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> Preliminary requirement for filing application in US <p>USFDA is very critical regulated agency for submission. This review reveals how to submit an Abbreviated New Drug Application (ANDA) as per FDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&amp;C Act) (21 U.S.C. 355(j)).ANDA Submission contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.<br>Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the public. All approved products, both innovator and generic, are listed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).</p> Snehal Shah Jitendra Kumar Badjatya ##submission.copyrightStatement## 2018-12-20 2018-12-20 6 4 1 8 10.22270/ijdra.v6i4.276 Integrating PLCM strategy in Pharmaceutical Emerging Market <p>All products and services must denote definite life cycles. The life cycle talks about the period from the product‘s first launch till it wind-up onto the market. Throughout this age noteworthy modifications are made in a way that the product is manifesting i.e. its mirror image with respect of sales. Ultimately increase of sustainable profit is the aim that every company aspires of the PLCM strategy. The understanding of a product‘s life cycle, can help a company to understand and realize when it is time to introduce and withdraw a product from a market, its position in the market compared to competitors, and the product‘s success or failure. This article details regarding Product Lifecycle Management in light of Pharmaceutical environment for the emerging markets (India, China, Russia, Brazil, and South Africa). Also an attempt has been made to compare PLCM of stated emerging countries with- highly regulated market (US).</p> Sawagat Tripathy Padala Narasimha Murthy Bibhu Prasad Patra ##submission.copyrightStatement## 2018-12-20 2018-12-20 6 4 21 32 10.22270/ijdra.v6i4.280 Corporate strategies adopted by Indian Pharmaceutical Industry for restructuring <p>The Indian pharmaceutical industry has developed rapidly over the last few decades. Before TRIPS, the Indian regulatory system recognized only process patents. The Indian Pharmaceutical companies were engaged in the development of new processes for manufacturing drugs. They mainly concentrated on the domestic markets and unregulated markets. The Indian companies focussed very little on Research &amp; Development (R&amp;D). Even large pharmaceutical companies showed little interest on innovation and R &amp; D. They mostly depended on imitation and reverse engineering of the patented products. But after TRIPS, product patent was reintroduced and the companies spent their expenditure on R&amp;D, synthesis of new chemical entities (NEC), and on modification of already existing entities to develop new formulations and development of generics to obtain regulatory approvals for marketing already patent expired drugs. The multinational companies have turned to contract manufacturing and research services (CRAMS), marketing alliances, collaborative research and clinical trials to save time and cost.&nbsp; The main advantage of the Indian firms lies with their capability for low cost of production, and in their highly skilled technical labour. The manufacturing cost is less in India when compared to the US and the European countries. The Indian Pharmaceutical industry developed different types of strategies in order to survive and expand in the international pharmaceutical sector which involve collaborative strategies, business strategies, and overall corporate growth strategies.</p> Bhuvana Madhuri Chokkakula Venkata Ramana Murthy Kolapalli Vijaya Ratna Jayanti ##submission.copyrightStatement## 2018-12-20 2018-12-20 6 4 33 41 10.22270/ijdra.v6i4.282 Transnail drug delivery device:A prominent approach for Onychomycosis therapy <p>Onychomycosis is often challenging therapeutically and demands a multipronged approach both in terms of systemic as well as topical delivery. The conventional treatment modalities available for onychomycosis are marred with challenges such as low permeation, infection reoccurrence and resistance development. Henceforth, the current article explores the concept of a Transnail drug-delivery device as a promising tool offering high clinical potential and aesthetic suitability against onychomycosis.</p> Zeeant Iqbal Nazia Hassan Rahmuddin Khan ##submission.copyrightStatement## 2018-12-20 2018-12-20 6 4 42 45 10.22270/ijdra.v6i4.285 Comparative study of the harmonization of pharmaceutical regulations in the western and central sub-regions of Africa <p>The harmonization of pharmaceutical regulations in Africa aims to offer States a coherent body of texts and practices by combining limited resources. The objective of this study was to describe policies to harmonize pharmaceutical regulations in West and Central Africa in order to highlight similarities and disparities. The methodology used consisted of visiting the historical stages of the process in the two regions and comparing the preferred methodological approaches as well as the achievements obtained. It emerges from this work that if choices, guided by the health priorities of the regions in question, have led the actors to favor, depending on the sub-region, certain areas of pharmacy rather than others, in terms of harmonization, reality the aim pursued is the same namely the protection of public health by the availability of medicines safely and cheaply. It is hoped that cooperation not only between the two sub-regions but also with other pharmaceutical regulatory systems will optimize the processes initiated for better protection of public Health.</p> AMARI Antoine Serge Yavo J.C. Yessibi Pola E Pabst Jean-Yves ##submission.copyrightStatement## 2018-12-20 2018-12-20 6 4 46 51 10.22270/ijdra.v6i4.288 Requirements for introducing Medical devices in India and US market - A comparative study of regulations <p>Medical devices are widely used in the healthcare sector and are manufactured by the pharmaceutical industry.The Government of India has periodically come out with certain guidelines, to be followed by the companies, manufacturing medical devices. There are some challenges which have to do with the medical devices.&nbsp; They are designed by manufacturers in answer to the demands and expectations of doctors, are appraised by doctors and are used in patients. Phase I trials are not possible for them as they cannot be tested on healthy volunteers. Adverse Drug Reactions are not detected in medical devices as easily as for medicines. There are no separate regulations (apart from Schedule M III of Drugs and Cosmetics Act) for Medical Devices in Indiabefore 2017. U.S. FDA has robust regulations for medical devices. If any company wants to market its medical device in the U.S.A, it should be proved to be substantially equivalent to a chosen predicate device that is already there in the market in the USA. This paper studies the current scenario in India and the USAregarding regulations concerning medical devices. It concludes that India cannot have a policy of “accept in India if it is accepted abroad”. Acceptance requirement should include certification from Notified Technical Bodies of India. India should have better connectivity between regulators and doctors as far as medical devices are concerned. A National Registry should be developed for each variety of Class D medical devices, such that “recall action”, if necessary, can be taken in a fast and systematic manner.</p> Vijaya Ratna Jayanti Parimalambica Madisi Kolapalli Venkata Ramana Murthy ##submission.copyrightStatement## 2018-12-15 2018-12-15 6 4 9 20 10.22270/ijdra.v6i4.279