pharmaceutics-1unit-1-221214121936-550b56aa.pptx

Diploma notes

1. HISTORICAL BACKGROUND AND DEVELOPMENT OF PROFESSION OF PHARMACY

2. PHARMACY PHARMACON – Greek word- Drug/Medicine. Pharmacy is a health profession which is concerned with knowledge about medicines from a natural source (Plants, animals, minerals) and synthetic methods. Pharmacy is an arts and science and technique of identification of drugs, its properties, uses, pharmacological actions, side effects, adverse drug reaction, preparation methods, preservation (storage condition), analysis and standardization of drugs and medicines which are meant for administration for diagnosis, prevention, mitigation and treatment of diseases.

3. PHARMACIST The pharmacist is qualified health care professional educated and licensed or registered to Prepare and dispense medication. Monitor drug interaction. Provide drug information to other Healthcare professionals. Counsel Patient regarding the drug and dietary supplements.

4. PHARMACEUTICS Pharmaceutics is the discipline of  pharmacy that deals with the process of turning a  New Chemical Entity  (NCE) or old drugs into a medication to be used safely and effectively by patients. It is also called the science of dosage form design. There are many chemicals with  pharmacological properties , but need special measures to help them achieve therapeutically relevant amounts at their sites of action. Branches of pharmaceutics include: Pharmaceutical formulation Pharmaceutical manufacturing Dispensing pharmacy Pharmaceutical technology Physical pharmacy Pharmaceutical jurisprudence

5. HISTORICAL BACKGROUND & DEVELOPMENT OF PROFESSION OF PHARMACY The evolution of the profession of pharmacy can be divided into Five Historical Periods , Ancient Era: The beginning of time to 1600 AD Empirical Era: 1600 to 1940 Industrialization Era: 1940 to 1970 Patient Care Era: 1970 to present Biotechnology and genetic engineering: The new horizon

6. 1. ANCIENT ERA: THE BEGINNING OF TIME TO 1600 AD In earliest times, medicine was based in magic and religion. They used leaves, mud and cooled water to stop bleeding and heal wounds They used these methods by observing how animals heal their wounds. In many cultures, physicians were priests, and sometimes considered as gods. Dry clay was used to splint broken bones. Sumerians living around 4,000 BC believed that demons were the cause of illness . From 6 th millennium BC to early 2 nd millennium BC sumerians used “Cuneiform clay tablets” to note the instructions given for the use of medicines. Engraving (Impression) tablet are an official monograph took birth before 500BC. First know trademark was “Terra Sigillata ”.

7. The advanced evolution of Buddhism in ancient Babylonia (Iraq): Babylon ancient Mesopotamia , ( cradle of civilization) In ancient Babylon provides the earliest known record of practice of art of the apothecary. Practitioners of healing of this era (about 2600 B.C.) were priest, pharmacist and physician, all in one. The symptom of illness, the prescription and direction for compounding are recorded as medical tests on clay tablets.

8. Pharmacy in Ancient Indian Dhanvantari - (Physician of the Gods) It was the incarnation of Lord Vishnu who invented the Science of Medicine in the universe and it is he who quickly cures all ailments of the ever- diseased living being. According to the reference, the commonly Worshiped Hindu God of Medicine, “DHANVANTARI” is the original exponent Of the Indian medicine. Vedas – Earliest record (Rig V eda- 3000BC) Ayurveda, the “Science of Life” practiced by the Ancient Indians is based on Atharveda . It was one of the oldest scriptures of the Hindus, About 3,000 years old. 1/5 th of the human Race practices it even today.

9. Charaka and Sushruta They are medical doctors as well as pharmacists, so they studied more than 1000 herbs thoroughly. The Charaka Samhita (Medical, >650 drug-Animal, plant, mineral sources) classified herbs in 50 groups and wrote 8 books with 120 chapters (Sutra Sthana  (General principles) - 30 chapters, Nidana Sthana  (Pathology) - 8 chapters, Vimana Sthana  (Specific determination) 8 chapters, Sarira Sthana  (Anatomy)- 8 chapters, Indriya Sthana  (Sensory organ based prognosis) – 12 chapters, Cikitsa Sthana  (Therapeutics) – 30 chapters, Kalpa Sthana  (Pharmaceutics and toxicology) - 12 chapters, Siddhi Sthana  (Success in treatment) - 12 chapters). The   Sushruta Samhita (Surgical), in its extant form, is divided into 186 chapters and contains descriptions of 1,120 illnesses, 700 medicinal plants, 64 preparations from mineral sources and 57 preparations based on animal sources .

10. The  Susruta-Saṃhita is divided into two parts: the first five books ( Susruta Sthanas ) are considered to be the oldest part of the text, and the “Later Section” Susruta Uttaratantra ). The Charaka Samhita is the oldest known Hindu text on Ayurveda (life sciences), followed by the Sushruta Samhita and Ashtanga Hrdaya . Except for some topics and their emphasis, they discuss many similar subjects such as General Principles, Pathology, Diagnosis, Anatomy, Sensorial Prognosis, Therapeutics, Pharmaceutics and Toxicology. The Sushruta and Caraka texts difference in one major aspect, with Sushruta Samhita providing the foundation of surgery, while Caraka Samhita being primarily a foundation of medicine. Sharngadarasanhitha – write the above mentioned monograph into three section ( Prathama khanda , Madhya khanda , Uttar khanda ) to make the language or text in a easy and simple understandable way.

11. Vagbhaṭa - 7 th century A.D He is one of the most influential writers, Scientist, Doctor and advisor of  ayurveda . Several works are associated with his name as author, principally the  Ashtāṅgasaṅgraha  and the  Ashtangahridayasaṃhita . They contains Eight limbs of Ayurveda ( Kaay Chikitsa ( Internal medicine), Baalachikitsa ( Treatment of children and paediatric), Graha chikista (Demonology and Psychology), Urdhvanga chikitsa (Treatment above clavicle- Head/ Neck), Shalya chikitsa (Surgery), Visha chikitsa ( Toxicology), Jara Chikitsa (Rejuvenation-Make young and youthfull ), Vrsh chikitsa ( Aphrodisiac therapy-Sexual therapy). The Ayurveda had been used by his devotees for medical purposes . It eventually spread over Asia with the advanced evolution of Buddhism.

12. Pharmacy in Ancient china Oldest Chinese literature work included a script named “Recipes for 52 Ailments” found in Mawangui tomb sealed in 168 BC . In China during the Han Dynasty in the 1 st century AD, a manuscript entitled Shennong Bencao Jing (Divine Farmer) dealing with medicinal substance was compiled by shennong (Father of Chinese medicine). He analysed bark, herb, root and their properties etc and medicinal plants include podophyllu , rhubarb, ginseng, stramonium , cinnamon bark, ephedra etc. He has written the first book in Chinese medicine Pen T-Sao (Great Herbal) consist of nearly 365 drugs of natural and mineral sources and 150 separate and particular hells. He has investigated hundreds of herbs and documented. Still it is worshiped by Chinese people.

13. Days of the Papyrus Ebers The papyrus itself is in the form of a scroll 22 yards long, and about 12 inches wide, and it actually corresponds to a modern formula book or collection of recipes, in the compounding of which, something like 700 drugs are mentioned . It contains 110 pages on anatomy and physiology, toxicology, spells, and treatment recorded on papyrus. The papyrus also has many prescriptions showing the treatment of many disorders like urinary system, blood, hair, and bites by animal, plant, and mineral toxins. This is purchased from Upper Egypt then transferred it to university library and published in 1875 by George Eber . Egyptian medical document Papyrus Ebers and Papyrus Edwin Smith were written in 1550 BC and 16 th century BC respectively. A few papyri have survived, from which we can learn about Egyptian medicine. The Kahun (1825BC) - Gynecological Papyrus. The Eber Papyrus (1534BC)- (Internal medicine) Opthalmology , diseases of the digestive system, the head, the skin and specific and number of prescription and recipes. The Edwin Smith surgical Papyrus (1600BC) - Sugical diagnosis and treatments. Brugsha medical papyrus

14. Hippocrates-The Father of Medicine (466-377 BC ) He was a philosopher, Physician and Pharmacist . He liberated medicine from the mythical “Bad Spirits” He also wrote the Oath of Hypocrites Proposed that disease came from natural, not supernatural causes. Established the theory of humors which needed to be imbalanced for good health: Air- blood, Water- phlegm, Earth-black bile, Fire- yellow bile . Aristotle (384/3 B.C.-322/1 BC) He not only contributed enormously to medicine per se, but also to the natural sciences, for he was the first to classify animals. It seems that he sustained the notion that certain "inferior" animals such as insects (whose name derived from the evident segmentation of the body into its components) came into the world spontaneously from decomposing material regenerating and so their growth could not be limited or restrained.

15. Aristotle elaborated a physiological system centred on the heart, in which according to him, there burned a life-giving vital flame maintained by a spirit named pneuma or spiritovitale (vital spirit) that produced heat. He felt that the lungs and the brain had a primary function of cooling. The heart was the most important organ because when the heart stopped, the body died. Furthermore, in his studies of embryology. In his theory, heat was the most important thing and gave life. He sustained that man, having a great deal of heat, managed to use all his body's resources and to produce sperm. On the other hand, women did not have enough heat so a part of the body's blood was eliminated during menstruation. With its heat, sperm acted on menstruation, producing the embryo.

16. Theophrastus – Father of Botany (370 BC) Theophrastus was born in 370 B.C. and was a student of Aristotle. He was a scholar, botanist, biologist, and physicist. He wrote two large books, on the History of Plants and  on the Causes of Plants . These books described attempts to cultivate wild plants. He asked his students and staff to collect specimens and conduct experiments as they worked, which helped to determine which plants could be put to various uses.. His observations about the medicinal qualities of herbs have proven uncannily accurate. Theophrastus covered most aspects of botany: Descriptions of plants, classification, plant distribution, propagation, germination, and cultivation.

17. Mithridates -VI - King of Poison (120-63BC ) He contributed to toxicology. They test toxin or poison and their antidotes on himself and his prisoners. They came up with formula for universal antidote against poisoning called Antidotum Mithridatium . Pedanius Dioscorides - A Scientist Looks At Drugs (040-80 BC) He was a Greek physician and botanist. Greek physician linked botany to this field & wrote materia medica ( Pharmacopoeia of medicinal plant) which included various drugs of vegetable origin. He described various naturally occurring drugs & provided the basic information regarding its identification, cultivation, collection & storage . He published five volumes on medicine and pharmacy that covered over 600 plants and their healing properties. His book was used for 1500 years and its was translated in Latin entitled De Materia Medica it served as foundation for other books of medical profession.

18. Galen- Experimenter in Drug Compounding - Father Of Pharmacy - (130-200 AD) Galen was a prominent Roman (of Greek ethnicity) physician, surgeon, and philosopher. Developed principles of preparing and compounding medicinal agents Sought to restore humeral balances within a patient by the use of medicine of opposing qualities . E.g. Inflammation would be treated with cucumber, a cool drug. Galenical pharmacy - The first pharmacy. Described the process of creating extracts of active medicinal from plants Practiced and taught both pharmacy and medicine during 130–200 AD in Rome. His principles of preparing and compounding medicines reigned in the Western world for 1,500 years. He was the originator of the formula for a cold cream, essentially similar to that known today. His name still is associated with that class of pharmaceutical compounded and extracted from herbal plant- Galenicals .

19. Abu al Qasim Al- Zahrawi ( Abulcasis )- Father of Modern Surgery-936-1013 Regarded as one of the greatest of the Arab physicians, he excelled in the fields of internal medicine, surgery, and ophthalmology. First physician to Describe an abdominal (ectopic) pregnancy in 963. Identify the hereditary nature of haemophilia. Discover the root cause of paralysis Illustrate the various cannula. To treat wart with an iron tube and caustic metal as a boring instruments. To draw hooks with a double tip for use in surgery. He gave detailed descriptions of for using probes, surgical knives, scalples , and hooks. He also devised and invented surgical scissors, grasping forceps and obstetrical forceps. His illustrations of surgical instruments were the earliest intended for use in teaching and in methods of manufacturing them. His greatest contribution to history is the Kitab al- Tasrif a thirty volume encyclopedia of medical practice.

20. Saints Cosmas and Damian -300BC Cosmas and Damian were third century Arabian-born twin brothers who represent the closeness of pharmacy and medicine and practised medicine and surgery without a fee. This led them to being named  anargyroi  (The silverless ' or unmercenaries ). They reputedly cured blindness, fever, paralysis and reportedly expelled a breast serpent. Al- Biruni - Kitab Al- Saydalah (973-1050) The book describes Pharmacology of drugs, drugs properties, role of pharmacy and pharmacist. The Holy Roman Emperor Fredreick -II -Separation of Pharmacy and Medicine (1231-1240 AD) He presented first European edictCompletely separating their responsibilities from those of Medicine, and prescribing regulations for their professional practice in Western Europe.

21. Ibn Sina or Avicenna- Canon of Medicine (980-1037 ) The “Persian Galen” Among the brilliant contributors to the sciences of Pharmacy and Medicine during the Arabian era was one genius who seems to stand for his time - the Persian, Ibn Sina (about 980-1037 A.D.), called Avicenna by the Western world. Pharmacist, poet, physician, philosopher and diplomat, Avicenna was an intellectual giant, a favorite of Persian princes and rulers. He wrote in Arabic, often while secluded in the home of an apothecary friend. His pharmaceutical teachings were accepted as authority in the West until the 17th century; and still are dominant influences in the Orient.  

22. Paraselsus - Father of Toxicology (1493-1541) He was chemical entrepreneur and believed in chemical treatments and discounted herbal medicine. He developed mineral salts which might have a potential of being universal curative agents. He developed the basic thinking of using individual chemical moiety responsible for treatment of diseases . Renaissance period (End of ancient era-1350-1650 AD) During Renaissance period of middle ages, pharmacy went through many changes. Pharmacy became an independent profession. Pharmacy as a profession achieved status and become socially accepted. University education of pharmacist were required. New chemical medicines were introduced that gave pharmacist broader expertise.

23. THE EMPIRIC ERA 1600-1940: Pharmacopeia's were used to protect public health. Roots, Bark, Herbs Flowers etc. were used and controlled by the government. They questioned the toxicological affects on the human body. Created interest in testing of drugs and how they affected the body. The first English (London )Pharmacopeia : The first pharmacopoeia was not printed until 1618, and on April 26, 1618, James I commanded that all apothecaries follow that and only that official listing of drugs and preparations. Until 1617 drugs and medicines as were in common use are sold in England by Apothecaries and grocers. The first London Pharmacopoeia contained 1028 drugs preparations, 300 herbs and list of many roots and seeds. 1729: Christoper Marshall opened America's first apothecaries in a colony in Philadelphia .

24. 1751: Benjamin Franklin started the first hospital in Pennsylvania PA. The first pharmacist to work in that hospital was Jonathan Roberts . 1752: The first hospital pharmacy was established by John Morgan . 1820: Pharmacopoeias were used to protect public health . 1821- The philadelphia college of pharmacy was founded. During this time period: The following drugs and chemicals were identified: Nitrogen, Chlorine, Zinc, Oxygen, Morphine, Codeine, and Penicillin. October 6-8, 1852: The American Pharmaceutical Association is formed in the hall of the Philadelphia College of Pharmacy.

25. The Father of American Pharmacy William Procter, Jr., graduated from The Philadelphia College of Pharmacy in 1837. Operated a retail pharmacy business. Worked as Professor of Pharmacy for 20 years. Founder & president of American Pharmaceutical Association. 1860's:  The medicinal herb industry hit its peak in the United States, playing a particular importance to the Shakers. 1870- Birth of pharmacy in madras state of India. The medical students use to practice. 1881: Bangalore institute were started to train compounders. 1884: Henry Hurd Rusby brought 45,000 botanical specimens from the Amazon. Many of the new drug plants are still important to medicine today.

26. 1894: The first biological medicines were created by putting diphtheria into horses to produce an antitoxin for disease . 1900s: Aspirin arrives by the Bayer drug and dye firm . 1905: New York requires graduation from a two year course in pharmacy in order to get licensed . 1907: Paul Ehrlich creates Compound Salvarsan 6o6 that targeted the syphilis bacteria without damaging the rest of the body. He is later awarded the Noble Prize . 1914: The Harrison Narcotic Act requires addictive substances such as cocaine and opium to be registered.

27. January 11, 1922:  Insulin  was first used in the treatment of diabetes. Discovered by Sir Frederick G Banting .   1928: Penicillin was created by Alexander Fleming. 1937: B.Pharmacy started in Banaras Hindu University.

28. INDUSTRIALIZATION ERA 1940-1970 During the World Wars: Due to war, more people needed medicine so mass production was used through industrial machines. 1961: The Thalidomide scandal of 1961 caused an increase in the regulation and testing of drugs before licensing. 1970s: Provided a wave of cancer drugs, as part of the US government’s “war on cancer”. The cancer  survival rates have doubled since the early 70s. 1984: Retrovir is proven effective to help those with HIV or AIDS . PATIENT CARE ERA- 1970- PRESENT 1990: Electronic prescribing systems are used to automate the supply and administration of medicine in hospitals. Today: New Problems such as allergic reactions and drug interactions are occurring. Today: Pharmacy and drug sales represent in the United States a $236 billion industry.

29. BIOTECHNOLOGICAL ERA- PRESENT TO FUTURE New advances DNA and Genetic technology. Currently, Gene therapy is being conducted on diseases and genetic defects. Scientists are trying to modify genes to prevent or cure diseases. Smart Packaging is a blister pack that contains a micro chip that is able to monitor when doses pop out. The data can be transmitted to a mobile phone or tablet. The Pharmacy Robots and other automated dispensary systems are still being tested for future use in hospitals and homes. The Smart pill is a sensory pill that is ingested by the patient and provides information such as heart rate to physicians. This helps provides how the patient responds to medicine.

30. PHARMACEUITICAL EDUCATION IN INDIA

31. PHARMACEUITICAL EDUCATION IN INDIA A variety of Pharmacy programs/courses are offered in India today: Diploma in Pharmacy (D. Pharm.) Bachelor of Pharmacy (B. Pharm.) Master of Pharmacy (M. Pharm.) Master of Science in pharmacy [MS (Pharm)] Practice-based Doctor of Pharmacy (Pharm. D.) Master of Sciences in Pharmacy [MS ( Pharma )] Master of Technology in Pharmacy [ MTech (Pharm)] Doctor of Philosophy in Pharmacy (Ph. D) Integration of two courses like B. Pharm+MBA or M. Pharm+MBA has also been initiated by some institutions.

32. The entry point, for D.Pharm , B.Pharm , and Pharm.D programs is 12 years of formal education in the sciences. Diploma in Pharmacy The D.Pharm program requires a minimum of 2 years of course followed by 500 hours of practical training should be completed within 3 months in either a hospital or community setting. Bachelor of Pharmacy ( B.Pharm ) The B.Pharm involves 4 years of study in colleges affiliated with universities. Students holding a B.Pharm degree can earn an M.Pharm degree in 2 years, of which the second year is devoted to research Master in Pharmacy ( M.Pharm ) M.Pharm programs on industrial pharmacy, quality assurance, and pharmaceutical biotechnology have been introduced. To train the graduate pharmacist to provide clinicaloriented services, the M.Pharm program in pharmacy practice was introduced at Jagadguru Sri Shivaratreeswara (JSS) College of pharmacy at Mysore in 1996 and at Ooty in 1997.

33. MS (Pharm) There are 6 National Institutes of Pharmaceutical Education and Research (NIPERs) in India offering MS (Pharm), M.Tech (Pharm), and higher-level degrees. The NIPERs were created with the vision of providing excellence in pharmacy and pharmacy-related education. Doctor of Philosophy in Pharmacy (Ph. D) Students with an M.Pharm degree in any discipline can work toward a Ph.D. with an additional minimum of 3 years of study and research. Doctor of Pharmacy (Pharm. D) The Pharm.D program constitutes 6 years of full-time study. The Pharm.D (post baccalaureate) program is a 3-year program. The Pharm.D program was introduced in 2008 with the aim of producing pharmacists who had undergone extensive training in practice sites and could provide pharmaceutical care to patients.

34.   PRE HISTORICAL ERA In India, from ancient days field of medicines was well known. In 6 th century BC to 1000 AD, Era of Aryans gathered four Vedas whereas classical Ayurvedic texts were extended with contribution of authors like charaka , susruta , and vagabhata was noted. Charaka samhita is the oldest next in Ayurveda. susruta is a first surgeon of the world and known for great book “ susruta samhita ”. 7 th century AD Vagabhata wrote “ Ashtanga Ayurveda”. During 13 th century AD, Greek-Arab medicine which was known as ‘ unani ’ medicine was introduced in India. In 1563, an article named ‘ Cologuious dos stroples a drogus da indica ’ describes various Indian herbs, was published by Garcia d arota , a Portuguese physician cum teacher. In 1664, the general hospital was established in Chennai. In 1835, 1836 Madras Medical College (Chennai), Calcutta Medical College (Kolkata) were started respectively.

35. PRE INDEPENDENCE ERA Thus pharmacy Profession and education system was integral part of medical colleges and hospitals by considering remedies based on the herbal and ayurvedic systems. The modern medicine system included allopathic system was introduced in India by British researchers In 1824 London Pharmacopoeia became available in India in the form of Hidustani version. This version described the control procedures of the pharmaceutical activities in India. As a result the Indian community was forced to import drugs from overseas and Indian pharmacy was pushed to an under developed stage. In 1840, Goa Medical College was started at Panjim , Goa. In 1841, WBO Shaugh Neesy (an editor prof.) published Bengal Dispensary and Pharmacopoeia-Volume 1 in Calcutta. In 1843, the Devnagri transcription of London Pharmacopoeia in Hindi and Bengali was made available in India. In 1864, Bengal Pharmacopoeia and General Conspectus of Medicinal Plants (Bengal Pharmacopoeia) were published .

36. In 4 th March 1864 E. J. Wang tabled the motion for publication of Indian Pharmacopoeia. In 1866, H. W. Honey was first qualified person to get recognition as chemist and druggist in India. In 1868, “First Pharmacopoeia of India” was published in India under British Monarchy. In 1869, Moder Sheriff, “Pharmacist” in Chennai College and Hospital, compiled “Vernacular names of Indian Medicinal Plants and Herbs”. It was fundamental book very useful to prepare the first edition of Indian Pharmacopoeia. In 1870, madras medical college conducted licentiate exam of candidates who were willing to work as Chemist and druggist. In 1874, regular two years course for “Chemists and Druggists Diploma” was started at MMC, Chennai. In 1881, Pharmacy education pattern was based on the instructions provided by the pharmaceutical society of Great Britain. A formal training of the compounders was started in Bengal.

37. In 1893, “Chemists and Druggist Diploma” course of MMC, Chennai made equivalent to that overseas diploma issued by Royal Pharmaceutical Society of Great Britain, London, and (2 Years study + 3 months practical training + 1 year internship ) Drug enquiry committee In 11 th August 1930 Government of India appointed a committee under the chairmanship of Col. R.N .Chopra to study the various steps to be taken to improve pharmacy education. In 1931 this committee published and reported that there was no recognised specialized profession of pharmacy. A set of people known as compounders were filling the gaps. In 1932, the Vice Chancellor of Banaras Hindu University (BHU), late Pt. Madan Mohan Malviya included Pharmaceutical Chemistry as a subject course at BHU, Varanasi .

38. In November 1935, The first pharmaceutical society with education platform was developed under the banner of BHU Pharmaceutical Society which acted as a nucleus for the emergence of an All India Association – United Provinces Pharmaceutical Association (UPPA) registered in December 1935 but the name UPPA was soon replaced with Indian Pharmaceutical Association (IPA) in 1936 and first All India Pharmaceutical Conference was held at Banaras in January 1941. In 1937, Prof. M. L. Schroff (Prof* Mahadeva Lal Schruff - Father of pharmacy education in India) initiated pharmaceutical education ( B.Pharmacy ) at university level in the Banaras Hindu University (BHU), Uttar Pradesh. The course provided for studies in pharmaceutical chemistry, pharmacy, pharmacognosy , pharmaceutical economics and German Human physiology and pharmacology were not included. The graduates generally preferred to go for jobs in pharmaceutical manufacturing and analysis. It was later that human physiology and pharmacology got to form part of the syllabus at the BHU. In 1937, Andhra University was started .

39. In 1938, Madras University was started. In 1939, First issue of Indian journal of Pharmacy was released – an official publication of IPA. In 1940, Master of pharmacy ( M.Pharm ) post graduate course was also started in BHU by Prof. M. L. Schroff . In 1940, Subhadra Kumar Patni became the first Pharmacy Graduate in India. Formation of Pharmacy and Allied Manufacturers & Distributors Association Ltd. (PAMDAL) – head quartered at Mumbai. In 1941, Post of Hospital Pharmacist created at KEM Hospital, Mumbai. (Modern pharmacy services started at CMCH, Vellore; Jaslok ; JJ Hospital and other hospitals in India). 1943, Gorakh Prasad Srivastava become the first Post Graduate in pharmacy in India from BHU. In 1943, Bombay University was started .

40. In 1944, the University of the Panjab , Lahore, which came next to institute the degree course in pharmacy aimed at producing man power particularly for professional pharmacy. Dr Khem Singh Grewal was the founder of pharmaceutical education at the Panjab University, the nucleus he created now stands as the famous University Institute of Pharmaceutical Sciences of the Panjab University at Chandigarh. R. Khem Singh Grewal became an accomplished pharmacologist. As Professor of Pharmacology he headed the Department of Pharmacology at the K. E. Medical College (1940-47). In 1945, PhD degree in Pharmaceutical Sciences is started at BHU. In 1945, Govt. brought the Pharmacy Bill to standardize the Pharmacy Education in India. In 1946, Association of Pharmaceutical Teachers of India (APTI) was formed. In 1947, L. M. college was starded .

41. POST-INDEPENDENCE ERA Pharmacy Council of India (PCI) In 1948, Indian Pharmaceutical Congress Association (IPCA) was floated at Calcutta and the first annual conference was held in Calcutta itself in December 1948 with Prof. M.L. Shroff as a president Elec. But this address was read in absentia which a surprise was for . everybody . In 1948, Indian Pharmacopoeial Committee was constituted under the chairmanship of late Dr. B.N. Ghosh . The statutory regulation of pharmacy institutions in India was established with the enactment of the Pharmacy Act 1948. In 9 th March 1949, as per Pharmacy Act 1948, ‘Pharmacy Council of India’ (PCI) was established. Objectives of PCI is, To regulate the pharmacy education in the country. To all the registration as a pharmacist under the pharmacy Act. To regulate the profession and practise of pharmacy.

42. In 1949, First Diploma in Pharmacy education institute started at Jalpaiguri , West Bengal. In 1953, Sheovihari Lal became the first Ph.D holder in Pharmacy field, obtaining his Doctorate degree from University of Patna (Patna Medical College) under the guidance of Dr Achari , Department of Pharmacology. In 1953, first ‘Education Regulation’ (ER) was introduced by PCI under section 19 of the act. Which were subsequently amended in 1972, 1981 and implemented step by step in some states, and finally implemented throughout the India in 1991. As per ER-53 minimum qualification for registration as pharmacist is10 th + 2 year D-Pharm + 1 year professional training or experience. As per ER-91 minimum qualification for registration as pharmacist is 12 th +2year D-Pharm + professional training. As per ER-91, to increase professional standards patient oriented subjects like health education, community pharmacy, hospital pharmacy , biochemistry, clinical Pathology and drug store business management were added and their amendments in 1991,1994,1996.

43. According to ER-2001 the minimum qualification for registration as pharmacist is 12 th +4yr B-Pharmacy or 12 th +2yearD.Pharm+Professional training to improve pharmacy education to world standards and their amendments are come in ER-2014, 2020 . In 1954, Pharmacy Enquiry Committee Report (Major General S.L. Bhatia) recommended pay scales for pharmacists. In 1954, a one and half year M.Pharm , which was partly by paper and partly by research was introduced by L. M. college of pharmacy, Ahmedabad. In 1955, First Edition of Indian Pharmacopoeia (IP) was published. In 1957, Two years M.Pharm course started in Sagar University. In 1960, Master of Pharmacy syllabus was drafted by AICTE. In 1966, Second Edition of Indian Pharmacopoeia released. In 1978, Nayudamma Committee directed holding of GATE examination for M.Pharm courses with scholarship. In 1980, Establishment of Pharmacy graduates Association (IPGA). In 1985, Third Edition of Indian Pharmacopoeia released .

44. In 1991, Establishment of National Institute of Pharmaceutical Education & Research (NIPER) at Mohali, Punjab and Dr C.L. Kaul appointed as the First Director. Presently there are seven such institute, namely at Ahmedabad, Guwahati, Hajipur , Hyderabad, Kolkata, Mohali and Raebareli and four are proposed institutes in Visakhapatnam, Nagapur , Jhalawar , and Chattisgarh . In 1994, All India Board of Pharmaceutical Education and National board of Accreditation was formed. In 1996, Fourth Edition of Indian Pharmacopoeia released. In 2007, Fifth Edition of Indian Pharmacopoeia was published. In 10 th March 2008, The Pharm.D regulations of the Pharmacy Act 1948, have been notified in the Gazette of India, with an aim to equip the future pharmacist of India with skills of not only dispensing medicines but also to serve as counselor of medicines with focus towards patients and prescriber of drugs.

45. PRESENT ERA Currently, pharmaceutical education in India imparted as D.Pharm ( two year course after 10+2 science), B.Pharm (Four years [8 semester] after 10+2 sciences), B.Pharm (Practice) 2 ears after D,Pharm , Pharm.D , Post graduate course like M.pharm (2 years after B.Pharm ) in various braches such as Pharmaceutics, industrial Pharmacy, Pharmaceutical Technology, Pharmaceutical Chemistry, Pharmaceutical Analysis, Pharmacology, Pharmacognosy , Pharmaceutical Quality Assurance, Pharmaceutical Biotechnology, Phytopharmacy and Phytomedicine , Regulatory Affairs and Pharmacy Practice. Student who qualified in GPAT (Graduate Pharmacy Aptitude Test) examination and admitted to M.Pharm are entitled for scholarship sanctioned by AICTE. From inception of the programmes, the curriculam for D.Pharm and Pharm.D has been same across the country. However, till 2017-18 B.Pharm and M.Pharm curriculum were varying from university to university. PCI has recently introduced B.Pharm regulation 2014, M.Pharm regulation 2014 , D.Pharm regulation 2020 and accordingly suggested single syllabus at the national that was implemented by universities .

46. Until the early 1980’s, only 11 universities and 26 colleges offered pharmacy degree programmes in India. A growth spurt followed, and according to the PCI 2005 calendar, there were 220 recognized degree institutions with an enrolment of 12,506 students and as per AICTE, the total number of degree colleges were 445 with a total admission of 24,672 students. In 2007, the number increased to 854 with an intake of more than 52,000 students and there were also 583 institutions providing Diploma in Pharmacy with a capacity of more than 34,000 students. The majority of these pharmacy institutions are privately funded, and the private sector now accounts for an astounding 91% of all pharmacy students admitted.

47. HISTORY OF PARMACY RELATION TO PHARMACEUTICAL INDUSIRY

48. HISTORY OF PARMACY RELATION TO PHARMACEUTICAL INDUSIRY Before independence Post-independence Pharma industry in 21 th century In ancient India the sources of drugs were of vegetable, animal and mineral origin ( Ayurveda ). They were prepared empirically by few experienced persons. Knowledge of thatmedical system was usually kept secret within a family ( Folkore )). There were no scientific methods ofstandardizationof drugs. Muslin rule in India The Indian system of medicine declined during the Muslimrule while the Arabic or the Unani-Tibbi system flourished. British rule in India The western the so-called Allopathic system came into India with British traders who later become the rulers. BEFORE INDEPENDENCE Initially all drugs were imported from UK, France and Germany. Later some drugs of this system began to be manufactured in this country. The beginning of the modern pharmaceutical industry can be traced to early part of the 20 th century with the starting of the 1 st Indian owned drug firm. In 1901, the ‘Bengal Chemical and Pharmaceutical Works in Kolkata by AcharyaPrafulla Chandra Ray in Kolkata. In 1903, a small factory in Bombay at Parel , Mumbai by Prof. T. K. Gujjar . In 1907, which was grown into the Alembic Chemical works was set up in Baroda. Other big units during early part of century were Sarabhai Chemical Works, The Bengal Immunity Laboratory and few government laboratories for the manufacture of vaccines and sera. Drugs were mostly exported in crude form and imported in finished form, In 1914-1920, During World War-I the imports of drugs cut- off,Imports ofdrugs were resumed after the War. In 1920, Modern drug research in India started when Sri RamNath Chopra set up active centre of research on Indian medicinal plants at the school of Tropical Medicine, Kolkata. In 1922, Dr.UpendranathBrahmachari at the Campbell Medical School, Kolkata introduced Urea Stibamine for the treatment of Kala- azar . World War-I: Simple cough syrups, tablets, capsules. Quinine- By Govt. in Darjeeling and Nilgiris . In 1930- sera, vaccines, anaesthetics like ether, chloroform, few simple drugs based on coal-tar distillation products began in the country. World war-II: Plant based synthetic drugs and biologics. Manufacture of anti-dysentery drugs like Iodochlor , Chemotherapeutic drugs like Arsenical, Anti Leproticdrugs , colloidal preparations of calcium, silver Iodine etc. was started during this period. Production of biologics like Liver extracts, pituitary extracts, Adrenaline solution was taken up. Manufacturer abroad took advantage of the situation. The consequences were as follows Foreign manufacturers dumped inferior quality medicines and adulterated drugs. Markets were full of all sorts of useless and deleterious drugs were sold by unqualified men. Example , medicines and 300 surgical by March 2025.

49. Poisoning due to quinine Putting of croton oil into eye instead of atropine solution. Selling of chalk powder tablet in place of quinine. Potent drugs like compounds of antimony and arsenic and preparations of digitalis were dispensed without any standard. Drug enquiry committee In 11 th August 1930,Government ofIndia appointed a committee under chairmanship of Late Col R. N. Chopra to see into the problems of Pharmacy in India and recommend the measures to be taken. The committee gave report in 1931 and recommended following acts to be enacted to improve pharma industry in India. 1937- Import of drug act 1940- Drug bill 1941- Drug Technical Advisory Board (DTAB) 1954- Drugs and Magic Remedies Act 1955- Medicinal and Toilet preparation Act 1985- Narcotic drugs and Psychotropic act 1935, the chemical, industrial and pharmaceutical laboratories was established in Mumbai. The name of the company was changed to ‘ Cipla limited’ on 20 th July 1984. 1937: Government of India brought ‘ Import of Bill ’ later it was withdrawn. 1940: Govt. brought 'Drug Bill to regulate theimport,manufacture , sale and distribution of drugsin British India. This Bill was finally adopted as ‘Drug Act of 1940’ 1941: The first Drugs Technical Advisory Board (DTAB) under this act as constituted. Central Drugs Laboratory established in calcutta . 1942, Council of Scientific and Industrial Research (CSIR) was registered, to coordinate various activities of industrial reseach and development.

50. POST-INDEPENDENCE DEVELOPMENT In 1947, a survey was undertaken of the country ’ s industrial potential in all the sectors and a programme of development was undertaken in the first 5 years, subsequently followed every 5 years. 1954, Hindustan Antibiotic Limited (HAL) was set up at Pimpari near Pune to reduce the dependency on imports and increase the production of antibiotics (specially penicillin and streptomycin). 1959, trinity Laboratories Ltd was started by U. N. Mehta later renamed Torrent Pharmaceutical Limited. In 1960, collaboration between R&Ds, industry, national laboratory was started. In 1964, Indian Drug and Pharmaceutical Limited were set up b government to provide a boost to the production of bulk drugs and formulations in Hyderabad and Rishikesh . 1968, Lupin Ltd was started in Mumbai, Maharashtra. In 1970, upsurge of R&D within the industry because of the encouragement provided by the govt. to establish R&D units within the industry in the form of liberal tariff and tax concessions and financial incentives. Special provision given in patent at 1940 to exclude the product patent for drugs and medicine, food and chemicals provided the right climate for innovation in the development of alternative routes for the synthesis of existing drugs. In 1984, Dr. Reddy ’ s Laboratories was incorporated in Hyderabad. In 1986, AurobimdoPharma Limited was established in Ahmedabad .

51. PHARMA INDUSTRY IN 21 TH CENTURY The Indian pharmaceutical industry is the world’s 3rd largest by volume and 14th largest in terms of value. Total Annual Turnover of Pharmaceuticals was Rs. 2,89,998crore for the year 2019-2020. Total pharmaceutical exports and import were to the tune of Rs. 1,46,260crore and Rs. 42,943 crore respectively in the year 2019-20. Major Segments of the Pharmaceutical Industry are Generic drugs, OTC Medicines and Active Pharmaceutical Ingredient (API)/Bulk Drugs, Vaccines, Contract Research & Manufacturing, Biosimilars & Biologics. India has the second-highest number of US FDA-approved plants outside the US. India is a global leader in the supply of DPT(diphtheria, tetanus, and pertussis ), BCG(Bacillus Calmette-Guérin vaccine)), and Measles vaccines. India accounts for 60 percent of global vaccine Production, contributing 40 to 70 percent of the WHO demands for Diphtheria, Tetanus and Pertussis (DPT) and Bacillus Calmette–Guérin (BCG) vaccines, and 90 percent of the WHO demand for the measles vaccine. India is the largest provider of generic drugs globally. Access to affordable HIV treatment from India is one of the greatest success stories in medicine. India is one of the biggest suppliers of low-cost vaccines in the world. Because of the low price and high quality, Indian medicines are preferred worldwide, thereby rightly making the country the “Pharmacy of the World”. The Pharma sector currently contributes to around 1.72% of the country’s GDP. India’s pharmaceutical sector forms a major component of the country’s foreign trade, with attractive avenues and opportunities for investors.

52. India supplies affordable and low-cost generic drugs to millions of people across the globe and operates a significant number of United States Food and Drug Administration (USFDA) and World Health Organization (WHO) Good Manufacturing Practices (GMP)-compliant plants. India has occupied a premier position among pharmaceutical manufacturing countries of the world. India is 3rd largest market for APIs globally, 8% share in the Global API Industry, 500+ different APIs are manufactured in India and it contributes 57% of APIs to prequalified list of the WHO. Department of Pharmaceuticals The Department of Pharmaceuticals was created on the 1st July, 2008 under the Ministry of Chemicals & Fertilizers with the objective to give greater focus and thrust on the development of pharmaceuticals sector in the country and to regulate various complex issues related to pricing and availability of medicines at affordable prices, research & development, protection of intellectual property rights and international commitments related to pharmaceuticals sector which require coordination with other Ministries. Bureau of Pharma PSUs of India (BPPI) Bureau of Pharma PSUs of India (BPPI) – set up on 1st December, 2008 by the Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Government of India, with the objective to have focused and empowered structure to implement the Jan Aushadhi Scheme launched by Department of Pharmaceuticals. Public Sector Undertakings manufacturing units of Government of India Central Public Section undertakings- the Department has 5 Central Public Section undertakings under its Administrative control, they are- Indian Drugs & Pharmaceuticals Ltd. (IDPL), Dundahera Industrial Complex, Dundahera , Gurgaon , Haryana,

53. Hindustan Antibiotics Ltd, Pimpri , Pune , Maharashtra, Karnataka Antibiotics & Pharmaceuticals Limited, Bangalore-560010, Bengal Chemicals & Pharmaceuticals Ltd, Kolkata, West Bengal and Rajasthan Drugs and Pharmaceuticals Limited, Road NO.12, V.K.I. Area, Jaipur-302013. PradhanMantriBhartiyaJanaushadhiPariyojana (PMBJP) The branded (Generic) medicines are sold at significantly higher prices than their unbranded generic equivalents, though are identical in the therapeutic value. With an objective of making quality generic medicines available at affordable prices to all especially for the poor and the deprived ones, PradhanMantriBhartiyaJanaushadhiPariyojana (PMBJP) was launched by the Department in the year 2008. Under this scheme, dedicated outlets known as PradhanMantriBhartiyaJanaushadhiKendras (PMBJK) are opened all over the country to provide generic medicines to the masses. Salient features of the Scheme The Scheme has been approved for continuation with the financial outlay of Rs. 490 crore for the period from 2020-2021 to 2024-2025. The target is to open 10,500 PMBJP Kendras in all over the country by March 2025. It has also been decided to enhance the product basket of PMBJP up to 2,000

54. HISTORY OF PROFESSION OF PHARMACY IN INDIA RELATION TO ORGANISATION

55. HISTORY OF PROFESSION OF PHARMACY IN INDIA RELATION TO ORGANISATION Some of the major development events related to pharmacy organisations in India are summarised below, In 1 8 9 8, the import of Sea Customs Act Goods with ‘false trade description’ was prevented. In 1909, the Bengal Excise Act was implemented. In 1912, the United Provinces (now Uttra Pradesh) prevention of Adulteration Act was referred to adulteration of food and drugs. In 1914, the Punjab Excise Act was established. In 1919, the Bengal Food Adulteration Act, the Bihar and Orissa prevention of Adulteration and Madras Prevention of Adulteration Act (concerned with food adulteration) were passed. In 3 rd November 1920, the first organised move to form a pharmaceutical society, the Calcutta Chemists and Druggists Association was released and in 1926, it’s named changed into Bengal Chemists and Druggists Association. In 1923, the pioneer organisation in the true sense of ‘Qualified Pharmacists’ was formed by the chemist and druggists of Chennai region under the banner of the pharmaceutical association. In 1925, this association changed its name to pharmaceutical society of India and practiced the pharmacy profession up to 1950. In 11th August 1930, Government of India appointed a committee under the chairmanship of Late Col. R.N.Chopra to see into the problems of Pharmacy in India and recommend the measures to be taken. This committee published its report in 1931. It was reported that there was no recognized specialized profession of Pharmacy. A set of people known as compounders were filling the gap.

56. In 1930, the Dangerous Drug Act and Drug Enquiry Committee under the chairmanship of Col. R.N. Chopra (Chopra Committee) were passed in 1930. In January 1941, the first All India Pharmaceutical Conference was held at Banaras. In 1940, government introduced the Drugs Bill 1940 to regulate the import, manufacture, sale and distribution of drugs in British India. This bill was later accepted as the Drugs Act 1940 which partly implants the Chopra committee. In 1945, the Drug and Cosmetic Act and Rules were established. In 1945, government introduced the Pharmacy Bill for standardising the pharmacy education in India. In 1946, the Association of Pharmaceutical Teachers of India (APTI) was formed. 1n 1946, the Health Survey Development Committee ( Bhore Committee) reported tblr recommending 3 tier system of pharmacy education in India, viz , diploma degree and technologists in pharmacy. In 194 8 , the In Pharmaceutical Congress Association (IPCA) was developed in Calcutta where in December19 8 4 its first annual conference was held with Prof. M. L. Shroff as a president elected. In 194 8, the Indian Pharmacopoeial Committee was constituted under the chairmanship of Late Dr. B. N. Ghosh . With the enactment of the Pharmacy Act 1948, the statutory regulation of pharmacy institutions was established in India. In 1949, the Pharmacy Council of India was established. In 1953, the First Education regulation (ER) was framed which were amended in 1972, 191 and 1991. In March 1954, IPCA and IPA were united. IPCA was to hold the annual conferences and IPA was to carry all the other professional activities. The first joint conference of the congress was held at Baroda.

57. In 1954, the pay scales for pharmacists were recommended by Major General S. L. Bhatia in the Pharmacy Enquiry Committee report. In 1954, Drugs and Magic remedies (Objectionable Advertisements) Act was passed to stop misleading advertisements ( E.g Cure all pills). In 1955, the Medicinal and Toilet Preparations (Excise Duties) Act was passed to enforce uniform duty for all states for all products. In 1961, the Indian Drug Manufactures Association (IDMA) was founded. In 1963, the Indian Hospital Pharmacists Association (IHPA) was formed with its headquarters at New Delhi. In 1965, the Organisation of Pharmaceutical Producers of India (OPPI) was established with its headquarters at Mumbai. In 1979, the All India Organisation of Chemists and Druggists (AIOCD) was formed, merging all the other bodies. In 19 8 0, the Indian Pharmacy Graduates Association (IPGA) was established. In 19 85, the Narcotic and Psychotropic Substances Act was passed to protect the society from dangers of additive drugs. In 1984, an amendment in Pharmacy Act was made that restricted the pharmacy practice only to ‘Qualified Registered Pharmacists’. In 1994, the All India Board of Pharmaceutical education and National Board of Accreditation was formed. In 1995, Drug Price Control Order was formed. In 2003, several initiatives including the rolling out of the Charter of Pharma Vision 2020 was undertaken by Pharmacy council of India (PCI), India Pharmaceutical Asssociation (IPA) and leaders of pharmacy profession.

58. Charter of Pharma Vision 2020 was released by late Dr. A. P. J. Abdul Kalam during 55 th IPC 2003 at Chennai and roadmap document during the 58 th IPC 2006 at Mumbai proposing various activities to shape the future of pharmacy profession and pharmaceutical services in India in 2020.

59. PHARMACY AS A CAREER

60. 1 . Practice setting i) Community pharmacy a. Retail pharmacy b. Whole sale pharmacy ii) Hospital Pharmacy iii) Clinical pharmacy 2. Pharmaceutical Industries Research and development Production and manufacturing Packaging Quality control Quality Assurance Pharmaceutical Marketing Regulatory Affairs 3. Other settings Academics Regulatory (Government) Clinical Research Pharmacovigilance Medical Transcription Consultancy Opportunities in Abroad

61. 1 . Practice setting i) Community pharmacy a. Retail pharmacy A community pharmacist deals directly with people in the local area. They have responsibilities including Managing inventory and storage of medicines and allied products. Handing, checking prescription for safety and correctness. Compounding, counselling, checking and dispensing of prescription drugs to the patients with care, accuracy, and legality. Patient counselling, demonstration of medical devices. Doing screening (blood pressure, blood sugar, and height-weight). Responding to symptoms and recommending medicines for simple ailments. b. Whole sale pharmacy It is business oriented type of pharmacy where the medicines are taken from manufacturer and distribute to the medical stores, pharmacies and hospitals in bulk on affixed percentage of profit .

62. ii) Hospital Pharmacy Hospital pharmacists are referred to those who work in a hospital. They have responsibilities including Medicine selection. Managing inventory and storage of medicines and allied products. Small scale manufacturing compounding sterile supplies. Dispensing of medicines to in and out patient. Patient counselling. Health promotion. Taking part in national health programmes. iii) Clinical pharmacy Clinical pharmacists work directly with physicians, other health professionals, and patients to ensure that the medications prescribed for patients contribute to the best possible health outcomes. They have responsibilities including ADR (Adverse Drug Reaction) prevention, detection, monitoring, Reducing drug interactions and drug related problems. Taking patient medication history. Taking part in ward rounds along with doctors and nurses. Deciding or adjusting medication dosing for patients. Provide drug information

63. 2. Pharmaceutical Industries Research and development Pharmacists provide an invaluable interface in this process by establishing working relationship between scientists and clinicians across the development arena. During the discovery research phase of development of a medicine pharmacist will work with other scientists to develop and select drug compounds that may be valuable as medicines. Drug discovery, reverse engineering, formulation and process development, scale up from pilot to manufacture, troubleshooting, stability testing, packaging development. Production and manufacturing Responsible for organizing resources and activities required to produce pharmaceutical products in order to keep the smoothness of the operation and deliver quality products in timely manner. Production, manufacturing of bulk drugs and intermediates, finished medicines, vaccines and other biological products, veterinary medicines, Ayurvedic medicines, diagnostic products and medical devices. Packaging Pharmaceutical packaging (or drug packaging) is the packages and the packaging processes for pharmaceutical preparations. It involves all of the operations from production through drug distribution channels to the end consumer .

64. Quality control Product testing throughout the life cycle of the drug and finished product (from raw materials, packing material to finished product, stability etc ). Pharmaceutical QC aims at investigating manufactured drug products according to compendial specifications and standards to monitor that they are of the required quality. QC is concerned with setting up specifications, drawing samples, testing them, and generating documentation related to the tests and their reports Quality Assurance The purpose of pharmaceutical quality assurance is to ensure that the medication being manufactured will provide the desired effect to the patient. • Quality assurance also guarantees that there are no contaminants present and that the medications will meet quality requirements and all relevant regulations. Preparing, reviewing and submitting documents, conducting training, internal audits etc. hence assuring overall quality management. Pharmaceutical Marketing Broadly speaking, pharmaceutical marketing involves all of the promotional activities and strategic planning carried out by an organisation to make pharmaceutical products and care a reality, and available to customers (patients and other decision makers) from the manufacturer. Working as a medical representative .

65. Regulatory Affairs Regulatory pharmacists help ensure that drugs and medical products meet certain regulations before they are put on the market. They handle all of the red tape that goes into a successful release of a drug. They coordinate with pharmaceutical companies and scientists to facilitate drug research, plan drug trials and review and interpret scientific report data. Preparing, reviewing, communicating, submitting registration documents on pharmaceuticals to regulatory agencies to get R&D testing, production and marketing approvals, issues related to patents. They might also coordinate with international regulatory offices as well. 3. Other settings Academics Academic Pharmacists are full-time faculty members of an educational institute (e.g. University, Polytechnic, etc.). They are involved in teaching and training of the future generations of pharmacists and pharmaceutical scientists. Besides teaching, academic pharmacists in a university also engage in research

66. Regulatory (Government) Also known as government pharmacy, regulatory pharmacy is responsible for creating rules and regulations for the safe use of medicine to promote positive health outcomes. This includes pharmacists working in public health and regulatory health boards, such as CDSCO (Central Drugs Standard Control Organisation) in India. Their task is to ensure that the pharmaceuticals in the market- right from raw material to finished product and the distribution from the manufacturing facility to the customer is regulated, so as to ensure the safety, efficacy, and quality of pharmaceuticals. Drug inspectors, assistant drug controllers drug controllers carry out inspection, are in giving clinical trial approvals, manufacturing approvals, marketing approval etc. They working in the drug testing laboratories associated with the drug control department (Pharmaceutical chemist/ analyst). Clinical Research In clinical research the phase of testing drug in human in product development is called the clinical trial Therapeutic effect and drug-drug interaction knowledge is required in clinical Research. The jobs are in clinical research, clinical research associate, regulatory affairs associate, clinical data manager, statistical analysis software technician. Pharmacovigilance Pharmacovigilance is pharmacological science relating to the collection, detection, monitoring and prevention of adverse effects with pharmaceutical products. Pharmacovigilance is more concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients .

67. Medical Transcription Medical transcription is an allied health profession that deals in the process of transcription or converting voice recorded reports as dictated by practitioners or other healthcare professionals, into text format. Consultancy Pharmacist may serve as consultants for local, national and international organization. Service in pharmacy are offered in various fields such as regulatory affairs, manufacturing, analytical services, documentation, approvals, research marketing policies. Opportunities in Abroad Learning opportunities for higher studies exist in both the practice as well as research. They need to clear one or more entrance exam like, GRE (Graduate Record Exam), TOEFL (Test of English as a Foreign Language), IELTS (International English Language Testing System). In order to work as pharmacist in a particular country, one will have to clear registration exam like USA-FFPGEE (Foreign Pharmacy Graduate Equivalency Examination), NPLEX (North American Pharmacist Licensure Examination).