.</p> Pooja Nemichand Jain Meera H. Rathod Vineet C. Jain Vijayendraswamy S. M. ##submission.copyrightStatement## 2018-06-15 2018-06-15 6 2 22 29 10.22270/ijdra.v6i2.232 Regulatory requirements for the approval of Anti-Cancer drug (Mercaptopurine) in Myanmar as per ACTD <p>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.</p> Meera Hasmukhbhai Rathod Pooja N. Jain Vineet C. Jain Swamy Vijyendra S. M. ##submission.copyrightStatement## 2018-06-15 2018-06-15 6 2 35 40 10.22270/ijdra.v6i2.235 Regulatory requirements for Drug master file in context to Canada and Australia <p>Drug Master Files are required in most countries as supporting documents for the registration of drug products. DMFs generally contain information pertaining to the chemistry, manufacturing and controls (CMC) sections of the drug submission and reflect the drug’s identity, strength, purity and quality. Canada and Australia which are consider as highly regulated markets (HRMs). In CANADA, DMF filing was done through New Drug Submission (NDS) for both drugs and biologic products. They use MF terminology for DMF which contain four types of MASTER FILE- ASMFs, CCS MFs, Excipient MFs, Drug product MFs. In AUSTRALIA different application processes and regulatory requirements apply depending on the type of therapeutic goods that is applied. They consist of eight phase for DMF registration. Where EU guidelines adopted in Australia include references to EU legislation. Now from 2016 onwards most of the regulated countries will use eCTD or their electronic format for their DMF submission. Compare DMF regulatory requirements in the above-mentioned countries so that reader can have clear idea on how to file DMF.</p> Meghna Danej Ronak Dedania Sanket Gandhi Juhi Randeria Kankrej Gaurav ##submission.copyrightStatement## 2018-06-15 2018-06-15 6 2 41 47 10.22270/ijdra.v6i2.236 A retrospective study of Warning Letters issued by US FDA over 2015-2017 <p>This paper provides contemporary climate of warning letters issued by US FDA over 2015 to 2017. With 1300$ Billion Revenue in 2017 United States stands as World’s largest Pharmaceutical Market. Being the largest, diversified and due to globalization, US Pharma industry is the most competitive and critical sectors of the economy. So, exporting to the US is a great opportunity which is leveraged by many countries and US FDA was formed to check the quality standards of Medicines. Since the inception of US FDA, it has been giving many warning letters to Pharmaceutical Companies for violating regulatory guidelines. The back bone of this paper is to analyse warning letters and to identify what are the major violations in case of Pharmaceuticals.</p> Lakshmi Ananth Nirmal K. Gurbani Saurabh Kumar Bharat Gujavarti ##submission.copyrightStatement## 2018-06-15 2018-06-15 6 2 48 53 10.22270/ijdra.v6i2.242 Regulation of Medicines in Bhutan: Current Status, Challenges and Opportunities <p>Medicines Regulatory Agencies (MRAs) are responsible for evaluation of quality, safety and efficacy of medicinal products before it is approved for consumption. The regulatory procedures, however, differs from one country to another. Medical products including vaccines, blood and blood products, diagnostics and medical devices are essential for healthcare delivery across the world. The Drug Regulatory Authority (DRA) is an independent national agency for regulation of medicinal products in Bhutan and reports to Bhutan Medicines Board (BMB), the highest policy making body for regulation of medicinal products in the country.</p> <p>Medicines Act of the Kingdom of Bhutan is the legal tool for regulation of medicines in Bhutan. Medicinal products are regulated through premarketing and post-marketing control systems. All medicinal products available in the Bhutanese market are registered. DRA regulates all the medicinal products including vaccines, blood products and traditional medicines used for human and veterinary.</p> <p>DRA is fully financed by the Government of Bhutan. Bhutan’s medicines regulatory system has evolved over the last one decade. However, as the regulatory mandate continues to increase, DRA is faced with several challenges in terms of human resource, infrastructure and testing laboratory among others. There are also opportunities for the DRA to improve its regulatory capacities to ensure availability of quality and safe medicines for the public.</p> <p>Understanding the current practice of medicines regulation in Bhutan can help identify gaps and existing opportunities for improving the regulatory capacity. This article documents the existing practices, challenges and opportunities for regulation of medicinal products in Bhutan.</p> Pelden Chejor Jigme Tenzin Jigme Dorji ##submission.copyrightStatement## 2018-06-15 2018-06-15 6 2 54 58 10.22270/ijdra.v6i2.243 General requirements for marketing authorization transfers in Thailand, Malaysia, Singapore, Indonesia and Philippines <p>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.&nbsp; 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.</p> Jyothshna devi Katamreddy Prathyusha Jeeva ##submission.copyrightStatement## 2018-06-15 2018-06-15 6 2 59 66 10.22270/ijdra.v6i2.244 Regulatory requirement for the approval of Generic Drug in Cambodia as per ASEAN Common Technical Dossier (ACTD) <p>Drug approval process differs from one country to another country. In some countries only single body regulates the drug as well as responsible for all regulatory work which is a challenging task for the pharmaceutical companies to prepare single dossier that can be simultaneously submitted in many countries for approval. In all countries there is a similar characteristic in regulatory environment but there is a difference in their registration requirements. The purpose of this study is to give a comparative overview on generic drug market regulation in ASEAN Countries Cambodia and Malaysia. The aim of study is to facilitate proper knowledge regarding main critical issues, differences as well as similarities of related drug regulation. There is a different requirement for registration of generic product in each regulatory system but also comprises of some similar outline that includes some common rules. These are variances and regulatory hurdles such as Number of batches for submission in dossier, stability conditions, registration of product, analysis, bioequivalence and clinical study requirement. ASEAN countries for generic drug product approval ACTD submitted to country specific authority. For solid oral dosage forms as per ASEAN guideline there are 4 parts have to be submitted. Part I contains Administrative requirements which is not a part of common technical document. Part II is Quality contains 3 sections that are a) Table of Content b) Quality overall Summary c) Body of data. Part III contains Non clinical. Part IV contains Clinical data. For the generic drug product Part III and Part IV is not required.</p> Ravish Patel Amit Patel Tejasvini Gohil ##submission.copyrightStatement## 2018-06-15 2018-06-15 6 2 67 71 10.22270/ijdra.v6i2.245 Regulation of Blood and Blood products in India, USA and EU <p>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.</p> Swati Gupta Harvinder Popli ##submission.copyrightStatement## 2018-06-15 2018-06-15 6 2 72 84 10.22270/ijdra.v6i2.246 Regulatory requirements for Vaccine registration in United States <p>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).&nbsp; 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.</p> Shailaja Pashikanti Sowmya A.N.V.L Jyothi Sri Durga V ##submission.copyrightStatement## 2018-06-15 2018-06-15 6 2 85 91 10.22270/ijdra.v6i2.253 Establishment of blending control for Hand operated Double Cone Blender <p>In the current study, a fundamental approach is used to establish operation procedure, for a hand operated double cone blender.&nbsp; 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.&nbsp; 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.</p> Bayya Subba Rao Anuroop Raveendran Ratnakar Baki Adithya Jinuka ##submission.copyrightStatement## 2018-06-15 2018-06-15 6 2 30 34 10.22270/ijdra.v6i2.233 Comparative Study of Triglyceride Level in Ischemic Heart Disease Patients in different age groups of Patients in south east Rajasthan <p>Backgrounds: Elevated body triglycerides have been implicated as a risk factor of ischemic heart disease (IHD).<br><br>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.<br><br>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.<br><br>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 (&gt;60years of age) smokers (304.20±88.60mg/dl) compared to non smoker (206.37±48.88mg/dl), elderly male with high (&gt;150mg/dl) LDL (323.48±86.73mg/dl) compared to patients with normal (&lt;150mg/dl) LDL (249.33±66.12 mg/dl). Similarly male patients of IHD with high (&gt;40mg/dl) VLDL had significantly higher serum triglyceride (326.49±77.95mg/dl) compared to male patients with normal (&lt;40mg/dl) VLDL (257.18±85.46mg/dl).<br><br>Conclusion: High serum triglyceride level (&gt;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.</p> Darab Singh Underwal Sushma Pandey Deepak Gupta ##submission.copyrightStatement## 2018-06-15 2018-06-15 6 2 92 99 10.22270/ijdra.v6i2.256