GENERAL PRINCIPLES OF LAW, HISTORY AND VARIOUS ACTS RELATED TO DRUGS AND PHARMACY PROFESSION: A TEACHER’S COMPREHENSIVE GUIDE
Welcome, future pharmacists and healthcare professionals!
As a pharmacy law and ethics educator with years of experience teaching pharmaceutical legislation, I have observed that understanding the general principles of law, history, and various acts related to the drugs and pharmacy profession is essential for every pharmacy student. Law and ethics work together to maintain society. Law is a rule of conduct that is formally recognised as binding and enforced by a society. Ethics, on the other hand, is a branch of moral philosophy that aids in supervising individuals about their conduct.
In this comprehensive guide, I will take you through the definition and meaning of law, characteristics of law, definition and meaning of ethics, general principles of law, and the history and various acts related to the drugs and pharmacy profession. We will also explore the Drug Enquiry Committee and its recommendations. By the end of this article, you will have a thorough understanding of the legal and ethical framework governing the pharmacy profession in India. Let us begin.
DEFINITION AND MEANING OF LAW
Law refers to a set of rules and regulations that control both the actions of individuals and the entire society. Law is formulated and published by a government. The concept of law has been explained by various philosophers and thinkers throughout history.
The Rig Veda states that law is the king of monarchs, far more powerful and right than they, by whose aid, even the weak may conquer over the strong. This ancient wisdom highlights the supremacy of law over even the most powerful rulers.
John Locke, the famous philosopher, said that every law is a veritable freedom, the ends of Law are not to abolish or confine but to preserve and increase freedom. This perspective emphasizes that law is not meant to restrict freedom but to protect and enhance it.
Characteristics of Law
- It pre-supposes the existence of a state.
- The state creates or authorises to create laws, as well as recognise and approve laws.
- Approvals must be in place for the laws to be effective.
- Laws are enacted to achieve a specific goal (social purpose or to serve some personal ends of a despot).
- Violation of law leads to punishment (imprisonment or fine or both).
DEFINITION AND MEANING OF ETHICS
Ethics is a branch of moral philosophy that aids in supervising individuals about their conduct. Ethics are rules or guidelines formulated by individuals or legal and professional norms. Unlike law, violation of ethics does not cause punishment. However, ethical violations can lead to loss of professional reputation, disciplinary action by professional bodies, and loss of public trust.
In the pharmacy profession, ethics play a crucial role in guiding the conduct of pharmacists. The Code of Pharmaceutical Ethics provides a framework for ethical decision-making and professional conduct.
GENERAL PRINCIPLES OF LAW
Principle of Democracy
According to Abraham Lincoln, democracy is “government of the people, by the people, and for the people.” Freedom, equality, and self-determination are among the values that support democracy. In a democratic system, laws are created through a representative process and are meant to serve the interests of the people.
Principle of Constitutionalism
Constitutionalism is defined as a collection of political ideals and goals that express the wish to preserve freedom by establishing both external and internal restraints on the authority of the state. It ensures that the government operates within the limits set by the constitution and respects the rights of citizens.
Principle of Justice
Justice is a fundamental principle of law that ensures fairness and equity. It has two main aspects:
- Corrective Justice: Restoring equality after it has been disrupted due to wrongdoing.
- Distributive Justice: Pertains to how the state bestows honours and awards on individuals based on their respective deserts.
Principle of Liberty
Liberty means the ability to think and act as one wishes. Allowing an individual to exercise their autonomy over the kind of life they wish to lead is crucial. Liberty is a cornerstone of democratic societies and is protected by constitutional provisions.
Principle of Equality
Equality means like things considered to be treated similarly and unlike things to be handled differently. It suggests that everyone is subject to the same laws and the same courts’ jurisdiction, regardless of status. Equality before the law is a fundamental right guaranteed by the Indian Constitution.
Principle of Fraternity
Fraternity means brotherhood among disparate body of people united in their interests, aims, and so on. It promotes a sense of community and mutual respect among citizens, which is essential for a harmonious society.
HISTORY AND VARIOUS ACTS RELATED TO DRUGS AND PHARMACY PROFESSION
Initially in the 19th century, pharmacy emerged as a modern and independent science. Prior to that, pharmacy developed as a branch of medicine from antiquity. The evolution of pharmacy in India has been marked by several significant events and legislative milestones.
Timeline of Pharmacy Acts and Events
| Year | Event/Act |
|---|---|
| 1878 | Opium Act was passed |
| 1901 | Bengal Chemical and Pharmaceutical Works (Calcutta) established by Acharya P.C. Ray |
| 1903 | Small factory at Parel (Bombay) initiated by Prof. T.K. Gajjar |
| 1907 | Alembic Chemical Works (Baroda) laid down by Prof. T.K. Gajjar, Rajmitra, and B.D. Amin |
| 1919 | Poison Act was passed |
| 1930 | Dangerous Drugs Act was passed |
| 1932 | Prof. M.L. Schroff initiated first pharmacy department of Pharmaceutics at BHU |
| 1935 | Uttar Pradesh Indian Pharmaceutical Association was formed |
| 1939 | Prof. M.L. Schroff started the Indian Journal of Pharmacy |
| 1940 | Drug Bill put forward in Legislative Assembly; All India Pharmaceutical Congress Association founded |
| 1941 | First Drugs Technical Advisory Board (DTAB) established; Central Drugs Laboratory founded in Calcutta |
| 1945 | Pharmacy Bill brought (later Pharmacy Act, 1948); Ph.D in Pharmaceutical Sciences started at BHU; Drugs Rules effective; Drug and Cosmetics Rules framed |
| 1946 | Indian Pharmacopoeial List published; Bhore Committee recommended 3-tier pharmacy education; APTI formed; Industrial Employment Act passed |
| 1947 | Drug Act, 1940 enforced (regulates import, manufacture, distribution, sale of drugs and cosmetics) |
| 1948 | Pharmacy Council of India established; Pharmacy Act enacted |
| 1949 | First Diploma in Pharmacy institute started at Jalpaiguri, West Bengal |
| 1953 | Education Regulation of PCI laid down D.Pharm as minimum qualification |
| 1954 | Pharmacy Enquiry Committee Report; Drugs and Magic Remedies Act passed |
| 1955 | Medicinal and Toilet Preparations (Excise Duties) Act; First Edition of Indian Pharmacopoeia published |
| 1960 | Master of Pharmacy syllabus drafted by AICTE |
| 1961 | Indian Drug Manufacturers Association (IDMA) founded |
| 1963 | Indian Hospital Pharmacists Association (IHPA) formed (HQ New Delhi) |
| 1965 | Organisation of Pharmaceutical Producers of India (OPPI) established (HQ Mumbai) |
| 1970 | Drugs Price Control Order passed |
| 1978 | Nayudamma Committee directed GATE examination for M.Pharm with scholarship |
| 1979 | All India Organisation of Chemists and Druggists (AIOCD) formed |
| 1980 | Pharmacy Graduates Association (PGA) established |
| 1985 | Third edition of Indian Pharmacopoeia released; Narcotic and Psychotropic Substances Act enacted |
| 1994 | All India Board of Pharmaceutical Education and National Board of Accreditation formed; Drugs and Magic Remedies Act approved |
| 1995 | Drug Price Control Order formed |
| 1996 | Fourth Edition of Indian Pharmacopoeia released |
| 2005 | Disaster Management Act passed |
Other Related Enactments
- Prevention of Food Adulteration Act, 1954 and Rules
- The Industries Development and Regulation Act, 1951
- The Industrial Employment (Standing Order) Act, 1946 and Rules
- Industrial Dispute Act, 1947
- Factory Act, 1948
- The Indian Patent and Design Act, 1970
- The Trade and Merchandise Mark Act, 1958
- The Epidemic Diseases Act, 1897
- Shops and Establishments Act, 1962
- The Clinical Establishment (Registration and Regulation) Act, 2010
DRUG ENQUIRY COMMITTEE (DEC)
DEC was established in 1930 under the chairmanship of Col. R.N. Chopra. The committee comprised five members: Shri C. Govindan Nair (secretary), Dr. B. Mukherjee (assistant secretary), Mr. H. Cooper, Maulvi Abdul Matin Chowdhary, and Fr. J.F. Caius. The committee played a pivotal role in shaping the pharmaceutical landscape of India.
Functions of DEC
- Identify the quality and quantity of impure drugs imported, manufactured, or sold in British India as per the British Pharmacopoeia.
- Report the recommendations for the above by different approved medicinal preparations and indigenous drugs preparations.
- Enquire the legislations that allow only qualified persons to access the pharmacy profession.
Recommendations by DEC (Report 1931)
- A drug industry should be established in India.
- A Central Legislation should be implemented (combined or individually as the Drugs and Pharmacy Act).
- An advisory board should be appointed by the Central Government to look after the objectives of the Act.
- All Indian states should have modern test laboratories and quality control laboratories.
- Crude drugs individually or compounded into medicines in traditional treatment system should be included under the Legislation.
- Manufacturing should be gradually reduced in Medical Stores Departments.
- Guidelines should be framed for pharmacy courses; training courses in pharmacy should be setup; minimum qualification for registration as a pharmacist should be imposed.
- Patent and proprietary medicines of undisclosed formula should be registered. Cinchona cultivation in India should be initiated.
- Compilation of Indian Pharmacopoeia is required.
SUMMARY: LAW vs ETHICS
| Feature | Law | Ethics |
|---|---|---|
| Definition | Rules formally recognised as binding, enforced by society | Branch of moral philosophy supervising conduct |
| Formulation | Formulated and published by government | Formulated by individuals or legal/professional norms |
| Violation Consequence | Punishment (imprisonment, fine, or both) | No punishment |
A TEACHER’S HISTORICAL INSIGHTS
Over my years of teaching pharmacy law and ethics, I have developed a few key insights about the history of pharmaceutical legislation in India that I always share with my students:
- The Drug Enquiry Committee (DEC) of 1930 was a watershed moment in Indian pharmaceutical history. Its recommendations laid the foundation for the modern pharmaceutical regulatory framework in India.
- The Pharmacy Act, 1948, established the Pharmacy Council of India and set the stage for the professionalisation of pharmacy in India.
- The Drugs and Cosmetics Act, 1940, and Rules, 1945, form the cornerstone of drug regulation in India, ensuring the quality, safety, and efficacy of drugs and cosmetics.
- Understanding the historical context of these laws helps us appreciate the evolution of the pharmacy profession and the importance of regulatory compliance.
FREQUENTLY ASKED QUESTIONS (FAQs)
1. What is the difference between law and ethics?
Law is a set of rules formally recognised as binding and enforced by society, while ethics is a branch of moral philosophy that supervises conduct. Violation of law leads to punishment, while violation of ethics does not cause legal punishment.
2. What are the characteristics of law?
The characteristics of law include: it pre-supposes the existence of a state, the state creates or authorises laws, approvals must be in place for laws to be effective, laws are enacted to achieve a specific goal, and violation leads to punishment.
3. What is the Drug Enquiry Committee?
The Drug Enquiry Committee was established in 1930 under the chairmanship of Col. R.N. Chopra to inquire into the quality of drugs in British India and make recommendations for the pharmaceutical sector.
4. What were the key recommendations of the DEC?
The DEC recommended establishing a drug industry in India, implementing central legislation, appointing an advisory board, setting up modern test laboratories, framing guidelines for pharmacy courses, and compiling an Indian Pharmacopoeia.
5. When was the Pharmacy Act enacted?
The Pharmacy Act was enacted in 1948, establishing the Pharmacy Council of India and regulating the pharmacy profession.
6. What is the principle of constitutionalism?
Constitutionalism is a collection of political ideals that express the wish to preserve freedom by establishing restraints on the authority of the state.
7. What is the difference between corrective and distributive justice?
Corrective justice restores equality after wrongdoing, while distributive justice pertains to how the state bestows honours and awards on individuals based on their deserts.
SUMMARY
The general principles of law, history, and various acts related to the drugs and pharmacy profession form the foundation of pharmaceutical regulation in India. Law and ethics work together to maintain society and guide the conduct of pharmacy professionals. The evolution of pharmaceutical legislation in India, from the Drug Enquiry Committee of 1930 to the modern regulatory framework, reflects the growth and professionalisation of pharmacy. Understanding these principles and historical developments is essential for pharmacy students and professionals to ensure compliance with legal and ethical standards.
As I always tell my students: “Understanding the history and principles of pharmacy law is not just about passing exams—it is about understanding the foundation of our profession and the responsibilities we carry as healthcare professionals.”
REFERENCES AND FURTHER READING
- Drug Enquiry Committee Report, 1931. Government of India.
- The Pharmacy Act, 1948. Government of India.
- The Drugs and Cosmetics Act, 1940 and Rules, 1945. Government of India.
- Ministry of Health and Family Welfare. (2022). History of Pharmaceutical Legislation in India. Government of India.
- Pharmacy Council of India (PCI). (2022). Pharmacy Education and Practice Regulations. Retrieved from https://www.pci.nic.in.
Disclaimer: This article is for educational purposes only and does not constitute legal advice. Always refer to the latest regulatory guidelines and consult legal experts for compliance matters.
Dr. Saint Paul is a pharmacy educator, Pharm.D graduate, and academic content creator from Jawaharlal Nehru Technological University Kakinada (JNTUK), where he completed his Doctor of Pharmacy (Pharm.D) degree between 2015 and 2021.
He has more than 7 years of experience creating pharmacy educational content, writing study materials, and reviewing academic articles for pharmacy students. He has also contributed guest articles to pharmacy education platforms, including PharmD Guru.
At D.PharmGuru, his work focuses on simplifying complex Diploma in Pharmacy (D.Pharmacy) subjects into easy-to-understand notes, practical explanations, and exam-oriented educational resources for students across India.
His areas of focus include Human Anatomy and Physiology, Pharmaceutics, Pharmacology, Pharmaceutical Chemistry, Hospital and Clinical Pharmacy, and other core D.Pharmacy subjects.
