Introduction
Schedule X is a critical provision under the Drugs and Cosmetics Rules that lists controlled, habit-forming and potentially abused drugs requiring strict regulatory control. For B.Pharm students, mastering Schedule X details—legal definition, categories of narcotic and psychotropic substances, prescribing and dispensing rules, secure storage, record-keeping, licensing requirements and penalties—is essential for safe pharmacy practice and regulatory compliance. Core elements include mandatory prescriptions, separate sales registers, secure storage under lock and key, retention of prescription copies for two years and stringent enforcement measures. Understanding Schedule X helps pharmacists prevent diversion, protect public health and maintain professional standards. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What best describes a Schedule X drug under the Drugs and Cosmetics Rules?
- Common over-the-counter analgesics
- Controlled drugs requiring strict regulation and restricted sale
- Food supplements and nutraceuticals
- Cosmetic ingredients with mild restrictions
Correct Answer: Controlled drugs requiring strict regulation and restricted sale
Q2. What is the primary purpose of Schedule X classification?
- To increase sales of pharmaceutical companies
- To restrict import of all medicinal products
- To prevent misuse, diversion and abuse of habit-forming drugs
- To standardize drug prices across the country
Correct Answer: To prevent misuse, diversion and abuse of habit-forming drugs
Q3. Which of the following is a mandatory requirement when dispensing a Schedule X drug?
- Sale without any prescription is allowed
- Sale only on prescription issued by a registered medical practitioner
- Sale on pharmacist’s discretion without documentation
- Sale only to hospital stores without prescription
Correct Answer: Sale only on prescription issued by a registered medical practitioner
Q4. How must Schedule X drugs be stored in a retail pharmacy?
- On general shelves with OTC medicines
- Under lock and key in a separate secure area
- In a refrigerator irrespective of stability
- In the cashier’s counter area
Correct Answer: Under lock and key in a separate secure area
Q5. What record-keeping is required for sale of Schedule X drugs?
- No special records beyond invoices
- Maintain a separate register and retain prescription copies
- Record only monthly sales summaries
- Record only when government inspects
Correct Answer: Maintain a separate register and retain prescription copies
Q6. For how long should a pharmacist typically retain copies of prescriptions for Schedule X drugs?
- 6 months
- 2 years
- 10 years
- No retention required
Correct Answer: 2 years
Q7. Which authority issues licenses for stocking and selling Schedule X drugs at the state level?
- State Drug Control Authority / Licensing Authority
- Municipal Corporation
- Central Bureau of Investigation
- Pharmacy council of India
Correct Answer: State Drug Control Authority / Licensing Authority
Q8. What are the likely legal consequences for unlawful sale of Schedule X drugs?
- Only a written warning
- Only a fine
- Both fine and imprisonment depending on the offense
- No action unless repeated
Correct Answer: Both fine and imprisonment depending on the offense
Q9. Compared with Schedule H drugs, Schedule X drugs are generally:
- Less regulated and freely available
- Equally regulated with identical controls
- Subject to stricter controls and additional record-keeping
- Only for veterinary use
Correct Answer: Subject to stricter controls and additional record-keeping
Q10. Which of the following is most likely to be listed in Schedule X?
- Paracetamol
- Morphine (strong opioid)
- Vitamin C
- Antacid suspension
Correct Answer: Morphine (strong opioid)
Q11. Which drug is least likely to be classified under Schedule X?
- Cocaine
- Heroin
- Paracetamol
- Methadone
Correct Answer: Paracetamol
Q12. Schedule X primarily targets control of which categories of substances?
- Antacids and digestive enzymes
- Narcotic and psychotropic substances with potential for abuse
- Topical cosmetic agents
- Herbal supplements
Correct Answer: Narcotic and psychotropic substances with potential for abuse
Q13. Can a pharmacist dispense a Schedule X drug on a telephonic order without a written prescription?
- Yes, if the patient is known
- Yes, for emergency cases without documentation
- No, a valid written prescription must be presented
- Yes, if the pharmacist documents the call
Correct Answer: No, a valid written prescription must be presented
Q14. Are Schedule X prescriptions transferable from one pharmacy to another?
- Yes, freely transferable
- Yes, only with patient consent
- No, they should not be transferred between retail pharmacies
- Transfer allowed after 7 days
Correct Answer: No, they should not be transferred between retail pharmacies
Q15. Which of the following practices is required at the time of dispensing a Schedule X drug?
- Providing the drug without any labeling
- Recording details in the Schedule X register and keeping prescription copy
- Allowing pharmacist to alter the prescription freely
- Dispensing in unmarked packaging to protect patient identity
Correct Answer: Recording details in the Schedule X register and keeping prescription copy
Q16. For institutional procurement of Schedule X drugs for research, what is required?
- No formal permission is needed for research
- Institution must obtain appropriate license/authorization and maintain records
- Only a purchase order is sufficient
- Permission from the local police is sufficient
Correct Answer: Institution must obtain appropriate license/authorization and maintain records
Q17. Which of the following statements about labeling of Schedule X containers is true?
- No special labeling is necessary
- Containers should be clearly labeled and identified as controlled drugs
- Labels must be in a foreign language
- Labeling is only required for export consignments
Correct Answer: Containers should be clearly labeled and identified as controlled drugs
Q18. Who is primarily responsible for preventing diversion of Schedule X drugs at the retail level?
- The patient alone
- The prescribing physician only
- The licensed pharmacist and the retail establishment
- The drug manufacturer only
Correct Answer: The licensed pharmacist and the retail establishment
Q19. If a pharmacy wants to stock Schedule X drugs, what endorsement is typically required?
- No endorsement; any shop can stock them
- Specific license or endorsement for Schedule X on the retail license
- Only a pharmacist degree certificate
- Endorsement from a private hospital
Correct Answer: Specific license or endorsement for Schedule X on the retail license
Q20. Which of the following actions should a pharmacist take if presented with a suspicious Schedule X prescription?
- Dispense immediately to avoid inconvenience
- Refuse to dispense and report to the appropriate drug control authority
- Supply half the quantity requested
- Rewrite the prescription to make it legal
Correct Answer: Refuse to dispense and report to the appropriate drug control authority
Q21. How should expired Schedule X stock be handled by a retail pharmacy?
- Return or dispose following regulatory guidelines and record disposal
- Donate to patients in need
- Sell at discounted price
- Mix with other waste for disposal
Correct Answer: Return or dispose following regulatory guidelines and record disposal
Q22. Which document is essential to present when purchasing Schedule X drugs from a wholesaler?
- Only cash receipt
- Valid retail license with Schedule X endorsement and purchase order
- Photocopy of any ID proof
- Manufacturer’s pamphlet
Correct Answer: Valid retail license with Schedule X endorsement and purchase order
Q23. What role does record audit play in Schedule X compliance?
- Audits are optional and not useful
- Periodic audits help detect diversion, errors and ensure regulatory compliance
- Audits are only required for export businesses
- Audits should be kept secret from regulators
Correct Answer: Periodic audits help detect diversion, errors and ensure regulatory compliance
Q24. Which professional responsibility is emphasized for pharmacists regarding Schedule X drugs?
- Maximizing sales irrespective of regulation
- Ensuring legal compliance, patient safety and preventing abuse
- Encouraging self-medication with controlled drugs
- Avoiding record-keeping to speed service
Correct Answer: Ensuring legal compliance, patient safety and preventing abuse
Q25. In case of loss or theft of Schedule X stock, the pharmacist should first:
- Ignore and continue business
- Immediately inform the drug control authority and police and record the incident
- Replace stolen items without reporting
- Sell remaining stock quickly
Correct Answer: Immediately inform the drug control authority and police and record the incident
Q26. Which of the following is a safe dispensing practice for Schedule X prescriptions?
- Altering dose on prescription without prescriber approval
- Verifying prescriber credentials when in doubt and documenting the transaction
- Refusing to document sales to simplify records
- Dispensing multiple times on a single prescription indefinitely
Correct Answer: Verifying prescriber credentials when in doubt and documenting the transaction
Q27. What is the significance of maintaining a separate Schedule X register?
- To hide sales from tax authorities
- To track controlled substance transactions and aid regulatory inspections
- To increase profit margins
- To avoid issuing receipts
Correct Answer: To track controlled substance transactions and aid regulatory inspections
Q28. Can a Schedule X drug be dispensed on an expired prescription?
- Yes, always permissible
- Yes, if the patient requests urgently
- No, dispensing on expired prescriptions is not permitted
- Only if pharmacist initials the prescription
Correct Answer: No, dispensing on expired prescriptions is not permitted
Q29. Which of the following best describes the pharmacist’s ethical duty regarding Schedule X drugs?
- To sell as many controlled drugs as possible
- To balance patient need with public safety and follow legal safeguards
- To ignore regulations in favor of convenience
- To recommend Schedule X drugs for minor self-limited conditions
Correct Answer: To balance patient need with public safety and follow legal safeguards
Q30. Regular training of pharmacy staff on Schedule X requirements primarily helps to:
- Reduce compliance and increase risk
- Improve adherence to regulations, reduce diversion and enhance patient safety
- Confuse staff with unnecessary rules
- Only increase paperwork without benefit
Correct Answer: Improve adherence to regulations, reduce diversion and enhance patient safety
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