Pharmacy Act of 1948 Quiz

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Questions and Answers

What is one of the primary objectives of the Pharmacy Act of 1948?

To establish a national drug distribution network

To create a government pharmaceutical manufacturing unit

To regulate the profession and practice of pharmacy (correct)

To manage the pricing of pharmaceuticals

Which committee recommended that pharmacy practitioners should possess proper knowledge before the enactment of the Pharmacy Act?

The Health and Family Welfare Committee

The Medical Council of India

The Drugs Inquiry Committee

The Health Survey and Development Committee (correct)

What was one of the significant changes introduced by the Pharmacy Act of 1948 regarding pharmacy education?

Standardization of pharmacy textbooks across colleges

Introduction of online pharmacy courses

Elimination of practical training requirements

Regulation of diploma in pharmacy programs (correct)

Which body was constituted as a result of the Pharmacy Act, 1948?

Pharmacy Council of India Signup and view all the answers

Before the enactment of the Pharmacy Act, what was the status of pharmacy practice in India?

Non-existent with no formal education Signup and view all the answers

What is the minimum qualification required for at least four members nominated by the Central Government?

Diploma in Pharmacy Signup and view all the answers

How many members are elected by the State Pharmacy Council?

24 Signup and view all the answers

What is one of the major functions of the Pharmacy Council of India?

Designing educational patterns Signup and view all the answers

Which body is responsible for nominating one representative to the Pharmacy Council of India?

University Grants Commission Signup and view all the answers

What must an institution do to gain approval to conduct a pharmacy course?

Send an application to PCI Signup and view all the answers

How many ex-officio members are there in the Pharmacy Council of India?

3 Signup and view all the answers

Who selects one member from the Medical Council of India for the Pharmacy Council of India?

Medical Council of India Signup and view all the answers

What is the function of maintaining a Central Register of pharmacists?

To ensure all pharmacists are registered Signup and view all the answers

Which types of drugs require a licence for import?

Drugs specified in Schedule C and C1 Signup and view all the answers

What is considered manufacturing in the context of drugs?

Any process for making, altering, ornamenting, packaging, or labeling with the purpose of sale Signup and view all the answers

What type of drug is prohibited from being manufactured?

Non-standard quality drugs or spurious drugs Signup and view all the answers

What condition must a licensee fulfill to manufacture Schedule C and C1 drugs?

Ensure compliance with Good Manufacturing Practices Signup and view all the answers

Which type of drug is allowed for import with a prescription from a Registered Medical Practitioner?

Drugs for personal use Signup and view all the answers

What requirement exists for testing the strength and quality of drugs?

The testing unit should be separate from the manufacturing unit Signup and view all the answers

What is one of the conditions for granting a licence to manufacture drugs?

The licensee should provide adequate space for drug manufacture Signup and view all the answers

Which of the following drugs can be imported without a license?

Drugs for personal use prescribed by a Registered Medical Practitioner Signup and view all the answers

What is the primary purpose of the legal framework concerning narcotics drugs?

To amend and consolidate the law related to narcotics drugs Signup and view all the answers

Which of the following is NOT included in the definition of cannabis?

Coca leaf Signup and view all the answers

What is one of the functions of the Narcotic Commissioner appointed by the Central Government?

To supervise the cultivation of opium poppy Signup and view all the answers

Which of these substances is derived from the opium poppy?

Morphine Signup and view all the answers

What does the term 'Essential narcotic drugs' refer to?

Narcotic drugs designated for medical and scientific use Signup and view all the answers

What does the NDPS Consultative Committee primarily advise on?

The administration of the NDPS Act Signup and view all the answers

Which activity is prohibited under the NDPS regulations?

Cultivation of Coca plants Signup and view all the answers

What is the meaning of 'Commercial quantity' in relation to narcotic drugs?

Any quantity greater than that specified by the central government Signup and view all the answers

What type of penalty is associated with the contravention of the NDPS Act?

Rigorous imprisonment for 10-20 years Signup and view all the answers

What is the legal classification of 'Opium'?

The coagulated juice of the opium poppy Signup and view all the answers

What is one of the obligations of the Central Government regarding international conventions related to NDPS?

To coordinate NDPS authorities in other countries Signup and view all the answers

Which of the following correctly describes 'Narcotic drugs'?

Coca leaf, cannabis, opium, and manufactured drugs Signup and view all the answers

Which of the following is NOT a characteristic of the NDPS Consultative Committee?

It has the power to conduct independent investigations Signup and view all the answers

What is excluded from the definition of opium?

Preparations containing no more than 0.2% morphine Signup and view all the answers

What must individuals obtain from the government regarding the cultivation of narcotic plants?

Permits and licenses Signup and view all the answers

What consequence may result from embezzlement of opium by licensed cultivators?

Rigorous imprisonment and fines Signup and view all the answers

What is the ceiling price formula used to calculate the price of a new drug?

P(c) = P(s) * (1 + M/100) Signup and view all the answers

How much margin is set for retailers according to the governmental policy?

16% Signup and view all the answers

Which of the following is NOT an objective of the Pharmaceutical Policy 2002?

To eliminate all imported drugs Signup and view all the answers

What is one of the specified requirements for companies under the Pharmaceutical Policy 2002 regarding R&D investment?

Invest at least Rs. 10 crore per annum Signup and view all the answers

According to the Code of Pharmaceutical Ethics, what is the primary focus of ethics in pharmacy?

To provide benefits to others Signup and view all the answers

What aspect does the Pharmaceutical Policy 2002 NOT directly address?

Direct consumer pricing strategies Signup and view all the answers

Which of the following statements accurately describes the role of the Pharmaceutical Research and Development Committee?

To identify the needs of pharmaceutical companies for R&D Signup and view all the answers

What does P(s) represent in the ceiling price formula?

The price to retailer of all brands and generics with significant market share Signup and view all the answers

Study Notes

Pharmacy Law and Ethics - D Pharma Second Year

This document is about Pharmacy law and ethics for second-year D Pharma students, written in easy English.
The author of the document (S R Pharmacy) provides it for free, but requests a fee of 100 rupees for those who request a copy.
The document provides details of various acts related to drug and pharmacy practices.

The table of contents lists the various chapters and their respective page numbers in the document, covering topics like general principles, different acts related to the pharmacy profession, and the National Pharmaceutical Pricing Authority (NPPA).

General Principles of Law

The document details general legal principles, including:
- Rule of Law
- Separation of power
- Ignorance of law is not an excuse
- Consent is not a cause of action if harm was willingly placed
- An act does not make someone guilty unless the intent is present
- No one should be punished twice for the same offense
- No person can be judge in his own case.
These principles are relevant to understanding various pharmacy-related legal concepts.

Pharmacy Act 1948 and Rules

The Pharmacy Act 1948 and Rules define the rules, regulations, course duration, qualifications, and penalties, all pertaining to the pharmacy profession.
Objectives of the Act were to regulate the profession better, improve status, provide standard in education, create a pharmacy council for India and regulate pharmacy institutions.
Definitions of terms like Central Council, State Council, Registered Pharmacist, etc. are present in the document, with details about these.

The document details the history of modern drug manufacturing, which began in India in the late 19th century, and the development of pharmacy acts.
These include the Pharmacy Act, Drug and Cosmetic Act, Narcotic Drugs and Psychotropic Substances Act, Drugs and Magic Remedies Act, Prevention of Cruelty to Animals Act, Poison Act, FSSAI Act and Rules, Medical termination of pregnancy Act, Clinical Establishment Act, and the Consumer Protection Act.

Pharmacy Act 1948 and Rules (Continued)

The document details the objectives of the Pharmacy Act of 1948, which focused on establishing standards for the pharmacy profession, and definitions of important terms. This section continues the focus on the legal aspects of the field.

Other Act Descriptions (Summarized)

The document details different acts related to drugs and pharmacy, such as the Drug and Cosmetic Act, Narcotic Drugs and Psychotropic Substances Act, Preventing Cruelty to Animals Act, and the act pertaining to Poison.
This section describes the different categories of drugs and covers their manufacture, handling, import, and sale, emphasizing regulations and standards.
It also tackles the roles of different government authorities and agencies like the Central Drugs Standard Control Organisation (CDSCO) and the Indian Pharmacopoeia Commission (IPC) which are very relevant .

Good Regulatory Practices

The document outlines good regulatory practices for pharmacies, emphasizing the need for proper maintenance, records, registration processes, documentation of drug purchases for sale and storage, and procedures pertaining to prescriptions.
Specific requirements for licenses are included.

National Pharmaceutical Pricing Authority (NPPA)

The document talks about the National Pharmaceutical Pricing Authority (NPPA) and its role in setting and controlling the price of essential drugs.
The document details the objectives, definitions, responsibilities, and functions of the NPPA.
The document describes the essential medicines list and regulations, and mentions details about the act (DPCO) and different drug classifications in relation to price control.

New Drug Development

This section describes the Biopharmaceutics Classification System , different classifications of drugs.
This section details important aspects of new drug applications (NDA) and clinical trials, as well as aspects of intellectual property and emergency use authorizations.

Blood Bank

It outlines the requirements and functionality of blood banks, including premises, personnel, equipment, procedures, and storage of blood products.
It comprehensively details the types of blood products and their appropriate storage conditions.

Clinical Establishment Act and Rules

Describes rules for establishing clinical establishments in accordance with Indian law, including requirements like registration, documentation, types of registration (provisional and permanent), information needed for registration, and penalties for non-compliance.

Biomedical Waste Management Rules 2016

This section details the rules pertaining to biomedical waste management policies, classification of waste materials, appropriate handling, duties and responsibilities of parties involved, and general waste handling procedures.

Bioethics

This section introduces the concept of bioethics, covering its history and principles, which include respect for autonomy, beneficence, non-maleficence, and justice.
It touches on significant events historically and their importance to present day bioethics practice.

Consumer Protection Act

It discusses the Consumer Protection Act of 2019, emphasizing its objective to provide protection to consumers through various measures and activities like investigation, resolving disputes both in the national, district, state levels and online.
It describes the types of complaints and their thresholds and requirements for each level of filing a complaint.

Introduction to the Disaster Management Act

This chapter focuses on the Disaster Management Act of 2005. It discusses what constitutes a disaster, the roles and responsibilities of different authorities in disaster management (both central and state), and plans, activities, and guidelines for disaster management (including the National Disaster Response Force).

Medical Devices Act

This section outlines the Medical Devices Act and related regulations, covering the categorization of medical devices by risk level (low, moderate, high).
Focuses on regulatory approval requirements, quality controls, clinical and regulatory considerations.

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Description

Test your knowledge about the Pharmacy Act of 1948 with this quiz. Covering key objectives, committees, and changes in pharmacy education, this quiz will enhance your understanding of this important legislation. Perfect for students and professionals in the field of pharmacy.