History of the Pharmacy Profession in India

The history of the pharmacy profession in India, in relation to pharmacy education and industry, can be traced back to several significant developments.

Pharmacy Education:

• Pharmacy education at the certificate level was initiated in Goa by the Portuguese in 1842. Formal training of pharmacists began in Bengal in 1881 and was established as a university-level program in 1937 at Banaras Hindu University in Varanasi.
• The post-World War II age brings advancements in science and technology, leading to changes in the pharmacy profession.
• In 1948, the independent government of India enacted “The Pharmacy Act” to regulate the pharmacy profession and education.
• William Procter Jr., an American pharmacist, is often regarded as the “Father of Pharmacy.” In India, Mahadev Lal Schroff is recognized as the “Father of Indian Pharmacy.”
• Traditionally, pharmacy has been known as the art and science of preparing drugs. The term “Pharmacy” originates from the Greek word “PHARMAKON,” meaning drug.
• In ancient times, physicians themselves practiced pharmacy, with Hippocrates, the Greek physician considered the father of medicine, being involved in the preparation of prescriptions.
• Apothecaries were historical professionals who formulated and dispensed medicines to physicians and patients. The earliest pharmacies were known as apothecary shops.
• Pharmacists played a role in compounding medicines, preparing and dispensing them based on prescriptions from physicians. They also provided appropriate advice for consuming the medications.
• In the past, physicians used crude drugs for diagnosis, and pharmacists provided the necessary herbs and drugs. Drugs were identified based on their morphological appearance and organoleptic characteristics.
• In India, pharmacy was an integral part of Ayurvedic and Siddha systems of medical practice.

Pharmacy in Industry:

Pharmacists play various roles in the pharmaceutical industry including:

Formulation Development: Pharmacist involvement in pharmaceutical companies facilitates the development of commercial formulations and enhances understanding of drug substances and products.

They participate in formulation testing and combine active pharmaceutical ingredients (APIs) with inactive excipients to create successful pharmaceutical formulations.

The physicochemical analysis aids in the excipient selection, stability assessment of drug substances and products, and identification of critical material attributes for formulation performance.

Manufacturing Department: Pharmacists contribute to ensuring proper equipment, procedures, and conditions in manufacturing units.

They develop and maintain Standard Operating Procedures (SOPs) and provide effective training to production staff.

Pharmacists establish sanitation and hygiene conditions and determine safety areas and environments for manufacturing units.

They assist in reviewing production batch records for necessary information and support research and development projects.

Quality Control and Quality Assurance: Quality control (QC) involves sampling, inspection, and testing of raw materials and packaging materials according to pharmacopoeial standards.
Skilled pharmacists are responsible for QC, stability testing, and evaluating the shelf life and microbial activity of raw materials and finished products.

Quality assurance (QA) departments ensure the maintenance of desired quality levels in services or products. They assure appropriate drug doses and formulations based on patients’ needs and convenience.

Drug Information: Pharmacists, known as drug experts, possess extensive knowledge gained during their academic training. In the industry, they provide information on drug composition, formulation, advantages, disadvantages, and potential interactions with other drugs.

Pharmacists determine the chemical activity of drugs and provide information about suitable excipients, such as coloring agents and flavoring agents.

Regulatory Affairs: Regulatory affairs professionals ensure compliance with government regulations and standards related to the safety and efficacy of medicinal products.
They monitor and evaluate projects, services, or facilities to ensure the quality of drugs and contribute to scientific and commercial development.

Regulatory departments keep track of changing legislation and provide advice on regulations and requirements in different regions where a company distributes its products.

Sales and marketing play an important role in the growth and development of pharmaceutical industries. Pharmaceutical marketing serves as a comprehensive information system for updating physicians about the availability, safety, efficacy, hazards, and usage techniques of medicines.

Pharmacists are directly involved in patient and physician interactions, providing complete information about public needs and requirements.

Marketing in pharmaceuticals involves understanding and fulfilling the needs and wants of customers (demand) while achieving organizational goals. Pharmacists contribute to creating new needs or reformulating existing ones. They provide information about drug composition, formulation, advantages, and disadvantages to support effective marketing strategies.

Management: Marketing management encompasses the analysis, planning, implementation, and control of actions aimed at establishing, maintaining, and enhancing favorable exchanges with target buyers for the achievement of organizational objectives such as profit generation, sales volume growth, and increased market share.

Pharmacists with expertise in management contribute to strategic and technical advice, making significant contributions both commercially and scientifically.

They stay updated on changing legislation and provide guidance on legal and scientific requirements.

Marketing management in the pharmaceutical industry involves understanding and fulfilling customer needs while aligning with the goals of the organization.

Pharmacy Practice and the Role of Professional Associations

Introduction: Pharmacy practices and professional associations are instrumental in organizing educational programs and research activities to raise awareness of the importance and scope of quality standards for drugs and related materials. Pharmacists helping in serving the healthcare system, serve as academic pharmacists, industrial pharmacists, community pharmacists, clinical pharmacists, hospital pharmacists, and veterinary pharmacists.

Regardless of their field, pharmacists contribute directly or indirectly to the nation’s health. Their primary responsibility is to ensure that they distribute medicines as per patient needs, at the right time, in the right dose, through the right route, and in administration.

General/Clinical Practice:

• Clinical pharmacists apply their medication knowledge to devise treatment plans for individual patients, assessing factors such as dose appropriateness, side effects, efficacy, and drug interactions.
• In many cases, clinical pharmacists work directly with patients, helping them understand their medications and encouraging proper adherence.
• Pharmacists monitor patients’ progress with medications, make recommendations for changes, evaluate medication therapy, and provide appropriate guidance to patients and healthcare providers. They are often considered primary informers in the medical field.
• As per new government regulations, pharmacists can now open their own clinics and provide primary treatment to patients, including emergency care in the absence of doctors.

Academic Practice:

• Academic pharmacists focus on teaching, research, and training future pharmacists. Based on their knowledge and skills, pharmacists are appointed to various positions in academic institutes.
• Through seminars, projects, and system academia, pharmacists contribute significantly to the healthcare system, motivating professionals in the field.
• Pharmacist education encompasses a broad understanding of scientific principles, pharmaceutical sciences, and the ability to stay updated with medical and pharmacy advancements throughout their careers.
• Pharmacists also impart knowledge about drug preparation, distribution, action, and usage. Educational training programs equip professionals with current knowledge, while academic pharmacists play a crucial role in the preliminary aspects of the pharmacy profession.

In Health Programs:

As per World Health Organization, health is related to physical, mental, and social well-being. The concept of health aligns with Ayurveda, defining it as a “well-balanced metabolism.” Despite variations in the WHO’s definition, the overall goal of health is universal.

Health is a central element of development, emphasizing the importance of healthcare professionals like pharmacists, physicians, nurses, compounders, and dispensers. Pharmacists provide additional health-related services, such as:

• Health missions
• Health consultancy
• Doctor’s assistance

In-Hospital Pharmacy:

• Hospital chemists are essential in managing all aspects of the hospital’s medication supply, including purchasing, manufacturing, dispensing, and quality assurance. They work along with pharmacy technicians and helpers.
• Hospital pharmacists provide information on potential side effects and check for compatibility with existing medications.
• They monitor treatment effects to ensure their effectiveness, safety, and appropriateness. Similar to doctors, pharmacists actively participate in ward rounds and contribute to treatment decisions.
• Some pharmacists specialize as consultants in areas like Hematology, Nephrology, Cardiology, Urology, Pediatrics, Diabetes, and Infectious Diseases, actively participating in:

• Prescribing
• Dispensing
• Administration
• Documentation
• Monitoring

Pharmacovigilance: Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other problems associated with medicines or vaccines. The term “pharmacovigilance” combines the words “pharmakon” (meaning drug) and “vigilar” (meaning to keep watch). Pharmacovigilance focuses on identifying potential hazards associated with pharmaceutical products and minimizing the risk of harm to patients.

Research and Development: When it comes to the creation and formulation of pharmaceuticals, chemists are particularly important to research and development. They conduct numerous experiments, develop drug formulations, and create convenient dosage forms based on demands and needs. Pharmacists also maintain registers of drugs and select suitable excipients for active pharmaceutical ingredients (APIs). Additionally, they contribute to the development of combination drugs and are involved in vaccine preparation.

Pharmaceutical Marketing and Management: Pharmacists also participate in pharmaceutical marketing and distribution by providing knowledge about drugs to physicians. They contribute to advertisements, news dissemination, and multimedia campaigns related to pharmaceutical products. Furthermore, management is a key aspect of the pharmaceutical industry, encompassing regular drug check-ups, temperature control, moisture regulation, light availability, and other essential factors. Pharmacists’ inclusion in all levels of management promotes an ethical approach to management policies.

Chemist Shops and Medical Stores: Pharmacists are authorized to open their own chemist shops, where they are responsible for checking and dispensing prescription drugs, as well as providing advice on drug selection and usage. This role is often referred to as community pharmacy. Community pharmacists have direct interaction with the public and provide comprehensive information about diseases and medications. They are increasingly taking on clinical roles that were traditionally reserved for doctors, such as managing asthma, and diabetes, and performing blood pressure tests. Community pharmacists also assist individuals in quitting smoking, offer dietary advice for improved health, and provide guidance on reproductive health matters.

In the Pharmaceutical Industry: Pharmacists play diverse and significant roles in the pharmaceutical industry. They are involved and responsible for a wide range of activities, including drug discovery, drug safety studies, formulation development, clinical trials, marketing, and management.

Roles of Pharmacists in the Industry:

• Formulation development
• Manufacturing department
• Quality control and quality assurance
• Sales and marketing
• Management

Related: Drugs and Cosmetics Rules Schedule 1945

Pharmacopoeia:

Introduction to Pharmacopoeia:

A recognized organization called Pharmacopoeia works to ensure the reliability and quality of pharmaceuticals. It serves as a standard book for drug preparation. Each country has its own Pharmacopoeia, and we will discuss the Pharmacopoeia of some countries.

Indian Pharmacopoeia: On behalf of the Indian Ministry of Health and Family Welfare, the Indian Pharmacopoeia Commission (IPC) publishes the Indian Pharmacopoeia. It serves as the legal and official book regulated by the IPC. The Indian Pharmacopoeia is written in English, with monograph titles given in Latin. It fulfills the requirements of the Drug and Cosmetics Act of 1940 and its rules. The Indian Pharmacopoeia Committee, established in 1948, published the first edition in 1955 under the chairmanship of Dr. B.N. Ghosh. The IPC, headquartered in Ghaziabad, Uttar Pradesh, ensures the consistent quality of medicines in India.

The publication of the Second Edition of the Indian Pharmacopoeia in 1966 marked a significant milestone in the field. Building upon this achievement, a supplement to this edition was later published in 1975, adding further depth to the existing body of knowledge. It is worth noting that on June 30, 1978, the Indian Pharmacopoeia committee underwent reconstitution by the esteemed government of India Ministry Of Health and Family Welfare. This pivotal step was taken under the capable Chairmanship of Dr. Nityanand, who served as the Director of the Central Drug Research Institute Lucknow (CDRI). The committee’s reconstitution ushered in a new era of progress and innovation in the pharmaceutical landscape.

Continuing this remarkable journey, the Third Edition of the Indian Pharmacopoeia made its appearance in 1985, captivating the minds of professionals and researchers alike. This edition, consisting of two comprehensive volumes, presented a wealth of information and insights. Volume 1, known as the Addendum, was published in 1989 and encompassed a wide array of topics such as legal notices, prefaces, acknowledgments, introductions, general notices, and monographs spanning from A to P. The diligent efforts put forth in the creation of this Addendum resulted in the addition of 46 new monographs and the amendment of 126 existing ones.

The journey through the Indian Pharmacopoeia’s evolution continued with the publication of Volume 2 of the Addendum in 1991. This volume extended its coverage to monographs from Q to Z and showcased 62 new monographs alongside 110 amended ones. These additions and revisions further enriched the knowledge base, solidifying the Indian Pharmacopoeia’s reputation as a reliable and authoritative resource in the pharmaceutical realm.

In 1996, the Fourth Edition of the Indian Pharmacopoeia emerged under the capable chairmanship of Dr. Nityanand, who remained at the forefront of this endeavor. This edition was a testament to the dedication and commitment of the Indian Pharmacopoeia committee. Notably, it included essential updates such as the introduction of addendums for veterinary products in 2002 and 2005, as well as Supplement Volume 1 A to P and Volume 2 Q to Z. The veterinary supplement to the Indian Pharmacopoeia 1996 featured an impressive collection of 208 monographs, reflecting the growing scope and relevance of the field.

With the turn of the millennium came the Fifth Edition of the Indian Pharmacopoeia in 2007, accompanied by an addendum in 2008. This edition presented itself in three volumes, each containing invaluable insights and findings. Volume 1, the first among the trio, encompassed general notices and general chapters, setting the stage for a comprehensive exploration of the subject matter. Volume 2 continued the journey with general monographs on drug substances, dosage forms, and pharmaceutical aids, covering a wide spectrum from A to M. As the Indian Pharmacopoeia embraced the future, the Sixth Edition was published in 2010, reinforcing its commitment to excellence and innovation.

The Indian Pharmacopoeia Commission (IPC) took over responsibility for printing the 6th edition of the Indian Pharmacopoeia in 2010. This edition, presented across three volumes, served as a testament to the IPC’s dedication and passion for advancing pharmaceutical knowledge. Volume 1 played a crucial role in providing readers with essential information, including notices, prefaces, the structure of the IPC, acknowledgments, introductions, and general chapters. Volume 2 expanded upon this foundation by offering general notices, monographs on dosage forms and drug substances, and monographs on pharmaceutical aids from A to M. The journey culminated in Volume 3, which featured monographs on drug substances, dosage forms, and pharmaceutical aids from N to Z, followed by monographs on vaccines and immunosera for human use, herbs and herbal products, blood and blood-related products, biotechnology products, and veterinary products.

The release of the seventh edition of the Indian Pharmacopoeia in 2014 marked yet another significant milestone in the field. Published by the Indian Pharmacopoeia Commission (IPC) on behalf of the Government of India Ministry of Health and Family Welfare, this edition was presented in four volumes, each brimming with valuable information and insights. A remarkable addition to this edition was the incorporation of 2,550 drug monographs, out of which 577 were entirely new, encompassing APIs, excipients, dosage forms, herbal products, and more.

Building upon the successes of its predecessors, the eighth edition of the Indian Pharmacopoeia was published in 2018. The IPC, in collaboration with the Ministry of Health and Family Welfare, Government of India, meticulously curated this edition, ensuring it met the highest standards of quality and comprehensiveness. With four volumes at its disposal, the Indian Pharmacopoeia 2018 presented a wealth of knowledge to the eager minds of pharmaceutical professionals.

The Indian Pharmacopoeia 2018 silent features:

including the incorporation of 220 new monographs, 170 new chemical monographs, 49 APIs, 64 formulations, 53 fixed-dose formulations, 2 excipients, 2 antibiotics, 15 new herbs and herbal product monographs, 3 new radiopharmaceutical monographs, 14 new veterinary non-biological monographs, 18 new biological monographs, 2 vaccines and immunosera for human use, 6 biotechnology-derived therapeutic products, and 10 blood and blood-related products. This comprehensive collection aimed to cover a wide range of pharmaceutical substances, ensuring that professionals had access to the latest and most relevant information.

Silent features of the Indian Pharmacopoeia include:

IP is a published commitment to the mission of the IPC, which revolves around improving the health of the population by guaranteeing the quality, safety, and efficacy of medicines. The Indian Pharmacopoeia achieves this through its meticulous procedures for the analysis and specification of pharmaceutical substances, excipients, and dosage forms. Notably, the eighth edition saw the revision of general chapters on volumetric glassware, conductivity, dissolution tests, disintegration tests, and dimensions of hard gelatin capsule shells.

The Indian Pharmacopoeia has evolved to encompass products of biotechnology, indigenous herbs, herbal products, veterinary vaccines, additional antiretroviral drugs, and formulations, including commonly used fixed-dose combinations (FDCs). It now includes 170 chemical monographs, 15 herbal monographs, 10 blood and blood-related products monographs, 6 biotechnology monographs, 3 pharmaceuticals monographs, 2 vaccines and immunosera monographs, and 14 veterinary and non-biological products monographs.

Monographs in the Indian Pharmacopoeia provide comprehensive information on official substances or preparations, covering various aspects such as definition, description, identification, packaging, storage, specifications, impurities, assay and specific tests, and analytical procedures. The use of specific tests, such as infrared, ultraviolet spectrophotometry, and high-performance liquid chromatography (HPLC), has been prioritized over general chemical tests and thin-layer chromatography (TLC), ensuring greater accuracy and specificity in assays and the evaluation of impurities.

The Indian Pharmacopoeia has embraced chromatographic methods extensively, recognizing their importance in assessing the nature and extent of impurities in ingredients and products. Additionally, measures for controlling the microbial quality of medicinal products, including maintenance, preservation, identification, disposal of microorganisms, and pyrogen tests, have been revised. The bacterial endotoxin test (BET) has replaced pyrogen tests in parenteral preparations, ensuring enhanced safety and quality standards.

In conclusion, the Indian Pharmacopoeia has embarked on a remarkable journey of evolution and growth since its inception. From the Second Edition in 1966 to the Eighth Edition in 2018, each edition has contributed significantly to the advancement of pharmaceutical knowledge in India. With its meticulous monographs, updated procedures, and comprehensive coverage of various pharmaceutical substances, excipients, dosage forms, and more, the Indian Pharmacopoeia stands as a reliable and authoritative guide for professionals in the field.

United States Pharmacopoeia (USP)

The United States Pharmacopoeia, an authoritative organization dedicated to ensuring the constituency and quality of medicine and vitamins, stands as a pillar of regulatory guidance. Its influence is widely acknowledged, fostering a sense of assurance in the realm of pharmaceuticals. The USP’s standards, recognized by the FDA as the gold standard for testing vitamins and medicines, act as a strong safeguard against subpar products, significantly contributing to public health and overall well-being.

United States Pharmacopeia- NF

The United States Pharmacopeia-National Formulary (USP-NF) is a book of public pharmacopeial standards. It contains standards for medicines, dosage forms, drug substances, excipients, medical devices, and dietary supplements.

British Pharmacopoeia (BP)

Immerse yourself in the enlightening world of British Pharmacopoeia, a publication birthed under the careful watch of the esteemed Health Ministry of the United Kingdom. This time, often referred to as the National Pharmacopoeia of the United Kingdom, exemplifies the commitment to excellence ingrained within the British pharmaceutical framework. A testament to its prominence, the British Pharmacopoeia boasts its headquarters in London, United Kingdom.

Reference:

United States Pharmacopeia – National Formulary (USP-NF)
Indian Pharmacopoeia
https://www.ijper.org/article/32