Lakshmi Prasanthi Nori

Abstract

Nutraceuticals are the products isolated from foods that are generally sold in medicinal form. They are of particular interest to reduce the expensive and high-tech disease treatment approaches currently employed in developed countries. Nutraceuticals show increase in shift towards preventive therapies and increasing disposable income, favourable pricing environment growth in pharma retail chain and increase in healthcare spending is mainly responsible for increasing market for nutraceuticals, but lack of standardisation and awareness, high pricing, marketing and distribution are some challenges. Nutraceuticals are a clear example of advancement in biotechnological products with a disproportionate and inadequate input into generating quality scientific evidence to back or refute their validity. To achieve better quality of life people started eating more vegetables, fruits, dietary supplements, nutraceuticals, phyto therapeutical substances and other plant foods. With the advancements in the qualitative and quantitative determining parameters, the requisition of these products has been found to be amplified. Due to this, the nutraceutical market has become a million-dollar industry at a global level. Urbanization, market globalization and economic development have led to changes in diet and lifestyle. Development of better characterized and research proven products will help to enhance the customer confidence in nutraceutical and functional food products in global market. Keywords: Diet, Dietary Supplement, Prebiotics, Probiotics, Nutraceuticals

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Abstract

Biosimilars are biological products that are the replicas of their innovator biopharmaceuticals. At the moment, biological products account for 10 -15% of the total pharmaceutical market. More than one-fifth of new medicines launched on the world market each year are now biotechnology derived. These are developed after patent expiration of innovator biopharmaceuticals and are submitted for separate marketing approval. In view of the structural and manufacturing complexities of biopharmaceuticals, biosimilars should not be considered as biological generics. Each class of biologic varies in its benefit and risk profile, the nature and frequency of adverse events, the breadth of clinical indications and whether surrogate markers for efficacy are available and validated. But most of the countries do not have specific guidelines for potential market of biological products. Following the legislation that allowed the FDA to approve biosimilars in the United States, biological products that are similar to the reference product in terms of safety, purity and potency are gradually entering into the market. To date, only five biosimilars have been approved in the U. S. although many agents are currently undergoing trials and may soon become available. This article will address the differences between biosimilars and generics, issues concern with the approval process, use of biosimilars and need. Keywords: Generics, Biologics, Biosimilars, Patent expiration, Approval

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Abstract

Now a day’s medical devices are being used at greater extent in many countries. Medical devices are marketed according to the compliance with the requirements of various regulatory bodies. For commercialization of medical devices in the European Union, a CE Mark certificate is needed. CEis a "European Conformity" is the translation of the French term "Conformité Européenne". It also significantly reduces the time and resources need to compile application for registration, easy in the self-declaration for medical devices, simplifies exchange of regulatory information between regulatory authorities and playing field good for export market CE marking is the medical device manufacturer’s claim that product meet all regulatory requirements for all relevant European Medical Device Directives. The CE mark is a legal requirement to place a device on the market in the EU. The intension of this presentation is to know about the regulatory requirements and to analyze the requirements for obtaining CE marking for medical devices and simplifying CE marking procedures for various medical devices. It is given based on the description of research design. The marking certification process undergoes six steps to affix the CE mark. At present system Notified bodies issues CE certificates valid for 3 years. For some High — risk devices validity period may only one year. However, the status of your CE certification is dependent on maintaining your quality system certification. Keywords: Medical devices, Technical file, Combination products, IVD self­certified devices, Quality

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