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Pharmaceutical Jurisprudence Schedule

The document provides an overview of pharmaceutical jurisprudence, detailing key laws and schedules related to drug regulation in India, including the Drugs and Cosmetics Act and the Pharmacy Act. It outlines various schedules that categorize drugs based on their regulation, safety, and usage, such as Schedule H for prescription drugs and Schedule Y for clinical trials. Additionally, it mentions the regulatory bodies overseeing the pharmaceutical industry and the penalties for non-compliance.

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Abhay Shukla
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604 views2 pages

Pharmaceutical Jurisprudence Schedule

The document provides an overview of pharmaceutical jurisprudence, detailing key laws and schedules related to drug regulation in India, including the Drugs and Cosmetics Act and the Pharmacy Act. It outlines various schedules that categorize drugs based on their regulation, safety, and usage, such as Schedule H for prescription drugs and Schedule Y for clinical trials. Additionally, it mentions the regulatory bodies overseeing the pharmaceutical industry and the penalties for non-compliance.

Uploaded by

Abhay Shukla
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Pharmaceutical Jurisprudence & Schedule Questions with Answers

Q: What is pharmaceutical jurisprudence?


A: It is the branch of pharmacy that deals with laws, rules, and regulations governing the
manufacture, sale, distribution, and use of drugs.
Q: What is the Drugs and Cosmetics Act, and when was it enacted?
A: It is the principal law regulating drugs and cosmetics in India, enacted in 1940.
Q: What is the purpose of the Drugs and Cosmetics Act?
A: To regulate the import, manufacture, distribution, and sale of drugs and cosmetics to ensure
safety, efficacy, and quality.
Q: What is the Pharmacy Act of India?
A: It was enacted in 1948 to regulate the profession of pharmacy in India.
Q: What is Schedule A in the Drugs and Cosmetics Act?
A: It includes various forms and licenses related to drug regulation.
Q: What is Schedule B?
A: It lists the fees for tests and analysis of drugs and cosmetics.
Q: What is Schedule C?
A: It contains a list of biological and special products like vaccines and sera.
Q: What is Schedule C1?
A: It includes additional biological products like insulin and antibiotics.
Q: What is Schedule D?
A: It provides exemptions for certain imported drugs and cosmetics from the rules.
Q: What is Schedule E1?
A: It lists poisonous substances used in Ayurveda, Siddha, and Unani medicine.
Q: What is Schedule F?
A: It includes standards for vaccines, surgical dressings, and blood products.
Q: What is Schedule G?
A: It lists drugs that must be sold with a caution label and require continuous medical supervision
(e.g., hormonal drugs).
Q: What is Schedule H?
A: It contains prescription drugs that should not be sold without a registered medical practitioner's
prescription.
Q: What is Schedule H1?
A: It includes drugs with higher abuse potential, such as certain antibiotics and habit-forming drugs,
requiring stricter regulations.
Q: What is Schedule J?
A: It lists diseases and conditions for which no drug should claim a cure (e.g., AIDS, cancer).
Q: What is Schedule K?
A: It provides exemptions for specific categories of drugs from certain rules (e.g., homeopathic
medicines).
Q: What is Schedule M?
A: It defines Good Manufacturing Practices (GMP) for pharmaceutical industries.
Q: What is Schedule N?
A: It lists the minimum requirements for pharmacy premises and equipment.
Q: What is Schedule P?
A: It includes standards for drug shelf life and storage conditions.
Q: What is Schedule Q?
A: It contains a list of permitted colors for drugs and cosmetics.
Q: What is Schedule X?
A: It contains narcotic and psychotropic substances requiring strict regulation.
Q: What is Schedule Y?
A: It provides guidelines for clinical trials and new drug approvals in India.
Q: Who regulates the pharmaceutical industry in India?
A: The Central Drugs Standard Control Organization (CDSCO) and the Drug Controller General of
India (DCGI).
Q: What is the Narcotic Drugs and Psychotropic Substances (NDPS) Act?
A: A law enacted in 1985 to regulate the manufacture, sale, and distribution of narcotic drugs.
Q: What is the Pharmacy Council of India (PCI)?
A: To regulate pharmacy education and practice in India.
Q: Which schedule regulates Good Laboratory Practices (GLP)?
A: Schedule L1.
Q: Which act governs the advertisement of drugs in India?
A: The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954.
Q: What is a prescription audit?
A: A review of prescriptions to ensure compliance with legal and ethical standards.
Q: What is the penalty for selling Schedule H1 drugs without a prescription?
A: Strict legal action, including fines and imprisonment as per the Drugs and Cosmetics Act.

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