This presentation emphasize about drugs. Drugs which are made up of Recombinant DNA technology and how it produce and various types of drugs which are industrially important and commercially produced by the help of some microorganism like e.coli .How these drugs are classified within the ACT system what are the biosafety assessment of these durgs and pharmaceutical companies to provide guidelines for the drugs production various ethical issues related to the drugs like justice ,honest etc. I gave information about the top 10 pharmaceutical companies associated in the world and India also. What is drug abusement and what are the drugs pollution you can also found in this presentation

1. Topic- Assessment of Drugs
PRESENTED BY PRESENTED TO
NIDHI GOSSAI Dr. DIGVIJAY VERMA
Msc IM IIIrd Sem

2. CONTENTS
• Introduction
• Recombinant Drugs
• Manufacturing process for recombinant products
• Classification of recombinant products
• Biosafety assessment of drugs
• Hazard identification
• Pharmacopoeia
• Drugs related organizations
• Top 10 pharmaceutical company in world and India
• Ethical issue related to drugs
• Drugs pollution ,sources and effect , prevention
• Drug abusement
• Types of drugs
• International and national organization

3. What is Drugs
• A drug is any substance that cause a change in an organism physiology or
psychology when consumed.
• A pharmaceutical drug also called a medication or medicine , is a chemical
substances used to treat, cure, prevent or diagnose a disease or to promote well
being.
• WHO define drugs as – any substance or product that is used or intended to be
used to modify or explore physiological systems or pathological state for the
benefit of the recipient.
• Anatomical therapeutic chemical classification system the most widely used drug
classification system assign drugs a unique ATC code which is an Alphanumeric
code that assign it to specific drug classes within the ATC system
• Now a days various human disease are treated with the help of drugs developed
by recombinant technology such as Erythropoietin, coagulation modulator
enzyme, hormone, interferon, interleukins, granulocytes , etc.
• Drugs developed by recombinant technology are known as biologics
biopharmaceuticals recombinant dna expressed products.

4. Recombinant Drugs
• The recombinant technique was developed by Cohen in 1973.
• The general procedure starts from the identification of the gene responsible for the
production of the desired product. The gene is isolated from human cells and
inserted into other carrier or vector cells like bacteria (Escherichia coli) or yeast
(Saccharomyces cerevisiae, Hansenulla that proliferate and produce large amounts
of the desired product.
• The central theme of recombinant DNA technology is the process of gene cloning
which consists of the production of a defined fragment of DNA and its propagation
and amplification in a suitable host cell.
• Recombinant technology was only possible after the discovery of restriction
endonucleases, the enzymes used as cutters for a desired segment of genes known
as recognition sequences.
• There are various other enzymes that have great value in recombinant technology
such as DNA polymerases, ligases, kinases, alkaline phosphatases, and nucleases.
• [Recombinant technology, thus, is a new method for the development of drugs and
other life-saving products that involves the blending of discoveries in molecular
biology, DNA alteration, gene splicing, immunology, Now a days, various human
diseases are treated with the help of drugs developed by recombinant technology,
such as hepatitis-B vaccine, antibodies erythropoietin, hormones, interferons,
interleukins, granulocyte colony-stimulating factors, anti-rheumatoid drugs etc.

5. MANUFACTURING PROCESS FOR RECOMBINANT
PRODUCTS
The following steps are involved in the production of
recombinant products
Extraction of the DNA from a donor organism and the plasmid
from bacteria
↓
Cleaved with restriction endonucleases
↓
Joined to form a recombinant DNA molecule or vector
↓
Insert this vector into host cell or expression system (E. coli or
Yeast)
↓
Multiplication of recombinant DNA molecules
↓
Formation of clone

6. continued
↓
Scale-up (harvesting) of cell to produce recombinant
drugs
↓
Purification (centrifugation or filtration)
↓
Preformulation
↓
Preclinical studies (animal testing)
↓
Clinical studies (human testing)
↓
Final product

7. CLASSIFICATION OF RECOMBINANT PRODUCTS
• The following products or biologics are obtained by recombinant or genetic engineering
technology:
• (I) Recombinant erythropoietin Epoetin-α Epoetin-β Epoetin-ω
• (II) Recombinant blood coagulation modulators
(a) Coagulants Factor-VII A Factor-VIII Factor-IX
(b) Anticoagulants Lepirudin,Desirudin,Drotecogin
• (III) Recombinant enzyme
(a) Thrombolytic enzymes- Alteplase, Anistreplase, Duteplase, Reteplase Saruplase
. Streptase or streptokinase Tenecteplase Tissue plasminogen activator Urokinase
(b) Therapeutic enzymes - Agalsidase beta Aeromonas aminopeptidase Alpha- .
. glactosidase-A Dornase alpha Imiglucerase or glucocerebrosidase or alglucerase . .
. Laronidase or alpha-L-iduronidase Galsulfase
• (IV) Recombinant hormones

8. • (a) Insulin and its analogs
Human insulin
Insulin aspart
Insulin glargine
Insulin lispro
Insulin glulisine
Insulin-like growth factor-I
Insulin-like growth factor-II
• (b) Growth hormone and its analogs
Growth hormone
Growth hormone (ovine)
Growth hormone
• (c) Gonadotropins
Recombinant follitropin-α
Recombinant follitropin-β
Recombinant choriogonadotropin

9. • (V) Recombinant interferons
Interferon alfa-2a
Interferon alfa-2b
Interferon beta-1a
• (VI) Recombinant interleukins
Interleukin-1 alpha
Interleukin-1 beta
• (VII) Recombinant granulocyte colony stimulating
factors
Filgrastim
Lenograstim
Molgramostim
(VIII) Recombinant anti-rheumatoid agents
Inß iximab
Adalimumab
Basiliximab
(IX) Miscellaneous agents
Recombinant antibodies
Recombinant albumin
Chymosin
Endostatin human
Epidermal growth factors
Relaxin
TNF
Recombinant vaccines
Thrombopoietin
Other hormones
Calcitonin
Glucagon

10. Biosafety Assessment of Drugs
• Biosafety committee
• Biosafety manual
• Biosafety officer
• Biosafety level 2 enhanced or BSL 3
• Biosecurity
• Good manufacturing practices GMP
• Hazard identification

11. Pharmacopoeia
• It is a book which contains a list of established and officially approved
drugs with description of their physical and chemical characteristics and
test of their identification, purity, and method of storage
• Some of the pharmacopoeia are the Indian Pharmacopoeia BP British
pharmacopoeia EP European P.
• The first p. published in the United states as compiled for army use.
• USP was first published in 1820.
• IP commission is an institution of the Ministry of health and family
welfare which sets standard for all drugs that are manufactured sold
and consumed.

12. Drugs Related Organizations
• World Health Organizations
• World Bank
• UNICEF( United Nation Children s Fund)
• USAID ( United State Agency for International Development)
• CDC ( Centre for Disease Control and prevention)
• NGO ( Non Governmental Organization)
• NIH ( National Institute of Health)
• NIDA (National Institute on Drug Abuse)
• FDA ( Food and Drug Administration)
• DCGI ( Drug Controller General of India )
• CDCSO (Central Drug Standard Control Organisation)

13. Top 10 Pharmaceutical company in the World
• Pfizer - USA
• Roche -Swiss pharmaceutical company
• Sanofi -French
• Johnson & Johnson
• Merck & co.(MSD) – America
• Novartis - Switzerland
• Abbvie - America
• Gilead sciences – California
• Glaxo Smith Kline ( GSK) – British
• Amgen - America

14. Top 10 pharmaceutical company in India
• Aurobindo Pharma ltd. - Hydrabad
• Cadila Healthcare ltd. - Ahemdabad
• Cipla ltd. - Mumbai
• Divis Laboratories ltd. - Hyderabad
• Dr. Reddys Laboratories ltd. - Hyderabad
• Glenmark Pharmaceutical ltd. -Mumbai
• Lupin ltd. -Mumbai
• Sun Pharmaceutical Industries - Mumbai
• Torrent p.ltd.
• Wockhardt ltd - Mumbai

15. Ethical Issue Related to Drugs
Ethics is a term that can imply lofty (giant), philosophical discussions, far removed from the
everyday world. In reality, workers in the substance abuse treatment field are constantly faced
with ethical dilemmas on an individual as well as a societal level.
Ethics is an intellectual approach to moral issues, a philosophical framework from which to
critically evaluate the choices and actions people take to deal with various aspects of daily living
Working in the substance abuse treatment field presents dilemmas relating to personal beliefs,
judgments, and values.
Ethical Issues for Treatment Providers
The Ethics of HIV/AIDS
HIV/AIDS has its own unique ethical issues. Because HIV can be transmitted through sexual
activity and by sharing drug equipment, it evokes significant personal feelings and judgments in
the general public, as well as in health and social service providers.

16. Ethics on micro and macro level
Ethical issues are both personal (micro) and societal (macro) in nature. There is an ongoing
struggle between legislating morality for the "public good" and fighting to retain an individual's
right to autonomy. It is the intense emotional nature of such concerns that takes an issue from a
personal level to a societal level.
Balancing Personal and Professional Standards
Alcohol and drug counselors must balance what is right for them personally with what may be
right based on professional standards.
The Need for Staff Training
Basic Ethical Principles
The study of ethics has produced an abundance of writings, and many standards and principles have
been brought forth. However, there are five general principles that provide a firm basis from which to
explore the ethical concerns that arise daily in the substance abuse treatment and HIV/AIDS field

17. • Justice
• Autonomy
• Beneficence
• Nonmale fiecence
• Fidelity
• Empathy and Excellence
• Honesty
DRUGS POLLUTION
Drug is the pollution of environment with pharmaceutical drugs and
their metabolites which reaches the aquatic environment through
wastewater

18. SOURCES AND EFFECTS
Most such pollution comes simply from the drugs having been cleared and excreted
In the urine. The portion that comes from expired or unneeded drugs that are flushed
unused down the toilet is smaller but it is also important especially in hospitals.
PREVENTION
The main action for preventing drug pollution is to incinerate unwanted
pharmaceutical drugs. Burning them chemically degrade their active molecule
Another aspect of drug pollution prevention is environmental law and regulation
although it face the problem of enforcement cost enforcement corruption and
negligence.

19. Drugs Abusement
• Drug abuse is, when you use legal or illegal substances in ways you should
not .
• A pattern of repeated drug or alcohol use that often interfere with health
work or social relationship.
• Commonly used illegal drugs include MARIJUANA , HEROIN
AMPHETAMINES and METHAMPHETAMINES and CLUB DRUGS.
TYPES OF DRUGS
Stimulant e.g. COCAINE
Depressant e.g. ALCOHOL
Opium related painkillers e.g. Heroin
Hallucinogens e.g. LSD

20. International Organization
• CCSA (Canadian centre on substance abuse)
• ISAM (International society of addiction medicine)
• SSA ( Society for the study of addiction)
• INCASE ( International coalition for addiction)
• IAS ( International AIDS society)
NATIONAL ORGANIZATION
CDCSO ( The central drugs standard control organization)
ADI ( Approve drugs in india)

21. Refrences
• Copyright Notice
• Bookshelf ID: NBK64933
• https://www.ncbi.nlm.nih.gov/books/NBK64933/
• Nova Scotia. Department of Health Promotion and Protection. (2008). Addiction Services. Available
at: http://www.addictionservices.ns.ca/
• ^ Ontario Public Health Association. (2008). Alcohol Policy Network. Mission. Available
at: http://www.apolnet.ca/aboutus/mission.html
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