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> en-US <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> (Dr. Jitendra Kumar Badjatya) Thu, 15 Mar 2018 18:37:52 +0000 OJS 60 AN OVERVIEW ABOUT NOVEL FAST DISSOLVING ORAL FILMS <p>Nowadays, novel fast dissolving oral films (FDF) have come in existence as an alternative dosage form in comparison with tablet, capsules, syrup and other oral dosage forms with respect to patient convenience and compliance. Fast dissolving oral films are helpful to paediatric and geriatric patients who experience difficulties in swallowing traditional oral solid-dosage forms. The FDF drug delivery systems are solid dosage form which disintegrate or dissolve within seconds when placed in the mouth cavity without need of water or chewing. FDF provide better drug dissolution, faster onset of action, bypassing the first pass metabolism of drugs and thus enhance their oral bioavailability with reduced dosing frequency. These formulations are suitable for cough, cold, sore throat, allergenic conditions, nausea, pain, hypertension and CNS disorders. The present review provides the details about the recent advancement in design and development of oral fast dissolving film.</p> Pravin Kumar Sharma, Pankaj Kumar Sharma, Gajanan N Darwhekar, Birendra Shrivastava ##submission.copyrightStatement## Thu, 15 Mar 2018 00:00:00 +0000 REGULATIONS OF REGISTRATION AND IMPORT OF MEDICAL DEVICE IN INDIA <p>India is a huge market for medical devices and is increasing constantly for the last few years. The registration certificate and import license is mandatory for a manufacturer of India who wishes to import any medical device in India. If a company which wants to imports its medical devices in India does not have a registered office in India it needs Indian agent authorized by CDSCO, to do so. Duly filled form-10 is required to be submitted for import license, while form-44 duly filled is required to be submitted for marketing authorization of a new medical device or its re-registration. The review focuses on regulation concerned to the registration procedures import of a new medical device in India with latest amendments in the regulation concerned.</p> Vikaas Budhwaar, Yogesh Rohilla, Manjusha Choudhary, Prateek kumar ##submission.copyrightStatement## Thu, 15 Mar 2018 00:00:00 +0000 RISING AIR POLLUTION: DEMAND ACTION-DRIVEN ADVOCACY AND BEHAVIOUR CHANGE FOR HEALTHER LIVES <p>Air pollution is a major environmental health problem affecting the developing and the developed countries alike. The effects of air pollution on health are very complex as there are many different sources and their individual effects vary from one to the other. It is not only the ambient air quality in the cities but also the indoor air quality in the rural and the urban areas that are causing concern. In fact in the developing world the highest air pollution exposures occur in the indoor environment. Air pollutants that are inhaled have serious impact on human health affecting the lungs and the respiratory system; they are also taken up by the blood and pumped all-round the body. These pollutants are also deposited on soil, plants, and in the water, further contributing to human exposure. (1) Governments alone are not responsible for addressing such issues and health care professionals (HCPs) need to consider whether their duty of care should extend beyond normal clinical boundaries. When considering the ethics around the generation and effects of air pollution, especially in relation to justice and health care, actions taken by HCPs (e.g. in a country such as India) potentially extend beyond treating individual patients one-at-a-time for toxic effects of emissions and include advocating on behalf of others. (2) This paper covers the health impacts arising from ambient and household air pollution globally and at the national level (India) and recommends policy measures to reduce the health impact from air pollution in the national context. (3) Community health advocacy is also considered as of the main tasks of public health. Health professionals try to solve health problems with effective strategies. One of them is, specifically, community health advocacy. To act on health problems in the global context, participation and communitarian perspective is a choice. In addition to this behaviour change towards healthier lives by modifications in specific practices pertaining to rationale use of energy, water, cooking etc. is crucial for quality of life.</p> Pratibha Chauhan, Rahul Chauhan ##submission.copyrightStatement## Thu, 15 Mar 2018 00:00:00 +0000 CURRENT REGULATION OF MEDICAL GASES IN INDIA AND FUTURE ASPECTS <p>Generally medical gases are administered or supplied directly to the patients. They should be manufactured and transferred with the highest quality possible as per standards and limits decided by the different regulatory authorities. In India medical gases are regulated by Ministry of Commerce and Industry and&nbsp; central drug standard control organization. Along with these various act are available for better regulation that are Explosives act 1884, Gas cylinder rules 2004, Drugs and Cosmetics Act and specifications of medical gases are given in Indian pharmacopoeias. Various facilities and requirements for the manufacturing and regulation of medical gases are covered. In spite of all the regulations, there are reports of problems associates with medical gas manufacturing and uses. What are steps should be taken for the solution of these problems.</p> Navdha N Soni, Dilip G Maheshwari ##submission.copyrightStatement## Thu, 15 Mar 2018 00:00:00 +0000 RISK ANALYSIS EVALUATION OF PIROXICAM 20MG CAPSULES MANUFACTURE PROCESS BY FMEA TECHNIQUE <p>This paper presents an application of FMEA (Failure Mode and Effects Analysis) on the manufacturing process of piroxicam 20mg capsules, with the objective of identifying possible failures and create subsidies for improvement of the production stages. Brainstorming or Collaborative critical analysis was used as a tool to collect information and support FMEA’s application. After the risk analysis, evaluation of the production process using FMEA, manipulation and secondary packaging were found to be the critical stages in the production process necessary for implementation of actions in order to mitigate the risks.</p> Priscila Cardoso, Marotta Flávia, Siqueira Kelen ##submission.copyrightStatement## Thu, 15 Mar 2018 00:00:00 +0000 FORMULATION AND EVALUATION OF SOLID DISPERSION OF TADALAFIL <p>Tadalafil is used for the treatment of the erectile dysfunction (ED) and pulmonary arterial hypertension. It is having low aqueous solubility thus it shows poor bioavailability of about 28% by after oral administration. To improve its solubility and dissolution profile solid dispersions (SDPs) of Tadalafil was prepared by physical mixing and solvent evaporation method using polyvinyl pyrollidone-K30 (PVP-30) as a hydrophilic polymeric carrier in different proportions with respect to drug (drug to polymer ratio 1:1 to 1:5). Drug and polymer compatibility studies were performed using FTIR study. The best suitable ratio and method was selected on the basis of enhanced aqueous solubility of drugs. Further selected SDPs were evaluated for various parameters like DSC analysis, percentage yield, percent drug content, saturation solubility, percent drug dissolution and stability studies. FTIR study indicated no incompatibility between Tadalafil and PVP-K30. SDPs prepared with drug to polymer ratio 1:3 and solvent evaporation method was found to be best as they shown significant increased (up to 10 fold) in aqueous solubility in comparison with that of others. DSC study also suggested the depression in the crystalline nature of Tadalafil. Selected SDPs exhibited good stability up to 3 months at 25 ± 2°C /60 ± 5% RH. Based on the results it can be concluded that, SDPs shown remarkable increase in the aqueous solubility and dissolution of Tadalafil and it may improve oral bioavailability of drug as compared with plain drug.</p> Pravin Kumar Sharma, Pankaj Kumar Sharma, Gajanan N Darwhekar, Birendra Shrivastava ##submission.copyrightStatement## Thu, 15 Mar 2018 00:00:00 +0000