Introduction: Schedule H is a critical component of the Drugs and Cosmetics Rules, defining prescription-only medicines and regulatory controls essential for safe pharmacy practice. For B. Pharm students, understanding Schedule H covers labeling requirements, prescription validity, pharmacist responsibilities, and how it differs from Schedule H1 and Schedule X. Mastery of these concepts supports rational dispensing, prevents antimicrobial misuse, and ensures legal compliance with the Drugs and Cosmetics Act and CDSCO guidelines. This topic links pharmacology, pharmacy law, and public health, making it vital for clinical decision-making and professional ethics. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary purpose of Schedule H under the Drugs and Cosmetics Rules?
- To classify over-the-counter medicines
- To list prescription-only medicines requiring a registered medical practitioner’s order
- To regulate cosmetic ingredients
- To control herbal supplements exclusively
Correct Answer: To list prescription-only medicines requiring a registered medical practitioner’s order
Q2. Which statement correctly differentiates Schedule H from Schedule X?
- Schedule H covers narcotics; Schedule X covers vitamins
- Schedule H includes prescription drugs; Schedule X imposes stricter control and record-keeping for certain habit-forming or dangerous drugs
- Schedule H is for veterinary drugs only; Schedule X is for human drugs
- Schedule H requires exports; Schedule X prohibits export
Correct Answer: Schedule H includes prescription drugs; Schedule X imposes stricter control and record-keeping for certain habit-forming or dangerous drugs
Q3. Which regulatory document contains Schedule H provisions?
- The Pharmacy Act
- The Drugs and Cosmetics Rules
- The Food Safety and Standards Act
- The Medical Council Regulations
Correct Answer: The Drugs and Cosmetics Rules
Q4. What phrase is typically required on the label of a Schedule H medicine?
- “Available over the counter”
- “Schedule H – To be sold by retail on the prescription of a Registered Medical Practitioner only”
- “Natural supplement — no prescription needed”
- “Cosmetic product — external use only”
Correct Answer: “Schedule H – To be sold by retail on the prescription of a Registered Medical Practitioner only”
Q5. Which authority enforces compliance related to Schedule H in India?
- Central Drugs Standard Control Organization (CDSCO) and state drug authorities
- Pharmacy Council of India only
- Food Safety and Standards Authority of India
- National Medical Commission exclusively
Correct Answer: Central Drugs Standard Control Organization (CDSCO) and state drug authorities
Q6. Which category of medicines is commonly listed under Schedule H?
- Multivitamin tablets available without supervision
- Antibiotics and many systemic prescription medicines
- Cosmetic creams for external use
- Homeopathic remedies
Correct Answer: Antibiotics and many systemic prescription medicines
Q7. How should a pharmacist respond when presented with a prescription for a Schedule H medicine?
- Dispense the medicine only after verifying the prescription and prescriber credentials
- Dispense without checking prescription details
- Replace with any over-the-counter alternative
- Refuse to dispense under all circumstances
Correct Answer: Dispense the medicine only after verifying the prescription and prescriber credentials
Q8. Which of the following is a key difference between Schedule H and Schedule H1?
- Schedule H1 is for cosmetics; Schedule H is for food
- Schedule H1 specifically lists certain antimicrobials and requires additional record-keeping and stricter controls
- Schedule H1 allows OTC sales; Schedule H does not
- Schedule H1 is obsolete and no longer used
Correct Answer: Schedule H1 specifically lists certain antimicrobials and requires additional record-keeping and stricter controls
Q9. Which practice is restricted for Schedule H medicines in terms of promotion?
- Advertising directly to the general public
- Providing samples to registered practitioners
- Scientific communication to healthcare professionals
- Labeling with active ingredient details
Correct Answer: Advertising directly to the general public
Q10. What is one major public health significance of enforcing Schedule H?
- Promotes indiscriminate use of antibiotics
- Helps prevent antimicrobial resistance and ensures rational drug use
- Encourages self-medication
- Removes professional oversight from dispensing
Correct Answer: Helps prevent antimicrobial resistance and ensures rational drug use
Q11. Which professional is authorized to prescribe Schedule H medicines?
- A registered medical practitioner with valid credentials
- A pharmacy intern without supervision
- A retail store manager
- An unregistered herbalist
Correct Answer: A registered medical practitioner with valid credentials
Q12. What is the pharmacist’s legal obligation when selling Schedule H1 medicines (as opposed to plain Schedule H)?
- No additional obligations; same as OTC items
- Maintain specific sale records/register and follow stricter verification for prescriptions
- Allow open display on shelves
- Promote these medicines to customers actively
Correct Answer: Maintain specific sale records/register and follow stricter verification for prescriptions
Q13. Which of the following is true about dispensing a Schedule H medicine without a prescription?
- It is permitted if the pharmacist knows the patient
- It is a legal offense under the Drugs and Cosmetics Rules
- It is encouraged to improve access to medicines
- It is allowed for first-time users only
Correct Answer: It is a legal offense under the Drugs and Cosmetics Rules
Q14. Which label color or marking is commonly associated with Schedule H drugs to alert retailers?
- A green mark for safe use
- A red warning label or conspicuous Schedule H statement
- A blue sticker for imported goods
- No special marking is required
Correct Answer: A red warning label or conspicuous Schedule H statement
Q15. In the context of pharmacy practice, why is familiarity with Schedule H important for B. Pharm students?
- It helps in marketing pharmaceuticals directly to consumers
- It ensures legal dispensing, patient safety, and alignment with clinical pharmacotherapy
- It is irrelevant to community pharmacy roles
- It only concerns hospital administrators
Correct Answer: It ensures legal dispensing, patient safety, and alignment with clinical pharmacotherapy
Q16. Which of the following drug classes is MOST LIKELY to be regulated under Schedule H?
- Topical cosmetic moisturizers
- Systemic antibiotics and antipsychotics
- Common table salt
- Homeopathic dilutions labeled as non-prescription
Correct Answer: Systemic antibiotics and antipsychotics
Q17. When comparing international practice, Schedule H-like regulations generally aim to:
- Allow unrestricted access to antibiotics
- Control access to prescription medicines to ensure safe use
- Ban all prescription drugs
- Promote advertising of prescription drugs to consumers
Correct Answer: Control access to prescription medicines to ensure safe use
Q18. Which action by a pharmacist would support compliance with Schedule H requirements?
- Refusing to check the prescriber’s registration number
- Verifying prescription authenticity and counseling the patient on proper use
- Substituting with unrelated OTC products without informing the prescriber
- Discarding prescription records immediately after dispensing
Correct Answer: Verifying prescription authenticity and counseling the patient on proper use
Q19. Schedule H restrictions most directly contribute to which aspect of antimicrobial stewardship?
- Increasing self-medication with antibiotics
- Reducing inappropriate antibiotic use through prescription control
- Encouraging overuse of broad-spectrum agents
- Making antibiotics freely available
Correct Answer: Reducing inappropriate antibiotic use through prescription control
Q20. Which of the following is an appropriate documentation practice related to Schedule H1 or Schedule X medicines?
- Maintaining a separate sales register for controlled prescriptions
- Never recording identity of purchaser
- Only verbal confirmation is sufficient
- Keeping no records to protect privacy
Correct Answer: Maintaining a separate sales register for controlled prescriptions
Q21. Which professional guideline aligns with Schedule H’s intent regarding patient counseling?
- No counseling is needed for prescription medicines
- Explain dosage, duration, adverse effects, and importance of adherence
- Provide only billing information
- Recommend self-adjusting doses as needed
Correct Answer: Explain dosage, duration, adverse effects, and importance of adherence
Q22. Which of these is NOT a consequence of poor enforcement of Schedule H?
- Increased antimicrobial resistance
- Improved rational prescribing
- Greater incidence of adverse drug reactions from misuse
- Undermining professional pharmacy standards
Correct Answer: Improved rational prescribing
Q23. A patient presents a prescription missing the prescriber’s professional registration number for a Schedule H medicine. The pharmacist should:
- Dispense without question
- Clarify and obtain missing prescriber details before dispensing
- Substitute with an OTC medicine
- Refuse and shred the prescription
Correct Answer: Clarify and obtain missing prescriber details before dispensing
Q24. In regulatory context, which schedule specifically emerged to tighten control over certain antimicrobials and reduce misuse?
- Schedule M
- Schedule H1
- Schedule J
- Schedule Y
Correct Answer: Schedule H1
Q25. Which of the following is a correct statement about advertising Schedule H medicines?
- They can be advertised to the general public freely
- Advertising is restricted and direct-to-consumer promotion is generally prohibited
- They must include pricing in all advertisements
- Advertising is unrestricted for online platforms only
Correct Answer: Advertising is restricted and direct-to-consumer promotion is generally prohibited
Q26. For B. Pharm students, learning Schedule H helps primarily to:
- Develop skills for illegal drug distribution
- Understand regulatory responsibilities, patient safety, and ethical dispensing
- Avoid clinical knowledge related to medicines
- Focus solely on pharmaceutical marketing tactics
Correct Answer: Understand regulatory responsibilities, patient safety, and ethical dispensing
Q27. Which record-keeping is typically associated with stricter schedules like H1 or X?
- Maintaining a detailed sales register and retaining prescription copies for audit
- Destroying all records weekly
- Keeping only electronic notes without signatures
- Recording only product batch numbers
Correct Answer: Maintaining a detailed sales register and retaining prescription copies for audit
Q28. Which scenario best illustrates compliance with Schedule H when dispensing an antibiotic?
- Dispensing without verifying a prescription
- Confirming diagnosis, verifying prescriber details, and counseling patient before dispensing
- Providing a different antibiotic without consulting the prescriber
- Offering the antibiotic as an OTC convenience
Correct Answer: Confirming diagnosis, verifying prescriber details, and counseling patient before dispensing
Q29. Which outcome is expected when pharmacists actively enforce Schedule H regulations?
- Higher rates of drug misuse
- Improved medication safety and reduced inappropriate use
- No change in public health outcomes
- Decreased professional accountability
Correct Answer: Improved medication safety and reduced inappropriate use
Q30. When studying Schedule H, which interdisciplinary topics are most relevant for B. Pharm students?
- Pharmacology, pharmacy law, clinical therapeutics, and public health
- Only pharmaceutical marketing
- Construction engineering and agriculture
- Astrophysics and marine biology
Correct Answer: Pharmacology, pharmacy law, clinical therapeutics, and public health
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
Mail- Sachin@pharmacyfreak.com