Pharmaceutical Jurisprudence PDF - Third Year B. Pharm

 A Text Book of PHARMACEUTICAL JURISPRUDENCE As Per PCI Regulations THIRD YEAR B. PHARM. SEMESTER V Sandeep D.S....

 A Text Book of PHARMACEUTICAL JURISPRUDENCE As Per PCI Regulations THIRD YEAR B. PHARM. SEMESTER V Sandeep D.S. Dr. R. Narayana Charyulu M. Pharm. M. Pharm., Ph.D. Assistant Professor, Professor and Head, Department of Pharmaceutics, Department of Pharmaceutics, NGSM Institute of Pharmaceutical Sciences, NGSM Institute of Pharmaceutical Sciences, Nitte (Deemed to be University), Nitte (Deemed to be University), Mangalore. Mangalore. Shabana S. M. Pharm Assistant Professor, Department of Pharmacognosy, East West College of Pharmacy, Bengaluru 91. N3999 Pharmaceutical Jurisprudence ISBN 978-81-942538-8-4 First Edition : August 2019 © : Authors The text of this publication, or any part thereof, should not be reproduced or transmitted in any form or stored in any computer storage system or device for distribution including photocopy, recording, taping or information retrieval system or reproduced on any disc, tape, perforated media or other information storage device etc., without the written permission of Authors with whom the rights are reserved. Breach of this condition is liable for legal action. Every effort has been made to avoid errors or omissions in this publication. In spite of this, errors may have crept in. Any mistake, error or discrepancy so noted and shall be brought to our notice shall be taken care of in the next edition. It is notified that neither the publisher nor the authors or seller shall be responsible for any damage or loss of action to any one, of any kind, in any manner, therefrom. 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Any type of error or mistake so noted, and shall be brought to our notice, shall be taken care of in the next edition. It is notified that neither the publisher, nor the author or book seller shall be responsible for any damage or loss of action to any one of any kind, in any manner, therefrom. The reader must cross check all the facts and contents with original Government notification or publications. [email protected] | www.pragationline.com Also find us on www.facebook.com/niralibooks Preface Pharmaceutical Jurisprudence is the study of basic pharmaceutical laws and regulations. It is the basic subject where pharmacy students should be informed about various acts and legislative principles related to the profession of pharmacy in India and as well as the pharmaceutical industry. A Text Book of Pharmaceutical Jurisprudence is the outcome of numerous efforts of authors to assimilate the voluminous knowledge of Jurisprudence. The present book has compiled all the topics which were included in the new revised syllabus for Semester-V of Third Year of the B. Pharm course implemented by Pharmacy Council of India regulations, New Delhi. The book is designed to have 05 units, divided into 13 parts with simple and lucid language. The authors tried to include objectives of each topic explaining the study outcomes once the students understand the topics. Apart from the basic topics, the two new topics RTI Act and IPR concepts were also included with latest information and implementations. The authors are delighted since it is a first attempt to write this book and hope the readers; teachers, students and the people working in pharmaceutical industries will be benefitted and may get the required information from the sources of the text book. The Authors convey the deep sense of gratitude to their family and fellow teacher colleagues who always remained as a force behind writing this book. The authors would like to thank the authorities of NGSM Institute of Pharmaceutical Sciences, Nitte (Deemed to be University), Deralakatte, Mangalore and East West College of Pharmacy, Bengaluru for positive and constant support. The authors of NGSMIPS and EWCP would like to thank librarian Mr. Chandrasekhar and Mr. Nagesh respectively who helped to utilize the library sources and digital library for preparing and successful completion of this book. The Authors would like to acknowledge their special thanks to publishers Shree Dinesh Furia and Shree Jignesh Furia and staff of Nirali Prakashan specially Malik Shaikh, Mrs. Manasi Pingle, Mrs. Roshan Khan, Mr. Ravindra Walodare Pune for bringing out nicely printed book. Any suggestions and comments for further improvements from students and teachers are welcome and will be thankfully acknowledged. Authors Syllabus UNIT - I 10 Hours 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 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 10 Hours 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 and Packing of Drugs - General Labeling Requirements and Specimen Labels for Drugs and Cosmetics, List of Permitted Colours. 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 10 Hours Pharmacy Act, 1948: Objectives, Definitions, Pharmacy Council of India; its Constitution and Functions, Education Regulations, State and Joint State Pharmacy Councils; 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 and Proprietary Preparations. Offences and Penalties. Narcotic Drugs and Psychotropic Substances Act, 1985 and Rules: Objectives, Definitions, Authorities and Officers, Constitution and Functions of Narcotic and 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 08 Hours 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, CPCSEA guidelines for 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. 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 07 Hours 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). ✱✱✱ Contents Unit I 1. The Drugs and Cosmetics Act, 1940 and Its Rules, 1945 1.1 - 1.18 1.1 Introduction 1.1 1.2 Objectives 1.1 1.3 Definitions 1.2 1.4 Schedules to the Act and Rules 1.5 1.4.1 Schedules to the Act 1.5 1.4.2 Schedules to the Rules 1.5 1.5 Import of Drugs 1.7 1.6 Manufacture of Drugs 1.11 1.6.1 Prohibition of Manufacture and Sale of Certain Drugs 1.11 1.6.2 Conditions for Grant of License 1.12 1.6.3 Types of Licenses for Manufacture of Drugs 1.12 1.6.4 Conditions of License for Manufacture of Drugs 1.13 1.7 Loan License 1.16 1.8 Repacking License 1.17 Exercise 1.17 Bibliography 1.18 Unit II 2. Drugs and Cosmetics Act, 1940, and Its Rules 1945 2.1 - 2.30 2.1 Detailed Study of the Schedules 2.1 2.2 Sale of Drugs 2.17 2.2.1 Wholesale, Retail and Restricted Sale Licenses 2.17 2.2.2 Offences and Penalties 2.20 2.3 Labelling and Packing of Drugs and Cosmetics 2.20 2.3.1 General Labelling Requirements 2.20 2.3.2 Special Labelling Requirements 2.21 2.3.3 Specimen Labels 2.22 2.4 List of Permitted Colours 2.24 2.5 Offences and Penalties 2.24 2.6 Administration of the Act and Rules 2.24 2.6.1 The Drugs Technical Advisory Board (DTAB) 2.24 2.6.2 The Central Drugs Laboratory (CDL) 2.25 2.6.3 The Drugs Consultative Committee (DCC) 2.26 2.6.4 Government Drug Analysts 2.26 2.7 Licensing Authorities 2.27 2.8 Controlling Authorities 2.27 2.9 Drug Inspectors 2.28 Exercise 2.29 Bibliography 2.30  Unit III 3. Pharmacy Act, 1948 3.1 - 3.10 3.1 Introduction 3.1 3.2 Objectives of the Act 3.1 3.3 Definitions 3.1 3.4 Constitution of Pharmacy Council of India 3.2 3.4.1 Functions of Pharmacy Council of India 3.3 3.4.2 Education Regulations for Pharmacy 3.3 3.5 State and Joint State Pharmacy Councils 3.5 3.5.1 Functions of State Pharmacy Councils and Joint State Pharmacy Councils 3.6 3.5.2 Offences and Penalties 3.9 Exercise 3.10 Bibliography 3.10 4. Medicinal and Toilet Preparations (Excise Duties) Act, 1955 4.1 - 4.12 4.1 Introduction 4.1 4.2 Objectives of the Act 4.1 4.3 Definitions 4.2 4.4 Licensing Procedure 4.3 4.5 Manufacture 4.4 4.5.1 Manufacture in Bond 4.4 4.5.2 Manufacture Outside Bond 4.7 4.6 Export of Alcoholic Preparations 4.8 4.7 Manufacture of Ayurvedic, Homeopathic and Patent and Proprietary Preparations 4.10 4.7.1 Ayurvedic Preparations 4.10 4.7.2 Homeopathic Preparations 4.10 4.8 Offences and Penalties 4.11 Exercise 4.12 Bibliography 4.12 5. Narcotic Drugs and Psychotropic Substances Act, 1985 and Rules 5.1 - 5.10 5.1 Introduction 5.1 5.2 Objectives of the NDPS Act 5.2 5.3 Definitions of the Act 5.2 5.4 Authorities and Officers 5.4 5.5 Narcotic Drugs and Psychotropic Substances Consultative Committee 5.5 5.6 National Fund for Control of Drug Abuse 5.5 5.7 Prohibition, Control and Regulation 5.6 5.8 Cultivation of Opium Poppy and Production of Opium or Poppy Straw Cultivation5.7 5.9 Manufacture, Sale, and Export of Opium 5.8 5.9.1 Manufacture of Opium 5.8 5.9.2 Sale of Opium 5.8 5.9.3 Export of Opium 5.9 5.10 Offences and Penalties 5.9 Exercise 5.10 Bibliography 5.10  UNIT IV 6. The Drugs and Magic Remedies (Objectionable Advertisements) Act and its Rules 6.1 - 6.6 6.1 Introduction 6.1 6.2 Objectives 6.2 6.3 Definitions 6.2 6.4 Prohibited Advertisements 6.2 6.5 Exempted Advertisements 6.3 6.6 Offences and Penalties 6.4 Exercise 6.5 Bibliography 6.6 7. The Prevention of Cruelty to Animals Act, 1960 7.1 - 7.6 7.1 Introduction 7.1 7.2 Definitions 7.1 7.3 Institutional Animal Ethics Committee (IAEC) 7.2 7.4 Breeding and Stocking of Animals 7.3 7.5 Performance of Experiments 7.4 7.6 Transfer and Acquisition of Animals for Experiment 7.5 7.7 Records 7.5 7.8 Power to Suspend or Revoke the Registration 7.5 7.9 Offences and Penalties 7.5 Exercise 7.6 Bibliography 7.6 8. National Pharmaceutical Pricing Authority 8.1 - 8.12 8.1 Introduction 8.1 8.2 History of Price Control Policy 8.1 8.3 Objectives of the DPCO Act 8.2 8.4 Definitions 8.3 8.5 Sale Prices of Bulk Drugs 8.4 8.5.1 Calculation of Retail Price of Formulations 8.5 8.5.2 Pricing of the Scheduled Formulations Covered under Drugs (Prices Control) Order, 1995 8.5 8.5.3 Ceiling Price or Retail Price of a Pack 8.6 8.6 Price of Formulations (Branded or Generic) Listed in the NLEM Launched by a Manufacturer 8.6 8.7 National List of Essential Medicines, 2011 8.7 Exercise 8.12 Bibliography 8.12 UNIT V 9. Pharmaceutical Legislations in India 9.1 - 9.4 9.1 History of Pharmaceutical Legislation in India 9.1 9.2 Drugs Enquiry Committee 9.2 9.3 Health Survey and Development Committee 9.3  9.4 Mudliar Committee 9.3 9.5 Hathi Committee 9.3 Exercise 9.3 Bibliography 9.4 10. Code of Pharmaceutical Ethics 10.1 - 10.6 10.1 Introduction 10.1 10.2 Pharmaceutical Code of Ethics 10.1 10.3 Pharmacist in Relation to his Trade 10.3 10.4 Pharmacist in Relation to Medical Profession 10.4 10.5 Pharmacist in Relation to his Profession 10.5 10.6 Pharmacist’s Oath 10.6 Exercise 10.6 Bibliography 10.6 11. Medical Termination of Pregnancy Act 11.1 - 11.4 11.1 Introduction 11.1 11.2 Definitions 11.1 11.3 Provisions of the Act 11.2 11.4 Requirement of Experience or Training for an RMP to Terminate Pregnancy 11.2 11.5 Maintenance of Records 11.3 11.6 Offences and Penalties 11.3 Exercise 11.3 Bibliography 11.4 12. Right to Information (RTI) Act 12.1 - 12.6 12.1 Introduction 12.1 12.2 Definitions 12.1 12.3 Right to Information and Obligations of Public Authorities 12.3 12.4 The Central Information Commission 12.4 12.5 The State Information Commission 12.4 12.6 Powers and Functions of the Information Commissions 12.5 Exercise 12.6 Bibliography 12.6 13. Intellectual Property Rights 13.1 - 13.8 13.1 Introduction 13.1 13.2 Patents and Patent Act 13.1 13.2.1 Indian Patent Act 13.1 13.2.2 Definitions of Indian Patent Act 13.2 13.2.3 Types of Patent 13.4 13.2.4 Procedure for Getting a Patent 13.4 13.3 Different IPR Approaches 13.5 13.4 Copyright 13.7 Exercise 13.7 Bibliography 13.8 ✱✱✱  UNIT I Chapter... 1 DRUGS AND COSMETICS ACT, 1940 AND ITS RULES 1945 ♦ LEARNING OBJECTIVES ♦ After completing this chapter, the reader should be able to understand: About the compilation of Drug and Cosmetic Acts 1940 and Rules 1945. Regulation of import, manufacture, sale and distribution of drugs and cosmetics. To avoid substandard drugs and to maintain high standards of drugs and cosmetics. 1.1 INTRODUCTION The Central Legislative Assembly passed the Drugs and Cosmetics Act 1940 and rules 1945 with an objective to regulate the import, manufacture and distribution and sale of drugs and cosmetics. It is applicable on Allopathic, Homeopathic, Unani and Siddha drugs as well on contraceptives, mosquitoe repellents, creams, lotions, cosmetics and devices used for internal and external use for diagnosis. Under this Act, the regulation of manufacture, sale and distribution of Drugs is primarily the concern of the State authorities while the Central authorities are responsible for approval of New Drugs, Clinical trials in the country, laying down standards for Drugs, control over the quality of imported drugs, co-ordination of the activities of Drug Control Organization and providing expert advice with a view of bringing about uniformity in the enforcement of Drug and Cosmetic Act. 1.2 OBJECTIVES 1. The Drugs and Cosmetics Act 1940 provides the Central legislation, which regulates import, manufacture, distribution and sale of drugs and cosmetics in the country. 2. The main objective of the Act is to ensure that the drugs available to the people are safe and efficacious and the cosmetics marketed are safe for use. (1.1) Pharmaceutical Jurisprudence 1.2 Drugs and Cosmetics Act, 1940 … 3. The D and C Act regulates the manufacture and import of drugs into India so that no substandard or spurious drugs get manufactured and imported in and into India respectively. 4. This provides the regulation of sale and distribution of drugs and cosmetics whereby only qualified and trained persons can undertake their handling, compounding and distribution. 5. This Act also provides the constitution of two boards namely, the Drug Technical Advisory Board (DTAB) and Ayurvedic and Unani Drugs Technical Advisory Board to advise the Central and State governments on technical matters arising out of the administration of this act. 6. It also provides the establishment of two Drugs Consultative Committees (DCC), one for allopathic and the other for Ayurvedic, Siddha, Unani drugs to advise the various Governments and Boards on matters tending to secure uniformity throughout the country in the administration of the act. 1.3 DEFINITIONS Drug: (i) All medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes. (ii) Such substances (other than food) intend to affect the structure or any function of the human body or intended to be used for the destruction of vermin or insects which cause disease in human beings or animals. (iii) All substances intended for use as components of a drug including empty gelatin capsules; and (iv) Such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals. Ayurvedic, Siddha or Unani Drug: It includes all medicines intended for internal or external use of human beings or animals for diagnosis, treatment, mitigation or prevention of disease or disorder in accordance with the formulae described in the authoritative books of Ayurvedic, Siddha and Unani Tibb system of medicine, specified in first schedule. Misbranded Drugs: A drug shall be deemed to be misbranded: (i) If it is so colored, coated, powdered or polished that damage is concealed or if it is made to appear of better or greater therapeutic value than it really is; or (ii) If it is not labelled in the prescribed manner; or Pharmaceutical Jurisprudence 1.3 Drugs and Cosmetics Act, 1940 … (iii) If its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular. Adulterated Drugs: A drug shall be deemed to be adulterated: (i) If it consists, in whole or in part, of any filthy, putrid or decomposed substance; or (ii) If it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filthy or whereby it may have been rendered injurious to health; or (iii) If its container is composed in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (iv) If it bears or contains, for purposes of coloring only, a colour other than one which is prescribed; or (v) If it contains any harmful or toxic substance which may render it injurious to health; or (vi) If any substance has been mixed therewith so as to reduce its quality or strength. Spurious Drugs: A drug shall be deemed to be spurious: (i) If it is manufactured under a name which belongs to another drug; or (ii) If it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly or conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or (iii) If the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or (iv) If it has been substituted wholly or in part by another drug or substance., or (v) If it purports to be the product of a manufacturer of whom it is not truly a product. Drug Inspector: A Drug Inspector appointed by the Central Government or a State Government who is an expert and qualified to monitor the safety, utility, efficacy and quality of a drug from its manufacturing till its sale at the retail shop. Cosmetic: Any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic. Pharmaceutical Jurisprudence 1.4 Drugs and Cosmetics Act, 1940 … Misbranded Cosmetics: A cosmetic shall be deemed to be misbranded: (i) If it contains a colour which is not prescribed; or (ii) If it is not labelled in the prescribed manner; or (iii) If the label or container or anything accompanying the cosmetic bears any statement which is false or misleading in any particular. Spurious Cosmetics: A cosmetic shall be deemed to be spurious: (i) If it is imported under a name which belongs to another cosmetic; or (ii) If it is an imitation of, or is a substitute for, another cosmetic or resembles another cosmetic in a manner likely to deceive or bears upon it or upon its label or container the name of another cosmetic, unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other cosmetic; or (iii) If the label or container bears the name of an individual or a company purporting to be the manufacturer of the cosmetic which individual or company is fictitious or does not exist; or (iv) If it is an imitation of, or is a substitute for, another drug or re-not truly a product. Drug Store: Licensed premises for the sale of drugs, a retail store which do not require the services of a qualified person and sells both prescription and non-prescription drugs. Pharmacy: Licensed premises for the sale of drugs, which require the services of a qualified person but where the drugs are not compounded against prescriptions. Qualified Person: (i) He is a person holding diploma or degree in Pharmacy or Pharmaceutical Chemistry; or (ii) Is a registered pharmacist, (under Pharmacy Act, 1948); or (iii) Has minimum 4 years experience of dispensing and has been approved by licensing authority as a ‘Qualified Person’ on or before 31st Dec 1969. Government Analyst: A Government Analyst appointed by the Central Government or a State Government who shall analyse or test or cause to be analysed or tested such samples of drugs as may be sent to him by Inspectors or any other persons or authority authorised by the Central Government or a State Government and shall furnish reports of the results of test or analysis in accordance with these rules. Further, shall from time to time forward to the Government reports giving the results of analytical work and research with a view to their publication at the discretion of the Government. Pharmaceutical Jurisprudence 1.5 Drugs and Cosmetics Act, 1940 … Manufacture: In relation to any drug or cosmetic includes any process or part of a process for making, altering, ornamenting, finishing, packing, labeling, breaking up or otherwise treating or adopting any drug or cosmetic with a view to its sale or distribution but does not include the compounding or dispensing of any drug, or the packing of any drug or cosmetic, in the ordinary course of retail business. Import: Means to bring into India. Patent or Proprietary Medicine: In relation to Ayurvedic, Siddha or Unani Tibb systems of medicine all formulations containing only such ingredients mentioned in the formulae described in the authoritative books of Ayurveda, Siddha of Unani Tibb systems of medicine specified in the First Schedule, but does not include a medicine which is administered by parenteral route and also a formulation included in the authoritative books. In relation to any other systems of medicine, a drug for internal or external administration of human beings or animals and which is not included in the edition of the Indian Pharmacopoeia or any other Pharmacopoeia or official books. Homeopathic Medicines: It includes any drug and whose therapeutic efficacy has been established through long clinical experience as recorded in authoritative Homeopathic literature, prepared according to the techniques of Homeopathic pharmacy. It does not include medicines, administered by parenteral route. 1.4 SCHEDULES TO THE ACT AND RULES 1.4.1 Schedules to the Act First Schedule: Names of books under Ayurvedic and Siddha systems. Second Schedule: Standard to be compiled with by imported drugs and by drugs manufactured for sale, stocked, or exhibited for sale or distributed. 1.4.2 Schedules to the Rules Sr. Schedules Significance No. 1. A Forms and formats of letters for applications of licensing etc. 2. B Fee structure for drug analysis by CDL (Central Drug Laboratory) or by the Govt. Analyst. 3. C Biological and special products for parenteral administration. Examples: Antibiotics, Vitamins, Bacteriophages, Surgical dressings and Opthalmic preparations whose import, manufacture, sale and distribution are governed by special provisions. Pharmaceutical Jurisprudence 1.6 Drugs and Cosmetics Act, 1940 … Sr. Schedules Significance No. 4. C1 Other special products for non-parenteral administration. Examples: Digitalis drugs, Ergot drugs, Adrenaline, Fish liver oil, Hormonal preparations whose import, manufacture, sale and distribution are governed by special provisions. 5. D Drugs exempted from the provision of import of drugs. 6. E1 Poisonous substances under Ayurvedic, Siddha and Unani system of medicines. 7. F & F1 Special provisions applicable for the production, testing, storage, packing and labelling of biological and other special products. 8. F2 Standards of surgical dressings. 9. F3 Standards of sterilized umbilical tapes. 10. FF Standards for ophthalmic preparations. 11. G Various drugs/ substances to be used under the medical supervision. 12. H Various drugs to be sold on the prescription of an RMP (Registered Medical Practitioner). 13. J Various ailments (diseases) that cannot be treated by any drug currently in market. 14. K Various substances and drugs exempted from provisions related to manufacture of drugs. 15. M Regulations for manufacturing, premises, waste disposal, requirements of plant and equipments (Good Manufacturing Practices). 16. M1 Requirements for factory premises, etc. for the manufacture of Homeopathic drugs. 17. M2 Requirements for factory premises for the manufacture of cosmetics. 18. M3 Requirements for factory premises for the manufacture of medical devices. 19. N Regulations and minimum requirements to run a pharmacy. 20. O Regulations and requirements for disinfectant fluids. 21. P Regulations regarding life period and storage of various drugs. 22. P1 Regulations regarding retail package size of various drugs. 23. Q List of permitted dyes and coal tar colours in cosmetics. Pharmaceutical Jurisprudence 1.7 Drugs and Cosmetics Act, 1940 … Sr. Schedules Significance No. 24. R Standards for condoms and other mechanical contraceptives. 25. R1 Standards for medical devices. 25. S Various cosmetics and toiletries, and directs the manufacturers of cosmetics to confirm to the latest BSI (Bureau of Indian Standards) requirements. 26. T Regulations and requirements for factory premises and manufacture of Ayurvedic, Siddha and Unani products. 27. U Maintenance of manufacturing and analytical records of drugs. 28. U1 Maintenance of manufacturing and analytical records of cosmetics. 29. V Standards for patent and proprietary medicines. 30. W List of drugs which can be marketed under generic names only. 31. X List of drugs which are habit forming, psychotropic and other drugs likely to be misused for addictive purposes. 32. Y Requirement and guidelines for clinical trials. 1.5 IMPORT OF DRUGS Prohibition of Import of Certain Drugs or Cosmetics: Following Drugs and cosmetics cannot be imported: 1. Any drug or cosmetic which is not of standard quality; 2. Any misbranded or spurious or adulterated drug or cosmetics; 3. Any drug or cosmetic without import license, for the import, for which an import license is prescribed. 4. Any patent or proprietary medicine, which has not displayed the true formula or list of active ingredients with their quantities as per the label. 5. Any drug which claims to cure or prevent any disease or ailments specified in Schedule J. 6. Any cosmetic or drug containing any ingredient, which is unsafe or harmful. 7. Any drug or cosmetic whose manufacture, sale, distribution and import of which is prohibited by rule made under this act, except for the purpose of examination, test or analysis. 8. Drugs not labelled in the prescribed manner. 9. Drugs after the expiry, and those which does not meet the standards, quality and purity specified in the schedule-F. Pharmaceutical Jurisprudence 1.8 Drugs and Cosmetics Act, 1940 … Import of Drugs under License: The following classes of drugs can be imported under the license or permit granted by the licensing authority: 1. Drugs specified in schedule C and C1 excluding those specified in schedule X. 2. Drugs specified in schedule X. 3. Minor quantities of drugs imported for the examination, test or analysis. 4. Drugs for personal use covered by a prescription of RMP. 5. Any new drug. 6. An application for an import License shall be made to the licensing authority by the manufacturer or by the manufacturer’s agent in India and shall be accompanied by a License fee of ` 1,000 for a single drug and ` 1,000 for each additional drug, duly signed by or on behalf of the manufacturer. Sr. Type of Import License Form Number No. Application License 1. Drugs other than Schedule X 8 10 drugs 2. Schedule X drugs 8-A 10-A 7. Any application for import license in Form 8 or 8-A, shall be accompanied by a copy of Registration Certificate issued in Form 41; in the case of emergencies, the issue of Import License by the central government in Form 10 or 10-A without issuance of Registration Certificate under Rule 27-A, for reasons to be recorded in writing. 8. The License remains valid upto 31st Dec of the year following the year in which its granted unless cancelled or suspended earlier. 9. The importer should have proper storage facilities for preserving imported drugs and properties. 10. A fee of ` 250 shall be paid for a duplicate copy of license, if the original is defaced, damaged or lost. Registration Certificate: ‘Registartion certificate’ means, certificate issued under Rule 27-A, by the licensing authority in Form-41, for the registration of premises and drugs manufactured by the manufacturer for import into and use in India. 1. A fee of ` 1,000 and US $ 500 dollars shall be paid through a Challan along with the application in Form 40 as registration fee for his premises meant for manufacturing of drugs intended for import and use in India. 2. A fee of US $ 300 dollars shall be paid for a duplicate copy of the Registration Certificate, if the original is defaced, damaged. Pharmaceutical Jurisprudence 1.9 Drugs and Cosmetics Act, 1940 … Suspension and Cancellation: Both the Import License and Registration Certificate will be suspended or cancelled, if the manufacturer or licensee fails to comply with any of the conditions. The licensing authority may after giving the manufacturer or licensee, an opportunity to show cause why such an order should not be passed, by an order in writing the reasons and further take measures for the same. The reasons for the cancellation may be: 1. The drugs in the schedule C and C1 are prohibited for import into the country after the expiry of potency of the drug product. 2. If the drug is banned in the country of origin then it is prohibited from importing into the country except for the purpose of examination, test or analysis. Conditions of Import License: An Import License is subject to the following conditions: 1. The licensee must observe at all the times the undertaking given by him or on his behalf in Form 9: 2. The licensee must allow any authorized Inspector to: (i) Enter the licensed premises where imported drugs are stored. (ii) Inspect the substances employed for testing. (iii) Take samples. 3. The licensee must furnish the adequate quantity of sample from the required batches to the licensing authority for examination along with complete protocols of the test applied. 4. If licensing authority so directs, until receipt of Certificate of Authorization, the licensee must not sell any batch products to which samples are submitted to the licensing authority. 5. The licensee must maintain the record of all sales of imported substances as prescribed under the rules, and should furnish the same during the inspection. 6. The licensee must maintain separate records for the sale or distribution of Schedule- X drugs. 7. Licensee must also comply with such further requirements, prescribed by the authority and of which he has been given not less then four months of notice. Import of New Drugs: 1. A written permission of the licensing authority is required for the import of new drugs. 2. For obtaining permission, all documentary and other evidence related to the standards of quality, purity and strength etc. should be supplied to the licensing authority. Pharmaceutical Jurisprudence 1.10 Drugs and Cosmetics Act, 1940 … 3. An application for an import License for small quantities of a new drug, as defined in rule 122-E for the purpose of treatment of patient. 4. Every application in Form 12-AA shall be accompanied by a fee of one hundred rupees for a single drug and an additional fee of fifty rupees for each additional drug. 5. The fees shall be paid through a challan in the Bank of Baroda. 6. A License for import of small quantities of a new drug, defined in rule 122-E, for the purpose may be cancelled by the licensing authority for the conditions subject to which the License was issued. If so, the licensee may appeal to the Central Government within three months of the date of the order of cancellation. Import of Drugs for Examination, Test or Analysis: 1. The drug is imported under a license in Form-11. 2. The drug must be exclusively examined in the place specified in the license by the licensing authority. 3. An authorized inspector must be allowed to investigate the manner in which imported substances are used; thereof allowed to take the samples. 4. The record of the imported substances along with their quantities, the date of importation and the name of manufacturer should be maintained and reported to the authority. 5. The licensee must comply with any further requirements as may be specified by the authority, and of which the licensing authority has given, to him not less than notice of a month. 6. In case if the license is cancelled, the licensee may appeal to the Central Government within three months of the date of the order of cancellation. Import of Drugs or Cosmetics for Personal use: Import of drugs which are otherwise prohibited under section 10 of the act can be imported on following conditions: 1. Drugs or cosmetics must be a part of a passenger’s bonafide baggage and must be intended for the exclusive personal use of the passenger. 2. They must be declared to the custom collector, if so directed. 3. The quantity of any single drug so imported must not exceed hundred average doses. 4. Any drug or cosmetic not forming the part of passenger’s baggage, may be allowed to import to an application made to the licensing authority in form 12-A. 5. If the licensing authority is satisfied, a permit is granted in Form 12-B. Pharmaceutical Jurisprudence 1.11 Drugs and Cosmetics Act, 1940 … *Note: Places through which Drugs may be imported into India: 1. Ferozpur Cantonment and Amritsar Railway Stations: by rail (across the frontier with Pakistan). 2. Ranaghat, Bangaon and Mohiassan Railway Stations: by rail (across the frontier with Bangladesh). 3. Chennai, Calcutta, Mumbai and Cochin: by sea 4. Chennai, Calcutta, Mumbai, Delhi and Ahmedabad: by air Offences and Penalties Relating to Import of Drugs: Sr. Offence Penalties No. First conviction Subsequent conviction 1. Import of adulterated or spurious Imprisonment upto 3 Imprisonment upto drugs or cosmetics or any years and fine upto 5 years or fine upto cosmetic containing any ` 5000. ` 10,000 or both. ingredient which may render it unsafe or harmful for the use under directions recommended. 2. Import of drugs or cosmetics Imprisonment upto 06 Imprisonment upto other than referred above the months or fine upto 1 year or fine upto import of which is prohibited. ` 500 or both. ` 1000 or both. 3. Import of drugs or cosmetics in Imprisonment upto 3 contravention of any notification years or fine upto issued under section 10-A. ` 5000 or both. 1.6 MANUFACTURE OF DRUGS 1.6.1 Prohibition of Manufacture and Sale of Certain Drugs The following drugs are prohibited to manufacture for sale under section 18 of the act: 1. Any drug or cosmetic which is not of a standard quality or is misbranded, adulterated or spurious; 2. Any patent or proprietary medicine, whose formula with the quantities, is not disclosed on the lable or container; 3. Any drug which purports or claims to prevent, cure or mitigate any such disease specified in schedule J; 4. Any cosmetic containing any ingredient which may render it unsafe or harmful for use; 5. Any drug or cosmetic in contravention of this act or rules made thereunder; Pharmaceutical Jurisprudence 1.12 Drugs and Cosmetics Act, 1940 … 1.6.2 Conditions for Grant of License The license is granted, if applicant complies with the following conditions: 1. The manufacture must be conducted under active direction and personal supervision of competent technical staff (approved manufacturing chemist), as per the rules. 2. The licensee and factory premises should comply with the conditions and requirements prescribed under Schedule M respectively. 3. The applicant must provide for various operations, adequate space, plant and equipment, as per Schedule M. 4. The applicant must provide separate testing unit or quality control section with an, independent head, with adequate facilities, for the test and standardization of drugs and raw materials. 5. The applicant should make adequate arrangements for the storage of drugs, manufactured. 6. For patent and proprietary medicines, the applicant must furnish the documents and data related to claims, safety, stability, therapeutic justifications etc., as per the rules. After completion of inspection, Drug Inspector forwards detailed report and his recommendations to the Central Licensing Authority. 1. On receipt of application in the prescribed form along with fees for grant or renewal of license by the applicant, the authority verifies the statement, post performance of the licensee and the above requirements. Thereafter, the Licensing authority on necessary enquiries and satisfaction, grants the license to the applicant in the prescribed form. 2. If Licensing authority is of the opinion that applicant is incapable to fulfill the requirements, it may refuse to grant or renew the license. 1.6.3 Types of Licenses for Manufacture of Drugs Sr. Classes of Drugs Form of Form of No. Application License 1. Other than Schedule C, C1 and X 24 25 2. Schedule X 24-F 25-F 3. Schedule C and C1 27 28 4. Schedule C, C1 and X 27-B 28-B 5. Loan License (other than Schedule C, C1 and X) 24-A 25-A 6. Loan License (only Schedule C, C1) 27-A 28-A 7. Repacking License (other than Schedule C, C1 and X) 24-B 25-B 8. Large volume parenterals, sera and vaccines 27-D 28-D Pharmaceutical Jurisprudence 1.13 Drugs and Cosmetics Act, 1940 … 1.6.4 Conditions of License for Manufacture of Drugs Manufacture of Schedule C, C1 and X Drugs: Following are the general conditions of license of schedule C, C1 and X drugs in Form 28-B and 28-D; other than schedule C and C1 drugs in Form 25; Schedule X drugs- Form 25-F. Sr. Licensee must No. 1. provide and maintain staff, premises and equipments (as per Schedule M and Schedule M3 for medical devices). 2. test raw materials and final products of each batch either in the laboratory approved by the licensing authority. 3. maintain records of manufacture and testing of each batch as per schedule U. 4. allow Drug Inspector to enter and inspect, premises, plant, process of manufacture, means of standardization and tests. 5. allow Drug Inspector to inspect all the registers and records maintained under the rules and to take samples of manufactured drugs. 6. provide the required information to Drug Inspector for ascertaining compliance for provisions of Act and Rules. 7. time to time report to the licensing authority: (i) Changes in expert staff responsible for manufacture or testing. (ii) Material alterations in premises or plant. (iii) samples of desired drugs and complete protocols of tests applied. 8. not sell any batch, sample of which is submitted to the licensing authority, until receipt of Certificate of authorization is issued. 9. withdraw from sale remainder of any batch or recall drugs already issued, if licensing authority directs to do so. 10. not sell any drug manufactured under the license unless due precautions, necessary for preserving its properties, are taken throughout the period after manufacturing, also must maintain such quantities of reference samples. 11. comply with the provisions of Drugs and Cosmetics Act, 1940, rules thereunder and such further requirements time to time published in Official Gazette. 12. maintain an “Inspection Book” in Form 35, to record impressions and defects noticed by Drug Inspectors. 13. comply with requirements of “Good Manufacturing Practices” as per schedule M. Pharmaceutical Jurisprudence 1.14 Drugs and Cosmetics Act, 1940 … 14. The licensee having license to manufacture schedule C, C1 and X drugs in Form 28-B must, (i) forward to the licensing authority every 3 months, a statement of sale to the manufacturers, wholesalers, retailers, hospitals, dispensaries, nursing homes, and registered medical practitioners. (ii) maintain as prescribed under rules, accounts of all transactions as regard to use, stock, manufacture, storage and sale of schedule X drugs. (iii) store always schedule X bulk drugs separately under custody of a responsible person. Manufacture of Drugs for Test, Examination and Analysis: A license is required to manufacture any drug in small quantity for the purpose of examination, test or analysis purpose. 1. If a person proposing to manufacture does not hold a license to manufacture drugs specified in Schedule C and C1 or other than Schedule C, C1 and X, shall obtain a license Form 29 before manufacturing such drugs. 2. The licensee shall carry the manufacture and examination of drugs at the place specified in the license. 3. In case of drugs which are unsafe for use, a license in Form 29 can be granted only on producing NOC (no objection certificate) from the licensing authority. 4. Application must be countersigned by the Head of the Institution, which proposes to undertake the manufacture. 5. License remains valid for a period of 1 year, unless cancelled or suspended. 6. Any drug for the purpose of examination, shall be placed in the containers, labelled for the purpose of manufacturing it, name and address of the manufacturer. Thereafter supplied to the any other manufacturer, when necessary. 7. The licensee shall allow Inspector to inspect the premises and satisfy himself that only examination is conducted. 8. The licensee shall keep a record the quantity of drugs supplied for analysis also mainatain ‘Inspection Book’. 9. The licensee shall comply with such requirements specified and of which the authority has given him not less than 1 month’s notice. Manufacture of New Drugs: As per the Rule 122 E of the Drug and Cosmetic Rules 1945, a New Drug can be: 1. A new substance of chemical, biological or biotechnological origin; in bulk or prepared dosage form; used for prevention, diagnosis, or treatment of disease in man or animal, which except during local clinical trials has not been used in the Pharmaceutical Jurisprudence 1.15 Drugs and Cosmetics Act, 1940 … country; and which, except during local clinical trials, has not been recognised in the country as effective and safe. 2. A drug already approved by the licensing authority for the proposed claims, which is now proposed to be marketed with modified or new claims; or A fixed dose combination of two or more drugs, individually approved earlier for certain claims, which are now proposed to be combined for the first time in a fixed ratio; or If the ratio of ingredients in an already marketed combination is proposed to be changed, with certain claims, like: (i) Indications. (ii) Dosage form (including sustained release dosage form). (iii) Route of Administration. 3. All vaccines shall be new drugs unless certified otherwise by the Licensing Authority. 4. A new drug shall continue to be considered as new drug for a period of four years from the date of its first approval or its inclusion in the Indian Pharmacopoeia, whichever is earlier. Conditions of License: 1. No ‘new drug’ can be manufactured, prior to the approval from the licensing authority. 2. The applicant, shall submit data as given in Appendix-1 to Schedule Y, including the results of clinical trials as per the format of Appendix-2 to Schedule Y. 3. While applying for the license, applicant shall furnish the evidence certificate that the drug has already been approved. Note: What is a Subsequent New Drug Application? A Subsequent New Drug application is an application for approval of an already approved new drug by the Central Drugs Standard Control Organization (CDSCO). It can be made for the following cases: 1. Bulk Drug already approved in the country (approved within 4 years). 2. New drug (Formulation) already approved in the country. 3. A drug already approved and proposed to be marketed with new indication. 4. A drug already approved and proposed to be marketed as a ‘New Dosage Form / New Route of Administration’. 5. A drug already approved and proposed to be marketed as a ‘Modified release dosage form’. 6. A drug already approved and proposed to be marketed with Additional Strength. Pharmaceutical Jurisprudence 1.16 Drugs and Cosmetics Act, 1940 … All the applications for approval of New Drug, Fixed Dose Combination and Subsequent New Drug are made under Form 44 (Application for grant of permission to import or manufacture a New Drug or to undertake clinical trial). 1.7 LOAN LICENSE It is issued by the licensing authority, to a person who does not own, arrangements for manufacture but intends to avail the manufacturing facilities owned by another licensee. 1. In the case of pharmacy business is operating its business in more than two states then it is required to obtain a drug license in each state where the business is carried on. A separate license shall be issued in case drugs are sold at more than one place. 2. After the license is granted to the business, the licensee must ensure that all the conditions of the drug license must be complied with during business. In the case of any changes or modification in business activity authority must be informed and all the registers, records, and forms must be maintained in a specified manner. Sr. Classes of Drugs Form of Form of No. Application License 1. Loan License (other than Schedule C, C1 and X) 24-A 25-A 2. Loan License (only Schedule C, C1) 27-A 28-A 3. Repacking License (other than Schedule C, C1 and X) 24-B 25-B 3. The licensing authority shall, before the grant of a loan licence, satisfy himself that the manufacturing unit has adequate equipment, staff, capacity for manufacture, and facilities for testing, to undertake the manufacture on behalf of the applicant for a loan licence. 4. Application for manufacture of more than ten items for each category of drug on a loan licence shall be accompanied by an additional fee of rupees three hundred per additional item specified in Schedule M and Schedule M3. 5. The licensee shall allow Inspector to inspect the premises and satisfy himself that only examination is conducted. 6. The licensee shall mainatain ‘Inspection Book’ in Form 35. 7. The licensee shall comply with further requirements specified by the authority. 8. The licensee shall test each batch of raw materials used and each batch of the final product and also maintain the records of manufacture and testing of each batch as per schedule U. 9. Shall maintain the reference samples from each batch for the period of 3 years. 10. Report to the licensing authority, regarding the changes in expert staff or change in the manufacture or testing units. Pharmaceutical Jurisprudence 1.17 Drugs and Cosmetics Act, 1940 … 11. For Schedule C and C1 drugs, the licensee shall furnish the data of stability and date of expiry to the licensing authority. 12. If the licensing authority is satisfied that a loan licence is defaced damaged or lost or otherwise rendered useless, he may, on payment of a fee of rupees one thousand, issue a duplicate licence. 1.8 REPACKING LICENSE 1. It is granted for the purpose of breaking up any drug than those specified in Schedule C and C1. Sr. Classes of Drugs Form of Form of No. Application License 1. Repacking License (other than Schedule C, C1 and X) 24-B 25-B 1. Repacking of drugs should be conducted under hygienic conditions under personal supervision of competent person, approved by the licensing authority. 2. The licensee must provide and maintain adequate arrangements for carrying out tests of drugs repacked, in the specified place by the authority. 3. The licensee shall allow Inspector to inspect the premises and to take samples of repacked drugs. 4. The licensee shall test each batch of raw materials used and each batch of the final product and also maintain the records of manufacture and testing of each batch as per schedule U. Records must be retained for 5 years from the date of repacking. 5. Licensee must allow the Inspector to inspect all the registers and records maintained. 6. The licensee shall mainatain ‘Inspection Book’ in Form 35. 7. Shall maintain the reference samples from each batch of repacked drugs, for the specified period. 8. Licences remain valid for a period of 5 years from the date its granted or renewed, unless suspended or cancelled. EXERCISE 1. Define the terms ‘Misbranded’, Ádulterated’ and ‘Spurious drugs’ according to the Drugs and Cosmetics act. 2. Write a note on Loan license and Repacking license. Pharmaceutical Jurisprudence 1.18 Drugs and Cosmetics Act, 1940 … BIBLIOGRAPHY 1. Shyam Chandak, Pharmaceutical Jurisprudence, 2017, 12.1. 2. Hollister LE and Csernansky JG: Clinical Pharmacology of Psychotherapeutic Drugs. Churchill Livingstone, New York, Third Edition 1990. 3. Dr. S.P. Agarwal and Dr. Rajesh Khanna, Pharmaceutical Jurisprudence and Ethics, 2017, 37. 4. B.S Kuchekar, Pharmaceutical Jurisprudence, 2016, 5.1. 5. Binay Kumar Jha, Pharmaceutical Jurisprudence, 2014, 34. 6. Drugs and Cosmetic Act (2012) Import of Newdrughttp://www.cdsco.nic.in/forms/ShowSearchResult.aspx?Search=clinical%20tr ials 7. K. Dubey, Rajesh Kumar and Pramila Tripathi, Global promotion of herbal medicine: India’s opportunity - Current Science, 2004, 86(1) 8. N.K. Jain, A Textbook of Forensic Pharmacy, 2014, 49. ✱✱✱  UNIT II Chapter... 2 DRUGS AND COSMETICS ACT, 1940 AND ITS RULES 1945 ♦ LEARNING OBJECTIVES ♦ After completing this chapter, the reader should be able to understand: About the compilation of Drug and Cosmetic Acts 1940 and Rules 1945. Regulation of import, manufacture, sale and distribution of drugs and cosmetics. To avoid substandard drugs and to maintain high standards of drugs and cosmetics. Administration of the D and C Act and Rules. 2.1 DETAILED STUDY OF THE SCHEDULES Schedule G: Most of these drugs are hormonal preparations. The drug label must display the text. "Caution: It is dangerous to take this preparation except under medical supervision" prominently. Examples: Testolactone, Hydroxyurea, Carbutamide, Primidone, Mercaptopurine, Methsuximide, Thiotepa etc. Schedule H: The drug label must display the texts "Rx" on the left top corner of the label and "Schedule H drug. Warning : To be sold by retail on the prescription of a Registered Medical practitioner only" prominently. It can only be supplied to licensed parties. It cannot be sold without a prescription and only the amount specified in the prescription should be sold. The time and date of prescription must be noted. Examples: Androgenic, anabolic, oestrogenic and progestational substances; Alprazolam, Hepatitis B vaccine, Adrenocorticotrophic hormone, Ibuprofen, Vasopressin etc. If a Schedule H drug also comes under the purview of Narcotic Drugs and Psychotropic Substances Act, 1985, it must carry the texts "NRx" in red on the left top corner of the lable and "Schedule H drug. Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only." on the label prominently. (2.1) Pharmaceutical Jurisprudence 2.2 Drugs and Cosmetics Act, 1940 … Schedule M (GMP-GOOD MANUFACTURING PRACTICES): It is defined as “the part of quality assurance which is aimed to ensure that the product are consistently manufactured to the quality appropriate to their intended use”. It prescribes the requirements of premises, plant and equipment needed for setting up manufacturing unit. Also documents every stage of manufacture, packing, storage, transportation checking and testing of medicinal product, maintenance or keeping records. Part-1: Requirements for Premises and Materials 1. Locations and Surroundings: The factory building shall be situated and constructed to avoid contamination from open sewerage, drain, disagreeable or obnoxious odour, dust and smoke etc. 2. Buildings and Premises: A building for manufacturing unit shall permit work under hygienic conditions. It should be free from any insects/rodents. Light and ventilation facility should be adequate. Walls and floor should be free from cracks and damp. Premises should also be confirmed with provisions of factory act. It shall be located so as to be: (i) Building should be compatible of other manufacturing operations carried out in same premises. (ii) Space should be adequate for placement of equipment and materials to avoid mix- up/contamination risk of different drugs and components. (iii) Designed, constructed and maintained to prevent entry of insects and rodents. Interior surface (walls, floors and ceilings) shall be smooth and free from cracks and permit easy cleaning and disinfection. The walls of the room in which the manufacturing operations are carried out shall be impervious to and be capable of being kept clean. (iv) The flooring shall be smooth and even and shall be such as not to permit retention or accumulation of dust or waste products. (v) Building should have a proper drainage system. Sanitary fitting and electric fixtures shall be proper and safe. (vi) Proper fire safety measures and proper exists should be there. (vii) Drying space for raw material, in process medicines should be separate and measures should be done to prevent it from flies/insects/dust etc. 3. Water Supply: Water supply should be pure and of potable quality. Adequate provision of water for wasting the premises shall be made. 4. Disposable of Waste: (i) Disposal of sewage and effluents from the factory should be as per “Environment Pollution Control Board’’. (ii) All bio-medical wastes should be destroyed as per “Biomedical Waste management rules-1996”. (iii) Hazardous, toxic and inflammable substances should be stored in suitably designed and segregated in enclosed areas, as prescribed by Central and State legislations. Pharmaceutical Jurisprudence 2.3 Drugs and Cosmetics Act, 1940 … 5. Stores: Store should have adequate space for independently and separately store raw material, packaging material and finished products. 6. Working Space: Manufacturing area should be adequate for orderly placement of equipment, machinery and material used during manufacturing operations and quality control to facilitate easy and safe working and to minimize or eliminate any risk of mix-up between different drugs, raw materials and to prevent the cross contamination during manufacturing, storage and handling operations. 7. Sterile Products: For the manufacture of sterile products separate enclosed areas shall be provided with the air lock system for the entry and shall be essentially dust free and ventilated with an air supply for all areas where aseptic manufacturing has to be carried out. Air supply shall be filtered through bacteria proof filter (HEPA filter) and shall be at a pressure higher than in the adjacent area. The filter shall be checked for performance an installation and periodically there after, and records there of shall be maintained. The entire surface in the manufacturing area shall be designed to facilitate cleaning and dis-infections. Routine microbial counts to facilitate cleaning and dis-infections. Routine microbial counts of all sterile area shall be carried out during manufacturing operation. The resultant of each shall be checked against established house standards and record maintained. Access to manufacturing area shall be restricted to minimum number of authorized personal. Special procedure to be followed for entering and leaving the manufacturing area shall be written down and displayed. 8. Container’s Cleaning: Washing, cleaning and drying section of containers such as bottles, vials and jars should have adequate arrangement and should be separated from manufacturing operations. 9. Machinery: To carry out manufacturing process, adequate machinery and equipment require. These machinery could be manually operated or semi-automatic or fully automatic based upon your need and investment. 10. Raw-Materials: The licensee shall keep on inventory of all raw material to be used at any stage of manufacture of drugs and maintain the record as per schedule U. All such raw material be: (a) Identified and their container examined for damage and assigned control number. (b) Stored at optimum temperature and relative humidity. (c) Conspicuously labelled indicating the number of materials, control numbers, name of manufacture and be labelled 'under test' or 'approved' or 'rejected'. (d) Systematically sampled by quality control personnel. (e) Tested for compliance with required standard of quality. (f) Released from quarantine by quality control personal through written instruction. (g) The stock rotation is so organized that, it is on the basis of first come first out. (h) The all rejected material are conspicuously identified and are destroyed or returned to the supplier as soon as possible and record maintained there of. Pharmaceutical Jurisprudence 2.4 Drugs and Cosmetics Act, 1940 … 11. Equipment: Equipment used for the manufacturing of drugs shall be constructed designed, installed and maintained to (i) Achieve operational efficiency to attain desired quality. (ii) Prevent physical, chemical and physico-chemical change through surface contact. (iii) Prevent contact of any substance required for operation of the equipment like lubricant etc. (iv) Facilitate through cleaning wherever necessary. (v) Minimize any contamination of drug and their container during manufacture. (vi) Equipment used for critical steps in progress shall be maintained by device capable of recording the parameter or with drawn systems to indicate malfunction. These devices shall be calibrated and tested and recorded there of shall be maintained. 12. Batch Manufacturing Record: Each batch record should be maintained irrespective of product manufactured (classical preparations or patent or proprietary medicines). (i) Manufacturing records are required to provide an account of the list of raw materials and their quantities obtained from the store, tests conducted during the various stages of manufacture like taste, colour, physical characteristics and chemical tests as may be necessary or indicated in the Drugs and Cosmetics Act. (ii) These tests may include any in-house or pharmacopoeial test adopted by the manufacturer in the raw material or in the process material and in the finished product. (iii) Manufacturing Batch record should be signed by production chemist and analytical chemist. Stock should be transferred to finished goods store along with record of testing with date and quantity of drug. (iv) Only after the manufactured drugs have been verified and accepted quality shall be allowed to be cleared for sale. (v) It should be essential to maintain the record of date, manpower, machine and equipments used. Master Formula Records: The licensee shall maintain MFR relating to all manufacturing procedure for each product which will be prepared and endorsed by the competent technical staff that is head of production and quality control. The master formula record should have: (a) The patent or propriatory name of the product along with generic name, if any, strength and the dosage form. (b) A description of identification of the final container packing material label and closer to be used. Pharmaceutical Jurisprudence 2.5 Drugs and Cosmetics Act, 1940 … (c) The identity and quality of the raw material to be used irrespective of whether or not it appear in the finished product, the permissible averages that may be included in formulation batch, should be indicated. (d) Description of all vessel and equipment and the size used in the progresses. (e) Manufacturing and control instruction along with parameter for critical steps such as mixing, drying, blending, sieving and sterilizing the product etc. (f) The theoretical yield to be expected from the formulation at different stage of manufacture and permissible yield limit. (g) Detail instruction on precaution to be taken in manufacture and storage of drug and of semi-finished product. The requirement of in processes quality control test and analysis to be carried out during each step of manufacture including designation of person or department responsible for execution of such test and analysis. 13. Health Clothing, Sanitation and Hygiene of Workers: (i) All workers should be healthy and should be free from any contagious diseases. (ii) Proper uniform should be provided to workers according to nature of work and the climates. (iii) A uniform may include cloth or synthetic covering for hands, feet and head wherever required. (iv) Adequate facilities for personnel use should be provided like clean towel, soap etc. Lavatories for men and women should be separate and should be away from processing and manufacturing area. (v) Changing room facility should also be provided for changing their clothes and to keep their personal belongings. 14. Medical Services: Adequate facility for first aids should be provided by manufacturer. Medical examination of workers at the time of employment and periodical check-up should be conducted at least once in a year and proper record should be maintained. 15. Distribution Record: Distribution record (Dispatch register) should be maintained to facilitate process of prompt and complete recall of the batch. Distribution record should be maintained till expiry of batch. 16. Record of Market Complaints: A complain register should maintain to record all reports of market complaints received regarding the products sold in the market. The manufacturer shall enter all data received on such market complaints, investigations carried out by the manufacturers regarding the complaint as well as any corrective action initiated to prevent recurrence of such market complaints shall also be recorded. Once in a period of six months the manufacturer shall submit the record of such complaints to the licensing Pharmaceutical Jurisprudence 2.6 Drugs and Cosmetics Act, 1940 … authority. The Register shall also be available for inspection during any inspection of the premises. Reports of any adverse reaction resulting from the use of drugs shall also be maintained in a separate register by each manufacturer. The manufacturer shall investigate any of the adverse reaction to find if the same is due to any defect in the product, and whether such reactions are already reported in the literature or it is a new observation. 17. Quality Control: A manufacturer can set-up own quality control section or testing could be done through government approved testing laboratory. Part-2: Requirements for Plant and Equipments 1. Area: (i) Basic installation - Requires minimum of 30 sq. mt. (for tablets manufacturing, upto 60 sq. mt.) (ii) Ancillary area: 10 sq. mt. (for tablets manufacturing, upto 20 sq. mt.) 2. Equipment: Colloidal mill, mixing and storage tanks, stainless steel containers, Planetary mixer, Triple roller, tube filling equipments, filter proof cap sealing machine, water distillation unit, clarity testing inspection unit, disintegrator and sifter, granulator, tray or fluidized bed driers, weighing machine, tablet compression machine (single-multi-rotary punch), tablet inspection unit, dissolution test apparatus, hardness tester, friability tester, disintegration test apparatus, air conditioners, polishing pan, jacketed kettle, leakage test apparatus, capsule filling unit, hot air ovens, Laminar air flow unit, bottle washing machines, autoclave, transfer pumps, trimming machine, cutting machine etc. Parts of Schedule M Part 1: Describes Good Manufacturing Practices For Premises and Material. Part 1A: Describes the specific requirement for manufacture of sterile products. Parenteral preparations (Small Volume Injections and Large Volume Parentrals) and Sterile Ophthalmic Preparations. Part 1B: Describes the specific requirements for manufacture of oral solid forms (Capsule and Tablets) Part 1C: Describes the specific requirements for manufacture of oral liquids (syrups, elixirs, emulsions and suspensions). Part 1D: Describes the specific requirements for manufacture of topical products i.e. External Preparations (Cream, Ointments, Pastes, Emulsions, Lotions, Solutions, Dusting Powders and Identical Products) Part 1E: Describes the specific requirements for manufacture of Metered Dose Inhalers (MDI). The other associated codes such as those of Good laboratory practice (GLP) and Good clinical practice (GCP). Pharmaceutical Jurisprudence 2.7 Drugs and Cosmetics Act, 1940 … Schedule N: Describes the facilities and equipments for efficient running of a Pharmacy. 1. Entrance: Front of a pharmacy shall bear an inscription “Pharmacy” in front. 2. Premises: (i) Separated from rooms, well built, dry, well lit and ventilated with sufficient dimensions for stock of medicaments. (ii) Poisons to be kept in a clearly visible and appropriate manner. (iii) Dispensing department shall be not less than 6 sq. m. for one pharmacist working therein with additional 2 sq. m. for each additional pharmacist. (iv) Height of the premises shall be at least 2.5 metres. (v) Floor of the pharmacy shall be smooth and washable. (vi) Walls shall be plastered or tiled or oil painted so as to maintain smooth, durable and washable surface devoid of holes, cracks and crevices. (vii) A pharmacy shall be provided with ample supply of good quality water. (viii) The dispensing department shall be separated by a barrier to prevent the admission of the public. 3. Furniture and Apparatus: (i) A pharmacy shall contain furniture and apparatus, drawers, containers, glasses of suitable sizes and designed to prevent dust entry. (ii) Every container shall bear a labels, easily readable with names of medicaments as given in the Pharmacopoeias. (iii) Shall be provided with a dispensing bench, washable top etc. (iv) Separate cupboards with lock and key for Poisons, and shall be marked in red letters as ‘’POISON’’ on a white background. (v) All concentrated solutions shall be labelled as ‘’To be diluted’’. (vi) Pharmacy shall bear all the prescribed apparatus and books for official preparations and prescriptions. (a) Balance (b) Beakers, bottles, funnels (c) Filter and litmus papers (d) Mortar and pestle, other glasswares (e) Spatula, scissors, stands (f) Spirit lamp, thermometer (g) Water bath, distillation apparatus (h) Watch glasses, pill machines, suppository mould etc. Pharmaceutical Jurisprudence 2.8 Drugs and Cosmetics Act, 1940 … (i) Books: The Pharmacopoeia (current edition), National Formulary of India, The Drugs and Cosmetic Act 1940 and rules 1945, The Pharmacy Act, Narcotic and Psychotropic substances Act, 1985 etc. 4. General provisions: Pharamcist shall always wear a clean white overalls, records and registers shall be maintained as per the law, medicaments must bear labels when supplied as per the law. Schedule P: Schedule P describes the life period of drugs in months (unless otherwise specified) between date of manufacture and date of expiry which the labelled potency period of the drug shall not exceed under the conditions of storage specified. Sr. Drug Life period in Storage conditions No. months 1. Ampicillin 36 Cool place 2. Bacitracin 18 Cool place 3. Carbanicillin sodium injection 24 At temp. not exceeding 5°C. 4. Colistin sulphate 60 Protected from light 5. Erythromycin stearate 36 Cool place Note: Cool place means, a temperature of 10-25°c Schedule P1: Pack sizes of drugs Sr. Drug Dosage form Pack size No. 1. Albendazole Suspension 10 ml 2. Atenolol Tablets 14 3. Piperazine Granules 5 gm Schedule T: Contains various regulations and requirements for manufacture of Ayurvedic, Siddha and Unani products. Part 1: Describes the Good Manufacturing Practice of Ayurvedic, Sidha and Unani Medicines. A Manufacturing Premises should have adequate space for all daily activity like: 1. Receiving and Storage of Herbs, Packaging material and other raw material. 2. Production and Manufacturing Activity Area. 3. Quality Control Section. 4. Finished Goods Store. 5. Office and Administration. Pharmaceutical Jurisprudence 2.9 Drugs and Cosmetics Act, 1940 … 6. Rejected Products/Drugs Store. 7. Minimum area required for setting up Ayurveda, Sidha and Unani Medicine manufacturing unit is 1200 sq. ft. covered with separate cabins and partitions for each activity. If unani medicines/ayurvedic medicines are manufactured along with ayurvedic medicines/unani medicines additional 400 sq. ft. area is required. General Requirements: 1. Location and Surroundings: The factory building shall be situated and constructed to avoid contamination from open sewerage, drain, disagreeable or obnoxious odour, dust and smoke etc. 2. Buildings: A building for manufacturing unit shall permit work under hygienic conditions. It should be free from any insects/rodents. Light and ventilation facility should be adequate. Walls and floor should be free from cracks and damp. Premises should also be conformed with provisions of factory act. It shall be located so as to be: (i) Building should be compatible of other manufacturing operations carried out in same premises. (ii) Space should be adequate for placement of equipment and materials to avoid mix-up/contamination risk of different drugs and components. (iii) Designed, constructed and maintained to prevent entry of insects and rodents. Interior surface (walls, floors and ceilings) shall be smooth and free from cracks and permit easy cleaning and disinfection. The walls of the room in which the manufacturing operations are carried out shall be impervious to and be capable of being kept clean. (iv) The flooring shall be smooth and even and shall be such as not to permit retention or accumulation of dust or waste products. (v) Building should have a proper drainage system. Sanitary fitting and electric fixtures shall be proper and safe. (vi) Burner/Bhatti section could be covered with tin roof and proper ventilation, but care should be done to prevent flies and dust. (vii) Proper fire safety measures and proper exists should be there. (viii) Drying space for raw material, in process medicines should be separate and measures should be done to prevent it from flies/insects/dust etc. 3. Water Supply: Water supply should be pure and of potable quality. Adequate provision of water for wasting the premises shall be made. 4. Disposable of Waste: Proper waste management care should be done. 5. Container’s Cleaning: Washing, cleaning and drying section of containers such as bottles, vials and jars should have adequate arrangement and should be separated from manufacturing operations. Pharmaceutical Jurisprudence 2.10 Drugs and Cosmetics Act, 1940 … 6. Stores: Store should have adequate space for independently and separately store raw material, packaging material and finished products. 7. Working Space: Manufacturing area should be adequate for orderly placement of equipment, machinery and material used during manufacturing operations and quality control to facilitate easy and safe working and to minimize or eliminate any risk of mix-up between different drugs, raw materials and to prevent the cross-contamination during manufacturing, storage and handling operations. 8. Health Clothing, Sanitation and Hygiene of Workers: (i) All workers should be healthy and should be free from any contagious diseases. (ii) Proper uniform should be provided to workers according to nature of work and the climates. (iii) A uniform may include cloth or synthetic covering for hands, feet and head wherever required. (iv) Adequate facilities for personnel use should be provided like clean towel, soap etc. Lavatories for men and women should be separate and should be away from processing and manufacturing area. (v) Changing room facility should also be provided for changing their clothes and to keep their personal belongings. 9. Medical Services: Adequate facility for first aids should be provided by manufacturer. Medical examination of workers at the time of employment and periodical check-up should be conducted at least once in a year and proper record should be maintained. 10. Machinery and Equipment: To carry out manufacturing process, adequate machinery and equipment require. These machinery could be manually operated or semi- automatic or fully automatic based upon your need and investment. 11. Batch Manufacturing Record: Each batch record should be maintained irrespective of product manufactured (classical preparations or patent or proprietary medicines). (i) Manufacturing records are required to provide an account of the list of raw materials and their quantities obtained from the store, tests conducted during the various stages of manufacture like taste, colour, physical characteristics and chemical tests as may be necessary or indicated in the approved books of Ayurveda, Siddha and Unani mentioned in the First Schedule of the Drugs and Cosmetics Act. (ii) These tests may include any in-house or pharmacopoeial test adopted by the manufacturer in the raw material or in the process material and in the finished product. (iii) Manufacturing batch record should be signed by production chemist and analytical chemist. Stock should be transferred to finished goods stored along with record of testing with date and quantity of drug. Pharmaceutical Jurisprudence 2.11 Drugs and Cosmetics Act, 1940 … (iv) Only after the manufactured drugs have been verified and accepted, quality shall be allowed to be cleared for sale. (v) It should be essential to maintain the record of date, manpower, machine and equipments used and to keep in process record of various shodhana, bhavana, burning and fire and specific grindings in terms of internal use. 12. Distribution Record: Distribution record (Dispatch register) should be maintained to facilitate process of prompt and complete recall of the batch. Distribution record should be maintained till expiry of batch. For drugs who do not have expiry date like Bhasma, Rasa, Asava-arishtha etc. record should be maintained upto five years of the exhausting of stock. 13. Record of Market Complaints: A complaint register should be maintained to record all reports of market complaints received regarding the products sold in the market. The manufacturer shall enter all data received on such market complaints, investigations carried out by the manufacturers regarding the complaint as well as any corrective action initiated to prevent recurrence of such market complaints shall also be recorded. Once in a period of six months the manufacturer shall submit the record of such complaints to the licensing authority. The Register shall also be available for inspection during any inspection of the premises. Reports of any adverse reaction resulting from the use of Ayurvedic, Siddha and Unani drugs shall also be maintained in a separate register by each manufacturer. The manufacturer shall investigate any of the adverse reaction to find if the same is due to any defect in the product, and whether such reactions are already reported in the literature or it is a new observation. 14. Quality Control: A manufacturer can set-up own quality control section or testing could be done through government approved testing laboratory read in detail about Ayurvedic, Sidha and Unani manufacturing unit quality control section. Part 2: Describes list of recommended machinery, equipment and manufacturing premises required for the manufacture of various categories of Ayurvedic, Siddha system of medicines. Anjana/Pisti: End runner/Ball-Mill, Sieves/Shifter. Churna/Nasya/Manjan/Lepa: Grinder/disintegrator, Pulveriser, Powder mixer, Sieves/ shifter. Pills/Vati/Gutika Matirai and Tablets: Ball Mill, Mass mixer/powder mixer, Granulator, Drier, Tablet compressing machine, Pill/vati cutting machine, trays/container for storage and sugar coating, Polishing pan in case of sugar-coated tablets, Mechanised chattoo (for mixing guggulu). Kupi pakava/Ksara/Parpati/Lavana/Bhasma/Satva/Sindura Karpu/Uppu/Param: Bhatti, Karahi/Vessels/Patila Flask, Multani Matti/Plaster of Paris. Pharmaceutical Jurisprudence 2.12 Drugs and Cosmetics Act, 1940 … Copper rod, Earthen container, Gaj Put Bhatti, Muffle furnace (Electrically operated), End/Edge runner, Exhaust fan, Wooden/Steel spatula. Kajal: Filling/ packing and manufacturing room should be provided with exhaust fan and ultra violet lamps, Earthern lamps for collection of Kajal, Triple roller mill, End runner, Sieves. Capsules: Air conditioner