Pharmaceutical Regulatory Science MCQ - Bpharm final year


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 we will discuss the topic Indian drug regulatory authorities any medicinal product takes several years of research and number of resources to get ready for general population use all medicinal products need to be regulated effectively to meet the public demand and also to the changing scenario in the pharma industries drug regulatory authorities play the role in developing and implementing most of the legislation and regulations for pharmaceuticals every country has its own drug regulatory authority.


 in this site we will discuss the Indian drug regulatory authority India is a federal union of 28 states and 8 union territories in India drug is regulated at the central as well as state-level the central government and state government both work as regulators under the drug and cosmetic act 1940 the prime objective of drug regulatory authority is to ensure that safe effective and good quality drugs reach the patient's responsibilities of regulatory authority include product registration licensing of premises persons and practices regulation and control of drug promotion and information adverse drug reaction monitoring and regulation of drug manufacturing importation and distribution let's discuss briefly about structure and functions of national and state drug regulatory authority under directorate general of health services ministry of health and family welfare government of India central drugs standard control organization is the national regulatory authority of India.

it functions in a similar way as FDA in u.s and ema in EU functions cds ceo functions at the central level the cds ceo is headed by the drug controller general of India that is dcgi under dcgi deputy drug controller assistant drug controller drug inspectors technical data associate functions the headquarter of cdsco is located in New Delhi India it has six zonal offices seven sub-zonal offices 13 port offices and several laboratories spread across the country major functions of cd seo include regulatory control over the import of drugs approval of new drugs and clinical trials meetings of drugs consultative committee and drug technical advisory board approval of certain licenses as central license approving authority is exercised by cdsco headquarters at state-level drug authorities consist of food and drug administration.

one for each state and certain licensing authorities for the union territories the state drug commissioner heads the department drug commissioner reports to a joint secretary in the health department of state governments under drug commissioner joint commissioner assistant commissioner drug inspector and other supporting staff functions state drug regulatory authorities functions include licensing of manufacturing establishments and sale premises approval of drug testing laboratories monitoring of the quality of drugs and cosmetics marketed in India investigation and persecution in respect of the contravention of legal provision and recall of substandard drug the central and state drug regulatory authorities functions with the help of other statutory bodies they are drugs technical advisory board drugs consultative committee central drugs laboratory drugs technical advisory board provides.

Pharmaceutical Regulatory Science MCQ - Bpharm final year



 its guidance and advice to the central government and state governments on the technical matters arising out of the administration of the drugs and cosmetic act and carries out the other functions assigned by the act drug consultative committee is an advisory committee to advise the central government and state government and drug technical advisory board on any matter tending to secure the uniformity throughout the country in the administration of the drug and cosmetic act the central drugs laboratory located in Kolkata is the national statutory laboratory of government of India for quality control of drug and cosmetics subject expert committees subject expert committees evaluates the applications and provides advice on approvals of clinical trials drugs and medical devices their recommendations will be reviewed by technical review committee and based on the recommendations of technical review committee cisco decides about clinical trial and new drugs approval thanks for reading our article.


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