International Journal of Drug Regulatory Affairs 2018-03-19T15:16:51+00:00 Dr. Jitendra Kumar Badjatya Open Journal Systems <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> AN OVERVIEW ABOUT NOVEL FAST DISSOLVING ORAL FILMS 2018-03-19T15:09:23+00:00 Pravin Kumar Sharma Pankaj Kumar Sharma Gajanan N Darwhekar Birendra Shrivastava <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> 2018-03-15T00:00:00+00:00 ##submission.copyrightStatement## REGULATIONS OF REGISTRATION AND IMPORT OF MEDICAL DEVICE IN INDIA 2018-03-19T15:05:27+00:00 Vikaas Budhwaar Yogesh Rohilla Manjusha Choudhary Prateek kumar <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> 2018-03-15T00:00:00+00:00 ##submission.copyrightStatement## RISING AIR POLLUTION: DEMAND ACTION-DRIVEN ADVOCACY AND BEHAVIOUR CHANGE FOR HEALTHER LIVES 2018-03-19T15:01:39+00:00 Pratibha Chauhan Rahul Chauhan <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> 2018-03-15T00:00:00+00:00 ##submission.copyrightStatement## CURRENT REGULATION OF MEDICAL GASES IN INDIA AND FUTURE ASPECTS 2018-03-19T14:26:07+00:00 Navdha N Soni Dilip G Maheshwari <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> 2018-03-15T00:00:00+00:00 ##submission.copyrightStatement## RISK ANALYSIS EVALUATION OF PIROXICAM 20MG CAPSULES MANUFACTURE PROCESS BY FMEA TECHNIQUE 2018-03-19T15:11:14+00:00 Priscila Cardoso Marotta Flávia Siqueira Kelen <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> 2018-03-15T00:00:00+00:00 ##submission.copyrightStatement## FORMULATION AND EVALUATION OF SOLID DISPERSION OF TADALAFIL 2018-03-19T15:16:51+00:00 Pravin Kumar Sharma Pankaj Kumar Sharma Gajanan N Darwhekar Birendra Shrivastava <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> 2018-03-15T00:00:00+00:00 ##submission.copyrightStatement##