MEDICAL DEVICES A medical device is any instrument, device, implement, machine, appliance, implant, in vitro reagent, software, material, or other similar or related item that the manufacturer intends to use for a medical purpose, either alone or in combination. There…
DISASTER MANAGEMENT ACT, 2005 The Government of India passed the Disaster Management Act, 2005 (DMA 2005) on 23 December 2005. The prime purposes of introducing this act are: 1) To ensure the efficient management of disasters; and 2) To deal…
CONSUMER PROTECTION ACT, 2019 Earlier, the protection of rights and interests of consumers was governed by the Consumer Protection Act, 1986. However, due to some flaws in the Act with respect to the changed scenario, the existing Act was required…
BIOETHICS Bioethics is the discipline dealing with the ethical implications of biological research and application, especially in medicine. It includes the study of what is right and wrong in new discoveries and techniques in biology, such as genetic engineering and…
BIOMEDICAL WASTE MANAGEMENT RULES, 2016 Biomedical Waste Management Rules, 2016 (BMWM) was issued by the notification of the Ministry of Environment, Forestry, and Climate Change in March 2016 stating that every healthcare facility must take all necessary efforts to guarantee…
CLINICAL ESTABLISHMENT ACT AND RULES On 17th August 2010, the Clinical Establishments Act was passed by the Indian Parliament to provide for the registration and regulation of all clinical establishments in the country, with the goal of recommending minimum standards…
BLOOD BANK Blood banking is a process carried out in the laboratory to ensure that donated blood or blood products are safe to be used in blood transfusions and other medical procedures. Blood is collected and divided into its many…
BCS SYSTEM OF CLASSIFICATION Biopharmaceutics Classification System (BCS) is a fundamental guideline for determining the conditions under which In-Vitro In-Vivo Correlations (IVIVC) are expected. BCS is also used as a tool for developing in-vitro dissolution specifications. BCS Drug Classification Class…
GOOD REGULATORY PRACTICES (GRP) Good Regulatory Practices (GRP) are processes, systems, tools, and methods for improving the quality of regulations that are internationally recognised. Before government initiatives are implemented, GRP systematically implements public consultation and stakeholder involvement, as well as…
GOVERNMENT PHARMA REGULATORY BODIES Regulatory agencies are developing in various nations throughout the world as the pharmaceutical industry advances toward greater competition. Organisations and regulatory bodies are essential to a nation’s ability to comply with legal obligations pertaining to the…