International Journal of Drug Regulatory Affairs 2019-09-30T16:04:08+00:00 Dr. Jitendra Kumar Badjatya Open Journal Systems <p>IJDRA is Quarterly Open-access and peer-reviewed Journal circulated electronically and Print since 2013 to provide the quality information on the latest updates on Drug regulation. It is the first Journal for subject Drug Regulatory Affairs in India and it publishes Research articles, Review articles, and Case studies on all aspects of Drug Regulatory Affairs, Pharmaceutical Development,&nbsp;Medical and Health Sciences in association with Delhi Pharmaceutical Sciences and Research University (DPSRU), New Delhi, India. The journal serves researchers from academia and industry and intended to be of interest to a broad audience of Pharmaceutical, Medical and Health professionals.</p> Intellectual Property Right in India- A Review 2019-09-29T19:03:47+00:00 Zakir Hussain Shaik Md. Jennai Shiva Goli Venkateswarlu R. Suthakaran Syed Ghouse <p>The CDSCO prescribes standards and measures for ensuring the safety, efficacy and quality of drugs, diagnostics, cosmetics and devices in the country. Pharmaceutical research and development is an expensive, time consuming and uncertain process that may take 8-10 years to complete. Patent clock starts much before a new drug is approved for marketing and significant amount of time may be lost in the review and approval process by regulatory bodies. So in order to recoup the considerable time and resources invested in the drug development and approval process, the pharmaceutical companies depend on exclusivity provisions granted by the regulatory bodies. Patent strategy provides a check list for developing comprehensive patent strategies for the company.</p> 2019-09-17T19:15:01+00:00 Copyright (c) 2019 Zakir Hussain Shaik Md.; Jennai Shiva, Goli Venkateswarlu, R. Suthakaran, Syed Ghouse Orphan drug designation in Europe-Procedural guidance and challenges 2019-09-29T19:44:02+00:00 Christina Nicolodi <p>The European legislative framework on orphan medicinal products was implemented to stimulate the development of medicinal products against rare diseases and to ensure the patient’s adequate access to qualitative and specific treatment methods. Between 2000 and 2018 3210 orphan drug designation applications were submitted in Europe of which 2121 orphan designations have been issued by the European Commission. (1) Though the definitions for orphan medicinal products and the regulatory procedures are well defined, a high degree of regulatory knowledge is needed and strategic decisions on the development program must be considered at a very early stage of development: in fact, only 164 of the 2121 designated orphan development products have resulted in authorised orphan medicinal products since the orphan legislation was implemented.</p> <p>In this article, the requirements and procedures for the orphan designation application and maintenance at the time of marketing authorisation application are discussed in the context of the European Regulation.</p> 2019-09-15T00:00:00+00:00 Copyright (c) 2019 Christina Nicolodi Types of Biowaivers: A Discussion 2019-09-29T19:46:10+00:00 Atreyee Sarkar <p>The aim of the present review is to discuss the different types of biowaiver applications. Waiving of In vivo bioequivalence studies is known as biowaiver. Types of biowaiver applications include BCS based biowaiver, well established use application, also known as bibliographical application and Literature based submission. Biowaiver is acceptable for both BCS class I as well as class III drug molecules. These kinds of applications are generally submitted to countries like US, European Union and Australia. Well established use application and literature based submission is acceptable if the drug product is available in the market for at least ten years. The latter are acceptable by Europe and Australia only. This review discusses various types of biowaiver applications accepted by the regulated markets.</p> 2019-09-15T00:00:00+00:00 Copyright (c) 2019 Atreyee Sarkar A New Drug Approval Process in Europe: A Review 2019-09-29T19:46:55+00:00 Krishnasis Chakraborty <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 European Medical Agency (EMA) (1).</p> 2019-09-15T00:00:00+00:00 Copyright (c) 2019 Krishnasis Chakraborty National eCommerce Policy: What India’s new (Draft) eCommerce Policy outlines for Online Retailers and its Regulatory aspects 2019-09-29T19:48:18+00:00 Pratibha Chauhan Pooja Sharma Rahul Chauhan Ayushi Jain <p>The India Draft National eCommerce Policy is a high-level policy document proposed by India's Department for Promotion of Industry and Internal Trade in February 2019. It sketches out a series of policy recommendations that range from useful consumer protections to non-constructive protectionist industry regimes that would likely backfire and hurt businesses, entrepreneurs and consumers alike. The best of these recommendations would institute stricter consumer protections against annoying, unsolicited phone calls and emails. But the worst of them would make data transfers difficult, impose onerous liability on third party platforms, and institute data localization that would reduce business and consumer choices.<br>Within India, the draft policy boosts the government‟s schemes/ programmes, such as Digital India, Skill India, Make in India and Startup India, which rely on eCommerce and its components. For instance, it has introduced norms for consumer protection, recognized the importance of data, its protection and storage, granted infrastructure status to data centers and server farms, integrated different systems to track imports and introduced anti-counterfeiting and anti-piracy measures.<br>It is also in sync with the recently updated industrial policy which reflects the underlying brick-and-mortar economy. However, the stakeholders, including industry, its associations and the independent policy community, point out that in the government‟s enthusiasm to address all these many aspects of eCommerce, the Draft Policy has become ambiguous, raising questions about whether it is intended to be an internet policy or a specific eCommerce policy. (1)<br>The National eCommerce Policy is aimed to address concerns which go beyond the sale and purchase of products by electronic means. For example, environmentally sustainable growth by outlining regulatory aspects on Swachh Bharat Abhiyan, suitable policy will be devised to promote “reduce, reuse and recycle” practices by stakeholders. In the era of Industrial Revolution 4.0, economic development is based on data which is generated, stored, transmitted or processed in large volumes. The increasing importance of data warrants treating it at par with other resources on which a country would have sovereign right. The Policy recognizes the importance of data while enabling the domestic industry to benefit from the advantages and opportunities created by electronic commerce. (2)</p> 2019-09-15T00:00:00+00:00 Copyright (c) 2019 Pratibha Chauhan, Pooja Sharma, Rahul Chauhan, Ayushi Jain Regulatory architecture of biosimilars in Singapore: A critical overview 2019-09-29T19:49:13+00:00 Soundarya Reddy Kalva Sahitya Reddy Kalva Sudheer Kumar Gumme <p>A Biosimilar medicine is a medicine which is similar to a biological medicine that has already been authorized (the „biological reference medicine‟). The expiration of the patents on many biological products has prompted the development of these products as similar biological products. The European Medicinal Agency (EMEA) has done a commendable job at creating the regulatory path to facilitate approval of biosimilars. The Health Product Act requires all medicinal products sold in Singapore and manufactured locally for export to be licensed with the Health Products Regulation Group, Health Science Authority (HAS). Biosimilar products are eligible for the New Drug Application (NDA-2 and NDA-3) application types. The Biosimilar product should be evaluated and approved by at least one of HAS‟s reference agencies namely Australia, Health Canada, Europe, United States. Approved biosimilars must be demonstrated, through extensive characterization and appropriate clinical trials, to be as safe and effective as originators for the benefit of patients.</p> 2019-09-15T00:00:00+00:00 Copyright (c) 2019 Soundarya Reddy Kalva, Sahitya Reddy Kalva, Sudheer Kumar Gumme Comparative study of Regulatory requirements of Drug Product in Emerging market 2019-09-29T19:52:49+00:00 Preeti Patel Jitendra Kumar Badjatya Madhuri Hinge <p>Registration of Pharmaceutical drug product in Emerging Market is most demanding task. Regulatory requirements are harmonized in regulated countries by Common technical document (CTD) filing, while there is diversity of requirements in emerging markets. International conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has brought regulatory authorities and pharmaceutical industries of US, Japan and Europe together for various aspects of drug registration but there are is no such harmonized guideline for emerging market except Association of Southeast Asian Nations (ASEAN) and Gulf Co-operation Council (GCC) where harmonization exist in clusters with their mutual concern. The optimization and harmonization requirements has become mandatory and can be examined by the incidence of higher cost involved in availability of drugs, quality requirement of premise and research and development, regional registration requirements. Quality, Safety and Efficacy data has significance importance in dossier registration. Pharmaceutical Industries has to comply with regulatory requirement in Emerging market and for betterment of public Health and safety.<br>The review also explains a brief about different regulatory requirement for Registration of drug product in Emerging market and comparative data for registration of dossier application in Emerging market.</p> 2019-09-15T00:00:00+00:00 Copyright (c) 2019 Preeti Patel, Jitendra Kumar Badjatya, Madhuri Hinge Regulatory Dichotomy of Sucralfate, Its history and the new Bioadhesive polymerized Sucralfate barrier therapy for Oral health, Oncology support and Gastrointestinal disorders 2019-09-30T16:04:08+00:00 Ricky Wayne McCullough <p>Sucralfate is a biologically inert non-systemically acting compound. It requires polymerization for conversion into its biological active form, polymerized Sucralfate. Should this conversion occur in the body, using processes of the body to effect conversion subsequent to administering a dose, then the administered Sucralfate is a drug, as it enlists bodily functions to enact a chemical change. This form of Sucralfate should be regulated as drug. On the other hand, Sucralfate is manufactured as a polymerized product, requiring no bodily functions to enable its therapeutic effect, then this form of Sucralfate act as a medical device and should be regulated as such. This dichotomy of Sucralfate was first recognized by the US FDA in 2005 that subsequently cleared several polymerized Sucralfate barrier therapies as medical devices.<br>This review covers the history of the regulatory dichotomy or duality of Sucralfate, the biological basis for Sucralfate clinical effects and the regulatory position of several barrier therapies.</p> 2019-09-15T00:00:00+00:00 Copyright (c) 2019 Ricky Wayne McCullough