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This course is designed to impart basic knowledge on important legislations related to the profession of pharmacy in India.
Upon completion of the course, the student shall be able to understand:
1. The Pharmaceutical legislations and their implications in the development and marketing of pharmaceuticals.
2. Various Indian pharmaceutical Acts and Laws.
3. The regulatory authorities and agencies governing the manufacture and sale of pharmaceuticals.
4. The code of ethics during the pharmaceutical practice.
UNIT-I
Drugs and Cosmetics Act, 1940 and its rules 1945:
Objectives, Definitions, Legal definitions of schedules to the act and rules. Import of drugs – Classes of drugs and cosmetics prohibited from import, Import under license or 150 permit. Offences and penalties. Manufacture of drugs – Prohibition of manufacture and sale of certain drugs, Conditions for grant of license and conditions of license for manufacture of drugs, Manufacture of drugs for test, examination and analysis, manufacture of new drug, loan license and repacking license.
UNIT-II
Drugs and Cosmetics Act, 1940 and its rules 1945.
Detailed study of Schedule G, H, M, N, P, T, U, V, X, Y, Part XII B, Sch F & DMR (OA) Sale of Drugs – Wholesale, Retail sale and Restricted license. Offences and penalties Labeling & packing of drugs- General labeling requirements and specimen labels for drugs and cosmetics, List of permitted colors. Offences and penalties. Administration of the act and rules – Drugs Technical Advisory Board, Central drugs Laboratory, Drugs Consultative Committee, Government drug analysts, licensing authorities, controlling authorities, Drugs Inspectors
UNIT-III
Pharmacy Act –1948:
Objectives, Definitions, Pharmacy Council of India; its constitution and functions, Education Regulations, State and Joint state pharmacy councils; its constitution and functions, Registration of Pharmacists, Offences and Penalties • Medicinal and Toilet Preparation Act –1955: Objectives, Definitions, Licensing, Manufacture In bond and Outside bond, Export of alcoholic preparations, Manufacture of Ayurvedic, Homeopathic, Patent & Proprietary Preparations. Offences and Penalties. • Narcotic Drugs and Psychotropic substances Act-1985 and Rules: Objectives, Definitions, Authorities and Officers, Constitution and Functions of narcotic & Psychotropic Consultative Committee, National Fund for Controlling the Drug Abuse, Prohibition, Control and Regulation, opium poppy cultivation and production of poppy straw, manufacture, sale and export of opium, Offences and penalties.
UNIT-IV
Study of Salient Features of Drugs and magic remedies Act and its rules:
Objectives, Definitions, Prohibition of certain advertisements, Classes of Exempted advertisements, Offences and Penalties • Prevention of Cruelty to animals Act-1960: Objectives, Definitions, Institutional Animal Ethics Committee, Breeding and Stocking of Animals, Performance of Experiments, Transfer and acquisition of animals for experiment, Records, Power to suspend or revoke registration, Offences and Penalties • National Pharmaceutical Pricing Authority: Drugs Price Control Order (DPCO)-2013. 151 Objectives, Definitions, Sale prices of bulk drugs, Retail price of formulations, Retail price and ceiling price of scheduled formulations, National List of Essential Medicines (NLEM)
UNIT-V
Pharmaceutical Legislations
A brief review, Introduction, Study of drugs enquiry committee, Health survey and development committee, Hathi committee and Mudaliar committee • Code of Pharmaceutical ethics definition, Pharmacist in relation to his job, trade, medical profession and his profession, Pharmacist’s oath Medical Termination of pregnancy act • Right to information Act • Introduction to Intellectual Property Rights (IPR)
Drugs and Cosmetics Act,1940 and its rules 1945:
Objectives,Definitions,Legal definitions of schedules to the act and Rules
Session -2
Import of Drugs-Classes of drugs and cosmetics prohibited from import
Session-3
Import under license or permit.Offences and penalties.
Session-4
Sale of Drugs-Wholesale,Retail sale and Restricted license
session-5
Drugs and Cosmetics Act,1940 and its rules 1945,
Detailed study of schedule G,H,M,N,P,T,U,V,Y,Part XIIB,Sch F & DMR(OA)
session-6
manufacture of new drug,loan license and repacking license.
session-7
Manufacture of drugs for test,examination and analysis
session-8
conditions of grant of license and conditions of license for manufacturing of drugs
session-9
Manufacture of Drugs-Prohibition of manufacture and sale of certain drugs
session-10
Licensing authorites,controlling authorites
session-11
Drugs Consultative committee.Government drug alnalysts
session-12
Administration of Act and Rules-Drugs Technical Advisory Board,Central drugs Laboratory,
session-13
offences and penalties
session-14
List of permitted colours
session-15
Labelling and packing of Drugs-General labelling requirements and specimen labels for drugs and cosmetics
session-16
Drug Insepectors
session-17
session-18
Pharmacy council of India;its contitutionand function,Education regulations,
session-19
State and Joint State Pharmacy Councils;constitution and functions
session-20
Registration of pharmacists
session-21
Offences and Penalties
serssion-22
session-23
Licensing,In bond and outside bond
session-24
export of alcoholic preparations
session-25
Manufacture of Ayurvedic,Homeopathic,patent & proprietary preparations
session-26
offences and penalties
session -27
Constitution and function of Narcotic and psychotropic Consultative committee,
NARCOTICS DRUGS AND PSYCHOTROPIC SUBSTANCES ACT 1985 AND RULE
session-28
Narcotic Drugs and Psychotropic Substances Act-19875 and Rules:
Objectives,Definitions,Authorities and Officers
NARCOTICS DRUGS AND PSYCHOTROPIC SUBSTANCES ACT 1985 AND RULE
session-29
National fund for controlling Drug abuse,Prohibition,control and regulation
NARCOTICS DRUGS AND PSYCHOTROPIC SUBSTANCES ACT 1985 AND RULE
session-30
Opium poppy cultivation and production of poppy straw,manufacture,sale and export of opium
NARCOTICS DRUGS AND PSYCHOTROPIC SUBSTANCES ACT 1985 AND RULE
session-31
Offences and penalties
NARCOTICS DRUGS AND PSYCHOTROPIC SUBSTANCES ACT 1985 AND RULE
session-32
Study of salient Features of Drugs and Magic remedies Act and its rules:
Objectives,Definitions
session -33
prohibition of certain advertisements. Classes of exempted advertisements,
session-34
offences and penalties
session 35
Prevention of Cruelty to Animals Acts Act-1960:
Objectives,Definitions,Institutional animal ethics committee
session 36
CPCEA guidelines for breeding and stocking of animals,Performance of experiments
session 37
Transfer and acquisition of animals for experiment,Records, Power to suspend or revoke registration
session 38
offences and penalties
session-39
Pharmaceutical legislations-A brief review,Introduction,study of drugs enquiry committee,health survey and development committee
session 40
Hathi Committee and Mudaliar committee
session 41
Code of Pharmaceutical Ethics-Definitions,Pharmacist in relation to his job,trade
session 42
medical profession and his profession,Pharmacist's Oath
session 43
Medical termination of Pregnancy act
session 44
Right to information act
session 45
Introduction to Intellectual Property Right
Suggested Books:
1.Forensic Pharmacy by B. Suresh
7.Narcotic drugs and psychotropic substances act by Govt. of India publications
Drug Design and Nano formulations
I am Himansu Sekhor Panda, currently working as an Assistant Professor at Centurion University of Technology and Management, Balasore Campus. I have completed my B. Pharm and M.Pharm (Pharmaceutics) at CUTM, Bhubaneswar on 2021 and 2023 respectively, having a teaching experience of around 2 years.
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