University, Bhopal) 2 Assistant Professor (Sagar Institute of Pharmacy & Technology, Bhopal) 1.1 INTRODUCTION: Profession of Pharmacy is a noble profession as it is indirectly healing the persons to get well with the help of medical practitioners and other co-professionals. Government has restricted the practice of Pharmacy to only Profession Pharmacists i.e registered Pharmacist under the Pharmacy Act 1948. PCI framed the following ethics for Indian Pharmacists, which may be categorised under the following headings: 1.

Pharmacist in relation to his job. 2. Pharmacist in relation to his trade. 3. Pharmacist in relation to medical profession. 4.

Pharmacist in relation to his profession. CODE OF ETHICS AS DRAFTED BY PHARMACY COUNCIL OF INDIA (P.C.I.) Ethics is defined as ‘code of moral principles’. It emphasizes on the determination of right or wrong while doing one’s duty.

Code of Pharmaceutical Ethics as formulated by Pharmacy Council of India which are meant to guide the pharmacist as to how he should conduct himself (or herself), in relation to himself (or herself), his / her patrons (owner of the pharmacy), general public, co-professionals etc. and patients 1.2 HISTORY OF PHARMACY EDUCATION IN INDIA Early Pharmacy Education: The evolution of pharmacy education in India can be traced to first pharmacy course started in 1860 in Madras Medical college in which art of compound, dispensing and labeling of drugs were taught. Later, a two years diploma course of Chemists and Druggists was started in Madras Medical College and Vishakapatnam in 1937 with subjects of Materia medica, Chemistry and Practical Pharmacy. Compounder course was started in Bengal, Bihar, Bombay and United Provinces (now called as Uttar Pradesh).

Modern Pharmacy Education: First degree level pharmacy course (B.Sc Pharmaceutical chemistry 2 years course) was started in Banaras Hindu University (BHU) in 1932 under the pivotal role of Prof. Mahadev Lal Schrof, for which he is regarded as Father of modern education. In 1950, Department of pharmacy was started at Birla college (Now called as BITS, Pilani) by Prof.

M.L.Schroff. University of Sangar, University of Nagpur also followed the same footsteps by starting B.Pharm course. In 1940, M.Pharm course (one year duration) was started in Banaras Hindu University.

The course duration was increased to 1.5 years in 1952-53. Other universities which started M.Pharm are Punjab Univerrsity, Andhra University, University of Sangar, University of Madras, Birla college, SMS Medical college (Jaipur). Later, Doctor of Philosophy (research programme) was also started in pharmacy. 1.2.1 Pharmacy Education- Current Scenario and Future prospects: The origin and development of pharmacy education in India over the past 150 years is indicative of continuous changes with the time.

Nevertheless, pharmacy education has to keep pace with the emerging sceanario as there has been tremendous change in the number of drugs prescribed, methods of manufacturing, introduction of computers in drug designing and the current emphasis on the development of novel drug delivery systems. In the period of 1980s and 1990s there was great misuse of drugs which resulted in harmful consequences, poor wealth outcomes, resistance, adverse reactions. All these created a demand for the setup of special body of branch of pharmacy which could bring about safe and effective use of drugs.

As a result an improvised and collective branch of pharmacy called clinical pharmacy came into existence which required the pharmacists to work in close collaboration with the physicians. The ideology of clinical pharmacy is to impart immense knowledge to the hospital as well as community pharmacists in understanding the patient compliance and their necessities. The clinical practice metamorphed the Indian Pharmacy profession such that it played a significant role in healthcare system rather than being confined Only to technical or industrial level.

The pharmaceutical courses currently offered in India are broadly classified into: Diploma in pharmacy(D.Pharm), Bachelor in Pharmacy (B. Pharm), Doctrine of Pharmacy (Pharm.D), Master in Pharmacy (M. Pharm), Doctor of Philosophy (Ph.

D). The pharmacy education is under the dual control of All India Council of Technical Education (AICTE) and Pharmacy Council of India (PCI) which are responsible for maintaining the academic standards. 1.2.2 HISTORICAL BACKGROUND AND DEVELOPMENT OF PROFESSION OF PHARMACY AND PHARMACEUTICAL INDUSTRY Pharmaceutical Industry in India: 1. For the First time in India, a chemist shop was opened in 1811 in Calcutta by Mr.

Bathgate who came to India through East India Company. In 1910, this form started manufacture of Tinctures and spirits. 2. Another firm, Smith Stanistree and Co., started Apothecary shop in 1821 and commenced the manufacturing in 1918. 3.

Bengal Chemicals and Pharmaceutical Works, a small factory was started in Calcutta in 1901, by Acharya Prafulla Chandra Roy 4. In 1903, under the leadership of Prof. T.K.

Gajjar, a small factory at Parel was started which led to the development of other pharmaceutical units, like Alembic Chemical Works Ltd., at Baroda. 5. The other relatively big units added during the early part of the centuary were the Sarabhai Chemical works, Bengal Immunity Laboratory and a few governmental laboratories for the manufacture of vaccines and sera. 6. Modern Drug Research in India started in 1920, when Sir Ramnath Chopra setup an active research centre at the school of Tropical medicine in Calcutta. 7.

The efforts of Dr. Upendranath Brahmachari at the Camp-bell Medical School, Calcutta led to the introduction of Urea Stibamine in 1922 for the treatment of Kala-Azar. 8. During World war-I, when the local demand of allopathic medicines increased sharply and imports got completely cut off, a number of foreign and National residents who had experience in Ayurvedic preparations started manufacturing simple cough syrups, tablets and capsules. 1.2.3 Industry and organization Presently, Indian Pharmaceutical Industry is estimated to a $10 billion industry with drastic Industry expansion in the last two decades.

Pharmaceutical Industry in India is highly competitive sector with more than 23,000 registered units of which 300 are large scale companies and 10,000 small companies including 5 central public sector units. Leading 300 pharmaceutical companies contribute to 70% of the total Indian pharmaceutical industry produces 70,000 different drugs and the most important segment of domestic market is the anti-infectives accounting for one-quarter of total turnover followed by cardiovascular preparations, cold remedies and pain killers each accounting for one-tenth f the total turnover. It registered 14% growth rate in bulk drugs and 20% growth rate in formulations during 2007-2008.

Indian Pharma Industry has grown consistently at 9.5% CAGR compared to 7% annual growth rate of the world market. The Indian Pharmaceutical Industry has witnessed a robust growth over the past few years moving on from a turnover of approx. US $ 1 billion in 1990 to over US $30 billion in 2015 of which the export turnover is approximately US $ 15 billion.

The country now ranks 3rd world wide by volume of production and 14th by value, thereby accounting for around 10% of world’s production by volume and 1.5% by value. Globally, it ranks 4th in terms of generic production and 17th in terms of export value of bulk actives and dosage forms. Indian exports are destined to more than 200 countries around the globe including highly regulated markets of US, West Europe, Japan and Australia.

It has shown tremendous progress in terms of infrastructure development, technology base creation and a wide range of products. It has established its essence and determination to flourish in the changing environment. The industry now produces bulk drugs belonging to all major therapeutic groups requiring complicated manufacturing technologies.

Formulations in various dosage forms are being produced in GMP compliant facilities. Strong scientific and technical manpower and pioneering work done in process development have made this possible. Recognizing the potential for growth, the Government of India took up the initiative of developing the Indian Pharmaceuticals sector by creating a separate Department in July 2008.

The Department is entrusted with the responsibility of policy, pIanning, development and regulation of Pharmaceutical Industries. An assessment of the Indian Pharmaceutical Industry's strength reveals the following key features: • Strong export market- India exported drugs worth US$ 15 billion to more than 200 countries including highly regulated markets in the US, Europe, Japan and Australia. Large Indian pharma companies have emerged as among the most competitive in the evolving generic space in North America and have created an unmatched platform in this space.

Indian companies are also making their presence felt in the emerging markets around the world, particularly with a strong portfolio in anti-infective and antiretroviral. • Large domestic pharma companies have continued to grow, assuming leadership position in many therapies and segments in the Indian market as well as creating a strong international exports back-bone. • Competitive market with the emergence of a number of second-tier Indian companies with new and innovative business modules. • Indian players have also developed expertise in significant biologics capabilities. • Biologic portfolios while still nascent in India are being built with an eye on the future. • Multinational companies have continued to invest significantly in India and are making their presence felt across most segments of the Indian pharma market. Companies have also begun to invest in increasing their presence in tier II cities and rural areas and making medical care more accessible to a large section of the Indian population. • Low cost of production. • Low R&D costs. • Innovative Scientific manpower. • Excellent and world-class national laboratories specializing in process development and development of cost-effective technologies. • Increasing balance of trade in Pharma sector. • An efficient and cost effective source for procuring generic drugs, especially the drugs going off patent in the next few years. • An excellent center for clinical trials in view of the diversity in population. Experience & Expertise India is the only country with largest number of US-FDA compliant plants (more than 262 including APIs) outside of USA.

We have nearly 1400 WHO-GMP approved Pharma Plants, 253 European Directorate of Quality Medicines (EDQM) approved plants with modern state of the art Technology. No other country can boast of such an infrastructure. Thus Indian pharma companies have a wide variety of experience in manufacturing as per global standards.

Through intensive competition in the Indian market, Indian companies are experienced in the manufacturing of a variety of formulations that makes them efficient and competitive in their operations. The Indian pharma market is mature with decades of experience in generics manufacturing, catering to the needs of the general population. These companies have the experience and know-how to produce quality drugs in an efficient, high-quality and cost-effective manner without compromising on any aspect.

There are many companies manufacturing drugs for oncology, AIDS and other complex therapies. Low cost of manufacture India is capable of manufacturing low-cost generic alternatives due to a number of economic factors favoring the industry. Some of these include the competitive land rates, the cheap labor available, low resource costs like water, electricity etc., lower cost of production machinery.

Importantly, the various drugs like, Intermediates, APIs and Formulation companies are seamlessly integrated while following international regulations of safety. Research & Development The Government has taken several policy initiatives for strengthening Research & Development in Pharmaceuticals sector such as fiscal incentives to R&D units sector and streamlining of procedures concerning development of new drug molecules, clinical research and new drug delivery systems leading to new R&D set-ups with excellent infrastructure in the field of original drug discovery. India has a large branded generics market which enables most companies to launch their version of a generic drug in the market place.

Research and Development is an important aspect for development of generics that match the quality and cost targets. India is now increasingly recognized as a strategic partner in the drug discovery value chain. Further, there are Indian companies which are investing in their R&D centers and are offering early stage discovery services as well as promising molecules.

A large scientific pool in India is dedicated to Research and Development of patent non-infringing methodologies for drugs. Highly educated, specialized scientists India's rich human capital is the strongest asset for the Indian Pharmaceuticals Industry which is a knowledge-led industry. Various studies show that the scientific talent pool of Indians is the second largest English-speaking group worldwide, after the US.

This enables easier access to qualifications that handle the basic work in a plant or an R&D set-up in India. National Institute of Pharmaceutical Education and Research (NIPER) at Mohali is a premier institute in the field of Pharmaceuticals. The institute is a member of Association of Commonwealth Universities.

NIPER Mohali is offering Masters level programs and PhD programs in 15 streams. The laboratories here are fully equipped with modern facilities and the available facilities are of international level and standards. Further, six new National Institutes of Pharmaceutical Education and Research (NIPER) were opened in 2007.

Recently, three new NIPERs have been proposed in the states of Maharashtra, Rajasthan and Chattisgarh. Experience in International Servicing Many of the Indian pharmaceutical companies are experienced in servicing top multinational companies for their highly regulated markets, meeting their stringent quality expectations. The same experience enables Indian organizations to cater to the needs of the regulatory authorities of most nations across the world.

Further, technical consultancy capability of NIPERs is contributing to the growth of the industry. Indian clinical trials industry has developed a complete gamut of clinical research services capabilities of global standards. From medical writing to site management, data management, regulatory submissions to patient recruitment the expertise meets the highest standards of stringent regulatory conditions internationally.

There is an effective control system to monitor the quality of pharmaceuticals at all the levels in India. There are various agencies/ bodies under Ministry of Health & Family Welfare and Department of Pharmaceuticals. They are responsible for standard of drugs, market authorizations, import licenses, cGMP, monitoring of quality of drugs & cosmetics manufactured, pre & post licensing inspection, and price control etc.

The recent initiatives through new legislations and optimized processes are targeted towards regulating the industry better and effectively. Drugs have to comply with stringent quality provisions under the Drugs and Cosmetic Act of India. Any drug including API confirms to the specifications of the prescribed pharmacopeias or those claimed on the label ensuring that all the products manufactured in India are of highest quality.

All the pharmaceutical products are inspected at the customs port of the country by competent authorities before they are shipped out. 1.3 About the Profession of Pharmacy Pharmacy is a profession that involves the art and science of preparing medicines from natural and synthetic sources for disease treatment and prevention. It covers the identification, selection, synthesis, pharmacological action, and formulation of drugs and medicines. Pharmacy ensures the proper, safe distribution and appropriate use of drugs. 1.3.1 Pharmacy as a career Pharmacy is a vast profession with diverse career opportunities in different sectors: 1.

Community Pharmacy a. Pharmacists can open retail drug stores to serve the community. b. Large pharmacies employ multiple pharmacists to manage operations efficiently. 2.

Wholesale Pharmacy a. Pharmacists can run wholesale businesses, supplying drugs and medicines in bulk. 3. Industrial Pharmacy a.

The pharmaceutical industry offers various job roles across all educational levels: i. Production – Manufacturing medicines and ensuring quality standards. ii. Analytical & Quality Control – Testing drug purity, safety, and efficacy. iii.

Research & Development (R&D) – Innovating and formulating new drugs. iv. Marketing & Sales – Promoting and selling pharmaceutical products. Production b.

Pharmacists work as manufacturing chemists, supervising the production of pharmaceutical formulations. c. They oversee packaging, labeling, and storage of medicines. Analytical and Quality Control ▪ Responsible for testing raw materials and finished products to ensure quality. ▪ Pharmacists with a bachelor's degree often work as analytical chemists.

Research and Development (R&D) ▪ Pharmacists with master’s or doctorate degrees are suited for product development. ▪ Key R&D areas include: ▪ Synthesizing new drug compounds. ▪ Cultivating medicinal plants. ▪ Isolating and purifying active ingredients. ▪ Developing and testing drug formulations. ▪ Studying drug stability and determining expiry dates. ▪ Analyzing packaging materials for drug safety. Marketing and Sales ▪ Pharmacists bridge the gap between drug manufacturers and consumers. ▪ They play a key role in promoting and distributing pharmaceutical products. 4. Health System Pharmacy ▪ Pharmacists work in hospitals, clinics, and nursing homes to: i.

Dispense medications. ii. Prepare sterile solutions. iii. Advise professionals and patients on drug use. iv.

Monitor drug regimens. 5. Nuclear Pharmacy a. Specializes in preparing radioactive drugs for diagnosis and treatment. 6.

Pharmaceutical Education a. The growing demand for pharmacists has increased opportunities in teaching and training in pharmacy colleges. 7. Pharmaceutical Journalism a.

Pharmacists with writing and editing skills can contribute to medical publications, journals, and drug reference guides. 8. Drug Control Administration

• Operates at both central and state levels to regulate drugs and cosmetics.
• The Drugs and Cosmetics Act establishes key agencies for drug control:
• Advisory Agency: Includes Drug Technical Advisory Board and Drug Consultative Committees, advising on drug regulations.
• Analytical Agency: Includes Central and State Drug Laboratories, responsible for testing and analysis of drugs and cosmetics.
• Licensing Authority: Appointed by the central government to issue import licenses for drugs. 9. Drug Control Administration
• Pharmacists can work in national and state pharmacy associations and regulatory boards.
• Opportunities exist in Pharmacy Council of India (PCI) and All India Council for Technical Education (AICTE) for experienced pharmacists in policy-making and education. Fig 1:- Scope of Pharmacy Supplement to the British Pharmacopœia. The term "List" was somewhat misleading, as the book not only provided a list of important medicinal drugs but also set quality standards. It included around 180 monographs and several appendices, following the format of the British Pharmacopœia. The Indian Pharmacopœial List included around 100 monographs on medicinal plants found in India and their preparations, known as galenicals. It featured plant-based drugs such as artemisia, bael, berberis, cannabis, ispaghula, kaladana, kurchi, myrobalan, picrorhiza, punarnava, rauwolfia, and vasaka. Several medicinal oils, including ajowan, cassia, chaulmoogra, neem, and pudina,

were also included. The appendices provided detailed procedures for various tests mentioned in the monographs. In February 1947, the Pharmaceuticals and Drug Research Committee of the Council of Scientific and Industrial Research (CSIR) decided to create a "Brochure" to highlight information and clinical uses of important Indian medicinal plants.

However, they later opted to develop a "Codex" instead, modeled after the British Pharmaceutical Codex. The first Indian Pharmaceutical Codex was published in 1953 and was divided into two parts. The first part contained about 190 monographs on natural products, including plant- and animal-based drugs, along with some chemicals.

The second part provided formulations for galenical preparations and other medicinal products. The first edition of Pharmacopoeia of India was published in 1955: 1.5.2 Salient Features of the First Edition of Pharmacopœia of India (1955)- 1. Monograph titles are in Latin, with abbreviated and English titles listed below for reference. 2.

Weights and measurements follow the metric system, and dosages are given in both metric and imperial units. 3. Each monograph sets the official standards for the listed substances. 4. Some monographs include a list of related drug preparations at the end. 5.

Temperatures are in degrees Celsius, and solubility is described using terms like very soluble, sparingly soluble, or practically insoluble when exact values are unknown. After the first edition of the Pharmacopoeia of India was published, the Indian Pharmacopoeial Committee was restructured. The Committee then compiled a supplement to the first edition, which was released in 1960.

To assist in preparing the second edition, the Committee formed subcommittees and working groups. The second edition of the Pharmacopoeia of India was published in 1966, followed by a supplement in 1975. Salient Features of the Second Edition of Pharmacopœia of India (1966 & 1975)- 1.

Monograph titles have been changed from Latin to English, with the drug name appearing first (e.g., Injection of Aminophylline is now Aminophylline Injection). 2. Dosages are now expressed only in the metric system. 3. Solubility is specified in parts of solvent per unit part of solute. 4.

Drug preparations are listed immediately after the monograph of the main drug. 5. Updates include improved sterility tests (now detecting fungi as well), new analytical methods like non-aqueous titrimetry and column chromatography, and a "Usual Strength" section for tablets and injections. In 1979, the Government of India, Ministry of Health and Family Welfare, reorganized the Indian Pharmacopoeia Committee to work on the third edition of the Pharmacopoeia of India.

To help with the compilation, subcommittees and working groups were formed. The third edition was later published by the Government of India in 1985. Salient Features of the Third Edition of Pharmacopœia of India (1985)- 1.

New testing methods like Flame Photometry, Fluorometry, Electrophoresis, and Photometric Hemoglobinometry have been introduced for certain chemical analyses. 2. Dissolution Test has been added for some tablets, and the Disintegration Test has been improved with changes in equipment and testing methods. 3. New tests have been introduced, including a Microbial Limit Test for some medicines and a faster Pyrogen Test.

Gas Liquid Chromatography is now used to measure alcohol content, and viscosity testing has been improved with the Ostwald Viscometer. 4. A new section on Water for Pharmaceutical Use defines standards for purified water, water for injection, and sterile water. 5. Some drug names have been updated (Acetylsalicylic Acid to Aspirin), and the third edition includes many new drugs while removing some older ones.

In 1991, the Government of India, Ministry of Health and Family Welfare, reconstituted the Indian Pharmacopoeial Committee for five years to prepare the fourth edition of the Pharmacopoeia of India. Subcommittees and working groups were formed to speed up the process. The finalized monographs, appendices, and general notes were published as the fourth edition in 1996.

Salient Features of the Fourth Edition of Pharmacopœia of India (1996)- 1. The fourth edition has 1,149 monographs and 123 appendices, published in two volumes. 2. Computer-generated structural formulas have been introduced, and some drug names have been updated to reflect common usage in India (e.g., Hyoscine Hydrobromide instead of Scopolamine Hydrobromide). 3.

New identification methods using Infra-red and Ultraviolet spectrophotometry have been added, along with Infra-red reference spectra in an appendix. 4. High-Performance Liquid Chromatography (HPLC) is now widely used for drug analysis, replacing older, less accurate methods (e.g., Insulin’s biological assay is now done using HPLC). 5. New general monographs for various dosage forms (eye drops, nasal preparations, oral liquids, etc.) have been included, and certain tests (e.g., for bacterial endotoxins and particulate matter in injections) have been updated for better accuracy.

After the fourth edition of the Indian Pharmacopoeia was published in 1996, an addendum was released in 2000 to keep up with advancements in pharmaceutical sciences and technology. To further update the official compendium, Addendum 2002 was introduced, maintaining continuous page numbering with the 1996 edition and the 2000 addendum. The key updates included: 1.

Revision of several monographs with updated tests and standards. 2. Replacement of the pyrogen test with the bacterial endotoxin test. 3. Addition of a new appendix on residual solvents to monitor organic volatile impurities in pharmaceutical substances. 4.

Replacement of the HPLC appendix with an updated version covering ion chromatography. 5. Introduction of monographs for anti-retroviral drugs and their formulations. 6. Revision of vaccine monographs for Hepatitis B and Rabies.

On March 22, 2005, the Indian Pharmacopoeia Commission (IPC) was established by the Government of India, Ministry of Health and Family Welfare. Later, in 2007, the fifth edition of the Indian Pharmacopoeia was published. Salient Features of the Fifth Edition of the Indian Pharmacopoeia (2007 & 2010)- 1.

Structure & Content: Both editions are presented in three volumes covering drug substances, dosage forms, pharmaceutical aids, vaccines, herbal products, blood-related products, biotechnology, and veterinary medicines. The 2010 edition expanded to include 2,000 monographs, with 287 new additions and over 600 updates. 2. Analytical Advancements: Traditional chemical identification tests have been mostly replaced with infra-red and ultraviolet spectrophotometric tests.

Chromatographic methods, especially liquid chromatography, have been widely adopted for assays and impurity tests. 3. Microbial & Toxicity Testing: The pyrogen test using animals has been virtually eliminated, and the bacterial endotoxin test is now used for more items. The test for abnormal toxicity is now limited to certain vaccines.

A chapter on microbial contamination was extensively updated to align with international standards. 4. Expanded Scope & New Additions: The 2010 edition introduced new sections on biotechnology products, indigenous herbs, veterinary vaccines, and antiretroviral drugs. A chapter on liposomal products was added, along with a monograph on Liposomal Amphotericin B Injection. 5.

Quality & National Health Programs: Standards for new drugs and drugs used in National Health Programs were introduced. Many outdated drugs and formulations were removed, and excipients, anti-cancer drugs, herbal medicines, and antiretroviral drugs saw an increase in monographs. The 6th edition of Indian Pharmacopoeia was published in 2010 by Indian Pharmacopoeia Commission.

Salient Features of the Sixth Edition of Pharmacopoeia of India (2010)- 1. Three-Volume Structure:

• Volume I covers general chapters, introduction, and IPC structure.
• Volume II includes dosage forms, drug substances, and pharmaceutical aids (A-M).
• Volume III contains more dosage forms (N-Z), along with vaccines, herbal products, blood-related products, biotechnology, and veterinary medicines. 2. Expanded & Updated Content:
• Includes 2,000 monographs, with 287 new and 600+ updated monographs.
• Added liposomal products with a monograph on Liposomal Amphotericin B Injection. 3. Improved Testing & Analysis:
• Infra-red and ultraviolet spectrophotometry replaces traditional chemical tests.
• Many assays now use liquid chromatography for better accuracy.
• A new NMR chapter is included in the appendices. 4. Enhanced Safety Standards:
• Animal-based pyrogen testing is almost eliminated.
• Bacterial endotoxin tests are applied to more products.
• The abnormal toxicity test is now only for specific vaccines. 5. Broader Scope & International Alignment:
• Now includes biotechnology products, herbal medicines, veterinary vaccines, and antiretroviral drugs.
• Microbial contamination guidelines updated to match global standards.
• Outdated drugs and formulations removed to keep the list relevant. The 7th edition of the Indian Pharmacopoeia has been published by the Indian Pharmacopoeia commission in 2014 on behalf of the Government of India, Ministry of Health and Family Welfare. Salient Features of the Seventh Edition of Indian Pharmacopoeia (2014)- 1. Expanded to Four Volumes:
• Includes a separate Volume IV for veterinary medicines.
• A new chapter on cell cultures for veterinary vaccines is added. 2. More Monographs & Revisions:
• Contains 2,548 monographs, with 577 new ones covering APIs, excipients, dosage forms, and herbal products.
• Includes 19 monographs on radio-pharmaceuticals and a new chapter on the topic. 3. Updated Testing Standards:
• Chemical identification tests are replaced by infra-red, ultraviolet, and HPLC tests.
• Bacterial endotoxin testing replaces the old pyrogen test using animals. 4. Harmonization with International Standards:
• Water for injection and purified water monographs are upgraded to match global guidelines.
• Microbial contamination standards are revised to meet international requirements. 5. Focus on Relevant Drugs:
• New drugs and those under National Health Programmes are included.
• Outdated drugs and formulations no longer in use have been removed. The 8th edition of the Indian Pharmacopoeia has been published by the Indian Pharmacopoeia commission, including the Central Drugs Standard Control Organization (CDSCO) and the State Drugs Controllers in 2018. Salient Features of the Eighth Edition of Indian Pharmacopoeia (2018)- 1. New Monographs: The IP 2018 includes 344 new monographs, taking the total to 1,924 monographs. 2. Revised Monographs : 433 monographs were revised to align with international standards and updates in pharmaceutical technology. 3. New Chapters : New chapters were added on topics like pharmaceutical impurities, analytical validation, and biotechnology-derived products. 4. Updated Appendices : The appendices were updated to include new tables, figures, and guidelines. The Indian

Pharmacopoeia Commission (IPC) proudly presents the ninth edition of the Indian Pharmacopoeia (IP 2022), which replaces the eighth edition. This edition features updated standards to ensure the quality, safety, and efficacy of pharmaceutical substances, dosage forms, and pharmaceutical aids. Objectives of the Ninth Edition of Indian Pharmacopoeia (2022 )- 1.

Provide standards for the quality of pharmaceutical substances and products. 2. Ensure the safety, efficacy, and quality of medicines. 3. Facilitate the regulation of pharmaceuticals in India. 4.

Promote the use of modern analytical techniques. 1.6 British Pharmacopoeia (BP)

• The British Pharmacopoeia (BP) is the official drug standard for the United Kingdom, updated annually.
• It provides quality standards for medicines used in research, development, manufacturing, and testing. Key Editions of British Pharmacopoeia 1. 1st Edition (1864):
• Had two sections: ■ Part I: Materia Medica (study of medicinal substances). ■ Part II: Preparation & Compounds (formulations). 2. Subsequent Editions:
• 2nd Edition (1867)
• 3rd Edition (1885)
• 4th Edition (1898)
• 5th Edition (1914) 3. 8th Edition (1953):
• Drug names changed from Latin to English.
• Introduced the metric system for measurements. 1.7 European Pharmacopoeia The European Pharmacopoeia Commission started in 1964 to set quality standards for medicines in Europe. The first edition was published in 1969, and updates are released regularly. Key Editions of the European Pharmacopoeia- 1. 1st Edition – 1969 2. 2nd Edition – 1980 3. 3rd Edition – 1997 4. 4th Edition – 2001 ( Effective from 1 January 2002 ) 5. 5th Edition – 2004 ( Effective from 1 January 2005 ) 6. 6th Edition – 2007 ( Effective from 1 January 2008 ) 7. 7th Edition – 2010 ( Effective from 1 January 2011 ) 8. 8th Edition – 2013 ( Effective from 1 January 2014 ) 9. 9th Edition

– 2016 10. 10th Edition – Released in July 2019. 1.7 United States Pharmacopoeia (USP) The United States Pharmacopeia is a pharmacopeia for the United States published annually by the United States Pharmacopeial Convention, a nonprofit organization that owns the trademark and also owns the copyright on the pharmacopeia itself.

• The first edition of United States Pharmacopoeia was published by United States Pharmacopeial Convention on December 15th, 1820 in both Latin and English.
• It listed 217 drugs considered worthy of recognition.
• It was earlier revised every 10 years but after 1940, the convention decided that it must be revised after every 5 years.
• Interim supplements were issued whenever necessary to maintain satisfactory standards.
• USP XIX (1975) was the last USP to be published individually as subsequent editions were published in combination with the National Formulary. 1.8 Extra Pharmacopoeia (MARTINDALE) Martindale contains information on drugs in clinical use worldwide, as well as selected investigational and veterinary drugs, herbal and complementary medicines, pharmaceutical excipients, vitamins and nutritional agents, vaccines, radiopharmaceuticals, contrast media and diagnostic agents, medicinal gases, drugs of abuse and recreational drugs, toxic substances, disinfectants, and pesticides.
• It is published by the Royal Pharmaceutical Society of Great Britain and was first published in 1883 by William Martindale.
• It is an authoritative reference book on drugs and medicines users.
• It aims to provide practicing pharmacists and physicians with up to date information on al drug substances, official, unofficial & propriety that are currently used in pharmacy REFERNCES:- 1. Hajare Dr. Ashok “Pharmaceutics” Pharmacy profession and Pharmacopoeia,Vallabh Prakashan 2. Singh Harkishan HOP, Vol 2: Pharmaceutical Education 3. Gupta, Ashok K “Introduction to Pharmaceutics-1” CBS Publishers 4. Mehta R.M “Pharmaceutics-I, Vallabh Prakashan 5. Harkishan Singh “ Pharmaceutical History of India ” 6. Jain N.K., S.N. Professional Pharmacy, Vallabh Prakashan 7. Indian Pharmacopoeia Commission http://www.ipc.gov.in/ 8. Patidar Dindayal, Pharmaceutics -1, Shree Sai Prakashan.