Textbook of Forensic Pharmacy

Front Cover
Half Title Page
Title Page
Copyright
Dedication
Preface to the Second Edition
Preface to the First Edition
Contents
1. The Pharmacy Act, 1948
	Introduction
	Definitions
	The Pharmacy Council of India
	A. Constitution
	B. Term of Office, Vacancies, Remuneration and Allowances
	C. Committees
	D. Functions of PCI
	State Pharmacy Councils
	A. Constitution
	B. Term of Office, Vacancies, Remuneration and Allowances
	C. Inspection
	D. Committee
	E. Functions of State Pharmacy Council
	Miscellaneous
	Offences and penalties
2. The Drugs and Cosmetics Act, 1940 and Rules, 1945
	Introduction
	Definitions
	Schedules
	Administration of the Act and Rules
	The Drugs Technical Advisory Board
	The Drugs Consultative Committee
	The Central Drugs Laboratory
	Drugs Control Laboratories in the State
	Government Analysts
	Licensing Authority
	Controlling Authority
	Drugs Inspectors
	Import of Drugs and Cosmetics
	Quality of Drugs
	Import of Drugs
	Import of Small Quantities of Drugs
	Procedure for the Import of Drugs
	Other Provisions Regarding Import of Drugs
	Offences and Penalties Related to the Import of Drugs
	Miscellaneous Provisions Related to the Import of Drugs
	Manufacture of Drugs and Cosmetics
	Manufacture Applications, Licenses, Fees and Penalty
	Prohibition of Manufacture and Sale
	Manufacture
	I. Manufacture of Drugs other than those Specified in Schedules C, C1 and X and Manufacture of Drugs Specified in Schedule X and not Specified in Schedules C and C1
	II. Manufacture of Drugs Specified in Schedules C and C1 Excluding those Specified in Schedule X
	Manu Facture of Drugs Specified in Schedules C, C1 and X, and X
	Manufacture of Large Volume Parenterals/Sera and Vaccines Specified in Schedules C and C1 Excluding those Specified in Schedule X
	III. Manufacture for Examination, Test or Analysis
	IV. Loan License to Manufacture of Drugs
	A. Drugs other than those Specified in Schedules C and C1
	B. Drugs Specified in Schedules C and C1
	V. Repacking Licenses
	VI. Manufacture of whole Human Blood and Components for Sale or Distribution
	VII. Manufacture of New Drugs
	Some other Provisions Related to the Manufacture of Drugs
	Sale of Drugs
	Retail Sale
	Licenses for Retail Sale
	Wholesale of Drugs
	Categories of Licenses for Sale of Drugs by Wholesale
	Sale of Drugs from Motor Vehicles
	Other Provisions Related to the Sale of Drugs
	Offences and Penalties for Manufactures, Sales of Drugs and Cosmetics
	Miscellaneous Provisions Related to the Manufacture and Sale
	Dispensing and Compounding of Drugs and Supply of Drugs
	Labelling and Packing of Drugs
	Labelling of Dispensed Medicines
	Other Provisions Related to the Labelling of Drugs
	Provisions Relating to Ayurvedic, Siddha and Unani Drugs
	Prohibition of Manufacture and Sale of Certain Ayurvedic, Siddha and Unani Drug
	Manufacture for Sale of Ayurvedic (Including Siddha) or Unani Drugs
	Loan License to Manufacture of Ayurvedic, Siddha or Unani Drugs
	Sale of Ayurvedic, Siddha or Unani Drugs
	The Second Schedule
	Offences and Penalties
	Standards of Ayurvedic, Siddha and Unani Drugs
	Labelling, Packing and Limit of Alcohol in Ayurvedic (Including Siddha) or Unani Drugs
	Exemption in Labelling and Packing of Ayurvedic (Including Siddha) and Unani Drugs
	The First Schedule
	Provisions Applicable to the Homoeopathic Medicines
	Labelling and Packing of Homoeopathic Medicines
	Provisions Applicable to the Cosmetics
	Import of Cosmetics
	Import of Cosmetic for Personal Use
	Manufacture of Cosmetic for Sale or for Distribution
	Loan License to Manufacture Cosmetics
	Sale of Cosmetics
	Other Provisions Related to the Manufacture and Sale of Cosmetics
	Labelling, Packing and Standards of Cosmetics
	Import or Manufacture of New Drug for Clinical Trials or Marketing
	Permission to Import or Manufacture Fixed Dose Combination
	Application for Permission to Conduct Clinical Trials for New Drug/Investigational New Drug
	Special Provisions Relating to Biological and other Special Products
	Approval of Institute for Analysis
	Other Provisions Related to the Approval of Institute for Analysis
	Schedules
	Miscellaneous Provisions Related to the Drug and Cosmetic Act and Rules
	Standards
	List of Colours Permitted to be Used in Drugs
	Schedule D
	Schedule E
	Schedule E1
	Schedule G
	Schedule H
	Schedule J
	Schedule M (Good Manufacturing Practices)
	Part I—Factory Premises
	Part I A
	Part I B
	Part I C
	Part I D
	Part I E
	Part I F
	Part II
	Schedule M I
	Schedule M II
	Schedule M III
	Schedule N
	Schedule S
	Schedule V
	Schedule W
	Schedule X
	Schedule Y
	Design of Labels According to the D and C Act and Rules
3. The Medicinal and Toilet Preparations (Excise Duties) Act, 1955 and Rules, 1956
	Introduction
	Definitions
	The Schedule
	Appointment of Officers and Delegation of Powers to Them
	Standing Committee
	Levy and Collection of Duties
	Licensing
	Manufacture of Medicinal and Toilet Preparations
	Classification of Medicinal and Toilet Preparations Containing Alcohol
	Warehousing of Alcoholic Preparations
	Export of Alcoholic Preparations
	Inter-state Transport of Alcoholic Preparations
	Other Provisions
	Offences and Penalties
	Miscellaneous
4. The Narcotic Drugs and Psychotropic Substances Act, 1985 and Rules
	Introduction
	Definitions
	Authorities and Officers
	Prohibition, Control and Regulation
	Offences and Penalties
	Other Provisions Related to the Offences and Penalties
	Procedure
	Forfeiture of Property Derived from, or Used in, Illicit Traffic
	Miscellaneous Provisions related to the Act
	Opium Poppy Cultivation and Production of Opium and Poppy Straw
	Manufacture, Sale and Export of Opium
	Manufacture of Manufactured Drugs
	Import, Export and Transshipment of Narcotic Drugs and Psychotropic Substances
	Psychotropic Substance
	Schedule I
	Schedule II
5. The Essential Commodities Act, 1955
	Introduction
	The Essential Commodities Act, 1955
	Definitions
	Control of Production, Supply and Distribution of Essential Commodities
	Confiscation of Essential Commodity
	Appeal
	Offences and Penalties
	Miscellaneous
6. New Drug Policy
	Introduction
	The Main Objectives of Pharmaceutical Policy 2002
	Drug Policy of 1986
	Approach Adopted in the Review
7. The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954
	Introduction
	Definitions
	Prohibit Advertisement
	Classes of Advertisement Exempted Under the Drugs and Magic Remedies Act
	Entry, Search and Seizure
	Offences and Penalties
	Miscellaneous
8. The Poisons Act, 1919
	Introduction
	Definitions
	Import of Poison
	Possession and Sale of Poison
	Penalties
	Warrants
	Rules
	Savings
9. The Medical Termination of Pregnancy Act, 1971
	Introduction
	Definitions
	Termination of pregnancy
	Pregnancies may not be Terminated
	Qualification of Doctors
	Experience or Training
	Approval of a Place
	Inspection of a Place
	Cancellation or Suspension of Certificate of Approval
	Custody of Forms
	Maintenance of Records/Admission Register
	Offences and Penalties
	Miscellaneous
10. The Prevention of Cruelty to Animals Act, 1960
	Introduction
	Salient Features
	Definitions
	Cruelty to Animals Generally
	Animal Welfare Board
	Experimentation on Animals
	Institutional Animal Ethics Committee (IAEC)
	Performing Animals
	Performance of Experiments
	Breeding and Stocking of Animals
	Exemptions
	Offences and Penalty
	Miscellaneous
11. The Shops and Establishment Act, 1954
	Introduction
	The Delhi Shops and Establishments Act
	Definitions
	Registration of Establishments
	Work in Establishment/Hours and Timing of Works
	Health and Safety
	Service Conditions
	Inspection of Establishments
	Offences and Penalties
	Miscellaneous
12. The Insecticides Act, 1968
	Introduction
	Salient Features
	Definitions
	Administrative Agencies
	A. The Central Insecticides Board
	B. Registration Committee
	C. Central Insecticides Laboratory
	D. Insecticide Inspectors
	Registration of Insecticides
	Grant of License to Sale, Stock or Distribute Insecticide
	Import, Manufacture and Sale of Certain Insecticides
	Prohibition of Import, Manufacture and Sale of Certain Insecticides
	Offences and Punishment
	Exemption
	Miscellaneous
13. The All India Council for Technical Education Act, 1987
	Introduction
	All India Council for Technical Education
	Definitions
	Establishment of the Council
	Bodies of the Council
	Finance, Accounts and Audit
	Miscellaneous
14. The Factories Act, 1948
	Introduction
	Salient Features
	Definitions
	References to Time of Day
	Approval, Licensing and Registration of Factories
	Notice by Occupier
	General Duties of the Occupier
	The Inspecting Staff
	Certifying Surgeons
	Constitution of Site Appraisal Committees
	Health of the Workers
	Safety of Workers
	Welfare
	Holidays and Working Hours of Adults
	Register
	Prohibition of Employment of Young Children
	Wages
	Special Provision
	Offences and Penalty
	Cognizance of Offences
	Appeals
	Obligations and Right of Workers
	Miscellaneous
15. The Minimum Wages Act, 1948
	Introduction
	Definitions
	Provisions for Fixing Minimum Rates of Wages
	Boards and Committees
	Provision of Fixing Hours of Work
	Register-maintenance of Registers and Records by Employer
	Claims
	Inspectors
	Offences and Penalties
	Miscellaneous
16. Intellectual Property Rights
	Introduction
	Introduction of Intellectual Property Rights
	Intellectual Property Rights (IPR)
	Patents
	The Patents Act, 1970
	Definitions
	Patentable Invention
	Inventions not Patentable
	Inventions where only Methods or Processes of Manufacture Patentable
	Term of the Patent
	Procedure for Obtaining Patent/Applications for Patents
	Specification
	Exclusive Marketing Rights (EMR)
	Opposition to Grant of Patent
	Grant and Sealing of Patents and Rights Conferred Thereby
	Conditions
	Rights
	Term of Patent
	Patents of Addition
	Restoration of Lapsed Patents
	Surrender and Revocation of Patents
	Register of Patents
	Patent Office and its Establishment
	Working of Patents, Compulsory Licenses, Licenses of Rights and Revocation
	Appeals
	Offences and Penalties
	Patent Agents
	International Arrangements
	Patent Protection for Pharmaceutical Products
	Miscellaneous
	Copyrights
	Copyright Protects Works
	Rights Under Copyright
	Infringement of Copyright
	License
	Term of a Copyright
	Transfer of Copyright
	Duration of Copyright
	Public Domain
	Limitations
	Alternatives to Copyright
	Copyright in the News
	Trademarks
	Madrid Agreement
	The Madrid Protocol
	Different Between the Trademarks Act, 1999 and the Trade and Merchandising Marks Act, 1958
	Registered (Industrial) Design
	The Designs Act, 1911
	Definitions
	The Registration of Design
	Cancellation of Registration
	Piracy of Registered Design
	Penalties
	Strategy for Protection
	Protection of Integrated Circuit (IC) Layout Design
	Protection of Geographical Indications
	Protection of Undisclosed Information
17. The Consumer Protection Act, 1986
	Introduction
	Definitions
	Grant of Relief
18. The Standard of Weights and Measures Act, 1976
	Introduction
	Definitions
	Establishment of Standards of Weights and Measures
	Physical Representation of Standard Units
	Standard Weights and Measures
	Appointment and Powers of Director and other Staff
	Commodities in Packaged form
	Offences and their Trial
	Other Provision
	Miscellaneous
19. Code of Pharmaceutical Ethics
	Introduction
	Pharmaceutical Ethics
	Code of Ethics
	General Introduction to Code of Pharmaceutical Ethics
	Objectives of Code of Pharmaceutical Ethics
	Pharmacists in Relation to his Job
	Pharmacists in Relation to his Trade
	Pharmacists in Relation to Medical Profession
	Pharmacist in Relation to his Profession
	Pharmacist’s Oath
20. Medical and Health Accessories
	Introduction
	Medical/Surgical Accessories
	Official in Pharmacopoeia/Pharmaceutical Codex
21. Prescription and Non-prescription Drugs and Diagnostic Aids
	Introduction
	Prescription’s Drugs
	Prescription Drugs in India
	Non-prescription Drugs
	Non-prescription Drug Prescriptions
	Diagnosis
	Diagnostic Aids
	Some other Diagnostic Aids
	Appliance
22. New Drug Approval and Export Registration
	Introduction
	New Drug Application
	Drug Documents
	Export Registration
	Export Registration Procedure
23. Pharmacy, Pharmaceutical Education, Regulation and Career Option
	Introduction
	Types of Pharmacy Practice Areas
	The Future of Pharmacy
	Pharmaceutical Education
	Pharmacy Education
	Continuing Pharmacy Education
	Regulation of Pharmacy Education, Profession and Practice in India
	Career Options for Pharmacists
	Demand of Pharmacists
	International Demand of a Pharmacist
	Quality of Pharmacists in India
	Recommendations
24. Pharmaceutical Legislation, Pharmaceutical Industry
	Introduction
	Scope and objectives
	Functions
	Definitions
	Pharmaceutical Legislation
	Legislation Drugs Enquiry Committee
	Evaluation of the Concept of Pharmacy
	Bhore Committee
	Bhatia Committee
	Mudaliar Committee
	Hathi Committee
	New Drug Policy
	Pharmacopoeia
	IP
	USP
	BP
	Pharmaceutical Industry
	Pharmaceutical Industries in India
	History of the Indian Pharmaceutical Industry
	Present (Current) Scenario of the Pharmaceutical Industry
	Future Avenues for the Indian Pharmaceutical Industry
25. The National Pharmaceutical Pricing Authority (NPPA) and the Drug Price Control Order Act, 2013
	Introduction
	Price Monitoring and Resource Unit (PMRU)
	Introduction to the DPCO Act, 2013
	The Drug Price Control Order (DPCO) Act, 2013
	Definitions
	Essential Medicines
	Scheduled Formulation
	Non-scheduled Formulation
	NLEM
	Power of Directions
	Price Calculation
	Retail Price of Formulation
	Reference Data
	Pricing of the Formulations Under DPCO, 1995
	Ceiling Price or Retail Price of a Pack
	Price of Formulations in NLEM
	Price for the Existing Manufacturers
	Fixation of Ceiling Price
	Fixation of Retail Price
	Revision of Ceiling Price
	Amendment of the List
	Revision of Ceiling Price
	Fixation of Ceiling Price
	Monitoring the Prices and Availability
	Recovery of Dues
	Recovery of Overcharged Amount Under DPCO, 1987 and 1995
	Carrying into Effect the Price Fixed or Revised by the Government
	Control of Sale Prices of Bulk Drugs
	Records
	Miscellaneous
	Penalties
	Amendments
	Schedule
	Forms
26. The Right to Information (RTI) Act, 2005
	Introduction
	Definitions
	Right to Information Act, 2005
	Government Organizations
	Public Authorities and their Obligations
	Public Information Officer and their Duties
	Central Information Commission (CIC) and State Information Commission (SIC)
	Mandatory Disclosure of Information by Authority
	Procedure to File the RTI
	Appeal
	Penalty and Compensation
	RTI: Transparency and Accountability in Government
	Recent Amendments
	Other Issues
	Schedule
	Sample Application
27. Drugs and Cosmetics Act, 1940, Schedules (P, T, U, F, M) and Detailed Study of Schedules
	Schedule G, H, M, M-I, M-II, N, X, Y
	Schedule P
	Schedule P 1
	Schedule S (Standards for Cosmetics)
	Schedule T
	Good Manufacturing Practices for Ayurvedic, Siddha, and Unani Medicines
	Schedule-U
	Schedule U(I)
	Schedule-F
	Schedule-F “Part XII B”
	Blood Banks/Blood Components
	Blood Donation Cump
	Schedule M
	Schedule M-1
	Schedule M-Part-II
Important Questions for the Exam
Model Paper 1: Pharmaceutical Jurisprudence
Model Paper 2: Pharmaceutical Jurisprudence
Model Paper 3: Pharmaceutical Jurisprudence
Model Paper 4: Pharmaceutical Jurisprudence
Index
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