International Journal of Drug Regulatory Affairs <p align="justify">IJDRA is a broad-spectrum, open-access &amp; peer-reviewed International Pharmaceutical Journal circulated as electronically and Print issues. 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. Any delay will result in a delay in publication.</p> <p>I/we have read and agree with the terms and conditions stated Page 2 of this agreement and I/we hereby confirm the transfer of all copyrights in and relating to the above-named manuscript, in all forms and media, now or hereafter known, to the International Journal of Drug Regulatory affairs, effective from the date stated below. I/we acknowledge that the IJDRA is relying on this agreement in publishing the above-named manuscript. 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> <p>&nbsp;</p> </div> Regulatory aspects for Biologic Product licensing in Australia <p>The TG Act defines biological as product made, from or containing, human cells or human tissues, lives animal organs, cells or tissues, and that is used to treat or prevent disease or injury, Diagnose a condition of a person and Alter the physiological processes of a person.</p> <p>The Australian Regulatory Guidelines for Biologicals (ARGB) provide the keen information for manufacturers, sponsors, professionals in healthcare and also to public about the use of human cells and tissues based therapeutic goods, live animal cells, organs and tissues (1). These all products are Biologicals. This guideline is specially written for general public. If you are a sponsor or manufacture, this will:</p> <ul> <li>Explains the biological regulatory framework is applies to manufacturer’s product and their exemption conditions (1).</li> <li>Explains the Australian regulatory requirements for supplying of Biologicals</li> <li>Explains what is required for the market authorization as per TGA especially for Biologicals.</li> </ul> Sanjeev Kumar Maurya Vikesh Kumar Shukla Sunny Kumar Maurya Prachi Kaushik ##submission.copyrightStatement## 2019-06-16 2019-06-16 7 2 1 6 10.22270/ijdra.v7i2.310 Understanding the globally harmonized system of classification and Labeling of Chemicals-The Purple Book <p>Global Harmonized System (GHS), relating to hazard chemicals, is a process of making a regulation among countries uniform to the extent possible so as to benefit an industry to export its products to several countries with one communication system.&nbsp; On one side, the system is helpful to develop communication as labeling and material safety data sheets, and on the other side is helpful for the personnel in the chemical and pharmaceutical industry in using chemicals carefully, especially hazardous.&nbsp; Such international guidelines are believed to be the most reliable information so that the end user of hazard chemicals is confident enough in handling and using. The current article is a brief understanding of the guideline, an attempt, how the hazard chemicals are being classified, communicated as labels, symbols and material safety data sheets.</p> Bayya Subba Rao ##submission.copyrightStatement## 2019-06-16 2019-06-16 7 2 7 16 10.22270/ijdra.v7i2.312 A comprehensive study of Regulatory compliance for Biosimilars in US, EU and India <p>The biopharmaceutical industry has gained significant interest in the last decade as the numbers of blockbuster biologic products are losing their patent rights. The regulatory authority is also providing marketing approval for Biosimilar products. Biological medicines are biotechnology developed drugs having large molecule which is complex in nature and are very sensitive to manufacturing conditions and parameters. Even a minor change in manufacturing conditions alters the quality and safety aspects of end product owing to increased risk for immune response. Biopharmaceutical companies use information technology such as molecular modelling and statistical data for drug development. Biosimilar drugs have moderate marketing cost which is alluring and generally 40 to 50 % less to that of originator drug product. Biosimilars are also known as “follow on biologics” or “similar biologics”. The following points needs consideration such as global harmonization, extrapolation studies, interchangeability study, long term post marketing studies to gain physician confidence in biosimilars.</p> Anshul Bansal Vikesh Kumar Shukla Shikha Chauhan ##submission.copyrightStatement## 2019-06-16 2019-06-16 7 2 17 34 10.22270/ijdra.v7i2.313 Simultaneous estimation of xanthine alkaloids (Theophylline, Theobromine and Caffeine) by High-Performance Liquid Chromatography <p>Methylxanthines are mainly a group of phytochemicals which are derived from purine base xanthine. These xanthines are obtained from plant as a result of secondary metabolism. There are various physiological actions that have been attributed to these derivatives in neurogenerative diseases, respiratory diseases, cancer and diabetes. The aim of this study is to develop a suitable qualitative and quantitative method for these xanthine derivatives. HPLC method is suitable for simultaneous estimation of methylxanthines, based on their physicochemical properties. Theobromine, Theophylline and Caffeine that belongs to alkaloids possess their economic effects. They have various stimulant effects on cardiovascular system, gastrointestinal system, respiratory system, central nervous system etc. that results in increased motivation to work, increased energy and increased alertness. High performance liquid chromatography is used for simultaneous determination of theophylline, theobromine and caffeine from different tea leaves.</p> Shruti Mourya Ramesh Bodla Ravikant Taurean Akanksha Sharma ##submission.copyrightStatement## 2019-06-16 2019-06-16 7 2 35 41 10.22270/ijdra.v7i2.315 Pre-filled syringes in developed and developing region: An insight into Regulatory considerations <p>A Pre-filled syringe is a disposable syringe that is supplied already loaded with the substance to be injected. It is a unit dose of parenteral medication to which a needle has been fixed by a producer. They are small which make them easy to carry and are dependable for delivering a precise dose of medication. These reasons are leading to growth of parenteral medication in pharmaceutical market. The intent of this review article is to provide information on regulatory guidelines involved in submission approach for marketing authorization of pre-filled syringe in developed region (USA, EU) and developing region (India). It also further explains about complexities associated with Pre-filled syringes in terms of regulations, submission approaches and quality development considerations in developing region. There is a need to develop an effective regulatory framework to make regulations of Pre-filled syringes more comprehensive for regulatory bodies. A harmonized forum to be made through which single application can be made and single review process can be followed to avoid deviations in regulatory pathways.</p> Anjali Kapoor Geeta Aggarwal ##submission.copyrightStatement## 2019-06-16 2019-06-16 7 2 42 50 10.22270/ijdra.v7i2.317 Regulatory requirements for preparation of Dossier for registration of Pharmaceutical products in ACTD & CTD format <p>To prepare and compile the Dossier required for Registration of Pharmaceutical Products as per the requirements of each countries which shall be acceptable internationally to develop one regulatory approach. To avoid variation in the documents submitted in the form of dossier for registration of Pharmaceutical Products in the different countries of the world it’s important to know the requirements of Regulatory Authorities of each countries in which the Dossier is filled for the smooth Registration. This agreed upon common format in the form of CTD format and ACTD format for the technical documentation will significantly reduce the time and resources needed to compile applications for registration of human pharmaceuticals and will be more ease to submit the file having electronic database.</p> Shrikant Godiyal ##submission.copyrightStatement## 2019-06-16 2019-06-16 7 2 51 61 10.22270/ijdra.v7i2.318 Overview of current Regulations governing Medical Devices <p>Medical Device (MD) is one of the fastest growing sector and so are the associated regulations. From lack of even policies and guidelines to stringent MD legislations in others, the requirements vary across countries. Understanding and interpreting the global MD evolving regulations and requirements is important (for not just the manufacturers, importers, wholesalers and distributors but even the clinicians) in the current global competitive market. This review is an attempt to do that by giving an overview of the prevailing MD regulations in United States (U.S), Europe and India.<strong>&nbsp;</strong></p> Bobby George ##submission.copyrightStatement## 2019-06-16 2019-06-16 7 2 62 66 10.22270/ijdra.v7i2.321