BP505T Pharmaceutical Jurisprudence Theory

Pharmaceutical Jurisprudence PCI Syllabus

UNIT-I: Drugs and Cosmetics Act, 1940 and its rules 1945

Objectives/Legislative intent

Definitions

Schedules to the Act and Rules (Video Link: Click Here)

Import of drugs

Classes of drugs and cosmetics prohibited from import, Import under license or permit. Offenses 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 a 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.

Offenses and penalties

Labeling & Packing of drugs

General labeling requirements and specimen labels for drugs and cosmetics,

List of permitted colors.

Offenses and penalties.

Administration of the Act and Rules

Advisory:

Drugs Technical Advisory Board

Drugs Consultative Committee

Analytical:

Central drugs Laboratory

Drug Control laboratories in State

Government analysts

Executive:

Licensing authorities (Central and State)

Drugs Inspectors

Custom collectors

UNIT-III: Pharmacy Act –1948

Objectives / Legislative intent of Pharmacy Act

Definitions

Pharmacy Council of India; constitution and functions,

Education Regulations,

State and Joint state pharmacy councils; constitution and functions,

Registration of Pharmacists,

Offenses 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.

Offenses 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,

Offenses and Penalties

UNIT-IV: Drugs and Magic Remedies Act and its rules

Study of Salient Features of Drugs and Magic Remedies Act and its rules:

Objectives, Definitions,

Prohibition of certain advertisements,

Classes of Exempted advertisements,

Offenses and Penalties

Prevention of Cruelty to Animals Act-1960:

Objectives, Definitions,

Institutional Animal Ethics Committee,

CPCSEA guidelines for Breeding and Stocking of Animals,

Performance of Experiments,

Transfer and acquisition of animals for the experiment,

Records, Power to suspend or revoke the registration,

Offenses and Penalties

National Pharmaceutical Pricing Authority:

Drugs Price Control Order (DPCO)-2013.

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 the drugs inquiry committee,

Health survey and development committee,

Hathi committee and Mudaliar committee

Code of Pharmaceutical ethics:

Definition,

Pharmacist in relation to his job, trade,

the medical profession and his profession,

Pharmacist’s oath

Medical Termination of Pregnancy Act

Right to Information Act

Introduction to Intellectual Property Rights (IPR)

  1. Forensic Pharmacy by B. Suresh
  2. Text book of Forensic Pharmacy by B.M. Mithal
  3. Hand book of drug law-byM.L. Mehra
  4. A text book of Forensic Pharmacy by N.K. Jain
  5. Drugs and Cosmetics Act/Rules by Govt. of India publications.
  6. Medicinal and Toilet preparations act 1955 by Govt. of India publications.
  7. Narcotic drugs and psychotropic substances act by Govt. of India publications
  8. Drugs and Magic Remedies act by Govt. of India publication
  9. Bare act of the said laws published by Government. Reference books (Theory)

Pharmaceutical Jurisprudence Notes

Pharmaceutical Jurisprudence PDF

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