Drug approval process differs from one country to another country. The purpose of this study is to give a comparative overview on generic drug market regulation in ASEAN Countries Cambodia and Vietnam. The aim of study is to facilitate proper knowledge regarding main critical issues, differences as well as similarities of related drug regulation. There is a different requirement for registration of generic product in each regulatory system but also comprises of some similar outline that includes some common rules. These are variances and regulatory hurdles such as Number of batches for submission in dossier, stability conditions, registration of product, analysis, bioequivalence and clinical study requirement. ASEAN countries for generic drug product approval ACTD submitted to country specific authority. For solid oral dosage forms as per ASEAN guideline there are 4 parts have to be submitted. Part I contains Administrative requirements which is not a part of common technical document. Part II is Quality contains 3 sections that are a) Table of Content b) Quality overall Summary c) Body of data. Part III contains Non clinical. Part IV contains Clinical data. For the generic drug product Part III and Part IV is not required.
"Nutraceuticals" are the combination of Nutrition and pharmaceutical. The term Nutraceutical was given by Dr. Stephen in 1989. A dietary supplement is a product taken by mouth that contains a dietary ingredient (Vitamins, Minerals, Herbs, Amino acids etc.) Numerous definitions and nomenclature for dietary supplements exist worldwide. In India Food Safety and Standards authority (FSSA), defines Nutraceuticals as "foods for special dietary uses or functional foods or health supplements". In Philippines Nutraceuticals are known as food supplement & dilatory supplement. In Sudan, Nutraceuticals are known as dietary supplement & health product .In Cambodia Nutraceuticals are known as health supplement product. Every country has their own guidelines, regulatory requirements which deal with regulatory registration procedures of Nutraceuticals. In order to enter the Indian Nutraceutical market, some of the very important areas of focus include product evaluation, actual product analysis, procuring licenses and developing India specific health and label claims.
Nowadays, diet is thought to be much richer than it used to be. The people’s ignorance of the basic principles of nutrition has led a large part of the population to a non-balanced diet that is high in both calories and fat and low in proteins, vitamins and minerals. This is where Dietary supplement comes in role as it is any vitamin, mineral, herbal product, or other ingestible preparation that is added to the diet to benefit health. Dietary supplements are used worldwide and represent a broad category of ingestible products that are distinguishable from conventional foods and drugs. They do not belong to the category of common food neither medicines nor special dietary products and not intended for specific categories of people. It is very important to ensure that any product entering the market completely complies with the regulatory guidelines and requirements. The regulation of dietary supplement in the five countries India, Singapore, Malaysia, Ghana and Zimbabwe is reviewed and compared.
Drug repurposing is a phenomenon that aims at utilising an established and approved drug product or drug substance for an additional clinical indication apart from the one that it was intended for. The reprofiling of drug formulations creates an extensive arsenal of therapeutic options for drug products, thus making the practice a desirable and forthcoming procedure. There are several techniques and methods that have been adopted over the years to evaluate the various possibilities for the repurposing of drugs in search of a wider range of chemical therapeutics. The repurposing of drug products has provided, over the course of time several different advantages to the pharmaceutical industry, and yet remains an uncomprehended and over-looked procedure. The following paper attempts to identify the different benefits that are to be gained from the repurposing of drug products along with the approaches that have been used for the same. Additionally, the paper also discusses the regulatory perspective of drug repurposing, emphasising on the incentives that are available for various pharmaceutical sponsors as well the hurdles that are to be faced during the repurposing of a drug product or drug substance.
Despite all of the control approaches, tuberculosis (TB) is a major cause of death worldwide and onethird of the world's population is infected with TB. Plant-derived medicines have been used in traditional medicinal system for the treatment of many ailments worldwide. From last number of years, plants have advantageous in different type of diseases producing in human beings. The present aim to carry out the evaluation of the antimycobacterial activity of selected eleven medicinal plants. Three different extracts were prepared and evaluated for its antimycobacterial activity against Mycobacterium smegmatis using Mycobacterial Growth Indicator Tube (MGIT) assay. The MGIT assay consists of liquid broth medium that is known to yield better recovery and faster growth of mycobacteria. Isoniazid was used as standard antituberculosis drug. The percentage for anti-mycobacterial smegmatis activity among tested eleven medicinal plants, aqueous extract of Oscimum sanctum, Adhatoda vasica, Leptadenia reticulata and Cocculus hirsutus shows good antimycobacterial activity. Among these four Leptadenia reticulata and Cocculus hirsutus shows potent inhibition as compared to isoniazid. Thus, its result supports the uses of these plants in traditional medicine and also helps to cure and prevent tuberculosis. It can further have studied using more specific methods for antimycobacterial activity.
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