Text Book of Pharmacy Law & Ethics (ER2020-26T)

to Drugs and Pharmacy profession

Pharmacy Council of India; its constitution and  functions, Education Regulations, State and  Joint state pharmacy councils,  Registration  of  Pharmacists,  Offences  and Penalties.

Pharmacy Practice Regulations 2015

New Amendments

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 permit.

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.

Study of schedule C and  C1, G, H, H1, K, P, M, N, and X.

Sale of Drugs – Wholesale, Retail sale and  Restricted license, Records to be kept in a pharmacy

Drugs Prohibited for manufacture and  sale in India

Administration of  the  Act  and Rules  – Drugs Technical Advisory Board,  Central Drugs Laboratory, Drugs Consultative Committee, Government   analysts,    licensing authorities, controlling authorities, Drug Inspectors.

and Rules Objectives, Definitions, Authorities and  Officers, Prohibition,  Control  and  Regulation,  Offences  and Penalties.

Advertisements) Act 1954

Objectives, Definitions,  Prohibition  of  certain advertisements, Classes of Exempted advertisements, Offences and  Penalties.

Definitions, CPCSEA – brief overview, 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.

possession,  possession  for sales  and  sale  of any  poison, import of poisons

Act and Rules: brief overview and  aspects related to manufacture,  storage,  sale,  and   labelling  of  Food Supplements

Control Order  (DPCO)  – 2013.  Objectives, Definitions, Sale prices  of  bulk  drugs, Retail  price  of  formulations,  Retail price and ceiling price of scheduled formulations, Pharmaceutical Policy 2002,  National List of Essential Medicines (NLEM)

principles,  ethical  problem  solving,  registration,  code   of ethics for Pharmacist in relation to his job, trade,  medical profession and his profession, Pharmacist’s oath.

understanding, salient features, and  Amendments

Central  Drugs Standards  Control  Organization  (CDSCO), Indian Pharmacopoeia Commission (IPC)

renewals, e-governance) in Community Pharmacy, Hospital pharmacy, Pharma Manufacturing, Wholesale business, inspections, import, export of drugs and  medical devices

of  Clinical  Trials,  ANDA,  NDA,  New  Drug  development, New   Drugs  and   Clinical   Trials   Rules,   2019.   Brand   v/s Generic,  Trade  name concept, Introduction  to Patent Law and  Intellectual Property Rights, Emergency Use Authorization

Pharmacy

aspects, and  aspects related to pharma manufacture to disposal of pharma / medical waste at homes, pharmacies, and  hospitals

overview  of  ICMR’s  National  Ethical  Guidelines  for Biomedical  and   Health  Research  involving  human participants

manufacture and sale