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. 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> Covering Global Pharmaceutical Regulations in a Quality System <p>This article describes how to address compliance with a wide range of applicable regulations within a company’s quality system. The focus is on the way regulatory intelligence can be obtained and subsequently be interpreted within the quality system. Roles and responsibilities of those involved are also discussed.</p> <p>Regulatory agencies try to harmonise regulations regionally and to some extent globally, but that still requires a lot of work. To remain up-to-date with the Good Practices, i.e. remain in a continued state of compliance, one needs to be aware of the regulations, interpret their impact on the quality system and operations, and if necessary, then change, adapt and improve these. This process is a continuous improvement process cycle in Pharmaceutical Industries (1).</p> Siegfried Schmitt ##submission.copyrightStatement## 2018-09-15 2018-09-15 6 3 1 4 10.22270/ijdra.v6i3.257 A review on ANDA submission requirements for Generic drugs: “Paragraph IV certification” as per FDA CDER guidelines <p>USFDA is one the most regulated agencies wherein the submission process is most critical. The study depends on how to submit ANDA application as per FDA, CDER guidelines in paragraph IV submission in Federal Food, Drug, and Cosmetic Act (FD&amp;C Act). No drug would be available in the market until and unless it get approved by Regulatory Authorities. “Paragraph IV Certification” is useful for exclusive right to market the generic drug for 180 days. Submission is for the company which is seeking to copy branded drug before expiration of patents to get benefit over it, a generic applicant must provide in its application a "certification" that a patent submitted to FDA by the brand-name drug's sponsor and listed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book). A Generic Product must meet the standards established by FDA in RLD (Reference listed drug). This study covers the introduction of ANDA submission to FDA and ACT related to the submission in to paragraph IV and the details of ANDA filling in the eCTD format and overview of review process the checklist to the applicant.</p> Saffiya Khatun M Jyothshna Devi Katamreddy Jayachandra Reddy P ##submission.copyrightStatement## 2018-09-15 2018-09-15 6 3 5 12 10.22270/ijdra.v6i3.260 Registration of Drug Product dossier application as per EU Guidelines <p>Due to variations in the regulatory norms of registration dossier in different countries, there is a strong need for harmonization by ICH for approval of drugs. Generic drugs in EU are approved under the Marketing Authorization Application. Bioavailability and Bioequivalence study data is critical in the generic drug approval process. Moreover, there are several approaches to assess BA/BE, each regulatory authority has put forth its own regulations/guidances for conducting BA/BE studies. Medicinal products are highly regulated in the European Union (EU) and are subject to a separate, complicated system of approvals that governs how, when, where, and in what form such products will be allowed to be sold within the borders of EU. The present marketing authorization procedures applicable to European Economic Area included 27 EU member states and the three EEA European Free Trade Association states (Iceland, Liechtenstein and Norway). Marketing Authorization Application is applied based on National procedure, mutual recognition procedure, centralized and decentralized procedure. Hence procedure for Registration of Drug Products was discussed in detail in this current review.</p> Bhavya Kondepati Jyothshna Devi Katamreddy Jayachandra reddy P ##submission.copyrightStatement## 2018-09-15 2018-09-15 6 3 13 23 10.22270/ijdra.v6i3.261 Saxagliptin and Dapagliflozin for type 2 Diabetes mellitus: A Review <p>Qtern® is a fixed dose combination tablet of Saxagliptin and Dapagliflozin which is indicated for the advancement of glycaemic control in adults with type 2 diabetes mellitus (T2DM). It can be done either when medication with metformin and/or a sulfonylurea with a monocomponent of either Saxagliptin or Dapagliflozin render poor glycaemic control, or when the subject is treated with the free combination of Saxagliptin and Dapagliflozin. This review compiles pathophysiology of type 2 diabetes mellitus (T2DM) along with pharmacological properties, mechanism of action, and side effects of both the drugs. Furthermore, the method of determination of combination is described in this review. The agents have corresponding mechanisms of action, which further adds to the benefit of using this combination. The mixture is associated with reduced body weight and a low risk of hypoglycaemia. It is the first dipeptidyl peptidase-4 (DPP-4) inhibitor and sodium-glucose cotransporter (SGLT2) inhibitor fixed-dose combination available in the EU therefore can act as potent option for glycaemic control in patients with T2DM.</p> Deepshi Ranjan Akanksha Sharma Ramesh Babu Bodla ##submission.copyrightStatement## 2018-09-15 2018-09-15 6 3 24 30 10.22270/ijdra.v6i3.264 Drug approval process in US, Europe and India and its regulatory requirements: A Review <p>Current constrain of Regulatory Affairs reveals diverse countries need to follow different regulatory requirements for marketing authorization Application (MAA) approval of new drugs. In this present exertion, study expresses the drug approval process and regulatory requirements according to US Food and Drug Administration (UDFDA), European Medical Agency (EMA) and Central Drug Standard Control Organization (CDSCO) (1).</p> Krishnasis Chakraborty Kavita Yadav ##submission.copyrightStatement## 2018-09-15 2018-09-15 6 3 31 39 10.22270/ijdra.v6i3.266 Regulatory overview of biosimilars in Europe <p>A biosimilar is a biological medicine similar, but not identical, to an already registered reference bio therapeutic product in terms of quality, safety, and efficacy. These drugs are also called as biosimilar products‘, follow-on protein products’ and subsequent-entry biologics‘. The EU has pioneered the regulation of biosimilar medicines by establishing a solid framework for their approval and by shaping biosimilar development globally. Since the EU approved the first biosimilar in 2006, healthcare professionals have gained increasing experience with their use. Today, biosimilars are an integral part of the effective biological therapies available in the EU, supported by adequate safeguards protecting patient safety. In Europe, in 2001, legislation concerning biosimilar was codified as Directive 2001/83/EC to create a new marketing authorization procedure for similar biological medicinal products and also Committee for Medicinal Products for Human Use (CHMP) of the EMA is concern with these biosimilar products. The aim of biosimilars development is to demonstrate bio similarity - high similarity in terms of structure, biological activity and efficacy, safety and immunogenicity profile. Safety of biosimilars is monitored through pharmacovigilance activities, in the same way as for any other medicine. Biosimilars can offer advantages to EU healthcare systems, as it is expected to improve patients’ access to safe and effective biological medicines with proven quality.</p> Jyothi Sri Durga Vanacharla Shailaja Pashikanti Sowmya A. N. V. L ##submission.copyrightStatement## 2018-09-15 2018-09-15 6 3 40 44 10.22270/ijdra.v6i3.270 Study the effects of Nipah Virus – A Review <p>The effect of Nipah Virus Infection is increasing day by day in today’s scenario and more number of cases are found in various countries. In India it was discovered in Sikkim, Siliguri and West Bengal. It is near borders with China, Bangladesh, Nepal, and Sikkim. The primary pathways of transmission is from bats to people, in Bangladesh its transformed via contamination of raw date palm sap by bats with subsequent consumption by humans and through infection of domestic animals (cattle, pigs, and goats), presumably from consumption of food contaminated with bat saliva or urine with subsequent transmission to people. It is found in both species of humans as well as animals more numbers of deaths were found in the both spices, hence zoonotic.</p> <p>Laboratory investigations at the time of the outbreak did not show or identify an infectious agent. Approximately half of recognized Nipah cases in Bangladesh developed their disease following person to person transmission of the virus. Efforts to prevent transmission should focus on decreasing bat access to date palm sap and reducing family members' and friends' exposure to infected patients' saliva or body fluids.</p> Dhiraj Kumar Singh Rakhi Ahuja Nagendra Kumar Singh ##submission.copyrightStatement## 2018-09-15 2018-09-15 6 3 45 52 10.22270/ijdra.v6i3.275