Introduction to D & C Act 1940 and Rules 1945, Definitions, Various Schedules in D & C Rules 1945, Administration of the act and rules, Manufacturing , Distribution and sale of drug and cosmetic, Labeling and Packing of drug and cosmetic.
Medicinal and toilet preparations act and rules,1955Ganesh Shevalkar
It is an Act with provision for levy and collection of excise duties on medicinal and toilet preparations containing alcohol, opium, Indian hemp (cannabis) or other narcotic drugs.
At the end of the 19th century and early 20 century use of Allopathy system increases
Drugs of natural origin: Veg, mineral oil and animals
At that time, profit became main motive than service
Overdose of quinine.A Central law to control drugs and pharmacy profession.
This act gives an idea about the constitution and functions of PCI. Brief about Education Regulation in India. Registration procedure for the pharmacist in India.
Medicinal and toilet preparations act and rules,1955Ganesh Shevalkar
It is an Act with provision for levy and collection of excise duties on medicinal and toilet preparations containing alcohol, opium, Indian hemp (cannabis) or other narcotic drugs.
At the end of the 19th century and early 20 century use of Allopathy system increases
Drugs of natural origin: Veg, mineral oil and animals
At that time, profit became main motive than service
Overdose of quinine.A Central law to control drugs and pharmacy profession.
This act gives an idea about the constitution and functions of PCI. Brief about Education Regulation in India. Registration procedure for the pharmacist in India.
Codes of pharmaceutical ethics
In relation to his trade
In relation to his Job
In relation to his Profession
In relation to Medical Profession
Pharmacist's Oath
These presentation describes the rules and regulations for the manufacture of drugs and grant of license. Loan License and Repacking License is also described. These presentation is the part of series Drugs & Cosmetics Act.
State pharmacy council and joint state pharmacy council:
Under the Pharmacy Act each Sate Govt. is required to constitute a state pharmacy council for the maintenance of register of Pharmacists of the State and to monitor their professional activities.
Two or more states can also enter into an agreement to form a Joint State Pharmacy Council.
The prevention of cruelty to animals act 1960Shaik Rasheed
This presentation give the complete information regarding the The Prevention of Cruelty to Animals Act 1960 including the definitions, composition of IAEC, Breeding and stocking of animals, experiments, offences and penalties.
The poison Act, 1919 was passed on 3rd September , 1919, with a view to control the import, possession and sale of Poisons.
It extends to whole of India but is not applicable to the state J&K.
The Act of 1919 replaced the poison Act of 1904.
The term “Poison” has not been defined under the Act.
Under the Act, the central Govt. has been authorised to regulate the import of poison across, while the various State Govt. has been authorised to make rules regarding the possession and sale of poison within their respective territories.
Medicinal and toilet preparations (excise duties) act, 1995 and rules, 1956Ravish Yadav
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
objective, definition, IAEC, CPCSEA guidelines for breeding & stocking of animals, transfer of acquisition of animals for expt., power to suspect or revoke registration, offences & penalties.
IIMPORT AND REGISTRATION AS PER DRUG AND COSMETIC ACT Sagar Savale
The drug and cosmetic act was passed on 10th April, 1940.
Objective : To regulate the import, manufacture, distribution, and sale of Drug and Cosmetics.
All classes of the drugs and cosmetics imported into India, shall comply with the prescribed standards and labels.
Manufacture of all classes of drug require prior license.
This presentation is related to the drug price control order in India. It will give an idea to the readers how the prices have been fixed for the formulations. How the price has been calculated for scheduled formulations.
LINK FOR VIDEO LECTURES
https://youtu.be/-4nzP2vOGdg
DRUG TECHNICAL ADVISORY BOARD IS IN THE PHARMACY SYLLABUS AND THE QUESTIONS ARE ASKED IN THE PHARMACY EXAMS .
SUCH AS GPAT NIPER AND SEMSESTER EXAM/
The Drugs and Cosmetics Act, 1940 is an Act of the Parliament of India which regulates the import, manufacture and distribution of drugs in India. The primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards.
This presentation includes an brief idea about the pharmacy act 1948 in India and also deals with its the chapter that included in the act.(Education Regulations, PCI, State PCI, Registration of Pharmacist , Approval of Institutions, Offences penalties etc.)
All the schedules of Drugs & Cosmetics Act ,1940 as well the Rules,1945 are detailed described. Also the history, objectives, role, all the amendments & orders of the D & C Act are described in most simplified way.
Codes of pharmaceutical ethics
In relation to his trade
In relation to his Job
In relation to his Profession
In relation to Medical Profession
Pharmacist's Oath
These presentation describes the rules and regulations for the manufacture of drugs and grant of license. Loan License and Repacking License is also described. These presentation is the part of series Drugs & Cosmetics Act.
State pharmacy council and joint state pharmacy council:
Under the Pharmacy Act each Sate Govt. is required to constitute a state pharmacy council for the maintenance of register of Pharmacists of the State and to monitor their professional activities.
Two or more states can also enter into an agreement to form a Joint State Pharmacy Council.
The prevention of cruelty to animals act 1960Shaik Rasheed
This presentation give the complete information regarding the The Prevention of Cruelty to Animals Act 1960 including the definitions, composition of IAEC, Breeding and stocking of animals, experiments, offences and penalties.
The poison Act, 1919 was passed on 3rd September , 1919, with a view to control the import, possession and sale of Poisons.
It extends to whole of India but is not applicable to the state J&K.
The Act of 1919 replaced the poison Act of 1904.
The term “Poison” has not been defined under the Act.
Under the Act, the central Govt. has been authorised to regulate the import of poison across, while the various State Govt. has been authorised to make rules regarding the possession and sale of poison within their respective territories.
Medicinal and toilet preparations (excise duties) act, 1995 and rules, 1956Ravish Yadav
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
objective, definition, IAEC, CPCSEA guidelines for breeding & stocking of animals, transfer of acquisition of animals for expt., power to suspect or revoke registration, offences & penalties.
IIMPORT AND REGISTRATION AS PER DRUG AND COSMETIC ACT Sagar Savale
The drug and cosmetic act was passed on 10th April, 1940.
Objective : To regulate the import, manufacture, distribution, and sale of Drug and Cosmetics.
All classes of the drugs and cosmetics imported into India, shall comply with the prescribed standards and labels.
Manufacture of all classes of drug require prior license.
This presentation is related to the drug price control order in India. It will give an idea to the readers how the prices have been fixed for the formulations. How the price has been calculated for scheduled formulations.
LINK FOR VIDEO LECTURES
https://youtu.be/-4nzP2vOGdg
DRUG TECHNICAL ADVISORY BOARD IS IN THE PHARMACY SYLLABUS AND THE QUESTIONS ARE ASKED IN THE PHARMACY EXAMS .
SUCH AS GPAT NIPER AND SEMSESTER EXAM/
The Drugs and Cosmetics Act, 1940 is an Act of the Parliament of India which regulates the import, manufacture and distribution of drugs in India. The primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards.
This presentation includes an brief idea about the pharmacy act 1948 in India and also deals with its the chapter that included in the act.(Education Regulations, PCI, State PCI, Registration of Pharmacist , Approval of Institutions, Offences penalties etc.)
All the schedules of Drugs & Cosmetics Act ,1940 as well the Rules,1945 are detailed described. Also the history, objectives, role, all the amendments & orders of the D & C Act are described in most simplified way.
Drug & Cosmetic ACT 1940 & Rules 1945 unit I.pptxGayatriBahatkar1
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.
Drugs and Cosmetics Act 1940 and Rules 1945 - Detailed reviewMd Altamash Ahmad
OBJECTIVES
• To prevent substandard in drugs, presumably for treatment, maintaining high standards of medical
• To regulate the import, manufacture, distribution and sale of drugs & cosmetics through licensing.
• Manufacture, distribution and sale of drugs and cosmetics by qualified persons only.
• Act has nothing to do with the Excise duty
• To regulate the manufacture and sale of Ayurvedic, Siddha and Unani drugs.
• To establish Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committees (DCC) for Allopathic and allied drugs and cosmetics.
Introduction & Objectives
Schedules of the Act.
Schedules of the Rule
Definitions
Administrative bodies
Import & Registration.
Manufacture of drugs
Sale of drugs
Labeling & packaging of drugs
Conditions for grant of licenses
Detailed study of schedules g, h, M, N, P, T, U,V, X & Y
Similar to Drug and Cosmetic Act 1940 and Rules 1945 (20)
Indian Regulatory Requirements: Central Drugs Standard Control Organization (CDSCO). The Central Drugs Standard Control Organization (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India. The Drugs & Cosmetics Act,1940 and rules 1945 have entrusted various responsibilities to central & state regulators for regulation of drugs & cosmetics. Vision:
To Protect and Promote public health in India.
Mission:
To safeguard and enhance the public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices. Functions of CDSCO
Certificate of Pharmaceutical Product (COPP): The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO).
COPP establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country.
It is often mentioned in conjunction with the electronic Common Technical Document (eCTD). The Certificate of a Pharmaceutical Product is needed by the importing country when the product in question is intended for registration (licensing, authorization) or renewal (prolongation) of registration, with the scope of commercialization or distribution in that country. The Certificate of a Pharmaceutical Product is needed by the importing country when the product in question is intended for registration (licensing, authorization) or renewal (prolongation) of registration, with the scope of commercialization or distribution in that country.
COPP Importance: It is needed by the importing country when the product in question is infected for Registration (Licensing and Authorization) or renewal of registration.
With the scope of commercialization or distribution in that country.
Certification has been recommended by WHO to help undersized drug regulatory authorities or drug regulatory authorities without proper quality assurance facilities in importing countries to assess the quality of pharmaceutical products as a prerequisite of registration or importation. General Requirements for Submission of Application for Issue of COPP. Documents Required for Applying for Grating or
Revalidation of COPPS:
Application from the manufacturer.
Site master file (as specified under WHO TRS 823).
Cost of manufacturing license.
List of approved products.
List of products applied for issuance of COPPS.
List of SOPs and STPs.
Stability data (3 batches) accelerated/Real-time.
List of equipments and instruments.
List of technical staff, their qualification, and experience, and approval status.
Manufacturing layout plan.
Process validation for 3 batches of each product.
Schematic diagram of water system specifying circulation loop and MOC (Material of construction).
Schematic diagram of HVAC system specifying terminal filter configuration. Export data of the last 2 years in case of revalidation.
Flow chart
Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy and banking.
Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy and banking.
History of regulatory affair. Various Regulatory Authority. Role of Regulatory Affairs Department.
Pre-clinical or Non- clinical phase of drug development . Investigational New Drug Application (IND) Importance of IND. Investigator’s Brochure (IB). The Investigator’s Brochure (IB) is a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects. A complete and thorough investigator’s brochure should include the following: Title Page
I. A] Confidentiality Statement
II. Contents of the Investigator’s Brochure
II. A] Table of Contents
II. B] Summary
II. C] Introduction
II. D] Physical, Chemical, and Pharmaceutical Properties and
Formulation
II. E] Nonclinical Studies
II. F] Effects in Humans
II. G] Summary of Data and Guidance for the Investigator. Contents of the Investigator’s Brochure: II. A] Table of Contents
II. B] Summary:
Not longer than 2 pages.
Highlighting significant physical, chemical, pharmaceutical, pharmacological, toxicological, pharmacokinetic, metabolic and clinical information available that is relevant to the state of clinical development of the investigational product. II. D] Physical, Chemical, and Pharmaceutical Properties
and Formulation:
A description of the investigational product substances including the chemical and or structural formulae and the brief summary of the relevant physical, chemical and pharmaceutical properties.
For safety measures, a description of the formulations to be used including excipients (a substance formulated with the active ingredient of a medication) should be provided and justified if clinically relevant.
Instructions for the storage and handling of the dosage should be provided.
Structural similarities to other known compounds should be mentioned. Pharmacokinetics and Product Metabolism in Humans
A summary of information on the pharmacokinetics of the investigational product(s) should be presented, including the following, if available:
Pharmacokinetics (including metabolism, as appropriate, and absorption, plasma protein binding, distribution and elimination).
Bioavailability of the investigational product (absolute, where possible, and/or relative) using a reference dosage form.
Population subgroups (e.g. gender, age, and impaired organ function).
Interactions (e.g. product-product interactions and effects of food).
Other pharmacokinetic data (e.g. results of population studies performed within clinical trial(s). . Marketing Experience
The Investigator’s Brochure should identify countries where the investigational product has been approved.
technology transfer documents confidentiality agreements, licensing, mous.pdfDr. Ambekar Abdul Wahid
A confidentiality agreement also called a nondisclosure agreement or NDA.
It is a legally binding contract in which a person or business promises to treat specific information as a trade secret and promises not to disclose the secret to others without proper authorization.
Licensing is one of those terms that are used quite frequently and hold high importance.
Licensing can be defined as a contract or agreement between two companies, where one company permits another company to manufacture its products under specified conditions and for a specified payment. Different types of licensing
The Asian and Pacific Centre for Transfer of Technology (APCTT) is a regional institution of the United Nations Economic and Social Commission for Asia and the Pacific (ESCAP) servicing the Asia-Pacific region.
The National Research Development Corporation (NRDC) was a non departmental government body established by the British Government to transfer technology from the public sector to the private sector.
TIFAC is an autonomous organization set up in 1988 under the Department of Science & Technology to look ahead in technology domain, assess the technology trajectories, and support innovation by networked actions in select areas of national importance.
Biotech Consortium India Limited (BCIL) is a public limited company, promoted by the Department of Biotechnology (DBT), Ministry of Science and Technology, Government of India and set up by All India Financial Institutions including IDBI, ICICI, IFCI, UTI and IFCI Venture Capital Funds Limited.
A platform is a group of technologies that are used as a base
or infrastructure upon which other applications, technologies
or processes are developed for the end-user.
“a common or standard method, equipment, procedure or work practice that may be applied to the research, development or manufacturing of different products ” An array of multi-disciplinary technologies covering major aspects of the drug discovery and development processes have been established in Institute of Biotechnology and Pharmaceutical Research (IBPR)
PILOT PLANT SCALE- UP TECHNIQUE
Plant, Pilot Plant, Scale-up, Objective, Significance, Steps in scale up, General considerations, Master Manufacturing Procedures, GMP consideration.
Granularity of Technology Transfer Process, Documentation, Premises and equipment Qualification and Validation. Premises and equipments. Quality control: Analytical Method Transfer. Qualification and Validation
Role of IT in Pharma Industry, Role of Pharm Industry in Indian GDP, Role of Engineers in Pharmaceutical Industry, PHARMACY INFORMATICS, Importance in Pharma Industry, Pharmacy management software, Computerized Physician Order Entry (CPOE), Bar-coded medication administration, Enterprise Resource Planning (ERP), Laboratory Information Management System (LIMS), Customer Relationship Management (CRM), Sales Force Automation (SFA) Software, Electronic Batch Records (EBR) Software
Some of the software use in pharmaceuticals Research & Development, Virtual Labs.
Drug and magic remedies (objectionable advertisement) act 1954 and rules 1955Dr. Ambekar Abdul Wahid
Definitions, Class of Prohibitions Advertisement - Section 3, Classes of exempted advertisements, Powers of entry, search etc., Offenses and penalties, Scrutiny of misleading advertisements relating to drugs, Manner in which advertisements may be sent confidentially, Case Studies.
History, Objectives, Various Definitions, The Pharmacy Council of India (PCI), Functions and duties of PCI, State Pharmacy Council, Functions of The State PharmacyCouncils, Joint State Pharmacy Council, Offences and penalties and List of amending Acts and adaptation orders.
Brief History, Objectives, Various Definitions, Authorities and officers, The Narcotic Drugs and Psychotropic Substances Consultative Committee, National Fund for Control of Drug Abuse, Prohibition, Control And Regulation, Power to control and regulate controlled substances and Offences and Penalties, small quantity and a commercial quantity for some popular drugs and Amendments.
National Pharmaceutical Pricing Authority (NPPA) & Drug Price Control Order (...Dr. Ambekar Abdul Wahid
Introduction to NPPA, The Drug Regulatory System in India, NPPA Activities and Responsibility's, Function and Organization of NPPA, Introduction to DPCO 2013, Salient features of DPCO 2013, Prices of Bulk Drug, Retail price of Formulations, Pricing of Scheduled Formulations, Various Schedules related to DPCO Act and Amendments.
The presentation is about the basics of Sprayer dryer, its design, types of systems, process stages, Schematic representation of spray drying mechanism, and its application.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
263778731218 Abortion Clinic /Pills In Harare ,sisternakatoto
263778731218 Abortion Clinic /Pills In Harare ,ABORTION WOMEN’S CLINIC +27730423979 IN women clinic we believe that every woman should be able to make choices in her pregnancy. Our job is to provide compassionate care, safety,affordable and confidential services. That’s why we have won the trust from all generations of women all over the world. we use non surgical method(Abortion pills) to terminate…Dr.LISA +27730423979women Clinic is committed to providing the highest quality of obstetrical and gynecological care to women of all ages. Our dedicated staff aim to treat each patient and her health concerns with compassion and respect.Our dedicated group ABORTION WOMEN’S CLINIC +27730423979 IN women clinic we believe that every woman should be able to make choices in her pregnancy. Our job is to provide compassionate care, safety,affordable and confidential services. That’s why we have won the trust from all generations of women all over the world. we use non surgical method(Abortion pills) to terminate…Dr.LISA +27730423979women Clinic is committed to providing the highest quality of obstetrical and gynecological care to women of all ages. Our dedicated staff aim to treat each patient and her health concerns with compassion and respect.Our dedicated group of receptionists, nurses, and physicians have worked together as a teamof receptionists, nurses, and physicians have worked together as a team wwww.lisywomensclinic.co.za/
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
1. DRUGS AND COSMETICS
ACT 1940
AND RULES 1945
Dr. Ambekar Abdul Wahid
M. Pharm, Ph.D
Department of Pharmaceutics
Dr. Vithalrao Vikhe Patil Foundation’s
College of Pharmacy
Vadgaon Gupta (Vilad Ghat) PO MIDC
Ahmednagar (MS), India
E-mail: wahidambekar@gmail.com
1
2. History
British misrule: Providing poor healthcare system to
Indian citizens
The original act was prepared in accordance to the
recommendations of the R. N Chopra Committee formed
in 1930.
Observations made by-Drugs Enquiry Committee, Indian
Medical Association.
Reports in- Indian Medical Gazette during 1920 - 1930.
1940 – Drugs and Cosmetics Act.
1945 – Rules under the Act Extended to whole of
India……
2
3. List of Amending Acts and Adaptation Orders
1.The Drugs (Amendment) Act, 1955
2.The Drugs (Amendment) Act, 1960
3.The Drugs (Amendment) Act, 1962
4. The Drugs and Cosmetics (Amendment) Act, 1964
5.The Drugs and Cosmetics (Amendment) Act, 1972
6. The Drugs and Cosmetics (Amendment) Act, 1982
7. The Drugs and Cosmetics (Amendment) Act, 1995
8. The Drugs and cosmetics (Amendment) Act, 2008
9. The Drugs and cosmetics (Amendment) Act, 2013
10. The Drug and cosmetics (Amendment) Act, 2015
11. The Drug and cosmetics (Amendment) Act, 2016
3
4. To regulate the import, manufacture, distribution and
sale of drugs & cosmetics through licensing.
Manufacture, distribution and sale of drugs and
cosmetics by qualified persons only.
To prevent substandard in drugs, presumably for
maintaining high standards of medical treatment.
To regulate the manufacture and sale of Ayurvedic,
Siddha and Unani drugs.
To establish Drugs Technical Advisory Board (DTAB)
and Drugs Consultative Committees (DCC) for
Allopathic and allied drugs and cosmetics.
OBJECTIVES
4
5. Chapter I : Introduction
Short title, extent and commencement and definitions.
Chapter II : Various Boards
The drugs technical advisory board, The central drugs
laboratory and the drugs consultative committee and its
constitution.
Chapter III : Import of Drugs and Cosmetics
Standards of quality, misbranded drugs, adulterated
drugs, spurious drugs & cosmetics, and prohibition of
import of certain drugs or cosmetics.
Chapters in D & C Act, 1940
Cont…
5
6. Chapters in D & C Act, 1940
Chapter IV : Manufacture, Sale and Distribution of
Drugs and Cosmetics.
Standards of quality, misbranded drugs, adulterated drugs,
spurious drugs & cosmetics, and prohibition of manufacture,
sale and distribution of certain drugs or cosmetics.
Chapter IV(A) : Provisions relating to Ayurvedic,
Siddha and Unani drugs.
Cont…
6
7. Chapter V : Miscellaneous
Power to give directions, offences by companies, government
departments, penalties and sentences passed under this Act,
Magistrate’s power to impose enhanced penalties, etc.
Chapters in D & C Act, 1940
7
8. Important definitions in D & C
Act, 1940
Drug:
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 (reducing the severity or
painfulness) or prevention of any disease or disorder in
human beings or animals. Preparations applied on human
body for the purpose of repelling insects like mosquitoes.
Cont…
8
9. 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
for cleansing, beautifying, promoting attractiveness,
or altering the appearance. Includes any article
intended for use as a component of cosmetic.
Important definitions in D & C
Act, 1940
Cont…
9
10. Spurious drugs:
(a) if it is imported under a name which belongs to another drug;
or
(b) if it is an imitation of, or 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 and conspicuously marked so as to reveal its
true character and its lack of identity with such other drug;
or
Cont…
Important definitions in D & C
Act, 1940
10
11. (c) if the label or the 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
(d) if it has been substituted wholly or in part by another drug
or substance; or
(e) if it purports to be the product of a manufacturer of whom it
is not truly a product.
Cont…
Important definitions in D & C
Act, 1940
11
12. Cont…
Important definitions in D & C
Act, 1940
Adulterated drugs:
(a) if it consists, in whole or in part, of any filthy, putrid or
decomposed substance; or
(b) if it has been prepared, packed or stored under insanitary
conditions whereby it may have been contaminated with filth or
whereby it may have been rendered injurious to health; or
(c) 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
12
13. (d) if it bears or contains, for purposes of colouring only, a
colour other than one which is prescribed; or
(e) if it contains any harmful or toxic substance which may
render it injurious to health; or
(f) if any substance has been mixed therewith so as to reduce its
quality or strength.
Cont…
Important definitions in D & C
Act, 1940
13
14. Important definitions in D & C
Act, 1940
Misbranded drugs:
(a) if it is so coloured, 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
(b) if it is not labelled in the prescribed manner; or
(c) if its label or container or anything accompanying the
drug bears any statement, design or device which makes
any false claiming for the drug or which is false or
misleading.
14
16. Schedules of drugs
The Drugs and Cosmetics Rules, 1945 contains provisions for
classification of drugs under given schedules and there are
guidelines for the storage, sale, display and prescription of each
schedule. The Rule 67 details the conditions of licenses. The
Rule 97 contains the labeling regulations.
16
17. Schedules in D & C Rules, 1945
Schedule-A
Gives the specimens of prescribed forms necessary for
obtaining licenses, permits, certificates, intimations and so on.
There are in about 50 forms in this Schedule.
Schedule-B
This Schedule includes fees for test or analysis by the Central
Drug Laboratory or the Government Analyst.
Schedule-B (I)
This Schedule includes fees for the test or analysis by the
Pharmacopoeial Laboratory for Indian Medicine (PLIM) or
the Government analyst. Cont…
17
18. Schedules in D & C Rules, 1945
Cont…
Schedule-C
Includes biological and special products (Parenteral/
Injectable) such as Sera, Vaccines, Antigens, Toxin,
Antitoxin, Insulin, Bacteriophages, solution of serum
proteins intended for injection etc.
Schedule-C (I)
Includes other special products (Non Parenteral) such
as Fish liver oil, Ergot preparations, Liver extract,
Vitamins, Hormones, In-vitro devices for HIV, HCV etc.
18
19. Schedule-D
This Schedule includes Provides extent and conditions of
exemption regarding import of drugs such as Pre-digested
food, Condensed or powdered milk, Cereal preparations,
Chicken essence, Spices and condiments, Drugs and cosmetics
imported for manufacture and export in Special Economic Zone.
Schedule-D (I)
Contains information and undertaking required to be
submitted by the manufacturer or his authorized agent with the
Application Form for a Registration Certificate.
Schedules in D & C Rules, 1945
Cont… 19
20. Schedule-D (II)
Includes the information required to be submitted by the
manufacturer for registration of a bulk drug/
formulation/special product for its import into India. The
format shall be properly filled in and the detailed information,
secret in nature.
Schedules in D & C Rules, 1945
Cont…
20
21. Schedule-E
Omitted
Schedule-E (I)
List of poisonous substances under the Ayurvedic
(including Siddha) and Unani Systems of Medicine.
Drugs of Vegetable origin- Bhang, Dhatura, Jaiphala
Drugs of Animal origin- Snake poison
Drugs of Mineral origin- Hartala (Arsenic), Parada (Mercury)
Schedules in D & C Rules, 1945
Cont…
21
22. Schedule-F
It includes requirements for the functioning and operation like
Space, equipment and supplies required for a blood bank and/
or minimum requirement for grant of license for preparation of
blood components from whole human blood.
Schedule-F (I)
Part I- Provision applicable to the production of bacterial and
viral vaccines.
Part II- Provision applicable to the production of all sera from
living animals.
Part III- Provision applicable to the production and
standardization of diagnostic agents of bacterial origin.
Schedules in D & C Rules, 1945
Cont…
22
23. Schedule- F (II)
Standards for Surgical dressings that include bandage cloth,
absorbent gauze, rolled bandage etc.
Schedule- F (III)
Standards for sterilized Umbilical tapes like umbilical
polyester tape, cotton tape etc.
Schedule- FF
It lays down Standards for ophthalmic preparations.
Part- A: Ophthalmic solutions and suspensions.
Part- B: Ophthalmic ointments.
Labelled with words use within 1month of opening, not for
injection, name and concentration of preservatives.
Schedules in D & C Rules, 1945
Cont…
23
24. The notable 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 of substances under this schedule: Testolactone,
Hydroxyurea, Carbutamide, Primidone, Glibenclamide,
Hydroxyurea, Insulin, Metformin etc.
Schedules in D & C Rules, 1945
Cont…
24
25. Schedule H: The drug label must display the texts "Rx" and
"Schedule H drug. Warning : To be sold by retail on the
prescription of a Registered Medical practitioner. 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 (Xanax), Hepatitis B
vaccine, Ibuprofen, Vasopressin etc.
Schedules in D & C Rules, 1945
Cont…
25
26. Schedule X: All the regulations of Schedule H apply. The
retailer must keep a copy of the prescription for two years.
The drugs must be kept under lock and key.
Examples: Secobarbital, Glutethimide etc.
Schedule J: Contains a list of various diseases and
conditions that cannot be treated under any drug currently in
market. No drug may legally claim to treat these diseases.
Schedules in D & C Rules, 1945
Cont…
26
27. Schedule K: Contains various substances and drugs and their
corresponding regulation.
Schedule M: Contains various regulations for manufacturing,
premises, waste disposal and equipment for manufacture of
pharmaceutical products.
Part 1: Good Manufacturing Practices for premises and
materials
1A-Specific requirements for manufacture of sterile products,
parenteral preparations (small volume injectables & large
volume parenterals) and sterile ophthalmic preparations.
1B-Oral solid dosage forms (Tablets and Capsules)
Schedules in D & C Rules, 1945
Cont… 27
28. 1B-Oral solid dosage forms (Tablets and Capsules)
1C-Oral liquids (Syrups, Elixirs, Emulsions and Suspensions)
1D-Topical products (Creams, Ointments, Pastes, Emulsions,
Lotions, etc.)
1E-Metered-dose-inhalers (MDI)
1F-Specific requirements of premises, plant and materials for
manufacture of Active Pharmaceutical Ingredients (bulk
drugs)
Part 2: Requirements of Plant and equipment's.
Schedules in D & C Rules, 1945
Cont… 28
29. Schedule-M (I)
Prescribes in detail requirements of factory premises for the
manufacture of homeopathic drugs.
Schedule-M (II)
Prescribes requirements of factory premises for manufacture
of cosmetics.
Schedule-M (III)
Prescribes requirements of factory premises for manufacture
of medical devices.
Schedules in D & C Rules, 1945
Cont… 29
30. Schedule N: List of minimum equipments for the efficient
running of a Pharmacy. Entrance shall bear an inscription
“Pharmacy” in front.
Schedule O: Contains various regulations and requirements
for disinfectant fluids.
Schedule P: Contains regulations regarding life period and
storage of various drugs.
Schedule P-I: Contains regulations regarding retail package
size of various drugs
Schedules in D & C Rules, 1945
Cont… 30
31. Schedule Q: Contains a list of permitted dyes and pigments
in soap and cosmetics.
Schedule R: Contains various regulations and requirements
for condoms and other mechanical contraceptives.
Schedule S: Lists various cosmetics and toiletries, and
directs the manufacturers of cosmetics to conform to the
latest Bureau of Indian Standards requirements.
Schedules in D & C Rules, 1945
Cont… 31
32. Schedule T: Contains various regulations and requirements
for manufacture of Ayurvedic, Siddha and Unani products.
Schedule U: Contains various regulations and requirements
for record keeping.
Schedule V: Contains standards for drug patents.
Schedule Y: Contains requirement and guidelines for
clinical trials.
Schedules in D & C Rules, 1945
32
33. Administration of the act and rules
A) Advisory:
1) Drugs Technical Advisory Board (DTAB)
2) Drugs Consultative Committee (D.C.C.)
B) Analytical:
1) Central Drugs Laboratory (CDL)
2) Drug Control Laboratory in States
3) Government Analysts
C) Executives:
1) Licensing authorities
2) Controlling authorities
3) Drug Inspectors
33
34. Drugs Technical Advisory Board
(DTAB)
Ex-Officio:
(i) Director General of Health Services (Chairman)
(ii) Drugs Controller, India
(iii) Director of the Central Drugs Laboratory, Calcutta
(iv) Director of the Central Research Institute, Kasauli
(v) Director of Indian Veterinary Research Institute, Izatnagar
(vi) President of Medical Council of India
(vii) President of the Pharmacy Council of India
(viii) Director of Central Drug Research Institute, Lucknow
Cont… 34
35. Nominated:
1) Two persons by the Central Government from among
persons who are in charge of drugs control in the States.
2) One person by the Central Government from the
pharmaceutical industry.
3) Two persons holding the appointment of Government
Analyst under this Act, to be nominated by the Central
Government.
Drugs Technical Advisory Board
(DTAB)
Cont… 35
36. Elected:
1) One person, to be elected by the Executive Committee of the
Pharmacy Council of India.
2) One person, to be elected by the Executive Committee of the
Medical Council of India.
3) One pharmacologist to be elected by the Governing Body of
the Indian Council of Medical Research.
4) One person to be elected by the Central Council of the
Indian Medical Association.
5) One person to be elected by the Council of the Indian
Pharmaceutical Association.
Drugs Technical Advisory Board
(DTAB)
Cont… 36
37. Functions:
To advise the Central Government and the State
Governments on technical matters arising out of the
administration of this Act.
To carry out the other functions assigned to it by this Act.
(The nominated and elected members of the Board shall hold
office for three years, but shall be eligible for re-nomination
and re-election)
Drugs Technical Advisory Board
(DTAB)
37
38. Drugs Consultative Committee (DCC)
It is also an advisory body constituted by central government.
Constitution:
• Two representatives of the Central Government.
• One representative of each State Government.
Cont… 38
39. Functions:
To advise the Central Government, the State Governments
and the Drugs Technical Advisory Board on any other
matter tending to secure uniformity throughout India in
the administration of this Act.
The Drugs Consultative Committee shall meet when
required.
Has power to regulate its own procedure.
Drugs Consultative Committee (DCC)
39
40. The Central Drugs Laboratory, Kolkata is the national
statutory laboratory of the Government of India for quality
control of Drugs and Cosmetics.
Established under the Indian Drug & Cosmetics Act, 1940.
It is the oldest quality control laboratory of the Drug Control
Authorities in India.
It functions under the administrative control of the Director-
General of Health Services in the Ministry of Health and
Family Welfare.
Central Drug Laboratory (CDL)
Cont… 40
41. Regional Offices: Total 07
Central Drugs Laboratory (CDL), Kolkata, West Bengal.
Central Drugs Testing Laboratory (CDTL) Chennai , Tamil
Nadu.
Central Drugs Testing Laboratory (CDTL) Hyderabad, AP.
Central Drugs Testing Laboratory (CDTL) Mumbai,
Maharashtra.
Regional Drugs Testing Laboratory (RDTL) Guwahati,
Assam.
Regional Drugs Testing Laboratory (RDTL) Chandigarh.
Central Drugs Laboratory (CDL) Kasauli.
Central Drug Laboratory (CDL)
41Cont…
42. Central Drug Laboratory (CDL)
Functions:
• Analysis or test of samples of drugs/cosmetics sent by the
custom collectors or courts.
• Analytical Q.C. of the imported samples.
• Collection, storage and distribution of internal standards.
• Preparation of reference standards and their maintenance.
• Maintenance of microbial cultures.
• Any other duties entrusted by Central Government.
• Acting as an appellate authority in matter of disputes.
42
43. The functions of the Laboratory in respect of the following
Drugs or classes of drugs shall be carried out at the Central
Research Institute, Kasauli,
1. Sera
2. Solution of serum proteins intended for injection
3. Vaccines
4. Toxins
5. Antigens
6. Anti-toxins
7. Sterilized surgical ligature and sterilized surgical suture.
8. Bacteriophages
43
Central Drug Laboratory (CDL)
Cont…
44. The functions of the Laboratory in respect of Oral Polio
Vaccine shall be carried out by the following Institutes –
A) Pasteur Institute of India, Coonoor.
B) Entero virus Research Centre (Indian Council of Medical
Research), Haffkin Institute Compound, Parel, Mumbai.
C) The National Institute of Biologicals, NOIDA.]
44
Central Drug Laboratory (CDL)
Cont…
45. The functions of the Laboratory in respect of the following drugs
or classes of drugs shall be carried out at the Indian Veterinary
Research Institute, Izatnagar or Mukteshwar and the
functions of the Director in respect of the said drugs or classes
of drugs shall be exercised by the Director of either of the said
institutes.
1. Anti-sera for veterinary use.
2. Vaccines for veterinary use.
3. Toxoids for veterinary use.
4. Diagnostic Antigens for veterinary use
45
Central Drug Laboratory (CDL)
Cont…
46. The functions of the Laboratory in respect of human blood and
human blood products including components
To test for freedom of HIV antibodies, shall be carried out
by the following Institutes-
(A) National Institutes of Communicable Disease, Department of
Microbiology, Delhi.
B) National Institute of Virology, Pune
C) Centre of Advanced Research in Virology, Christian Medical
College, Vellore
46
Central Drug Laboratory (CDL)
47. The functions of the Laboratory in respect of
Homoeopathy shall be carried out at the Homoeopathy
Pharmacopoeia Laboratory, Ghaziabad.
The functions of the Laboratory in respect of Blood
Grouping reagent and diagnostic kits for Human
Immuno deficiency Virus, Hepatitis B Surface Antigen
and Hepatitis C Virus shall be carried out at the National
Institute of Biologicals, NOIDA.
47
Central Drug Laboratory (CDL)
48. Government analyst
These officers are appointed by the central or state
government and perform the duties.
Qualification:
1. Persons having qualification for appointment as
government as governmental Analysis for allopathic
drugs;
2. Having a degree in medicine, ayurved, sidha or unani
system and not less than three year post graduate
experience in the analysis of drugs in a laboratory
under control of a government analyst.
48Cont…
49. A post graduated degree in medicine or science or pharmacy or
pharmaceutical chemistry of a recognized university or has an equivalent
qualification recognized and notified by central government for such
purpose.
Associated Diploma of the Institution of chemists (India) with Analysis
of Drug and pharmaceuticals as one of the subjects and had not less than 3
years experience in the testing of drug in labrotary under the control of,
a) A government analyst
b) Head of an Institution or testing laboratory approved for the purpose by
the appointing authority or has completed two years training or testing of
drugs, including items stated in schedule C in Central Drug Laboratory.
49
Government analyst
Cont…
50. Duties:
1) The Government Analyst shall cause to be analyzed or
tested such samples or drugs and cosmetics as may be
sent to him by
Drug Inspectors.
2) A Government Analyst shall from time to time forward
reports to the Government giving the result of analytical
work and research with a view to their publication.
50
Government analyst
Cont…
51. Procedure on receipt of sample:
On receipt of a package of a sample from drug Inspector, the
government analyst compares the seal on the package or on portion
of sample or container with specimen impression of the seal
received separately and notes condition of seal on the pack or on the
portion of sample or container.
On completion of test or analysis he supplied to the inspector a report
of analysis in triplicate, together with full protocols of the test
applied.
If purchaser wants to analyze or test drug or cosmetic he has to make
an application for test or analysis in form accompanied with
prescribed fees and the report of test or analysis of such drug or
cosmetic is to be supplied in form by government analyst.
51
Government analyst
52. Licencing authority
Qualification:
(i) Graduate in Pharmacy on Pharmaceutical Chemistry or
in Medicine with specialization in clinical pharmacology or
microbiology from a University established in India by law;
and
(ii) Experience in the manufacture or testing of drugs a
minimum period of five years, Provided that the requirements
as to the academic qualification shall not apply to those
inspectors .
52Cont…
53. Duties:
1. To inspect all establishments licensed for the sale of
drugs within the area assigned to him;
2. To satisfy himself that the conditions of the licences are
being observed;
3. To procure and send for test or analysis, if necessary,
imported packages.
4. To investigate any complaint.
53
Licencing authority
Cont…
54. 5. To maintain a record of all inspections made and action
taken by him in the performance of his duties,
6. To make such enquiries and inspections as may be
necessary to detect the sale of drugs in contravention to
the Act;
54
Licencing authority
55. 55
Controlling authority
Qualification:
Graduate in Pharmacy or Pharmaceutical Chemistry
or in Medicine with specialization in clinical
Pharmacology or microbiology from a University
established in India by law and
Experience in the manufacture or testing of drugs or
enforcement of the provisions of the Act for a minimum
period of five years:
56. Drug Inspector
A person to be appointed as a Drug Inspector should
have No financial interest in the import, manufacture or
sale of the drug or cosmetics,
Drug Inspector is a Public Servant under sec 21 of
Indian panel code.
56Cont…
57. Qualification
A person who is appointed an Inspector under the Act
shall be a person who has a degree in Pharmacy or
Pharmaceutical Sciences or Medicine with Specialization
in clinical Pharmacology or Microbiology from a
University established in India by law-
57
Drug Inspector
Cont…
58. Provided that only those Inspectors: --
(i) Who have not less than 18 months experience in the
manufacture of atleast one of the substances specified
in Schedule C, or
(ii) Who have not less than 18 months’ experience in
testing of atleast one of the substances in Schedule C in
a Laboratory approved for this purpose by the licensing
authority, or
(iii) Who have gained experiences of not less than three
years in the inspection of firms manufacturing any of the
substances specified in Schedule C during the tenure of
their services as Drugs Inspector; shall be authorized to
inspect the manufacture of the substances mentioned in
Schedule C.
58
Drug Inspector
59. 59
Power of inspectors
a) Inspect
(i) Any premises where in any drug or cosmetic is being
manufactured.
(ii) Any premises where in any drug or cosmetic is being
sold, or stocked or exhibited or offered for sale, or
distributed;
(b) Take samples of any drug or cosmetic
(i) Which is being manufactured or being sold or is stocked
or exhibited or offered for sale, or is being distributed;
(ii) From any person who is in the course of conveying,
delivering or preparing to deliver such drug or cosmetic
to a purchaser or a consignee.
Cont…
60. Search any person in connection with the offence (fault)
Enter and search at all reasonable times any place or
premises in which he has reasoned to believe that an offence
is being committed or has been committed
Stop and Search any vehicle or other conveyance which he
has reason to believe, used for carrying any drug or cosmetic
in respect of which offence has been or has being committed.
Examine any record, register, document or any other material
object found while exercising above powers and sieze (Catch,
hold)) the same if he has reason to believe that it is an
evidence of the commission of an offence under the act.
Power of inspectors
Cont… 60
61. Give order in writing to the person in possession of drug or
cosmetic in respect of which offence has been committed or is
being committed, not to dispose stock of such drug or
cosmetic for a specified period not exceeding twenty days or
unless the defect may be removed by the possessor of the
drug or cosmetic, and may size the stock of such drug or
cosmetic or any substance or article employed for
commission of offence.
61
Power of inspectors
62. Penalty for obstructing Inspector
If any person willfully obstruct an Inspector in the exercise
of the powers conformed upon him or refuse to produce any
record, register or any other document when required or
any document when required, he shall be punishable with
imprisonment (jail) up to 3 year or with fine or with both.
62
63. Manufacture, Sale & Distribution of
Drugs and Cosmetics
MANUFACTURE
PROHIBITION OF MANUFACTURE
Drug not of standard quality or misbranded, adulterated
or spurious.
Patent or Proprietary medicine.
Drugs which claims to cure diseases specified in Sch-J.
Drugs which are Risky to human beings or animals.
Drugs without therapeutic value.
63
64. Types of manufacturing license
64
Sch.-X Sch.-C/C1 & X Drugs for the
purpose of
examinationtest
or analysis
Own Premises
Own Premises
Sch.- C/C1
But not-X
Other thanSch.-
C/C1 &X
Own Premises
Loan License
Repacking
license
AllopathicDrugs
65. Manufacturing of drugs other than in
Schedule C/C1
Conditions:
Premises should comply with schedule ‘M’.
Adequate facility for testing, separate from manufacturing.
Adequate storage facility.
Records of mfg. & testing-maintained for at least 2 years
from date of Exp.
License should provide sample to authority.
Furnish data of stability.
Maintain the inspection book.
Maintain reference samples from each batch.
Accounts of production recorded & maintained for 5 years
or 1 year after Expiry.
65
66. Manufacture of Schedule X drugs
Conditions:
Have to sent invoice of sale to licensing authority every 3
months
Store drugs in direct custody of responsible person.
Preparation must be labeled with XRx
Marketed in packing not exceeding
100 unit dose –Tablets/Capsules
300 ml- Oral liquid
5 ml - Injection
66
67. Manufacture of drugs those in Schedule
C/C1 (Biological)
Conditions:
Drugs must be issued in previously sterilized sealed glass or
suitable container.
Containers should comply with requirement of Schedule-
F/F1.
Drug must comply with standard (quality, purity, strength)
specified in schedule-F.
Parenteral in doses of 10 ml or more should be tested for
freedom from Pyrogens.
Separate laboratory for culture and manipulation of spore
bearing Pathogens.
Test for sterility should be carried out.
67
68. Penalties related to Manufacture
68
Offences Penalties
Manufacture of any spurious
drugs
a) 1-3 years imprisonment and Rs. 5000
fine
b) 2-6 years imprisonment & Rs.10000
fine on subsequent conviction
Manufacture of adulterated
drugs
a) 1 year imprisonment & Rs.2000 fine
b) 2 years imprisonment & Rs.2000 fine
for subsequent conviction
Manufacture of drugs in
contravention of the
Provisions
a) Imprisonment up to 3 months & Rs.
500 fine.
b) Imprisonment up to 6 months &
Rs.1000 fine on subsequent conviction
69. Loan License
Definition:
A person (applicant) who does not have his own arrangements
(factory) for manufacture but who wish to avail the
manufacturing facilities owned by another licensee Such
licenses are called Loan licenses.
Procedure:
Licence is obtained from licensing authority (FDA) on
application in prescribed forms (24-A , 27-A) with prescribed
fees (Rs. 6000, 1500).
Loan licenses are issued for:
1) Drugs other than specified in schedule C/C1 & X.
2) Drugs specified in schedule-C/C1
69
70. Repackaging license
Definition:
Process of breaking up any drug from a bulk container into
small packages and labeling with a view to their sale and
distribution.
Repackaging of drugs is granted for drugs other than
Schedule C/C1 and X.
Procedure:
Licence is obtained from licensing authority (FDA) on
application in prescribed forms (24-B) with prescribed fees
(Rs. 500, 200).
70
71. Manufacture of cosmetics
Prohibited for the following classes of drug:
Misbranded or spurious cosmetics and of substandard
quality.
Cosmetics containing hexachlorophene or mercury
compounds.
Cosmetics containing color which contain more than-
- 2 ppm of arsenic,
- 20 ppm of lead
- 100 ppm of heavy metals
Eye preparations containing coal-tar color
71
72. Sale of drugs
72
Allopathic Drugs
Whole Sale Retail Sale Sales From
Motor Vehicle
( Vendor)
General License Restricted
License
Drugs other
than sch.-
C/C1 & X
Drugs in
Sch.- C/C1
Drugs in
Sch.- X
For
Sch.- C/C1
73. Classes of drugs prohibited to be
sold
Misbranded, spurious, adulterated and drugs not of
standard quality
Patent/Proprietary drugs with undisclosed formula.
Sch-J drugs
Expired drugs.
Drugs used for consumption by government schemes such
as Employment State Insurance Scheme (E.S.I.S.),
Armed force.
Physician’s samples.
73
74. Wholesale of Other Than Those
Specified In C/C1 And X
All the conditions as discussed in for biological.
Compounding is made by or under the direct and personal
supervision of a qualified person.
74
75. Wholesale Of Biological (C/C1)
Adequate premises, with greater than 10 M2 area, with
proper storage facility.
Drugs sold only to retailer having license.
Premises should be in charge of competent person who is
Reg. Pharmacist.
Records of purchase & sale.
Records preserved for 3 years from date of sale.
License should displayed on premises.
75
76. Retail sale
For retail sale, two types of licenses are issued:
i) General licenses
ii) Restricted licenses
Restricted license:
Granted to those dealers who do not engage the services of
a qualified person and only deal with such classes of drugs
whose sales can be effected without qualified person and
vendors who do not have fixed premises.
76
77. Labeling & Packaging
A minimum area of 50 square meters shall be provided
for packing and labeling section.
All the general and specific labeling and packaging
specified to all classes of drugs and cosmetics should be
as per the provisions made under the act.
No person sell or distribute any drug unless it is labeled
in accordance with the Rules (Rule 95 of D & C Act).
77Cont…
78. Label – why?
Label is
A bridge between the producer and consumer.
Identification of the product, its contents, dosage
form.
Name and address of producer – to contact, if
needed.
Cautions & warnings.
Directions for use.
Batch number, date of manufacture, date of expiry.
Storage conditions.
Maximum retail price.
And insures against counterfeiting/ spurious
products.
78
Labeling & Packaging
Cont…
79. Importance of labeling
The safe use of all medicines depends on users reading
the labeling and packaging carefully and accurately and
being able to assimilate and act on the information
presented.
All labels must be clear and concise and must bear all
necessary information regarding the safe use of a product.
79
Labeling & Packaging
Cont…
80. Label – Pharmacopoeia defines:
Label means any printed packaging material, including
package inserts that provide information on the article.
( I.P. 2007 )
The term LABELLING designates all labels and other
written, printed or graphic matter upon an immediate
container of an article or upon, or in, any package or
wrapper in which it is enclosed, except any outer shipping
container. The term label designates that part of labelling
upon the immediate container. (U.S.P)
80
Labeling & Packaging
Cont…
81. A label is a piece of paper, polymer, cloth, metal, or other
material affixed to a container or article, on which is printed
a legend, information concerning the product, addresses,
etc. A label may also be printed directly on the container or
article.
( Wikipedia, the free encyclopedia)
FDA has asserted that oral statements by sales
representatives , speeches in CME programs and lectures
are “labeling”
81
Labeling & Packaging
Cont…
82. Components of Labeling:
The prescription drug labeling consists of following
components:-
Container/ Carton Label
Package Insert
Regulatory Requirements for Label :-
Rule 96 of the Drug and Cosmetic Rules (manner of
labelling) mandates the minimum information which
needs to be put on the label of all medicines.
82
Labeling & Packaging
83. The following particulars shall be either printed or written
in indelible ink and shall appear in a conspicuous manner
on the label of the innermost container of any drug and on
every other covering which the container is packed, namely
:-
1. Name of the drug
• Proper name, conspicuously, and brand name, if any
• Inclusion of the letters, I.P, NFI, B.P, USP, INN, or
descriptive of the true nature or origin ( generic name)
2. Net Quantity of contents
3. The content of active ingredients
83Cont…
Labeling & Packaging
84. 4. Name and Address of manufacturer
5. Batch or lot number(Batch No.)
6. Manufacturing license number (“Mfg. Lic. No.”)
7. Import License No. (if applicable):- the no. of license
under which the drug is imported, preceded by words
“Import Lic. No.”
8. Manufacturing date, Expiry date and Storage conditions
84
Labeling & Packaging
Cont…
85. 9. Other Specific Requirements
i. Physician Sample – ‘Not to be sold’.
ii. Alcohol content (if not less than 3%)
iii. Red vertical line - of not less than 1mm thickness.
(falling under schedule G, H, X, narcotic analgesics,
hypnotics, sedatives, tranquilizers, corticosteroids, hormones,
hypoglycemics, antimicrobials, antiepileptics, anticancer
drugs)
* Exceptions – Vet. drugs, external use, ophthalmic
preparations, ear drops, sterile sutures, surgical
dressings, preparations for parenteral use.
85
Labeling & Packaging
Cont…
86. Package Inserts
The Package insert is considered “adequate direction for
use”.
It is also directed to healthcare professional and help him
in making correct decision regarding the prescribing of drug
to a particular patient.
In India, it is governed by the ‘Drugs and Cosmetics
Act(1940) and Rules (1945). Schedule D 11 (section 6) of the
rules including the heading to which information to be
provided in the Package Inserts.
It is divided into two parts:
Therapeutic indications
Pharmaceutical information
86
Labeling & Packaging
87. Schedule G drug: “Caution: it is dangerous to take this
preparation except under medical supervision”
- Conspicuously printed, Surrounded by a line, No other
words. (Exception topical / external preparations.)
Schedule H drug:
• Rx on the left top corner conspicuously
• Schedule H drug: Warning: to be sold by retail on the
prescription of a Registered Medical Practitioner
only.
87
Contents of a label (Medicines )
Cont…
88. Schedule H drug – falling under NDPS Act, 1985
• NRx, in red colour, on the left top corner, conspicuously
• Schedule H drug: Warning: to be sold by retail on the
prescription of a Registered Medical Practitioner only.
Schedule H drug – specified in Schedule X
XRx, in red colour ,on the left top corner, conspicuously.
Schedule X drug – warning: to be sold by retail on the
prescription of a Registered Medical Practitioner only.
* if it is a bulk packing - only XRx in red colour, displayed
conspicuously
88
Contents of a label (Medicines )
Cont…
89. Liniment, lotion etc.: “FOR EXTERNAL USE ONLY.”
Contains industrial methylated spirit (for human use)
- declare the fact & “For external use only.”
If for veterinary use – “ Not for human use; for animal
treatment only ” and shall bear a symbol depicting the
head of a domestic animal.
Names of the approved colours added, if any.
Non sterile surgical ligatures & sutures:
“non sterile surgical ligature ( suture ) – not to be used for
operations upon the human body unless efficiently sterilized.”
89
Contents of a label (Medicines )
90. If, targeted for export:
Regulations of the importing country shall be adhered to.
Shall contain name & address of the manufacturer (code
number - if requested by the consignee)
If targeted for sale or consumption in India
Shall be manufactured by a licensed manufacturer.
Shall be labeled as prescribed.
Shall not contain misleading / false claims.
90
Contents of a label (Cosmetics )
91. Shall be labeled on inner and outer label
Name of the cosmetic,
Name and address of the manufacturer (if the container is
so small the name and principal place of business)
Use before ….. ,
Net contents (On outer label )
Adequate directions for use, warning, caution or special
directions, names and quantities of hazardous/poisonous
materials added (where hazard exists)
91
Contents of a label (Cosmetics )
92. • Batch number, preceded by “B”
• Manufacturing license number – preceded by “M”,
• List of ingredients of more than or equal to 1%, in the
order of addition, in descending order (exemption to less
than 60 ml/ 30 gm), preceded by the words
“INGREDIENTS”
• Schedule- S, r.w. BSI specifications, if any.
( directions issued by licensing authority)
92
Contents of a label (Cosmetics )
93. Toothpaste containing fluoride: Content of fluoride in ppm
(shall not be more than 1000 ppm)
• Date of expiry on tube and cartoon.
• Note:-Medicated toothpastes are drugs.
Hair dyes containing dyes, colours, pigments – shall bear
a caution (R-149)
“Caution: This product contains ingredients which may
cause skin irritation in certain cases and so a preliminary
test according to the accompanying direction should first be
made. This product should not be used for dyeing the eye-
lashes or eye-brows as such a use may cause blindness”.
93
Contents of a label (Cosmetics )
94. Each package shall also contain instructions in English
and local languages on the following lines for carrying
out the test:
“This preparation may cause serious inflammation of the
skin in some cases and so a preliminary test should always
be carried out to determine whether or not special
sensitivity exists. To make the test, cleanse a small area of
skin behind the ear or upon the inner surface of the
forearm, using either soap and water or alcohol. Apply a
small quantity of the hair dye as prepared for use to the
area and allow it to dry. After twenty-four hours, wash the
area gently with soap and water. If no irritation or
inflammation is apparent, it may be assumed that no
hypersensitivity to the dye exists. The test should, however,
be carried out before each and every application. This
preparation should on no account be used for dyeing eye-
brows or eye-lashes as severe inflammation of the eye or
even blindness may result”.
94
Contents of a label (Cosmetics )
97. Packing of Drugs
97
The pack sizes of drugs meant for retail sale shall be
as prescribed in Schedule P-1 to these rules.
The pack sizes of drugs not covered by the Schedule P-
1 shall be as given below: Unless specified otherwise in
Schedule P-1,
98. i. The pack sizes for Tablets/Capsules shall be: Where the
number of Tablets (coated or uncoated)/Capsules (hard or
soft gelatine) is less than 10, such packing shall be made by
the integral number. For numbers above 10, the pack sizes
of Tablets/Capsules shall contain multiples of 5.
ii. The pack sizes for liquid Oral preparations shall be 30 ml
(paediatric only) 60 ml/100 ml/200 ml/450 ml.
iii. The pack sizes for Paediatric Oral Drops shall be 5 ml/l0
ml/15 ml.
iv. The pack sizes for Eye/Ear/Nasal drops shall be 3 ml/5
ml/10 ml.
v. The pack sizes for Eye Ointment shall be 3 gm/5 gm/10
gm.
98
Packing of Drugs
99. Packing of drugs specified in Schedule X: The drugs
specified in Schedule X shall be marketed in packings not
exceeding-
(i) 100 unit doses in the case of tablets/capsules.
(ii) 300 ml in the case of oral liquid preparation.
(iii) 5 ml in the case of injections.
99
Packing of Drugs
100. Packing of drugs for hospital or
dispensary
Nothing in the rule shall apply to packing meant for use of a
hospital or a dispensary subject to the conditions that:
a. Such supplies are made by the manufacturers or
distributors direct to the hospitals/ dispensaries.
b. Hospital packs shall not be supplied to a retail dealer or
to a Registered Medical Practitioner.
100
101. References
1. The drugs and cosmetics rules, 1945 [As amended up
to 15th August, 2013].
2. A text book of forensic pharmacy by N.K Jain. Vallabh
Prakashan.
3. Handbook of drug law by M. L. Mehra.
4. Forensic pharmacy, 9th edition. Nirali Prakashan by
Kuchekar B.S.
5. Pharmaceutical regulatory affairs by Subrahmanyam
C.V.S and Thimma Setty J. Vallabh Prakashan.
101