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> <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). Posting of an article on a secure network (not accessible to the public) within the author’s institution is permitted.</li> <li>The right, subsequent to publication, to use the article or any part thereof free of charge in a printed compilation of works of their own, such as collected writings or lecture notes.</li> </ul> <p><strong>Note:</strong> All copies, paper, electronic or other use, of the information must include an indication of the IJDRA copyright and a full citation of the journal source.</p> <h3>Authorship:</h3> <ul> <li>If the article was prepared jointly with other author(s), the signing author has informed the co-author(s) of the terms of this copyright transfer and is signing on their behalf as their agent and represents that he or she is authorized to do so, then please confirm by checking the appropriate box following the signature line. 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> PHARMACOVIGILANCE IN CLINICAL RESEARCH: PAST, PRESENT AND FUTURE <p>The growing clinical research after the product patents rights for the pharmaceutical industries as per the trade related aspects of intellectual property rights agreement and adverse drug reaction monitoring of the marketed drugs have raised many ethical and regulatory issues regarding the promotion of new drugs in Indian markets. It becomes vital to understand the history, growth and evolution of the regulatory aspects of drugs which are handled by multiple Ministries and Departments of the Government of India. Although amendment to Schedule Y, registration of Ethics committee, registration of Clinical Trials, Speeding up review process, Pharmacovigilance (PhV) programme for India and Inspection of clinical trial sites have been started by the various regulatory agencies. India’s growing partaking in multinational trials, this artifact explores potential areas of Indian pharmacovigilance, requiring reform and provides recommendations for building a robust safety reporting system. (1) Despite global focus on Development Safety Update Report, local regulators are not yet insistent on real-time update of a drug's cumulative safety profile. Issues like reporting requirements for generic trials, pregnancy reporting and lenient timeline for death/life-threatening events need attention. (2)</p> Pratibha Chauhan Ashish Yadav Babita Kirodian ##submission.copyrightStatement## 2018-02-13 2018-02-13 4 4 1 6 PHARMACY PROFESSION IN GUJARAT: AN OVERVIEW <p>Pharmacy is the health profession that links the health science with chemical science and it is charged with ensuring the safe and effective use of pharmaceutical drugs. Gujarat has been one of the pioneer States in India with an exemplary track record. The State of Gujarat have country's most dynamic entrepreneurs who are original and fast-paced in their thinking and focused in their drive for growth and profitability. Accounting for 16 percent of the country's total industrial output and 18percent of the country's total investment, Gujarat is one of the most industrialised states in the country. It has a strong base of educational institutions imparting courses in Pharmacy and some of the institutions have international repute to its credit. Gujarat is one of the fastest growing states in the Country and nearly 3,200 Pharma and biotech companies are housed in the State. Gujarat is a vibrant pharmaceutical manufacturing hub for Medical Devices fortified with sound knowledge based institutions and skilled human resource available in the state, it provides innovative, quality and affordable health care solution to masses. In this short review author provides some of the glimpses of the pharmacy profession in Gujarat.</p> Suresh Kempaiah V. Balamuralidhara Pramod Kumar T.M. Puranik S.B. ##submission.copyrightStatement## 2018-02-13 2018-02-13 4 4 7 14 OCULAR DRUG DELIVERY: RECENT UPDATES <p>Ophthalmic route is one of the most promising delivery systems for the treatment of eye ailments. Delivery of medicaments to anterior segment of the eye is an easy task. However with the rising number of posterior segment diseases such as diabetic retinopathy, age-related macular degeneration etc. delivery to the target has become a challenging task. A number of scientists have tried various approaches to accomplish the objective. Novel drug delivery system is an effective strategy to combat anterior and posterior eye ailments. In addition, the technique improves the pharmaceutical and pharmacological performance of the drug molecule. The advent of nanotechnology and its use in devising newer and effective ocular systems has added impetus to ocular therapy. However the need of the hour is to create stable as well as non-toxic systems which are able to be used for chronic therapies. The role of various novel delivery stratagem such as nanoparticles, nanomicelles, liposomes, niosomes, dendrimers in ocular drug delivery has been discussed in addition to their recent advances in the area.</p> Zakir Foziyah Manvi Singh Zeenat Iqbal ##submission.copyrightStatement## 2018-02-13 2018-02-13 4 4 15 22