International Journal of Drug Regulatory Affairs 2020-03-26T07:11:41+00:00 Dr. Jitendra Kumar Badjatya Open Journal Systems <p>IJDRA is Quarterly Open-access and peer-reviewed Journal circulated electronically and Print since 2013 to provide the quality information on the latest updates on Drug regulation. It is the first Journal for subject Drug Regulatory Affairs in India and it publishes Research articles, Review articles, and Case studies on all aspects of Drug Regulatory Affairs, Pharmaceutical Development,&nbsp;Medical and Health Sciences in association with Delhi Pharmaceutical Sciences and Research University (DPSRU), New Delhi, India. The journal serves researchers from academia and industry and intended to be of interest to a broad audience of Pharmaceutical, Medical and Health professionals.</p> The Bureau of Indian Standards Act, 2016-An Overview 2020-03-26T06:09:49+00:00 Bhairavi Bantu Amina Fatima Kavya Parelli Pravalika Manda Bayya Subba Rao <p>Currently every country’s standards organization is representing International Organisation for Standardisation and with consultations and consensus are implementing specifications to products. Including a standard mark recognizes a company’s product complying with standards established by national or international authority. Standard marks can be considered as collective marks which can be observed for same product from several companies.&nbsp; The current objective is to understand how a country’s legislation establishes organizations through legislations and implement specifications to a good.</p> 2020-03-26T06:09:49+00:00 Copyright (c) 2020 Bhairavi Bantu, Amina Fatima, Kavya Parelli, Pravalika Manda, Bayya Subba Rao Health Care Revolution: Ayushman Bharat 2020-03-26T06:37:24+00:00 Suheta Tikoo Vikesh Kumar Shukla Amrish Chandra Ajay Kumar <p>India is a country with population of 133.92 Cr (2017). Due to the weak economic conditions people are unable to afford their health care thereby pushing 4.6 % of population below poverty line. It has also been noticed that three forth of Indians spend their substantial part of earning on purchasing various medicines and drugs for treatment of their ailment and other health related issues. In year 2018 there was announcement of Pradhan Mantri Jan Arogya Yojana for welfare of common masses by government of India. It covers more than 10.75 populations. Each family under scheme acts benefits insurance cover of Rs 5 Lakhs. The aim of the scheme is to provide the health care service as well as health insurance to population deprived of secondary and tertiary care service. Various government and private hospitals are empanelled under this scheme. The scheme is implemented through health and wellness centres existing over the length and breadth of country for non-communicable diseases, palliative, mental, dental, geriatric care etc. Centres are also equipped with basic medical tests. On basis of SWOT analysis conducted it has been found versatile for population. Hence scheme is going to revolutionize the health care practice prevalent in India as it increases and continue to increase access to quality health care services to the common populace of our nation.</p> 2020-03-16T00:00:00+00:00 Copyright (c) 2020 Suheta Tikoo, Vikesh Kumar Shukla, Amrish Chandra, Ajay Kumar Regulatory Strategies for API going off-patent 2020-03-26T06:16:05+00:00 Nisha Chaudhary Vikesh Kumar Shukla Amrish Chandra <p>Pharmaceutical industries are one of the most developing industries having enormous profit margins. Today the pharmaceutical companies are challenged with increased costs of drug discovery and development and intrusive competition from generic drug companies. The pharmaceutical companies have begun the process of drug development and in the same period also begin to espouse the various schemes to expand the duration of patent-holding. So, increasing patent term for the already patented products is an effective strategy for withstanding generic competition. Pharmaceutical industries can use various ways to optimize the patent protection on large products, optimizing the market lifecycles and the strategies for API going off-patent in pharmaceutical industries in India are outlined below to provide the significant pharmaceutical patenting information.</p> 2020-03-26T06:16:04+00:00 Copyright (c) 2020 Nisha Chaudhary, Vikesh Kumar Shukla, Amrish Chandra Study of Nutraceutical regulations around the Globe 2020-03-26T06:57:21+00:00 Akanksha Rani Vikesh Kumar Shukla <p>Nutraceutical is a food or fortified meals product that supposedly offer medicinal or health benefits such as the prevention and remedy of disorder. Nutraceuticals have appeared as a requisite for consumers in developed as well as developing countries with diseases due to changing lifestyles. As nutraceuticals blur the border between food, medicine and health supplements, it is difficult, with the aid of legal definition, to differentiate between nutrients, meals components, drug and pharmaceuticals. Globally, regulatory authorities are converging on the product safety and quality as such products are destined for human intake. When food product reaches from one country to another, it becomes important to maintain safety and quality standards in compliance with the different regulatory guideline set by the respective government; which can be a real driver for the growth of the industry. This article focuses mainly on the review of the regulatory framework for nutraceuticals in India, USA, Canada, Europe, and Australia with harmonized regulation for nutraceutical product registration in this market.</p> 2020-03-16T00:00:00+00:00 Copyright (c) 2020 Akanksha Rani Impact of rules for New Drug and Clinical Trial in India 2020-03-26T07:08:45+00:00 Akanksha Rani Vikesh Kumar Shukla <p>A good quality research requires the incorporation of good ethical practices throughout the conduct of the study. An efficient Ethics Committee will facilitate such a research at the site, and can achieve the major objective of ICH-GCP (International Conference on Harmonization-Good Clinical Practice) guidelines. Awareness of the changing rules among the stakeholders of clinical studies will ensure good clinical practice by safeguarding and protecting the rights, safety and well-being of the research participants. The draft of the New Drugs and Clinical Trials Rules was published in the Gazette of India by central government on March 19, 2019. Keeping abreast of the latest rules are essential for the uninterrupted conduct of clinical studies. We sought to give a summary of important changes in the new rules and to assess those rules from ethical perspective. India has a huge potential to attract drug discovery leader for the conducting clinical trials, in view of that the responsibility of the ethical regulation of clinical trial is a concern of Drug Controller General of India (DCGI). The DCGI takes all the decision regarding pharmaceutical-research and regulatory issues in India. The DCGI and their regularity team, ensures all the regulation for the clinical trial is taken with appropriate approval process. The present review will provide a platform to reader, about the approved trials in the past eight years and the current guidelines for the trial in India.</p> 2020-03-16T00:00:00+00:00 Copyright (c) 2020 Akanksha Rani Challenges in orphan drug development and regulatory requirements in India 2020-03-26T06:23:02+00:00 Nisha Chaudhary Vikesh Kumar Shukla <p>While regulatory policy is well-defined in the United States and Europe for the development of orphan drugs, Indian guidelines on rare diseases is still transforming. In India due to lack of a transparent definition and regulatory approval process for rare diseases therefore until now, has deterrent pharmaceutical industries to pursue drug development for rare diseases. The orphan medication program can help pharmaceutical organizations in gaining benefits and recouping their venture even with little patient population in the developed nation. In 2001 a conference was assemble by the Indian Drugs Manufacturers Association (IDMA) where a gathering of pharmacologists mentioned the Indian government to set up the Orphan Drug Act in India. Since, guidelines for the orphan drug have not been made by the Indian government. Indian rare disease patient relies upon developed nations approved orphan drugs. Developing countries are likewise feeling they ought to plan something for the elevation of orphan drug research and manufacturing. The lack of regulatory guidelines of orphan drug antagonistically affecting the monetary development of Indian medical businesses. One of the significant reasons is that the pharmaceutical company isn't quick to look into the improvement of orphan drugs as these medications don't catch a huge market. However, in this article, we have attempted to concentrate on drug regulation of United States and it has been noted that the two biggest populated nation India and China, both need national enactment for orphan drugs and rare diseases, which carries a significant negative effects on their patient population with rare diseases.</p> 2020-03-26T06:23:02+00:00 Copyright (c) 2020 Nisha Chaudhary, Vikesh Kumar Shukla Global scenario of Medical Device vigilance system 2020-03-26T07:11:41+00:00 Suheta Tikoo Vikesh Kumar Shukla <p>Patient all over the world depend on wide array of medical devices for diagnosis and management of diseases. Medical devices are considered as crucial component for patient care. It is difficult to establish a global definition of medical devices, as different countries have numerous regulatory bodies overseeing the market of medical devices. As per Global Harmonization Task Force (GHTF) definition, the term medical devices means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent and calibrator, software, material or other similar or related article intended by the manufacturer to be used alone or in combination for human beings for diagnosis, prevention, monitoring, treatment or alleviation of disease. Pharmacovigilance system is a branch of pharmacological science dealing with reporting of adverse reaction events which are caused by medicines and medical devices. Adverse event can have a major effect on population and hence is one of the potential concerns of public health which requires continuous recording, evaluation and monitoring. To achieve uniformity among the national medical device regulatory systems and increase the access to safe, effective, and clinically beneficial medical technologies, the Global Harmonization Task Force (GHTF) was conceived in 1992 by five members: European Union, United States, Australia, Japan, and Canada. All regulated countries have clearly defined medical devices, as has the GHTF. Although GHTF has tried to achieve harmonization with respect to medical devices, some differences still exist in the national laws of the countries of GHTF. Further, regulated countries have classified medical devices on the basis of their associated risk. India is lagging behind in medical device regulations, although now it is moving towards harmonizing its medical device regulations with those of regulated countries, this study aims to identify vigilance system of medical devices in various countries.</p> 2020-03-16T00:00:00+00:00 Copyright (c) 2020 Suheta Tikoo, Vikesh Kumar Shukla Regulatory aspects for vaccines in India and US 2020-03-26T06:29:35+00:00 Vivek Kumar Bihania Ashutosh Badola <p>Vaccines are the most significant health mediation. A vaccine is a biological preparation that builds resistance to a particular disease. The improvement of a vaccine is a perplexing and repetitive procedure. Throughout the development of a vaccine for its authorization, a strict administrative procedure must be made for determining the safety, efficacy, and quality. Center for Biologics Evaluation and Research (CBER) under the USFDA regulates the vaccines in the USA. Similarly, in India, the Indian National Regulatory Authority (CDSCO) is the regulatory body who is liable for the assembling and import of vaccines. To the clinical field, biotechnology gives inventive solutions with more than 200 biologic medications and vaccines. For registration of vaccines, Biologics License Application (BLA) in the USA, and in India, an application is made to the Drug Controller General of India (DCGI) on form 44 along with CMC reports and accessible pre-clinical and clinical examinations. After the enlistments of an immunization, post-marketing surveillance framework, i.e. Vaccine adverse event reporting system (VAERS) is made in the USA.</p> 2020-03-26T06:29:34+00:00 Copyright (c) 2020 Vivek Kumar Bihania, Ashutosh Badola