Manthan Janodia

Manipal Academy of Higher Education | MAHE · Manipal College of Pharmaceutical Sciences (MCOPS)

Introduction As the profession of pharmacy has evolved, pharmacy education has developed to include competencies and skills related to pharmacy administration services. Competencies taught in pharmacy administration courses are expected to provide graduates with skills to effectively undertake administrative functions. Our study aimed to assess per...

Background FDA issues warning letters to pharmaceutical manufacturers, distributors, or clinical investigators if it observes serious violations of federal regulations. These warning letters contain the details about the nature of the violations observed and the corrective actions recommended by the FDA. A follow-up inspection may be requested by t...

Background FDA issues warning letters to pharmaceutical manufacturers, distributors, or clinical investigators if it observes serious violations of federal regulations. These warning letters contain the details about the nature of the violations observed and the corrective actions recommended by the FDA. A follow-up inspection may be requested by t...

Medication turnaround time is the time it takes for the pharmacy to process a medication order. Reducing medication turnaround time is important to ensure timely availability of the drugs to the patient. Objective: This study measures the turnaround time for online indents of pharmacy reaching the patient wards and the factor affecting the turnarou...

Introduction: India has been promoting CBHI schemes as a part of National Rural Health Mission (NRHM) to reduce the burden of out of pocket expenditure.This study analyses the cost structure and package rates approved by the 5 CBHI schemes. Methodology: A Retrospective cross sectional study was conducted in a tertiary teaching hospital which includ...

Technology has improved speed and ease of communication using various platforms. Recent improvements in technology using Social Media (SM) has dramatically changed the way communication happens. Success stories of Facebook, Twitter, LinkedIn, WhatsApp, blog sites are some examples of how different media are used by people to communicate using digit...

Science driven therapeutics addresses only the diseases but does not provide cure and sometimes fails to meet the needs of patient. The pharmaceutical companies have, in recent years, started providing complementary products to improve the therapeutic value of the medicines. This is in the form of Fixed dose combination drugs (FDCs) The last couple...

New development in terms of Unitary Patent Protection (UPP) system in Europe is anticipated by the end of the year 2017. This article reviews the advantage of UPP over European Patent system (EPS). In addition, the upcoming Unified Patent Court (UPC) system allows parties to litigate in a single forum which would be time saving and cost effective....

This article is an attempt to quantify and compare number of SPCs granted, filed and invalidated in five important European Countries UK, France, Germany, Italy and Spain. The data is collected for those patents having expiry in between 1 January 1995 till 31 December 2025. The article further focuses on recent case laws evolved in Europe and its i...

Objective: Medical Representatives work involves lot of stress and burnout as reported by many studies. Hence the study is one of the first attempt to identify the factors influencing health related quality of life among the surveyed population of medical representatives. Methods: In this study a structured questionnaire was used to collect the soc...

A103 meet eligibility criteria when compared with their Caucasian counterparts. These identified shortcomings related to MTM delivery within the Part D population remain unresolved. In order to target beneficiaries that will benefit most from MTM services, and ensure optimal outcomes in all MTM delivery settings, our recommendations to CMS are as f...

Pharmaceutical products in Australia can win up to five years of Patent Term Extension (PTE). This article reviews Australian PTE Law and its relationship with regulatory pathway for approving medicinal products. The article describes recent PTE cases involving pharmaceutical products and analyses how effective these PTE provisions are in Australia...

Objectives: Evidence based medicine has been used for about two decades as methodology for obtaining, evaluating and presenting information on health related topics. The present study investigated the question of the appearance of the ideas of evidence based medicine in documents describing the functioning of European health care systems. MethOds:...

The Supplementary Protection Certificate (SPC) is a valuable intellectual property which allows its holder to maintain monopoly in the European Economic Area. The recent rulings by Court of Justice for Europe have considerably changed the understanding of the Article 3 of Regulation No 469/2009 which governs SPC provisions. The changes relating to...

Mission The Indian Hospital Pharmacist Association (IHPA) is the national professional body of Hospital Pharmacists engaged in Practice of Pharmacy. The IHPA is committed to provide a professional forum for Hospital Pharmacists for securing them their rightful place in the healthcare system and profession of pharmacy, promote and develop the Practi...

The Indian cosmetic industry is characterized by highly competitive marketing strategies. It depends on ability to introduce rapidly innovative products into the market without endless delays. A strategic marketing plan can be developed with the help of 4 P’s that is product, place, price and promotion which further helps a company to decide proper...

Orphan drugs are pharmaceutical agents that treat rare medical condition known as orphan or rare disease. According to U.S Rare Disease Act of 2002, any disease that affects less than 200,000 patients or 1 in 1500 is termed as a rare disease [1-3]. European Union defines rare disease as a life threatening or chronically debilitating disease which i...

Even though nano medicines (NM) are marketed for over a decade, these are relatively new to Trinidad and Tobago. Though NMclinical efficacy is well established, its newness on the pharmaceutical horizon has brought to the spotlight concerns about NM impact on the marketing and the regulations affiliated with its marketing. Presently NM is a very sm...

Informed consent is an ethical and legal requirement for research involving human participants. It is the process where a participant is informed about all aspects of the trial, which are important for the participant to make a decision and after studying all aspects of the trial the participant voluntarily confirms his or her willingness to partic...

There are 27 European Union (EU) member states, 3 European Economic Area (EEA) and European Free Trade Association (EFTA) states. For a company willing to market the medicinal product in to the EEA, marketing authorization (MA) for the respective product must be issued by competent authority of member state or authorization granted according to Reg...

Decision makers who undertake health technology assessments such as those conducted by NICE, deliberatively consider a new technologies cost per QALY, alongside other criteria (such as, equity, whether treatment is lifesaving and patient experience, etc) which are not captured in incremental cost-effectiveness ratios alone. The intention to impleme...

The Gulf cooperation council (GCC) region is considered as "Emerging market" for pharmaceutical export and bilateral trade. The understanding of the regulatory requirements of this region can be beneficial for pharmaceutical export. Some incidents of the year 2008-09, like recession or economic slowdown in highly well-off and regulated market of th...

Pharmacists are an integral part of healthcare team. Traditional role of pharmacist as dispenser of medicines has evolved and today pharmacists are expected to advise patients regarding safe use of medicines. According to World Health Organization (WHO) statistics, the number of pharmacists in India is approximately 5,90,000 or just 0.56 pharmaci...

Intellectual property is an important aspect for country's technological, economical and social development. It is observed that normally technologies are created in developed countries and benefits of these technologies are not spilled over to people in the developing countries. It is essential to make these technologies easily and economically av...

Indian Patent system has evolved over a period of time and since colonial rule various amendments have been made. Indian Patents Act 1970 that allowed only process patent in the fields of pharmaceuticals, food and agrochemicals was the driving force behind the success story of thriving Indian Pharmaceutical Industry and was modeled by various devel...

Marketing and advertising of pharmaceutical products to healthcare prescribers for prescription only products and to the consumers for Over the Counter medications has been one of the ethical issues and is a challenge to pharmaceutical companies. Various measures have been taken by certain regulatory agencies across the world to effectively control...

Chronic diseases like diabetes, Tuberculosis, hypertension, arthritis aremajor health challenges for the population around the world. While tacklingthese challenges it is necessary to give more emphasis on new methods forpreventing it, now it is time to balance the scales with little common sense.Scientists, healthcare professionals and experts agr...