Pharmaceutical Books

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Indian Pharmacopoeia 2022: Published By Indian Pharmacopoeia Commission (IPC)

Effective Date : 1st December 2022 (Tentative)

Salient Features:

◗ New Monographs: 92 APIs: 27 Dosage Forms (Chemicals): 33
◗ Vitamins, Minerals, Amino acids, Fatty Acids etc.: 21
◗ Biotechnology Derived Therapeutic products: 03
◗ Herbs & Herbal Products: 02
◗ Blood & Blood Related Products: 02
◗ Vaccines and Immunosera for human use: 04
◗ New General Chapters: 12

The Indian Pharmacopoeia (IP) is published by the Indian Pharmacopoeia Commission (IPC) on behalf of Ministry of Health & Family Welfare, Government of India to fulfil the requirements of the Drugs and Cosmetics Act 1940. IP prescribes the official standards for drugs produced and/or marketed in India and thus contributes in the control and assurance of the quality of the medicines. The standards of the IP are authoritative and legally enforceable. It intends to help in the licensing of manufacturing, inspection and distribution of medicines in our country.

IP 2022 contains a total of 92 new monographs including 60 Chemical, 21 Vitamins, Minerals, Amino acids, Fatty acids etc., 3 Biotechnology-derived Therapeutic Products, 4 Human Vaccines, 2 Blood and Blood Related Products, 2 Herbs and Herbal Related Products, and 7 Phytopharmaceutical Ingredient Category monographs. This has led to the total number of 3152 monographs in the current edition of IP. In additions, 12 new general chapters have also been introduced.

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The Japanese Pharmacopoeia is the pharmaceutical standard that the Japanese Minister of Health, Labour and Welfare (MHLW) establishes to regulate the properties and quality of drugs.

As with other pharmacopoeias, the document is revised periodically. The 18th edition (JP18) came into effect on June 7, 2021. The text is originally prepared in Japanese and translated to English after the publication of the Japanese version. This usually is done within one year. According to the publication schedule, Supplement I to JP18 is to be published in December 2022 and Supplement II in 2024. It is planned that the 19th edition will be published in 2026.

_{Content of JP18 English Version}

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Available to order from July 2022 / Effective from 1 January 2023

The European Pharmacopoeia (Ph. Eur.) is the primary source of official quality standards for medicines and their ingredients in Europe. Ph. Eur. standards provide a scientic basis for the quality control of a product throughout its life cycle, supporting the pharmaceutical industry and healthcare systems.

As laid down in the Council of Europe Convention on the Elaboration of a European Pharmacopoeia and in European Union and national pharmaceutical legislation, these standards are legally binding. They become mandatory on the same date in all states parties to the convention.

•  New edition, legally binding in 39 European countries as of 1 January 2023 and applied in more than 130 countries worldwide.
• Continually updated and modernised to meet users' needs. 
• The 11th Edition of the Ph. Eur. contains:
  • 2 469 monographs (including dosage forms);
  • 386 general texts (including general monographs and methods of analysis);
  • and more than 2 800 descriptions of reagents.
• Released in July 2022 and will be updated with eight periodic supplements over the following three years (11.1 to 11.8).

• three initial volumes (11.0), followed by eight non-cumulative supplements (11.1 to 11.8);
• available in either English or French;
• now with QR codes for easier linking to the Knowledge database for each monograph and general chapter;
• contains a subscription key (EPID code) giving access to the Ph. Eur. online archives.

Note that the 11th Edition print version will no longer contain change marks in revised and corrected texts.

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• Amended extracts from the Human Medicines Regulations 2012 relating to:
• manufacture, importation and assembly
• wholesale dealing
• brokering medicine
• manufacturing, importing and distributing active substances

• The Code of Practice for Qualified Persons, Guidance on Manufacture and Importation
• UK guidance on complying with the EU guidelines on Good Distribution Practice for wholesale distributors and brokers of medicines and manufacturers, importers and distributors or active substances
• UK guidance on: risk-based inspections, conditions of holding a manufacturer’s licence, wholesale dealer’s licence, a broker registration and an active substance registration, and controls on certain medicinal products.

• conditions of holding a manufacturing authorisation for investigational medicinal products,
• importing guidance for investigational medicinal products from countries on a list to Great Britain,
• Pharmaceutical Quality System expectations and Authorisation requirements for investigational medicinal products importation oversight,
• list of approved countries for import,
• pharmacovigilance for wholesalers,
• the naming of sites on a wholesale dealer’s licence,
• self-inspection for wholesale dealers and the responsible person for import.

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The pharmaceutical industry today is faced with significant challenges owing to the volatile and competitive business environment. For both survival and growth, it is imperative for pharmaceutical organizations to rethink their way of doing business, especially their marketing.

            The book 'Strategic Pharmaceutical Marketing' thus, focuses on the practice of marketing prescription medications. It highlights the political, economical, social, technological and regulatory perspectives of pharmaceutical marketing, examines consumers, prescribers and explores positive marketing, pricing and distribution strategies. It provides a detailed explanation of pharmaceutical marketing as well as provides real-world case studies to demonstrate certain aspects.

            The book is scripted from an industry and academic perspective. It allows pharmaceutical marketers to have a detailed understanding of the functions of pharmaceutical marketing thus, helping them plan their marketing strategies in a more accurate and precise way.

            Individuals entering the field of marketing pharmaceutical products - sales personnel, assistant product managers, marketing staff as well as policy makers will achieve an in-depth understanding of the pharmaceutical industry. The marketing models described in the book along with promotion, distribution, and pricing scenarios, competitive analysis and market research will benefit the pharmaceutical marketer as a whole.

            The book would provoke you to think of the surface and latent problems in new ways, find out different and more imaginative solutions and reflect on different options for tomorrow to scope with the chang ing situations.

            The book also deals with pharmaceutical marketing financial analysis to help measure the success of the marketing decisions and return on investment.

            This book, written in a reader-friendly style will help the marketers and CEOs of the pharmaceutical industry to bring about synergy in their strategies and operations, by thinking about the options, and looking at innovation as an important ingredient for progress. It will also help to generate cost-effective and new marketing approaches. Professionals in healthcare as also marketing executives in other industries will also find the book useful.

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The global generic drug industry is robust and growing. The total value of the global generic drug industry has crossed $900 billion in 2016, and is poised to cross the coveted $1 trillion soon. However, the generic sector is not very concentrated, with the top ten global generic companies accounting for about only 38 percent of the total value. Furthermore, only four companies — Mylan, Teva, Sandoz, Pfizer (General and Established Products) Generics division, and Sun Pharma, have a truly global presence. Why is it that only four out of the many generic drug companies are global, and the rest are not? What are the success secrets of these companies? Do they have a separate Success DNA? A Code for winning in the global generic drug markets? Can any of the other companies become global?

CRACKING THE GENERICS CODE unravels the mystery of the DNA for success in the international generic drug markets. It, as the title, suggests cracks the code to succeed in the global generic drug markets. The key to the generics code is a synthesis of insights gained from a detailed study of twenty leading players in the business. A detailed analysis of these twenty companies reveals the success code of a winning strategy’s ten essential elements. Therefore, CRACKING THE GENERICS CODE will be your valuable guide for formulating and executing strategies for winning in the global generics markets. The book presents insights gleaned and gained from the strategies employed by these twenty highly successful companies in a capsule form.

Every which way you look at it, CRACKING THE GENERICS CODE is your single-source success manual for winning at multi-source (generic drugs) product markets!

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Medicines are perhaps the greatest weapons of the mankind to fight diseases and death, but are double edged weapons. They help recovering from illness and restoring health if used properly; but can harm if not used appropriately, even causing life threatening situations including death. Inappropriate medicine use is unnecessary wastage of resources. Medicines have helped increasing life expectancy but in some situations they have harmed too. The antibiotics are becoming increasingly ineffective due resistance developed by random use. The book provides guidance on using medicines appropriately in a simple and easily understandable language.

           The book intends to empower the readers with skill and knowledge to make informed decisions about how to use medicines (including when not to use them) and get the maximum benefit. It helps to understand the importance of medicines inindividual’s health. The second edition of the book is updated with the new information on medicines as available. Many new themes are introduced with value addition like cartoons.

         It is a comprehensive medicine user guide for common public. A must for every one!

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Medical writing is part of drug development process. Medicomarketing writing is a type of medical writing where scientific information is presented as promotional literatures. Medicomarketing communication or healthcare communication has evolved as a profession over a decade. More and more pharmaceutical industries are outsourcing their work to medicomarketing communication or healthcare communication companies and freelance medical writers.

The skills required for medicomarketing writing are different from the skills required for any other profession. With more than 15 years of experience in medicomarketing communication segment, we have identified the skills required for medicomarketing writing and the lack of skill among the pharmacists, doctors and life science graduates, who have the ability to excel in medical writing. This is the first book, which gives practical insights into medicomarketing writing.

This book is ideal for graduates and postgraduates in Pharmacy, Medicine, Dentistry and Life science

This book is also useful for

Newbie medicomarketing writers

Product managers and medical advisors working in pharmaceutical companies

Senior medical writers working in publishing companies

Team leaders and project managers working in medical communication and medical advertising agencies

Freelance medical writers

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The pharmaceutical world is not flat. Only three regions - (North America, Western Europe and Japan), which inhabit a mere 13 per cent of population account for over 80 per cent of world pharmaceutical market. This is however changing mainly due to the rapid genericization driven by the winds of declining R&D productivity, vanishing market exclusivities consequent to patent expiries, and ever-increasing efforts by virtually every government on earth to contain healthcare costs.

Compete or Forfeit is the story of a small bunch of flatteners (about a dozen) and eighteen other firms who are followers or early adopters of these flatteners from India, who are determined to level the pharmaceutical world by creating world-class technological and manufacturing infrastructure and research and development capabilities. While these champion-entrepreneurs originate from the Indian sub-continent, their strategic vision and game plans are not restricted to any one nation or region and therefore, all the elements of their strategies are applicable to all aspiring companies who want to enhance their competitiveness and are raring to compete, wherever they are situated be it China, Latin America, CEE, Africa, Russia or Asia.

Compete or Forfeit offers very valuable insights into what can be done and more importantly how it can be done by showing how these thirty companies discussed in the book have accomplished in a tough, ruthless and unforgiving market place that demands nothing but the best and how they are converting entry barriers into gateways to the remunerative first world markets. These companies already account for:

•    Over 80 per cent of all ANDAs and DMFs filed by Indian companies  in the US, the largest generic market in the world
•    Over 90 per cent of all acquisitions made by Indian Pharma companies overseas
•    Over 75 per cent of all exports of APIs, and FDFs  from India
•    The maximum number of US FDA inspected facilities outside the US

To Develop World Class capabilities in todays hyper competitive world is no longer a matter of choice. It is rather mandatory.Remember if you are not competing you are forfeiting an opportunity to succeed.

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An integral part of the UK’s healthcare infrastructure and relied on by health professionals who prescribe, dispense, and administer medicines globally.  Containing guidance on best practice in prescribing, as well as legal and ethical considerations, BNF supports safe and effective decision-making at the point of care.

Extensive content updates in the BNF 86 edition include:

New monographs for:

• Livtencity® [maribavir] for cytomegalovirus disease in recipients of haematopoietic stem cell transplant or solid organ transplant
• Lupkynis® [voclosporin] for lupus nephritis
• Mounjaro® [tirzepatide] for type 2 diabetes mellitus
• Orgovyx® [relugolix] for prostate cancer
• Rezurock® [belumosudil] for chronic graft-versus-host disease
• Tezspire® [tezepelumab] for severe asthma

MHRA advice on:

• Dupilumab (Dupixent®): risk of ocular adverse reactions and need for prompt management
• Ibrutinib (Imbruvica®): new risk minimisation measures, including dose modification recommendations, due to the increased risk for serious cardiac events
• Metolazone (Xaqua®): exercise caution when switching patients between metolazone preparations
• Pholcodine-containing cough and cold medicines: withdrawal from UK market as a precautionary measure
• Terlipressin acetate: new recommendations to reduce risks of respiratory failure and septic shock in patients with type 1 hepatorenal syndrome
• Testosterone (Testogel®): risk of harm to children following accidental exposure

Other significant changes include updated guidance on:

• Specialist drug monographs: inclusion of the words “Specialist drug” alongside the monograph title to identify drugs used within specialist settings (such as drugs used for malignancy, and those given via intravitreal injection). These monographs continue to include information to support patient safety and non-specialist patient care (such as important safety information, interactions, side-effects, and contra-indications) but no longer include information which is within the remit of specialist care (such as doses, and directions for administration).
• Adrenaline/epinephrine: recall of Emerade® 500 micrograms and Emerade® 300 micrograms auto-injectors, due to the potential for device failure [National Patient Safety Alert advice]
• Pre-treatment screening advice on genetic testing for aminoglycoside exposure posing risk to hearing
• Management of iron deficiency anaemia, including update to oral iron dosing and monitoring based on British Society of Gastroenterology guidelines
• COVID-19 vaccines
• Management of uncomplicated genital chlamydia and non-gonococcal urethritis
• National genomic testing directory
• Ibuprofen: breast-feeding advice
• Management of metabolic disorders
• Management of obesity
• Management of osteoarthritis
• Prescribing in palliative care
• Respiratory system, inhaled drug delivery
• Smallpox and mpox vaccine

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Bullseyes and Blunders: Lessons from 100 Cases in Pharmaceutical Marketing is a first-of-its-kind of a book. The book is an invaluable resource for the practitioners as well as the students of pharmaceutical marketing. The case studies presented in the book offer many experiential insights into how some of the world’s renowned pharmaceutical marketers built, launched, defended and managed their brands and steered them clear of competition. The Bullseyes in the book present a snapshot of these winning brands.

Studying the Blunders or failures or flops too is significant for the practitioners and students of marketing alike. Because these provide the much-needed insights into the essential, Don’ts while building and managing their brands.

Bullseyes and Blunders provides a more practical understanding of various topics that are highly relevant for the Pharma brand managers and marketing managers. These are market opportunity analysis, product positioning, product launches, life cycle management, building and defending a disease-franchise among others.

About the Author:

Subba Rao Chaganti Has a masters in business administration and over fifty-two years of experience in pharmaceutical marketing covering the whole gamut and all facets of the industry from selling to sales management, product management to heading the total marketing activity.  His experience includes domestic and international marketing, and also Indian and multinational sectors.

He also taught for a few years a course on Advertising and Brand Management at Gitam Institute of Foreign Trade (now part of Gitam University) at Visakhapatnam as an adjunct professor and also taught a class on Marketing at Jawaharlal Nehru Technological University (JNTU) School of Management, Hyderabad as a visiting faculty.

Here is a list of his publications:

Books Published:

1. Pharmaceutical marketing in India: Concepts, Cases, Strategy
2. Game Plans for Post-Gatt Era: Action Agenda of Indian Pharmaceutical Industry
3. Compete or Forfeit: Strategies for Sustainable Competitive Advantage in Pharma Product Patents Era
4. Pharmaceutical Marketing in India for Today and Tomorrow - 25th Anniversary Edition

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Twenty-five years ago, Pharmaceutical Marketing in India: Concepts, Cases, Strategy was the first-ever sectoral marketing book in the Asia Pacific Region. Today, twenty-five years later, Pharmaceutical Marketing in India for Today and Tomorrow continues to be the most comprehensive sectoral marketing book in pharmaceuticals in the Asia Pacific Region.

            The new 25th Anniversary Edition of the book is an updated version of the original text with significant new content. The seventy-seven cases in the book show how some of the highly successful practitioners of Pharma marketing in India have positioned their products, launched and promoted their brands and defended their therapeutic segments. The experiential insights these cases provide are immensely useful for both the practitioners as well as the students of pharmaceutical marketing in India.

            What is new in this all-new 25th Anniversary edition? The book presents an introduction to all aspects of changes and initiatives that are happening in the first world markets and whatever baby steps that are being taken by Indian drug majors and their MNC counterparts in India. To name a few - changing detailing practices such as e-Detailing, iPad detailing or tablet detailing, digital marketing strategies, social media strategies for the pharmaceutical industry, multichannel marketing, closed-loop marketing among others.

         The new ways of engaging and building meaningful relationships with physicians in today’s declining physician access scenario are medical sales liaisons (MSL), key opinion leader (KOL) management and key account management (KAM). This latest edition includes these. The primary purpose of this edition is to make it not only relevant for today but also for tomorrow. In other words, to make it as future-proof as is possible.

About the Author:

Subba Rao Chaganti, has a masters in business administration and over fifty-two years of experience in pharmaceutical marketing covering the whole gamut and all facets of the industry from selling to sales management, product management to heading the total marketing activity. His experience covers domestic and international marketing, and also Indian and multinational sectors. He also taught for a few years a course on Advertising and Brand Management at Gitam Institute of Foreign Trade (now part of Gitam University) at Visakhapatnam as an adjunct professor and also taught a course on Marketing at the School of Management, Jawaharlal Nehru Technological University (JNTU), Hyderabad as a visiting faculty. 

 Here is a list of his publications: 

1. Pharmaceutical marketing in India: Concepts, Cases, Strategy
2. Game Plans for Post-GATT Era: Action Agenda of Indian Pharmaceutical Industry
3. Compete or Forfeit: Strategies for Sustainable Competitive Advantage in Pharma Product Patents Era

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