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Pharmaceutical Regulatory Affairs

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Ravi Kumar Reddy Juturi
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Nutraceuticals, functional foods give health benefits and are believed to support or avoid diseases or health-related conditions. However, till now, the shared definition and regulations are not well established worldwide. Moreover, some countries developed their regulatory framework, but they lack harmonization and differ in legislative procedures on health claims. Due to these unregulated systems, countries face some issues in the lack of a unified approach towards health claims and marketing. The global market is currently immersed in these foods because people are more concerned about their health and food habits, which leads to an increase in the number of claims in food-driven products. Present review article addressing the nutraceuticals and functional foods current regulatory system for health claims in India, US, Japan, and current challenges and market.
Ravi Kumar Reddy Juturi
added 5 research items
A Drug Master File (DMF) covers all comprehensive, accurate, and precise information about Active Pharmaceutical Ingredient (API) or Finished Product Dosage Form (FP). It is a confidential document that contains complete, factual, and correct information about the active pharmaceutical ingredient and drug product's chemistry, manufacture, stability, purity, impurity profile, packaging, and the cGMP (Current Good Manufacturing Practices) status of any human drug product. When a DMF is filed, it allows a company to safeguard its intellectual property from its partner while complying with regulatory requirements when its process details are disclosed. There is no legalised or regulatory requirement to file a DMF. A DMF comprises of two parts: (a) the Applicant's Part (Open Part), which contains all the information to assess the quality that the license-holder requires and submit a license or amendment application; and (b) the Restricted Part (Closed Part), which contains confidential information about the manufacturing procedure which is only disclosed to the authorities. A DMF can be used by a holder who establishes the file or by one or more parties to support their files or applications. The present study is to brief an overview of DMF filing in different countries, which are the USA, Europe, and India. It also gives information on regulatory requirements of Drug Master Files by Food and Drug Administration (USA), European Medicines Agency (Europe), and Central Drug and Standard Control Organization (India) and their comparison.
In the USA, medical devices are regulated by the Food and Drug Administration (FDA) with an aim to ensure the safety and effectiveness of the devices. The Center for Devices and Radiological Health (CDRH) is an FDA section and looks after this procedure. Medical devices are classified into three categories based on the associated risk, namely: Class I, II and III. With respect to that, most Class I devices are exempted from 510(k) premarket notification submission, while most of Class II devices are submitted for premarket notification. On the other hand, Class III devices need to go through the Premarket Approval Application (PMA) and other class III devices, which are exempted from PMA must submit a 510(k) notification to the FDA. In the 510(k) procedure must demonstrate that the device is substantially equivalent to one legally marketed in the United States: (1) before May 28, 1976; or (2) to a device that has been determined by FDA to be substantially equivalent. To mark a device as substantially equivalent, manufacturers need to compare their device with one or multiple existing devices and provide suitable facts to support the claim. The base device selected for the comparison is called “predicate”. It seems like the device and predicate are identical, but it’s not. The 510(k) approved class III medical devices causing major harm/risk to the patients. This article reviews the pros and cons along with cases on the most commonly utilized FDA 510(k) regulatory pathway
Nutraceuticals are treated broadly as food products, subject to manufacturing/quality standards, and restrictions on claims to prevent or mitigate disease. Even though Indian regulatory authority has come a long way by addressing many challenges, with the current lack of clarity and standardization issues such as definition, claims, and manufacturing standards, the mainstream industry complains that the Indian market is counterfeit and unregulated. Market players say the lack of carved-out nutraceuticals regulations leads to confusion and expediency. Nonetheless, India offers considerable potential for the growth of nutraceuticals from a modest base. It is currently estimated at 1-2% of global nutraceutical sales. To reach its full potential, food and pharmaceutical companies along with regulatory authorities need to address several regulatory, cultural, economic, and structural challenges in the Indian market.