History and Development of Pharmacy in India

Definition, Advantages and Disadvantages

1. History of Pharmacy Ms. Chitralekha G. Therkar Assistant Professor Department of Pharmaceutics, Siddhivinayak College of Pharmacy, Warora

2. History of Pharmacy in relation to Pharmacy profession In India Pharmacy is an art and science of manufacturing (compounding) and dispensing of drugs prepared from natural and synthetic sources and used them for the treatment and prevention of any diseases. History of pharmacy profession in India is divided into 3 parts. Ancient pharmacy profession Pre - independence pharmacy profession Post - independence pharmacy profession

3. 1. Ancient Pharmacy Profe s sion The Ayurveda is wrote in 5000 BC. Ayurveda works on internal medicine whereas Sushruta-Samhita deals mainly with surgical medicine. Charaka and Sushruta where physicians as well as pharmacists who studied more than thousand herbs. The reference to use of various herbs in treating diseases is mentioned in Rig-Veda. The subject of Ayurveda and yoga is considered to be very important in Indian pharmaceutical studies. The main principle behind life was five elements that is pancha-maha-bhuta namely Earth, Water, Fire, Air and Sky . These arises three doshas namely Vata, Pitta and Kapha . Ayurveda become very important until the 19th century when modern allopathy medicine started to come into the country. The first general hospital was set up at Madras in 1664. 2. Pre Independence Pharmacy Profession The first chemist shop was opened at Calcutta in 1811. In 19th century, various activities related to pharmacy practice were performed according to London pharmacopoeia. Research activities was started in Bombay in 1832 and the animal experiments in Madras in 1879. In India, first pharmaceutical company 'Bengal chemical and pharmaceutical works’ started in 1901 at Calcutta (Kolkata) by Acharya Prafulla Chandra Ray. In 1903, small pharmaceutical unit at Parel , Mumbai was started by professor T. K. Thakkar. In 1941 the first Drugs Technical Advisory Board (DTAB) was constituted under the D and C Act 1940.

4. 3. Post Independence Pharmacy Profession After independence, India take over the system for the pharmacy profession from the British rules that was unorganized and there were no legal restrictions on the practice of pharmacy. In 1948, the 'Pharmacy Act' was framed that describes minimum standard of educational qualification for pharmacy practice. The provisions of the act are implemented through the Pharmacy Council of India (PCI). As per pharmacy act, it is essential to establish state pharmacy council by individual states that are responsible for controlling and registering a pharmacist in their respective states. English was the only language of instructions for all pharmacy institutions. Today pharmaceutical industry in India is one of the largest and most advanced among the developing countries where pharmacist have various tasks. In last three decades PCI, IPA and leaders in pharmacy profession have collectively undertaken initiatives to improve activities of pharmacy profession. The recent development in pharmacy profession is e - pharmacy, the online sale of medicines.

5. The first pharmacy college in Asia was started at Goa in 1842 by the Portuguese. The first two year professional course 'Chemist and Druggist Diploma' was started in Madras M edical College in 1874. An industry oriented 3 year Bachelor of Pharmacy (B. Pharm) program was started by Prof. Mahadev Lal Shroff recognised as ‘ The Father of Pharmacy Education in India ' at Banaras Hindu University , Varanasi in 1932. The first M. Pharm program was introduced in1940 at BHU. In 1945 , doctor of philosophy (Ph.D) program was introduced at BHU. In 1947 Government of India brought the 'Pharmacy Bill' to regulate control and standardize pharmacy education in India. Phar m acy Ac t 1948 provided th e m i n imum s t a n d a r d of educational qualification for pharmacy practice to regulate the practice, education and profession of pharmacy. Pharmacy degree programs offered in India includes Diploma in Pharmacy (D. Pharm), Bachelor of Pharmacy (B. Pharm), Master of Pharmacy (M. Pharm), Master of Science (M.S. Pharm) and Master of Technology (M. Tech. Pharm), Doctor of Pharmacy (Pharm. D), and Doctor of Philosophy (Ph.D). History of Pharmacy in relation to Pharmacy Education In India

6. The D. Pharm program requires two years of coursework followed by 500 hours of practical training spread over three months either in hospital or community pharmacy affiliated to board. The B. Pharm. program consists of four year of study in college affiliated to University. The PCI regulation 2014 made the B. Pharm. and M. Pharm. curriculum uniform throughout the nation. Bachelor of Pharmacy program include 6 month project. Students after completion of bachelor of pharmacy may take admission to Master of Pharmacy course. This course is of 2 years in which second year is consists of research work. Master of Pharmacy course is available in different subjects pharmaceutics, pharmaceutical chemistry, pharmacology and toxicology, quality assurance, pharmacognosy, analysis etc. Presently in India there are 7 National Institute of Pharmaceutical Education and Research (NIPER) offering M.S. and M. Tech. in Pharmacy. Students after completing post graduation in pharmacy may take admission to Ph.D degree which is of minimum 3 years of research. In 2008 the Pharm. D. course of six years was introduced. B. Pharmacy degree holders can join the Pharm. D. program in the fourth year. Most of the institutions in the India are run by the private management and self financed. Presently near about 2,000 pharmacy colleges are present in India.

7. Eligibility criteria for admission – Admission to diploma in pharmacy course is made on the basis of group percentage of physics, chemistry, biology or mathematics in HSC exam. Admission to the Bachelor of Pharmacy course was made on the score of CET examination. Admission to the post graduate pharmacy course is based on the GPAT (Graduate Pharmacy Aptitude Test) score. Curriculum – The diploma pharmacy and Bachelor of Pharmacy course curriculum was as per the amendment of Pharmacy Act. The present education regulation for diploma in pharmacy is ER 2020 and for Bachelor of Pharmacy and Master of Pharmacy is ER 2014. For Pharm. D. the education regulation 2008 is present. Regulations – The pharmacy education in India is regulated by the PCI under the Pharmacy Act 1948 and by the All India council for Technical Education (AICTE) under AICTE Act 1987. The state Pharmacy council of respective state responsible for registration of pharmacist. Pharmacy council has no control over the Master of Pharmacy course.

8. History O f Pharmacy in relation to The Pharmaceutical Industry In India In 1892 , T he 'Bengal Chemical and Pharmaceutical Works' was the first Indian industry established. About 13% of Indian drug product requirement was produced by the number of indigenous firms during and after the world war II. The synthetic bulk drugs were produced in 1930. In 1940 and 1950 new medicines were marketed by multinational companies (MNCs) but indigenous industry not affected. In 1950 , the government established the Indian Drugs and Pharmaceuticals Limited (IDPL) and Hindustan Antibiotics Limited (HAL) with both indigenous and foreign technology collaboration. Collaborative efforts between CSIR (Council of Scientific and Industrial Research) and private manufacturing industry was a done to develop, apply and for advancement of skills in the pharmaceutical industry. A strong product patent system under the 'British Patents and Designs Act 1911' increased the influence of MNCs in Indian Pharmaceutical market. This results in decrease in the share of indigenous companies from 62 % (1950) to 32% (1970).

9. Ayyangar report concluded that foreign patent holders dominated the industry through large number of patent filing and grants and patents law in force failed to work in National interest. So Patents Act 1970 was introduced that restricted only to process in case of pharmaceuticals and agricultural chemicals and the term patents was reduced to 7 years. The Foreign Exchange Regulation Act 1973 and the National Drug Policy 1978 provided essential parameters for the growth of Indian generic industry. In mid of 1980 to 1990 , Indian generic industry increased the exports. In 1998 the domestic companies held 68% of the market share which grows up to 77% in 2003 and 85% by the 2020. The Indian Pharma industry has grown up to 1.6 lakh crore in 2020. The country is ranked 3rd in terms of volume of production and 14th largest by value. The share of export of drugs, pharmaceuticals and fine chemicals is more than rupees 5000 billion. The many Indian companies supplying life saving drugs to Africa, USA and western Europe. They achieved a milestone by manufacturing drugs of AIDS and COVID-19 vaccine. In terms of scale the Indian Pharmaceutical market ranks among the top 10 in the world.

10. History Of The Profession of Pharmacy in relation to Pharmacy Practice in India Pharmacy practice is the branch of pharmacy which deals with the professional roles of the pharmacist. The scope of pharmacy practice includes compounding and dispensing of medicines, modern services related to health care including clinical services, reviewing medications for safety and efficacy and providing drug information. The origin of pharmacy practice in India was started in 19th century. Previously , the pharmacy profession was business oriented. Those who were trained to sell drug were called drug sellers or dispensers. The pharmacy practice during pre - independence era was highly unregulated and there were no restrictions on the practice of pharmacy in India. The initiation of pharmacy practice in India was started by the Chemist and Druggist program in 1870 to train students to gain skill in pharmacy practice. In 1881, a formal training of the compounders was started in Bengal. Indian systems of medicines includes different systems like Ayurveda, Unani, Siddha, Yoga, Naturopathy and Homoeopathy. The profession of Pharmacy practice pass through five stages – Ancient Era – In 20th century , pharmacist were involved in the formulation, dispensing and study of medicinal properties of the natural products of animals, plants and mineral origins. Also pharmacist were involved in conducting animal experiments, classification of drugs for treatment and extraction of plant for preparation of medications.

11. 2. Empiric Era – It began after World War II. In this era pharmaceutical industry were started and drugs were made by the pharmacist in the factories. The pharmacist were involved in scientific study of drugs, mechanism of action of drugs, side effects of drugs and release of drugs from the dosage forms. 3. Patient Care Era – This era began in second half of the 20th century. In this pharmacist were educated in the area of clinical pharmacy to develop pharmacokinetics of drug which include absorption, distribution, metabolism and excretion of drugs. Also attention was given to pathophysiology to study disease and illnesses affecting the normal function of the body. 4. Industrialization Era – In 20th century the development of manufacturing of mass production of medicines was began. P reparation of biological products, increased use of parenteral medications were the part of this period. Pharmacist played an important role in the development of pharmaceutical industry in this era. 5. Genetic Engineering Era – In this Era the role of pharmacist was expanded which include appropriate use of medication, monitoring the response of drugs, educating patients and dispensing prescriptions. Today pharmacist play an important role in the healthcare sector as they take responsibility for patients medicine with genetically engineered drug. In India only the supply of medicines is the core activity of the pharmacist. Very few pharmacist in country offer patient oriented service (patient counselling).

12. History of Pharmacy in relation to Pharmaceutical Associations in India There are number of Pharmacy organizations and associations in India working for the well-being of the pharmacy profession and professionals. 1920 – " The Calcutta Chemist and Druggist Association " was formed which in 1926 changed their name as " Bengal Chemist and Druggist Association " . 192 3 - The P h a r m a c i st Ass o ci a tion was f o r m ed b y che m ist and d r uggist of Madras which was changed to " Pharmaceutical Society of India " in 1925. 1935 - Qualified professionals at BHU formed " BHU Pharmaceutical Society " . 193 5 – “ Uni t ed P r ov inces P h arm a c e u t ical Ass o ciat i on (UP P A)” was reg i stered which became the 'Indian Pharmaceutical Association (IPA) in 1936. 1940 – “ Allied Manufacturers and Distributors Association Limited” was formed in Mumbai. 1948 – “ Indian Pharmaceutical Congress Association” (IPCA) was formed at Calcutta. It is a federation of IPA, Indian Pharmacy Graduates Association (IPGA), Indian Hospitals Pharmacist Association (IHPA), Association of Pharmaceutical Teachers of India (APTI) and All India Drugs Control Officers Confederation (AIDCOC). 1963 - 'Indian Hospital Pharmacist Association' (IHPA) was formed at Delhi.

13. 1965 – Organization of Pharmaceutical Producers of India (OPPI ) established. 1970 – India join 'Commonwealth Pharmaceutical Association (CPA). 1973 – Indian Pharmacy Graduates Association (IPGA) was established at New Delhi. 1979 – All pharmacy associations merged to form 'All India Organisation of Chemist and Druggist ' (AIOCD). Some Important Associations And Organizations 1. IPA (Indian Pharmaceutical Association Mumbai), 1939 2. All India Organization of Chemist and Druggist (AIOCD). 3. Indian Drug Manufacturers Association (1961), Mumbai. 4. All India Cosmetics Manufacturers Association (1964). 5. Association of Pharmacy Teachers of India, Bengaluru (1966). 6. Indian Hospital Pharmacist Association, Pillani (1963). 7. Association of Community Pharmacist in India. 8. Indian Association of Colleges of Pharmacy.

14. Symbol of pharmacy Bowl of Hygeia along with rod of Asclepius is combinely known as Symbol of Pharmacy. The rod symbol indicates Asclepius is known as the God of medicines revered by Greeks . The bowl of the symbol indicates the contribution of Hygeia who was daughter of Asclepius and known as goddess of Health and Wellness . And the snake around the bowl and Rod indicates the cult of Asclepius known as the Serpent of Epidaurus . According to Greek mythology, Hygeia tended her fathers temples with a bowl of medicinal potion from which the serpent of wisdom, healing and immortality drank the medicines.

15. Pharmacy As A Career Career in pharmacy is one of the best career across the globe. Pharmacist are the health care professionals who dispense medications and provide advice to patients about the use of prescription drugs and over-the-counter drugs. Depending upon the qualifications, talent and experience the pharmacist has various job opportunities in pharmacy profession. Hospital Pharmacist – Hospitals have pharmacy department which is controlled and managed by a pharmacist. The pharmacy diploma or degree holders can work in hospitals as hospital pharmacist, community pharmacist and consultant pharmacist. Central and state governments – Employed as pharmacist in Department o f Health and Welfare, Pest Controls Division o f Agriculture, Department o f National Defense, Provincial Research Councils, Provincial Department o f Agriculture, Department o f National Defense, as a drug inspector to check quality of products. Pharmaceutical industry – Pharmacist can employed in production, manufacturing, packaging, store and purchase, quality control, quality assurance, research and development, pharmacovigilance, regulatory affairs, business operations, sales and administration etc.

16. Pharmaceutical sales – Registered pharmacist can sell bulk drugs and pharmaceutical products as distributor, wholesaler and retailer. Pharmaceutical marketing – People with good personality, knowledge and communication skill have a lots of job opportunities in pharmaceutical marketing. At higher level the position is as Manager while at lower level the position is as Medical Representative. 6 . Acade m ic s – The pharmacy graduate, post graduate and PhD candidates are employed as faculty in pharmacy colleges, universities in teaching and research. The diploma holders are employed as laboratory technician in pharmacy colleges. Higher education – The diploma holders can get admission to degree, then post graduation and then PhD. Pharmaceutical Journalism – The pharmacist who are specialist in writing and editing information has great potential in pharmaceutical journalism. Consultancy – Pharmacist can serve as consultant for local, state, national and international organizations which include field such as regulatory affairs, m an u f act u ring, an a lytical servi c e s, d oc u m e n t a tio n , marketing policies , ap p ro v al s , research.

17. 10. Clinical research – I n c l inic a l Rese a rch o r g a niza t ion phar m a c i s t are e m pl o y e d a s c l inic a l data m anage r , c l inic a l d e vel o pm e nt, p r oject m anage r , c l inic a l re s e a rch a s s ocia t e, regulatory affairs associate. 11. Medical Transcription – P h ar m a c i s t ca n w o r k with p h y s i c i a ns a s m edic a l transcr i pt o r . I n this, th e y convert voice recorded reports as dictated by doctors or practitioner's into text format to maintain the patient treatment history. Organizational management – State and National level organisational management offer's pharmacist on board of pharmacy. There is career for pharmacist in insurance sector as well in nationalized bank also. Opportunities abroad – Lots of higher Education and Research opportunities in the developed countries are available. Pharmacist job placement opportunities in education, sales, manufacturing and in hospitals as counsellor and as clinical pharmacist.

18. PHARMACOPOEIA The word pharmacopeia is derived from t wo Greek word s 'pharmakon' meaning 'drug' and 'poeia' means to make. It is the book prepared under the authority of government of respective countries which contains list of drugs, crude drugs, formulae for making different preparations, sources of drugs, their descriptions, standards, tests, actions, uses, dosage, storage condition etc. It is revised from time to time to include latest information available. To maintain the size of book in limit the drugs which are less frequently used are omitted from the new edition. In new editions new monographs are added. Pharmacopeia prepared under the authority of government of the respective countries known as national pharmacopoeias. For example IP, BP, USP, etc. International pharmacopoeia is used as a reference book by the law of the respective country to solve the problems arises regarding the drugs. Classification – The Drug compendia classified into two groups. Official compendia – Ex. British Pharmacopoeia (BP), British Pharmacopoeial Codex (BPC), Indian Pharmacopoeia (IP), United States Pharmacopeia (USP), National Formulary (NF), The pharmacopoeia of other countries. Non official compendia – Ex. Merck Index, Extra Pharmacopoeia, (Martindale) United States Dispensatory.

19. In d ian P h ar m ac o p o eia Indian Pharmacopoeia Commission (IPC) is autonomous establishment of the Ministry of Health and Family Welfare which sets the standards for all drugs that manufacture , sold and consumed in India. History and Publications of I P – The actual process of publishing the first pharmacopoeia was started in the ye a r 1944 under th e ch a irmanship o f Colo n e l R . N . Ch o pr a . I n 1946 , Government of India issued one list known as the 'Indian Pharmacopoeia list’. The Government of India constituted a permanent Indian Pharmacopoeia Committee in 1948. Tenure of this committee was five years. Indian Pharmacopoeia Committee under the leadership of Dr. B. N. Ghosh published first edition of IP in 1955. First edition of IP was written in English and official titles of monographs given in Latin. It covers 986 monographs. Supplement to this edition was published in 1960. Second edition of IP was published in 1966 under the leadership of Dr. B. Mukkerji . 274 monographs from IP 1955 and there supplement was deleted. 93 new monographs were added. Official titles of monographs given in English. Dose was expressed in metric system. For tablets and injection usual strength has given. Formulation of the drugs given immediately after the monograph of drugs and supplement to this edition was published in 1975 . 126 new monographs are added and 250 monographs amended. Cholera vaccine was deleted.

20. Third edition of IP published in 1985 with two volumes and nine appendices. 261 new monographs are added and 450 monographs were deleted. Addendum I to IP 1985 was published in 1989 in which 46 new monograph were added and 126 where amended. Addendum 2 was published in 1991 where in 62 new m o nographs where added and 110 were Amended. In 1978, the IPC for 3 rd edition of IP was reconstituted by the government of India under the chairmanship of Dr. Nityanand , Director of CDRI Lucknow. Fourth edition of IP was published in 1966 under the leadership of Dr. Nityanand . It covered 1149 monographs and 123 appendices. It includes 294 new monographs and 110 monographs have been deleted. It was published in two volumes. The Volume I contains Monographs from A to O. The Volume II contains Monographs from P to Z. It included 294 new monographs and 110 monographs were deleted. Addendum I was published in 31st December 2000 while Addendum II was published on 2002 . The supplement to 4th edition of IP published in 2002 for veterinary products which contained 208 monographs and 4 appendices. Fifth edition of IP was published under the chairmanship of Dr. Nityanand in 2007 and presented in user friendly format in 3 volumes. Addendum to this edition was published in 2008 . Volume I contents general notices and general chapters. Volume 2 and 3 contains general monographs on drug substances, dosage form and p harmaceutical aids.

21. Sixth edition of IP was published by IPC (Indian Pharmacopoeia Com m i s sio n ) under ch a irmanship o f Shri K. Chandramauli i n 2010 in Ghaziabad . It having three volumes. Volume 1 contains notices, structure of IPC, acknowledgements, introduction, general chapters. Volume 2 contains Monographs from A to M 12 volume 3 contents monographs from N to Z. Addendum to sixth edition of IP was published in 2012 which contains 52 new monographs. Seventh edition of IP was published in 2014 under the chairmanship of P. K. Pradhan , Secretary Health and Family Welfare Government of India in four volumes. It include 2548 monographs of drugs. First time 19 new radiopharmaceutical monographs are included in this pharmacopeia. The Addendum I was published in 2015, Addendum II was published in 2016 . The total number of IP standards was almost 3000 at par with other international pharmacopoeias. Eighth edition of IP was published in 2018 under the chairmanship of Dr. C. K. Mishra , Secretary Health and Family Welfare Government of India in 4 volumes. It include 220 new monographs and 366 revised monographs and 7 are deleted. Addendum to IP 2018 was published in 2019.

22. Edition Year Addendum Volume Monograph Colour Chairperson First 1955 1960 2 986 NS Dr. B. N. Ghosh Second 1966 1975 3 890 NS Dr. B. Mukkerji Third 1985 1989, 1991 2 261 NS Dr. Nityanand Fourth 1996 2000, 2002, 2008 3 1149 + 208 + 19 Blue Dr. Nityanand Fifth 2007 2008 3 271 Blue Dr. Nityanand Sixth 2010 2012 3 52 Blue Dr. Chandramauli Seventh 2014 2015, 2016 4 577 Red Dr. Ghulam Nazir, Dr. Pradhan Eighth 2018 2019 4 220 Orange Dr. C. K. Mishra

23. The British Pharmacopoeia is the national pharmacopoeia of the United Kingdom. British Pharmacopoeia is published annually and comprises of the standards required for maintaining the quality of medical substances of United Kingdom . BP is normally employed by professionals as well as organization s related to pharmaceutical research, development, manufacturing and testing. The fi r st edit i on o f B P was p u blished i n 186 4 . The a d dition w as co m piled with the help o f thr e e old phar m a c opeia wh i ch w e re Lo n don Pharmacopeia 1618, Edinburgh Pharmacopeia 1699 and Dulbin Pharmacopeia 1807 . The second edition of BP was published in 1874 . Third edition of BP was published in 1885 with its addendum in 1890 . In 1898 fourth edition of BP was published. The fifth edition of BP was published in 1914 which was little delay . As a result the commission was made in 1928 which published the sixth edition in 1932 . Recommendation was made by the commission to revise the British Pharmacopoeia once in a decade. In this edition diagnostic materials, standard test for antioxidants and insulin were included. Total 7 addendums are published to this edition of BP. 7th edition was published in 1948, 8th edition was published in 1953, 9th edition was published in 1958, 10th edition of BP was published in 1963 . BP 2010 was published by The Stationery Office (TSO), on the behalf of BP . The standards in the BP 2010 were made legally effective in the UK from 1st January 2010 . BP 2010 consists of four volumes and single volume of veterinary product. BRITISH PHARMACOPOE I A

24. BP 2020 is the most comprehensive collection of official standards for UK Pharmaceu t ical substances and m ed i ci n a l pr o duct s . It i n clude ar o und 4000 monographs including the veterinary and all European Pharmacopoeia monograph that makes the BP convenient and fully comprehensive set of standards that can be used across the Europe and worldwide. The new edition of BP 2021 is legally made effective from 1st January 2021 . This edition has incorporated with 30 new BP monographs and 20 new European Pharmacopoeia monograph along with significant number of revised monographs. Today BP is published on behalf of the health ministers of the UK . It has been prepared by the BP commission with the collaboration and support of its expert advisory groups and panels of experts. Today BP is used in more than hundred countries worldwide. British Pharmacopoeia including BP veterinary and European Pharmacopoeia are the two pharmacopoeias that have legal status in the United Kingdom. BP is published every year in August becomes effective on 1st January of the following year that incorporates all the monographs of the European Pharmacopoeia.

25. Sr. No. Editions Year 1 First 1864 2 Second 1867 3 Third 1885 4 Fourth 1898 5 Fifth 1914 6 Sixth 1932 7 Seventh 1948 8 Eighth 1953 9 Ninth 1958 10 Tenth 1963 11 Eleventh 1968 12 Twelfth 1973 13 Thirteenth 1980 14 Fourteenth 1988

26. UN I TED STATES PH A RMAC O POEIA The United States Pharmacopeia is a compendium of drug information for the United States, which published early by the United States Pharmacopeial Convention (USPC). It is published in a combined volume with the National Formulary as the USP-NF. If ingredients has an applicable as per USP quality standard, it must confirm in order to use the designation USP or NF. Drugs subject to USP standards include both human and animal drugs. USP also sets standards for dietary supplements and food ingredients. First edition of USP was published on 15th December 1820 in both Latin and English. From 1820 to 1942 it was published at 10 years interval, from 1942 to 2000 it was published at five years intervals and from 2002 it was published annually. The first national formulary of the United States was published in 1888.

27. National Formulary contains a list of medicines that approved for prescription throughout the country. It is useful for the guidance to the medical students, nurses and pharmacist working in hospitals and in sales department. It includes key information on the composition, description, selection, prescribing, dispensing and administration of medicines. There are various National formular ies, Australian Pharmaceutical Formulary (APF). The Australian national Formulary (ANF). British National Formulary (BNF) and British National Formulary For Children (BNFC). National Formulary of India (NFI) Sri Lankan National Formulary United States National Formulary it is merged with United States Pharmacopeia (USP- NF). In preparation of National Formulary of India (NFI) expert opinion of medical practitioners, teachers in medicine, nurses, pharmacist, and pharmaceutical manufacturers was obtained. The selection of drugs for inclusion in the INF was made by taking into consideration the relative advantages and disadvantages of the various drugs used, their extent of use in current medical practice and their availability in the country. The first edition of NFI was published in 1960 by the Government of India Ministry of Health, in 1966 second edition was published and 3 rd edition in 1979. Fourth edition was published in 2011 while 5th edition was published in 2016. National Formulary

28. EXTRA PH A RMAC O POEIA The Extra Pharmacopoeia originally created by William Martindale in 1883 and now published by the Pharmaceutical Society of Great Britain. It contains information on the drugs presently used in Great Britain. It was first published under the title 'Martindale - The Extra Pharmacopoeia' . Martindale contains information on drugs in the clinical use worldwide as well as selected veterinary drugs, Pharmaceutical excipients, radiopharmaceuticals, vitamins and nutritional agents, vaccines, diagnostic agents, medicinal gases, toxic substances, disinfectants and pesticides. Martindale book is arranged into two main parts which having three indexes. The Merck Index – It i s an e nc y c lopedia o f ch e micals, drugs and bio l ogical s . The f ir st edition was published in 1989 Jersey, USA by Merck and Company , Rahway. The International Pharmacopoeia - It is published by the World Health Organization and particularly used in developing countries. The first edition was published in 1951 (Volume I) in 1955 (Volume II). The object of this was to provide uniform list which would avoid the confusion caused by different National standard, strengths and names especially for the use of travelers who might need use the same prescription in different countries.

29. Following are some important distinguishing features of each edition of IP. Salient Features of First edition of I P The titles of monographs have been given in Latin language. Abbreviated titles for use in prescription have been given immediately below the Latin title. The English title has also been given below the abbreviation title. The weights and measures have been given in metric system. All statements contained in the individual monographs have been considered as constitute standards for the official substances. Doses are expressed both in the metric system as well as in the English system. A list of preparations has been given at the end of some of the monographs. The temperature has been expressed in Celsius thermometric scale. Descriptive terms (very soluble, freely soluble, sparingly soluble, slightly soluble, very slightly soluble, practically insoluble) have been used where the exact solubility of a pharmaceutical substance is not known. Salient features of Indian Pharmacopoeia

30. 44 Salient Features of Second edition of IP The titles of monographs have been changed from Latin to English. The words of the title have been transposed to give the name of the drug first. Eg. Injection of Aminophylline has been changed to Aminophylline Injection. Doses are expressed in the metric system only. Solubility is expressed in parts of solvent per unit part of solute. The preparations of a drug have been given immediately after the monograph of the parent drug. The te s t f or s te r ility has been m o d ified f or de t ection o f f u n gi in addition to aerobic and anaerobic bacteria. New an a lytical tech n iques s u ch a s non a q u e ous titration, colu m n chromatography have been included. In th e m onographs o f " T ab l et" and "In j ections" a new s ubheading " Usual Strength" has been given to represent the strength of the tablet or injection in which i t shoul d b e ge n era l ly marketed. Salient Features of Third edition of IP IUPAC system of nomenclature of organic chemical drugs has been used. Analyt i c a l tec h niqu e s like electrophoresis, f l u or o m etr y , f lame p h otome t ry have been recognize for first time. Instr u m ental t e ch n iques like U V s pect r o s co p y , gas liquid chr om at o gr a p h y have been used. Li m it te s t f or m ic r obial conta m i n ation has been m en t ioned f or new frequently used Pharmaceutical Aids . The pyrogen test has been revised to make the test less time consuming. Dissolution test has been introduced in the case of certain tablets. Disin t e gr a tion te s t has be e n a m en d ed b y m o d ifyi n g th e design o f the apparatus and method of testing.

31. Salient Features of Fourth edition of IP The computer generated structural formulae have been introduced. Infrared and ultra red absorption spectrophotometric tests for identification of drug substances have been introduced as alternative test to the classical chemical test. The infrared reference spectra of a number of drugs have been given in appendix. Number of general monographs like eye drops, eye ointment, creams, nasal preparations, suppositories, pessaries, oral liquids have been included. Some titles have been changed to include the more commonly accepted names of India for example hyoscine hydrobromide for scopolamine hydrobromide. Salient Features of Fifth edition of IP General chemical test for identification have been almost eliminated and most specific infrared and ultraviolet spectrophotometric test have been given. The test for pyrogens involving the use of animals has been virtually eliminated. Test for bacterial endotoxins has been introduced. The test for abnormal toxicity is confined (compulsory) to certain vaccines. The use of chromatographic methods been extended in essays to large number of p harmaceutical products. Labelling and storage are featured at the end of a monograph. Limit of bacterial contamination has been introduced for controlling the microbial quality of all medicinal products.

32. Salient Features of Sixth edition of IP The no. of monographs of excipients, anticancer dru g s, herb a l products and antiretroviral drugs has been increased. Mono g r a phs o f va c ci n e s and immun o sera are u p g r a ded i n v i ew of development of latest technology in the field. A new chapter on liposomal products and monograph of liposomal amphotericin B is added. Chapter on NMR is incorporated in Appendices. The chapter on microbial contamination is updated to meet the international requirements. Standards for new drugs and drugs used under National Health Programs are added and the drugs as well as their formulations not in use nowadays are omitted from this edition. Salient Features of Seventh edition of IP This edit i on includes ad v a nced technology and exper i m en t a l m et h o d s widely adopted in India and A broad. Drugs and their formulations not in use now a days are omitted. 19 new Radiopharmaceutical Monographs and one general chapter is first time being included in this edition. This edition is presented in four volumes. It incorporates 2550 monographs of drugs out of which 577 are new monographs consisting of APIs, excipients, dosage forms, antibiotics monographs, insulin products and herbal products .

33. Salient Features of Eighth edition of IP This edition has been brought into four volumes. Standards for new drugs and drugs used under National Health Programs are included. 5 3 new Fixed Dose Combi n a tions (FDCs) h a v e been i n c luded, out of which 25 FDC monographs are not available in any Pharmacopoeia. More emphasis is given on infrared and ultraviolet spectrophotometer and HPLC tests. The use of chromatographic methods has been greatly increased to identify the nature and extent of impurities in ingredients and products.

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