B.PHARM 5TH SEMESTER • BP505T • UNIT-III

Pharmacy Act, 1948 • MTP Act, 1955 • NDPS Act, 1985

Pharmacy Council • Pharmacist Registration • Medicinal Preparations • Narcotic Drugs & Psychotropic Substances

Unit-III of BP505T Pharmaceutical Jurisprudence covers three important areas of pharmaceutical legislation in India: the Pharmacy Act, 1948, the Medicinal and Toilet Preparations (Excise Duties) Act, 1955, and the Narcotic Drugs and Psychotropic Substances Act, 1985. These laws are important for understanding pharmacist registration, pharmacy education, manufacture of specified medicinal preparations, and legal control of narcotic drugs and psychotropic substances.

1. Unit-III at a Glance

Pharmacy Act, 1948

Pharmacy education, Pharmacy Council of India, State Pharmacy Councils, registration and offences.

MTP Act, 1955

Medicinal and Toilet Preparations, licensing, manufacture in bond, outside bond and excise control.

NDPS Act, 1985

Control and regulation of narcotic drugs and psychotropic substances, authorities, cultivation, manufacture, sale and offences.

2. Pharmacy Act, 1948

PHARMACY ACT, 1948

The Pharmacy Act, 1948 is an important legislation concerning the profession and practice of pharmacy in India. Its principal purpose is to regulate the profession of pharmacy and provide a framework for pharmacist education and registration.

2.1 Objectives

To regulate the profession and practice of pharmacy.
To establish statutory Pharmacy Councils.
To prescribe standards relating to pharmacy education.
To provide for registration of pharmacists.
To regulate who may practice pharmacy as a registered pharmacist.

Pharmacy Act, 1948 → Pharmacy Education → Pharmacy Councils → Pharmacist Registration → Regulated Profession

2.2 Important Definitions

Pharmacist: A person whose name is entered in the appropriate register of pharmacists maintained under the Pharmacy Act.

Registered Pharmacist: A person whose name is for the time being entered in the register of pharmacists of the State.

For examination purposes, students should learn the statutory definitions from the latest version of the Act prescribed by their university.

2.3 Pharmacy Council of India (PCI)

The Pharmacy Council of India (PCI) is the central statutory body established under the Pharmacy Act for matters relating to pharmacy education and professional standards.

Education

Prescribes and maintains standards of education in pharmacy within the statutory framework.

Regulations

Frames regulations concerning pharmacy education as authorized by the Act.

Inspection

Exercises statutory functions relating to inspection and recognition of approved courses/institutions.

Professional Standards

Supports the regulation of pharmacy education and professional registration framework.

2.4 Constitution of PCI

The Pharmacy Council of India is constituted in accordance with the provisions of the Pharmacy Act. Its composition includes prescribed categories of members representing pharmacy education, professional and governmental interests.

Exam tip: For a long-answer question, present the constitution under the headings elected members, nominated members and ex-officio members, and then write the functions separately.

2.5 Education Regulations

Education Regulations establish standards for pharmacy education, including requirements relating to the course of study, practical training, examinations and other educational requirements.

Education Regulations → Course of Study → Practical Training → Examination → Educational Standard

2.6 State Pharmacy Councils

State Pharmacy Councils are statutory bodies established for the registration and regulation of pharmacists at the State level under the Pharmacy Act.

Registration

Maintain the State register of pharmacists.

Registration Applications

Process applications according to the Act and applicable rules.

Professional Regulation

Perform statutory functions relating to registered pharmacists.

2.7 Joint State Pharmacy Councils

Two or more States may establish a Joint State Pharmacy Council according to the provisions of the Pharmacy Act.

State A + State B → Joint State Pharmacy Council → Registration / Regulation

2.8 Registration of Pharmacists

Registration is a central concept of the Pharmacy Act. A person meeting the prescribed qualifications and requirements may apply for registration with the appropriate State Pharmacy Council.

Recognized Qualification → Application → Verification → State Register → Registered Pharmacist

2.9 Offences and Penalties

The Pharmacy Act provides offences and penalties for violations of its provisions. The exact offence and penalty depend upon the specific provision involved.

Important: Do not rely on outdated numerical penalty values. For legal practice, always consult the current Act and amendments.

3. Pharmacy Act – Quick Revision

Topic	Key Point
Pharmacy Act, 1948	Regulates the profession and practice of pharmacy.
PCI	Central statutory body concerned with pharmacy education and professional standards.
Education Regulations	Prescribe standards for pharmacy education.
State Pharmacy Council	Maintains the State register and performs statutory functions relating to pharmacists.
Joint State Council	May be established by two or more States according to the Act.
Registration	Entry of eligible pharmacists in the State register.

4. Medicinal and Toilet Preparations (Excise Duties) Act, 1955

MEDICINAL AND TOILET PREPARATIONS ACT, 1955

The Medicinal and Toilet Preparations (Excise Duties) Act, 1955 provided a framework for levy and collection of excise duty on certain medicinal and toilet preparations containing alcohol, opium, Indian hemp and other specified substances.

4.1 Objectives

To provide for levy and collection of excise duty on specified medicinal and toilet preparations.
To regulate manufacture of specified preparations.
To control manufacture involving excisable substances.
To provide licensing and record requirements.

4.2 Important Definitions

Medicinal Preparation: Preparations intended for use in the treatment, mitigation or prevention of disease or disorder in human beings or animals, as defined under the applicable legislation.

Toilet Preparation: Preparations intended for use in toilet of the human body or for perfuming apparel, or similar purposes, falling within the statutory definition.

4.3 Licensing

Manufacture of preparations covered by the legislation is subject to prescribed licensing and excise-control requirements.

Application → Premises / Equipment → Verification → Licence → Authorized Manufacture

4.4 Manufacture In Bond

Under the bond system, manufacture is carried out under prescribed excise control and supervision. The system is designed to ensure proper accounting and control of excisable materials and finished preparations.

Raw Materials → Bonded Premises → Manufacture → Excise Control → Finished Preparation

4.5 Manufacture Outside Bond

Manufacture outside bond is conducted under the applicable provisions and conditions prescribed by the legislation and rules, with appropriate excise control and payment requirements.

4.6 In Bond vs Outside Bond

Feature	In Bond	Outside Bond
Manufacturing location	Bonded premises under prescribed control.	Approved premises under applicable provisions.
Excise control	Direct control/supervision according to the bond system.	Control according to applicable duty and regulatory requirements.
Documentation	Prescribed records and accounts.	Prescribed records and accounts.
Purpose	Controlled manufacture under bond.	Manufacture subject to applicable duty arrangements.

4.7 Export of Alcoholic Preparations

Export of specified alcoholic medicinal or toilet preparations is subject to prescribed conditions, documentation and excise requirements.

Alcoholic Preparation → Export Documentation → Excise Requirements → Export

4.8 Ayurvedic Preparations

Specified Ayurvedic medicinal preparations containing excisable substances are subject to the applicable provisions concerning manufacture, licensing and excise control.

4.9 Homoeopathic Preparations

Specified homoeopathic preparations covered by the legislation are subject to applicable requirements concerning manufacture and excise control.

4.10 Patent and Proprietary Preparations

Patent and proprietary medicinal preparations falling within the scope of the legislation are regulated according to the applicable statutory requirements.

4.11 Offences and Penalties

The legislation provides for offences and penalties for non-compliance with licensing, manufacturing, excise and other statutory requirements.

5. MTP Act – Quick Revision

MTP Act, 1955 → Licensing → Manufacture → Excise Control → Legal Compliance

6. Narcotic Drugs and Psychotropic Substances Act, 1985

NDPS ACT, 1985

The Narcotic Drugs and Psychotropic Substances Act, 1985 provides a comprehensive legal framework for control and regulation of operations relating to narcotic drugs and psychotropic substances.

The Act controls activities such as cultivation, production, manufacture, possession, sale, purchase, transport, storage, import and export, subject to statutory exceptions and authorized purposes.

6.1 Objectives

To control and regulate operations relating to narcotic drugs and psychotropic substances.
To provide stringent measures against illicit trafficking.
To regulate legitimate medical and scientific use.
To provide penalties for offences involving controlled substances.
To implement India's obligations under relevant international drug-control conventions.

6.2 Important Definitions

Narcotic Drug

Includes substances falling within the statutory categories specified by the NDPS Act.

Psychotropic Substance

A substance specified or covered by the statutory definition and relevant schedules.

Opium

Defined under the Act and includes the specified preparations or substances covered by the statutory definition.

Poppy Straw

The statutory definition covers the specified parts and material of the opium poppy plant after harvesting, subject to the Act.

6.3 Authorities and Officers

The NDPS regulatory framework involves designated Central and State authorities and officers responsible for implementation, enforcement, licensing and control.

NDPS Act & Rules → Central Authorities + State Authorities → Enforcement Officers → Regulatory Control

6.4 Narcotic Drugs and Psychotropic Substances Consultative Committee

The Act provides for a consultative committee to advise the Central Government on matters relating to administration of the Act and other connected matters.

6.5 National Fund for Control of Drug Abuse

The Act provides for establishment of the National Fund for Control of Drug Abuse. The fund is intended for activities connected with prevention of drug abuse and combating illicit traffic and other purposes specified by the Act.

6.6 Prohibition, Control and Regulation

The NDPS Act generally prohibits specified activities involving narcotic drugs and psychotropic substances except when they are authorized by the Act, Rules, orders or applicable licences and permits.

Narcotic / Psychotropic Substance → Prohibition or Authorized Activity → Licence / Permit / Regulation → Legal Use

6.7 Opium Poppy Cultivation

Cultivation of opium poppy is subject to strict statutory control and authorization. It is not a freely permitted agricultural activity.

Opium Poppy → Government Authorization → Licensed Cultivation → Collection / Delivery → Regulated Opium Production

6.8 Production of Poppy Straw

Production, possession and related activities concerning poppy straw are regulated under the NDPS framework.

6.9 Manufacture, Sale and Export of Opium

Manufacture, possession, sale and export of opium are subject to strict statutory control and authorization under the NDPS framework.

Opium → Authorized Manufacture → Controlled Possession → Authorized Sale / Supply → Permitted Export

6.10 Offences and Penalties

The NDPS Act contains stringent provisions for offences involving narcotic drugs and psychotropic substances. Penalties vary according to the nature of the offence, substance involved, quantity and other statutory circumstances.

Important examination point: Under the NDPS framework, the quantity of the substance can be a major factor in determining the applicable statutory treatment and penalty. Students should refer to the current Act and notifications for exact thresholds and penalties.

7. NDPS Regulatory Flowchart

Controlled Substance → Identification → Authorization / Prohibition → Regulated Activity → Monitoring → Enforcement

8. Comparison of Three Important Acts

Act	Primary Area	Major Examination Focus
Pharmacy Act, 1948	Pharmacy profession and education	PCI, State Councils, Education Regulations and registration.
MTP Act, 1955	Medicinal and toilet preparations	Licensing, manufacture in bond/outside bond and excise control.
NDPS Act, 1985	Narcotic drugs and psychotropic substances	Control, regulation, authorities, opium poppy and offences.

9. Unit-III Master Concept Map

PHARMACEUTICAL JURISPRUDENCE
↓
Pharmacy Act, 1948 → Profession → Registration

MTP Act, 1955 → Medicinal / Toilet Preparations → Excise Control

NDPS Act, 1985 → Narcotic / Psychotropic Substances → Control & Regulation

10. Quick Revision Points

Pharmacy Act, 1948
• Regulates pharmacy profession and practice.
• Establishes the Pharmacy Council framework.
• Deals with pharmacy education.
• Provides for registration of pharmacists.

MTP Act, 1955
• Deals with specified medicinal and toilet preparations.
• Includes licensing and excise control.
• Covers manufacture in bond and outside bond.

NDPS Act, 1985
• Controls narcotic drugs and psychotropic substances.
• Regulates authorized activities.
• Controls opium poppy cultivation and poppy straw.
• Provides stringent penalties for specified offences.

11. Important Examination Questions

Long Answer Questions

Explain the objectives, constitution and functions of the Pharmacy Council of India.
Discuss the constitution and functions of State and Joint State Pharmacy Councils.
Explain registration of pharmacists under the Pharmacy Act, 1948.
Discuss the objectives and licensing provisions of the Medicinal and Toilet Preparations Act, 1955.
Differentiate manufacture in bond and outside bond.
Explain the objectives and major provisions of the NDPS Act, 1985.
Discuss the control and regulation of narcotic drugs and psychotropic substances.
Explain the provisions relating to opium poppy cultivation and production of poppy straw.
Discuss offences and penalties under the NDPS Act.

Short Answer Questions

Write a note on the Pharmacy Act, 1948.
What are the functions of PCI?
What are Education Regulations?
What is a State Pharmacy Council?
What is pharmacist registration?
Write a note on the MTP Act, 1955.
What is manufacture in bond?
What is manufacture outside bond?
Write a note on the NDPS Act, 1985.
Define narcotic drug.
Define psychotropic substance.
What is the National Fund for Control of Drug Abuse?
Write a note on opium poppy cultivation.
What is poppy straw?
Write a note on offences under the NDPS Act.

12. Interactive Quick Quiz

Q1. Which Act primarily regulates the profession and practice of pharmacy in India?

Q2. Which body is associated with pharmacy education under the Pharmacy Act?

Q3. Which Act deals with narcotic drugs and psychotropic substances?

Q4. The Pharmacy Act provides for:

Q5. Manufacture of opium poppy is subject to:

13. One-Minute Memory Map

PHARMACY ACT, 1948
PCI → Education → State Council → Registration

MTP ACT, 1955
Medicinal/Toilet Preparations → Licence → In Bond / Outside Bond → Excise Control

NDPS ACT, 1985
Narcotic/Psychotropic Substances → Prohibition/Authorization → Control → Regulation → Penalties

Academic & Legal Note: These notes are intended for B.Pharm educational and examination purposes. Pharmaceutical legislation is subject to amendments, notifications and changes in regulatory frameworks. Exact statutory wording, definitions, penalties, licensing requirements and procedures should be verified from the latest official legislation before use in professional or regulatory practice.

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BP505T Unit-III: Pharmacy Act 1948, MTP Act 1955 & NDPS Act 1985 | B.Pharm Notes