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Topic (Section I) Hr
No s
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1 Definition and scope of Forensic Pharmacy 1
2 Pharmaceutical Legislation-A brief review: Introduction, Study of drugs enquiry committee, 2
Health survey and development committee, Hathi committee and Mudaliar committee
3 Code of Pharmaceutical ethics: Definition, Pharmacist in relation to his job, trade, medical 2
profession and his profession, Pharmacists oath.
4 Pharmacy act-1948 & new Amendments: Objectives, Definitions, Pharmacy Council of India; 2
its constitution and functions, Education Regulations, State and Joint state pharmacy councils,
Registration of Pharmacists, Offences and Penalties
5 Drugs and cosmetics act 1940 and rules 1945 & New Amendments: Objectives, Definitions, 9
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. 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. Detailed study of
schedule M, N and Y. Sale of Drugs - Wholesale, Retail sale and Restricted license. Labelling &
Packing of drugs- General labeling requirements and specimen labels for drugs and cosmetics,
List of permitted colors. Administration of the act and rules - Drugs Technical Advisory Board,
Central Drug Committee, Government analysts, licensing authorities, controlling authorities,
Drug Inspectors
6 Medicinal and Toilet preparations (Excise Duties) Act 1955: Objectives, definitions,
Licensing, Manufacture In bond and Outside bond, Export of alcoholic preparations, Offences
and Penalties.
7 Narcotic drugs and psychotropic substance act 1985 and rules: Objectives, Definitions,
Authorities and Officers, Prohibition, Control and Regulation, opium poppy cultivation and
Production of poppy straw manufacture, sale and export of opium, Offences and Penalties.
8 Drugs and Magic remedies act 1955: Objectives, Definitions, Prohibition of certain
advertisements, Classes of Exempted advertisements, Offences and Penalties.
9 Pharmaceutical Policy 2002 and its amendments: Objectives, Approaches in the review,
Salient features
10 Sales promotion employees (Conditions of service) Act Regulatory affairs
11 Consumer Protection Act
(Section II)
12 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.
13 Drugs (price control) order-1995 & New Amendments: Objectives, Definitions, Sale prices of
bulk drugs, Retail price of formulations, Retail price and ceiling price of scheduled
formulations, Implementation of prices Fixed/ revised.
14 New Drug Discovery and development: Stages of drug discovery, Drug development process,
pre-clinical studies, nonclinical activities, clinical studies, Concept of generics, Generic drug
product development
15 Regulatory authorities and agencies: Overview of regulatory authorities of United States,
Australia, United Kingdom. International Conference on Harmonization, World Health
Organization.
16 Regulatory Approval Process: Investigational New Drug (IND), New Drug Application
(NDA), Abbreviated New Drug Application (ANDA). Changes to an approved NDA / ANDA.
17 Registration of drug product in overseas market: Procedure for export of pharmaceutical
products, Technical documentation, Common Technical Document (CTD), electronic Common
Technical Document (eCTD)
18 Right to information act, 2005 Introduction & applications