II-D.
Pharm Pharmacy law and ethics Chapter-1
Chapter:1 General principles of Law, History and various Acts related to Drug and
Pharmacy Profession
INTRODUCTION
• Law and ethics work together to maintain the society.
• Law is a rule of conduct that is formally recognised as binding and enforced by a society.
Definition and Meaning of Law
• Codified common sense.
• Set of rules imposed by authority.
• Legal document that sets the rules that regulate a specific type of activity.
• According to 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."
• According to John Locke, "Every Law is a veritable freedom, the ends of Law are not to abolish or confine
but to preserve and increase freedom".
Law in Jurisprudence
• According to Austin, law is a sovereign's command that is enforced by sanctions.
• According to Salmond, law is a set of principles that the state recognises and applies in the
administration of justice.
• According to Roscoe Pound, law is a social engineering instrument.
• According to Kelsen, law is a normative science. The legal standards are 'Ought' norms, as opposed to 'Is'
norms of physical and natural science.
• Savigny discovered the origin of law in Volkgeist (general consciousness of people).
• According to Holmes, law is a declaration of the circumstances in which public force will be brought to
bear through courts.
General Principles of Law
• Rule of law
• Separation of powers
• Ubi jus ibi remedium
• Ignoration facti excusat-ignorantia juris non excusat
• Volenti non fit injuria (injury caused by consent is not a cause of action)
• Res ipsa loquitur (the thing speaks for itself)
• Actus non facit reum nisi mens sit rea (the intent and act coincide to commit the crime)
• Nemo debet bis vexari pro una et eadem causa (a man shall not be twice provoked for one and the
same)
• Fiat juastitia ruat coelom (let justice be done, though the heaven should fall)
• Principles of Natural Justice
Principles of Natural Justice
• Rules are not universally embodied and are not codified.
• Rules have been created to secure justice and to prevent failure of justice.
• According to the maxim, justice should not only be done, but should beclearly observed to be conducted.
• Applicable to administrative and quasi-judicial proceedings.
• Include the following rules:
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History and Various Acts Related to Drugs and Pharmacy Profession
Towards the closing of 19th century, manufacturing of modern drug began in India.
1. Bengal Chemical and Pharmaceutical Works (Calcutta) was established by Acharya P.C. Ray in 1901.
2. A small factory at Parel (Bombay) was initiated by Prof. T.K. Gajjar in 1903.
3. Alembic Chemical Works (Baroda) was laid down by Prof. T. K. Gajjar Rajmitra, and B.D. Amin in 1907.
4. All these became the foundation stone.
In the early 20th century, there was virtually no legislative control on drugs and on the pharmacy profession.
Although:
a) the Opium Act, 1878,
b) Poison Act, 1919.
c) Dangerous Drugs Act, 1930 were all in effect at the time, they were all very precise and completely
ineffective in managing the chaotic conditions dominant at that time.
• In 1927, the Council of States passed a resolution recommending to the Governor General in Council
that the Provisional Governments take immediate efforts to regulate indiscriminate drug use and
legislate for the standardization of drug manufacturing and sale.
• On 11th August 1930, Drugs Enquiry Committee (DEC) was constituted under the Chairmanship of Col.
R. N. Chopra. This was a historic development which marked the beginning of new era of drug
legislation in India.
• Before this committee was established, there was no such legislation to control the import,
manufacture, sale, and distribution of drugs. Neither was any Act laid mentioning the desired
qualification of a pharmacist nor a systematic procedure was adopted for registration as pharmacists.
Drug Enquiry Committee (DEC)
• In 1927, a resolution was made according to which Drugs Enquiry Committee (DEC) was setup by the
Indian Government; this committee is also known as Chopra Committee.
• Dr. B. Mukherjee, the Assistant Secretary of this committee later became the Director of Central Drugs
Laboratory and subsequently of the Central Drug Research Institute.
Functions of DEC were to
• 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, and
3) Enquire the legislations that allow only qualified persons to access the pharmacy profession.
A report was submitted in 1931 by the Drug Enquiry Committee they included following recommendations.
• A drug industry should be established in India.
• A Central Legislation should be implemented either 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 and to give timely advice about the necessary amendments in the Act to the Government.
• All Indian states should have modern test laboratories and quality control laboratories to test and
manage the quality of drugs and its products manufactured in pharmaceutical industries along with the
drugs imported.
• 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.
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• Guideline should be framed for pharmacy course.
• Patent and proprietary medicines of undisclosed formula (manufactured in which India or imported)
should be registered.
• Compilation of Indian Pharmacopoeia is required.
✓ Just after the publication of report, in 1932, Prof. M.L. Schroff initiated the first Pharmacy
department of Pharmaceutics at Banaras Hindu University (BHU).
✓ In 1935, at Uttar Pradesh, Indian Pharmaceutical Association was created.
✓ In 1939, Prof. M.L. Schroff started the Indian Journal of Pharmacy.
✓ In 1940, the Drug Bill was put forward in the Legislative Assembly. It was passed by considering the
report of Selection Committee. After seven years (in 1947), the Drug Bill was enforced as the Drug
Act, 1940.
✓ In 1940, the All-India Pharmaceutical Congress Association was founded. The pharmaceutical
conference held its sessions in several places to increase awareness of pharmacy as a whole.
✓ In 1941, the first Drugs Technical Advisory Board (DTAB) was established under, and the Central
Drugs Laboratory was founded.
✓ In 1945, the Drugs Rule under the 1940 Drugs Act was established. The Drug Act has been
amended from time to time, and it now covers cosmetics as well as Ayurvedic, Unani, and
Homeopathic medicines in some ways.
✓ In 1945, the Pharmacy Bill was introduced by the government to regulate pharmacy education in
India.
✓ The Drug and Cosmetics Rules, 1945 framed by the Central government is a set of rules for the
manufacture, distribution, and sale of drugs and cosmetics in India. These act and rules are
amended at suitable intervals of time.
✓ Drugs Enquiry Committee and Health Survey and Development Committee gave recommendations,
which laid the foundation for the Pharmacy Act, 1948 Government of India introduced the
Pharmacy Bill in 1945 to regulate the profession and practice of pharmacy. This Bill was later
passed as Pharmacy Act, 1948 (Act No. VIII of 1948).
✓ In 1948, under the chairmanship of late Dr. B.N. Ghosh, the Indian Pharmacopoeial Committee was
established.
✓ In 1949, the Pharmacy Council of India (PCI) was created under the Pharmacy Act 1948.
It became necessary after independence to control the advertisements of drugs which were in
overstated and deceptive form.
✓ Many manufacturers were making overstated claims for their medicines and exploiting the
weaknesses of human, particularly in the advertisements of STDs, menstrual disorders, loss of
vigour, stamina, etc.
✓ The Drugs and Magic Remedies (Objectionable Advertisements) Act was approved by the
Parliament in 1994 for the regulation of these offensive trends.
✓ The Medicinal and Toilet preparations (Excise Duties) Act was passed by the Parliament in 1955
for controlling the production, sale, and distribution of alcohol and for maintaining regularity in the
excise duties.
✓ The Drugs Price Control Order, 1970 was passed for regulating the prices drugs.
✓ In 1985, the Narcotic Drugs and Psychotropic Substances Act and Rules was passed with the
removal of the Dangerous Drugs Act, 1930 and Opium Act 1878.
Few more enactments which are directly or indirectly linked to manufacture distribution, and sale of Drugs
and Pharmaceuticals in India are:
• Prevention of Food Adulteration Act, 1954 and Rules,
• The industries (Development and Regulations) Act, 1951, 1946 and Rules,
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• The Industrial Employment (Standing Order) Act, 4) Industrial Dispute Act, 1947,
• Factory Act, 1948,
• The Indian Pater.t and Design Act, 1970,
• The Trade and Merchandise Mark Act, 1958,
• The Epidemic Diseases Act, 1897,
• Shops and Establishments Act of respective states.
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