International Journal of Drug Regulatory Affairs <p align="justify">IJDRA is a broad-spectrum, open-access &amp; peer-reviewed International Pharmaceutical Journal circulated as electronically and Print issues. 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> Nanoparticles and target Drug delivery for cancer treatment: A Comprehensive review <p>In the healthcare industry, the biggest challenges are cancer. However, there are several drugs are available for the treatment of cancer. In these treatments cure cancer affecting the collateral toxicity to healthy cells.&nbsp; In addition to the drug delivery systems in cancer have many barriers such as immune clearance or hepatic, renal. Thus, to improve treatment and overcome these problems the nanoparticle-loaded drug is one the solution. Moreover, the nanomedicine opens a new era in the healthcare industry as an effective drug delivery system.&nbsp; The nanoparticle drug delivery has significant characteristics for treatments such as less toxicity, high loading capacity, and stability of the drug. This review aims to present the conventional cancer treatment and elaborate on the nanoparticle-loaded drug delivery system to overcome the side effects of the conventional treatment.</p> Nandish Pathak Pratim Pathak ##submission.copyrightStatement## 2019-03-16 2019-03-16 7 1 53 58 10.22270/ijdra.v7i1.309 Regulatory aspects for Biologic product licensing in India <p>Biologics are the medicinal/ therapeutic/ diagnostic/ preventive preparations composed or derived from living organisms and their spin-off for human use. They include serums, vaccines, antitoxins, blood, antigens and blood components, gene therapy, tissues etc. Biotechnology is used as a unique approach in manufacturing such medicinal agents. The Indian National regulatory authority (CDSCO) is the body that is responsible for manufacturing and import of biological products in India. Biotechnology provides innovative solutions to medical field with more than 200 biologic medicines and vaccines. These developments benefits millions of patients worldwide and more than 600 products under development. At present these products can also be produced by manufacturers other than the innovator, with the expiry of some of patents. These new biotechnological medicines commonly referred to as ‘similar biologics’ offer a major opportunity to provide greater access to reasonable healthcare for several lifesaving medicines. India has emerged as one of the leading providers to the world market for ‘Biosimilars’. These may be considered to be very essential economical and therapeutical element for the pharmaceutical market in India. The Indian National Regulatory Authority is considered to be responsible for evaluating safety, efficacy and quality of all pharmaceuticals in India. The Department of Biotechnology in India is the department that governs the development, pre-clinical studies of all Biologicals.</p> Sanjeev Kumar Maurya Vikesh Shukla Prachi Kaushik SP Yamini Kanti Anshul Bansal ##submission.copyrightStatement## 2019-03-16 2019-03-16 7 1 1 5 10.22270/ijdra.v7i1.287 Filing of DMF in US, Canada & Europe <p>DMF (Drug master file) is a kind of confidential document which contains complete, factual and correct information about active pharmaceutical ingredient or finished drug dosage form. A DMF can be used by holder who establishes the file or by one or more parties in support of their files or applications. The Drug master file consist of 2 parts:- (a) the applicant’s part – that contains all the information that the license holder needs to review about quality of drug product &amp; (b) the restricted part – which contains all the confidential information about the manufacturing process that can only be presented in front of authorities. The purpose of this article is to present an overview of DMF filing in different countries which are USA, CANADA, and EUROPE. In USA, CANADA the drug master file is known as DMF only but in EUROPE it is known as ASMF (active substance master file).</p> S P Yamini Kanti Neha Jain Amrish Chandra Vikesh Kumar Shukla ##submission.copyrightStatement## 2019-03-16 2019-03-16 7 1 6 12 10.22270/ijdra.v7i1.295 Drug regulatory paradigm and challenges for Medical devices in India <p>The medical device industry in India&nbsp;&nbsp; has made speedy growth in the last few years but lag behind as compared to developed nations like USA, UK, etc. The government has taken the right step by separating the medical devices from general medicines from regulation viewpoint. Medical devices in India are governed by national drug regulatory agency, CDSCO (Central Drug Standard Control Organization) for quality and manufacturing standards. The CDSCO regulations are given to maintain the quality in manufacturing, packing and distribution of medical products. Each developed country has their own regulatory approval procedure and renewal requirements. The Indian government also adopted strict rules and regulations with respect to medical device and framed the new Medical Device Rules-2017. The medical device industry is principally import driven market close up to 75% and export up to 38% only. The national medical device policy2015 is driven out to strengthen the market of medical device and to reduce the burden on import of medical device (1). Recently NPPA capped the prices of medical devices such as coronary stents and knee implants under the DPCO (Drug Price Control Order). NPPA is the organization of government of INDIA which was established, to regulate the prices of controlled bulk drugs and formulations and in some extent medical devices. The NPPA have a mixed impact on Indian population and market, a large number of Indian population have received major benefits with respect to their healthcare costs (2, 3), at the same time major device manufacturer such as Abbott Healthcare , Medtronic filed the application to NPPA to increase the ceiling prices of their latest generation medical devices. As a negative impact, the MNCs withdraw their latest innovated products, affecting the quality of medical services, medical tourism, no investment in research and development of medical device etc.</p> <p>Recommendations to government include: spending more percentage of GDP on healthcare, prioritizing the most important medical devices and provide them at subsidize price to government organization. The government should have more focus on production/manufacturing of medical devices indigenously under “Make in India” scheme.</p> Anshul Bansal Vikesh Kumar Shukla Shikha Chauhan Yamini Kanti SP Sanjeev Kumar Archita katrolia ##submission.copyrightStatement## 2019-03-16 2019-03-16 7 1 25 33 10.22270/ijdra.v7i1.299 Drug approval process in India and Europe <p>Every time a new drug is developed it requires a great amount of research work in manufacturing, Pre- clinical Science, Controls, Chemistry &amp; Clinical trials. Regulatory agencies have Drug Reviewers who has the responsibility of checking that whether the data supports the Safety, Effectiveness and Quality control of a New Drug product to serve the public health. Every country has its own Regulatory agency which is responsible for regulating all the Rules and Regulations and forms the guidelines for regulating the Manufacturing, Processing and Marketing of the Drugs. This Article focuses on Drug Approval Process in Europe and India.</p> S P Yamini Kanti Ildiko Csoka Amrish Chandra Vikesh Kumar Shukla ##submission.copyrightStatement## 2019-03-16 2019-03-16 7 1 34 40 10.22270/ijdra.v7i1.304 Informed Consent form in Clinical Trial <p>Informed consent form is a vital requirement for research study on the human participant. It is the consent which is given by the subject before participate in clinical trial. Informed consent mainly came in existence after the Nuremberg trail and the other guideline line like Helsinki Declaration and Belmont Report also play an important role in there evaluation. Informed consent form mainly contents the complete information about the clinical trial, protocol, duration, potential risk and benefit of the trial. Informed consent is revised from time to time, as the new information is available. In some case waiver of consent done by proper review by Institutional Ethic Committees (IEC).</p> Sunny Panwar Hemant Pal Amrish Chandra ##submission.copyrightStatement## 2019-03-16 2019-03-16 7 1 41 46 10.22270/ijdra.v7i1.307 Scenario of Over the Counter Medicines Worldwide <p>Over the counter (OTC) drugs are medicines sold directly to consumer without any prescription. The OTC drug market in India is expected to grow by $6.6 billion by 2016 with Pharmaceutical companies and chemists increasing their presence in rural market. The market share of hospitals is expected to increase from 1.3% in 2009 to 26% in 2020. Also the Health Ministry has banned 344 fixed drugs combinations through a gazette notification issued over the weekend March, 2016. These include several cough syrup solutions, analgesics and antibiotic combinations and in which many of are sold over the counter. There is list of banned drugs which include Nimesulide which had been a cause for long for health experts for includes for its continued use in India despite being banned in most of the developed nations. Some of banned drug combinations are: a) Nimesulide + Diclofenac B) Diclofenac + Tramadol + Paracetamol C) Heparin + Diclofenac D) Azithromycin + Cefixime E) Telmisartan + Metformin and many more. Also India’s OTC drug market stood at $3 billion in 2011 and a rise to $6.6 billion is forecast by 2016 according to sectoral document for pharmaceuticals industry. And in future India is known and expected to rank amongst top three pharmaceutical markets in terms of incremental growth by 2020.</p> Sunny Panwar Khushboo Bhatia Amrish Chandra ##submission.copyrightStatement## 2019-03-16 2019-03-16 7 1 47 52 10.22270/ijdra.v7i1.308 A critical view of harmonization of regulatory requirements for Generic Drug approval submissions in ASEAN countries <p>To ensure quality, efficacy, and safety of drugs is the prime objective of any country and respective drug regulatory authority. Countries have their own regulatory setup to ensure the proper execution of drug regulatory guidelines in their country. There are several regional organization in world, ASEAN is one of them. It is Association of Southeast nations. ASEAN is very well representing its countries on global platform. The step of harmonization of drug regulatory guidelines by ASEAN is seen as major step taken by an Asian regional organization.</p> <p>ASEAN is an emerging market and every country has its own needs. As research and development sector is only developed in Singapore in ASEAN region so, generics emerge as a tool for other countries to fulfill UHC goals and Vision 2020 ASEAN. Every country has the different procedure for generic drug registration application approval. To clearly understand the procedure of generic drug registration application approval process we have gone through various guidelines and literature. There are 10 members in ASEAN i.e. Singapore, Malaysia, Thailand, Indonesia, Philippines, Brunei Darussalam, Laos PDR, Myanmar, Vietnam, and Cambodia. Each one’s generic drug approval process, requirements and effects on pharmaceutical trade after implementation of ACTD is explained in this research work. This research work also includes the statistical analysis and suggestions on how other countries and regional organization follow the model of ASEAN for drug regulatory harmonization procedure.</p> Jyoti Ghangas Neha Jain Anshuman Sinha ##submission.copyrightStatement## 2019-03-16 2019-03-16 7 1 13 24 10.22270/ijdra.v7i1.297