Legal definitions of schedules to the Act and Rules MCQs With Answer

This concise introduction explains legal definitions of schedules to the Act and Rules in a pharmacy regulatory context, tailored for B.Pharm students. It highlights how schedules attached to the Drugs and Cosmetics Act and Drugs Rules define classification, prescription status, manufacturing standards, clinical trial requirements and enforcement mechanisms. Key keywords include schedules to the Act, schedules to the Rules, Schedule H, Schedule H1, Schedule X, Schedule M (GMP), Schedule Y (clinical trials), CDSCO, State Licensing Authority, statutory force and amendment procedures. Understanding schedules helps in compliance for dispensing, manufacturing and research. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which schedule restricts the sale of certain drugs unless sold on a valid prescription?

• Schedule H
• Schedule M
• Schedule Y
• Schedule X

Correct Answer: Schedule H

Q2. Which schedule provides detailed guidelines for approval and conduct of clinical trials?

• Schedule M
• Schedule H1
• Schedule Y
• Schedule C

Correct Answer: Schedule Y

Q3. Which schedule prescribes Good Manufacturing Practices (GMP) for pharmaceutical manufacturing?

• Schedule H
• Schedule M
• Schedule X
• Schedule Y

Correct Answer: Schedule M

Q4. Which schedule lists drugs that are strictly controlled, habit-forming or require special licence and record keeping?

• Schedule H
• Schedule M
• Schedule X
• Schedule Y

Correct Answer: Schedule X

Q5. Which schedule mandates prescription-only sale and specific record maintenance for certain antibiotics and other medicines?

• Schedule H1
• Schedule M
• Schedule C
• Schedule X

Correct Answer: Schedule H1

Q6. What is the legal status of schedules appended to an Act or to subordinate Rules?

• Mere administrative guidance with no legal force
• Integral part of the statute or rules with binding legal effect
• Informal recommendations by regulators
• Internal departmental memos

Correct Answer: Integral part of the statute or rules with binding legal effect

Q7. Which national authority primarily administers and enforces drug schedules related to new drug approvals and clinical trials?

• Central Drugs Standard Control Organization (CDSCO)
• World Health Organization (WHO)
• State Medical Councils
• Pharmacy Council of India

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q8. Which authority normally grants manufacturing licences under provisions that include compliance with Schedule M?

• Central Government only
• State Licensing Authority
• Municipal Corporation
• Court of law

Correct Answer: State Licensing Authority

Q9. Amendment of a schedule that is part of the main Act generally requires what procedure?

• Executive notification by a ministry
• Central Government gazette notification without legislative approval
• Parliamentary amendment of the Act
• Order by a district magistrate

Correct Answer: Parliamentary amendment of the Act

Q10. Who can amend schedules that are attached to subordinate Rules made under an Act?

• Parliament only
• Central Government by notification under delegated powers
• State Governments without notification
• Courts of law

Correct Answer: Central Government by notification under delegated powers

Q11. How should schedules be interpreted when reading the Act or Rules?

• Schedules are read independently of the main text
• Schedules are read together with the related provisions of the Act and Rules
• Schedules override the operative sections of the Act
• Schedules are only advisory and need not be consulted

Correct Answer: Schedules are read together with the related provisions of the Act and Rules

Q12. Inclusion of a drug in Schedule H requires which label statement on the container?

• No special label is required
• Schedule H — To be sold by prescription only
• Label as Over-the-Counter (OTC)
• Label “For Hospital Use Only”

Correct Answer: Schedule H — To be sold by prescription only

Q13. Which schedules include provisions related to biologicals such as vaccines, sera and toxins?

• Schedule M only
• Schedule C and C1
• Schedule H and H1
• Schedule X only

Correct Answer: Schedule C and C1

Q14. Sale of Schedule X drugs typically requires which legal compliance?

• They can be sold OTC without record
• Special licence for sale and retention of the original prescription and records
• Any pharmacist may sell with only verbal consent
• Sale only permitted in hospitals with no records

Correct Answer: Special licence for sale and retention of the original prescription and records

Q15. Non-compliance with Schedule M manufacturing requirements may lead to which consequence?

• Only a warning with no legal impact
• Cancellation of manufacturing licence and possible prosecution
• Immediate approval of new products
• Exemption from regulatory inspection

Correct Answer: Cancellation of manufacturing licence and possible prosecution

Q16. What kind of information is typically contained in schedules to drug legislation?

• Detailed technical standards, classifications, lists and forms
• Company marketing strategies
• Tax and customs rates
• Patient medical records

Correct Answer: Detailed technical standards, classifications, lists and forms

Q17. How is an amendment to a schedule to the Rules formally communicated to the public?

• By an informal circular from a trade association
• By publication in the Official Gazette
• Only by social media posts
• By word of mouth among pharmacists

Correct Answer: By publication in the Official Gazette

Q18. Who at the retail level is chiefly responsible for ensuring dispensing complies with schedule restrictions?

• Registered pharmacist
• Drug manufacturer
• Central Drugs Standard Control Organization (CDSCO)
• Patients themselves

Correct Answer: Registered pharmacist

Q19. Requirements for labeling and storage conditions of specific drugs are most often specified where?

• Schedules appended to the Rules
• Trade magazines
• Pharmacy promotional brochures
• Non-binding textbooks

Correct Answer: Schedules appended to the Rules

Q20. The primary purpose of schedules in the Drugs and Cosmetics Act and Rules is to:

• Provide detailed technical and administrative specifications and lists
• Promote specific pharmaceutical companies
• Set tax rates for medicines
• Record individual patient histories

Correct Answer: Provide detailed technical and administrative specifications and lists

Q21. Which official normally carries out inspections of manufacturing premises to verify Schedule M compliance?

• State Drug Inspector
• Bank manager
• WHO regional manager only
• Pharmacy college professor

Correct Answer: State Drug Inspector

Q22. If a provision in a schedule to the Rules conflicts with the main Act, which document prevails?

• The main Act prevails
• The subordinate Rule prevails
• The schedule always prevails
• The newer document always prevails irrespective of hierarchy

Correct Answer: The main Act prevails

Q23. Which schedule specifically targets antimicrobial stewardship by requiring stricter sale controls and record keeping?

• Schedule M
• Schedule H1
• Schedule N
• Schedule P

Correct Answer: Schedule H1

Q24. In which legal document are most drug-related schedules published for Indian pharmaceutical regulation?

• Drugs and Cosmetics Rules, 1945
• Indian Penal Code
• Constitution of India
• Indian Pharmacopoeia

Correct Answer: Drugs and Cosmetics Rules, 1945

Q25. Legally, the term “schedule” in legislation most nearly means:

• An annexure or appendix to the Act or Rules containing detailed provisions
• A chapter title in a textbook
• The short title of the Act
• The name of the responsible minister

Correct Answer: An annexure or appendix to the Act or Rules containing detailed provisions

Q26. Which schedule should a B.Pharm student consult when designing a clinical trial protocol or informed consent procedures?

• Schedule M
• Schedule Y
• Schedule H
• Schedule X

Correct Answer: Schedule Y

Q27. What is the formal mechanism that ensures stakeholders are informed after a schedule attached to the Rules is changed?

• Publication of the amendment in the Official Gazette
• Posting on an unofficial blog
• Private letters to manufacturers only
• No formal mechanism exists

Correct Answer: Publication of the amendment in the Official Gazette

Q28. Which schedule is most important for pharmacy students to study for understanding facility design, personnel and production controls?

• Schedule M
• Schedule X
• Schedule H
• Schedule Y

Correct Answer: Schedule M

Q29. Dispensing a Schedule H drug without a valid prescription is:

• An offence punishable under the law
• Permissible if the patient requests
• A civil matter only with no criminal liability
• Encouraged for better access to medicines

Correct Answer: An offence punishable under the law

Q30. When technical ambiguity arises in a schedule, which authority can issue formal clarifications and guidance?

• Central Drugs Standard Control Organization (CDSCO)
• Individual pharmacists acting alone
• Manufacturers without regulatory approval
• Patients’ unions exclusively

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

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