1. GENERAL PRINCIPLES OF LAW, HISTORY & VARIOUS ACTS RELATED TO DRUGS & PHARMACY PROFESSION

PHARMACY LAW AND ETHICS

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.

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.
• Rig Veda: “Law is the king of monarchs, far more powerful and right than they, by whose aid, even the weak may conquer over the strong.”
• John Locke: “Every Law is a veritable freedom, the ends of Law are not to abolish or confine but to preserve and increase freedom.”

Characteristics of Law

1. It pre-supposes the existence of a state.
2. The state creates or authorises to create laws, as well as recognise and approve laws.
3. Approvals must be in place for the laws to be effective.
4. Laws are enacted to achieve a specific goal (social purpose or to serve some personal ends of a despot).
5. 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.
• Violation of ethics does not cause punishment.

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.

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.”

Principle of Justice

• 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.

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.

Principle of Fraternity

Fraternity means “brotherhood among disparate body of people united in their interests, aims, and so on.”

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.

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.

Functions of DEC

1. Identify the quality and quantity of impure drugs imported, manufactured, or sold in British India as per the British Pharmacopoeia.
2. Report the recommendations for the above by different approved medicinal preparations and indigenous drugs preparations.
3. Enquire the legislations that allow only qualified persons to access the pharmacy profession.

Recommendations by DEC (Report 1931)

1. A drug industry should be established in India.
2. A Central Legislation should be implemented (combined or individually as the Drugs and Pharmacy Act).
3. An advisory board should be appointed by the Central Government to look after the objectives of the Act.
4. All Indian states should have modern test laboratories and quality control laboratories.
5. Crude drugs individually or compounded into medicines in traditional treatment system should be included under the Legislation.
6. Manufacturing should be gradually reduced in Medical Stores Departments.
7. Guidelines should be framed for pharmacy courses; training courses in pharmacy should be setup; minimum qualification for registration as a pharmacist should be imposed.
8. Patent and proprietary medicines of undisclosed formula should be registered. Cinchona cultivation in India should be initiated.
9. 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