International Journal of Drug Regulatory Affairs 2018-02-13T18:11:09+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> PHARMACOVIGILANCE IN CLINICAL RESEARCH: PAST, PRESENT AND FUTURE 2018-02-13T17:54:18+00:00 Pratibha Chauhan Ashish Yadav Babita Kirodian <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> 2018-02-13T17:54:18+00:00 ##submission.copyrightStatement## PHARMACY PROFESSION IN GUJARAT: AN OVERVIEW 2018-02-13T18:03:21+00:00 Suresh Kempaiah V. Balamuralidhara Pramod Kumar T.M. Puranik S.B. <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> 2018-02-13T18:03:21+00:00 ##submission.copyrightStatement## OCULAR DRUG DELIVERY: RECENT UPDATES 2018-02-13T18:11:09+00:00 Zakir Foziyah Manvi Singh Zeenat Iqbal <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> 2018-02-13T18:11:09+00:00 ##submission.copyrightStatement##