Restricted license for sale of drugs is a crucial regulatory concept for B.Pharm students, covering legal, clinical and operational aspects of dispensing controlled medicines. This introduction explains licensing types, eligibility, documentation, record-keeping, storage, and compliance with the Drugs and Cosmetics Act and NDPS rules. Emphasis is on distinctions between retail, wholesale and restricted licenses, responsibilities of a registered pharmacist, Schedule H and X restrictions, inspection and penalties, and safe disposal. Understanding these regulatory requirements, pharmacy law, controlled drugs management and good pharmacy practice is essential for safe patient care and legal compliance. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What best defines a restricted license for sale of drugs?
- A general permit to sell over-the-counter medicines without supervision
- A temporary authorization for clinical trials only
- A legal permit to sell specific controlled or restricted category drugs under regulatory conditions
- A certificate allowing any person to import drugs for sale
Correct Answer: A legal permit to sell specific controlled or restricted category drugs under regulatory conditions
Q2. Which authority primarily issues retail or restricted drug sale licenses in India?
- Central Bureau of Investigation
- State Drug Control or Licensing Authority
- Medical Council of India
- Pharmacy Council of India
Correct Answer: State Drug Control or Licensing Authority
Q3. What is the minimum professional qualification generally required to operate a pharmacy with a restricted license?
- High school diploma in science
- Bachelor of Medicine, Bachelor of Surgery (MBBS)
- Registered pharmacist enrolled in the State Pharmacy Council
- Certificate in business management
Correct Answer: Registered pharmacist enrolled in the State Pharmacy Council
Q4. Which primary legislation governs the sale and licensing of drugs in India?
- Indian Penal Code
- Food Safety and Standards Act
- Drugs and Cosmetics Act, 1940
- Consumer Protection Act
Correct Answer: Drugs and Cosmetics Act, 1940
Q5. What is the basic sale requirement for Schedule H drugs?
- Available over the counter without prescription
- Sale only on prescription from a registered medical practitioner
- Free distribution by manufacturers
- Only for export, not domestic sale
Correct Answer: Sale only on prescription from a registered medical practitioner
Q6. What additional control is commonly applied to Schedule X drugs compared to Schedule H?
- They may be sold without a pharmacist present
- They require strict record-keeping and retention of prescriptions under regulated conditions
- They can be advertised to the public
- They are exempt from import controls
Correct Answer: They require strict record-keeping and retention of prescriptions under regulated conditions
Q7. Which law specifically addresses narcotics and psychotropic substances requiring special licensing for sale?
- Environmental Protection Act
- Narcotic Drugs and Psychotropic Substances (NDPS) Act
- Companies Act
- Indian Evidence Act
Correct Answer: Narcotic Drugs and Psychotropic Substances (NDPS) Act
Q8. Who is authorized to carry out inspections of licensed drug sale premises?
- Drug Inspector from the State Regulatory Authority
- Local municipal gardener
- Any practicing physician
- General public via complaint only
Correct Answer: Drug Inspector from the State Regulatory Authority
Q9. Which document is essential when applying for a restricted license for drug sale?
- Certificate of satisfaction from customers
- Proof of registered pharmacist and prescribed premises documents
- Certificate of income tax filing only
- Advertisement brochure of the pharmacy
Correct Answer: Proof of registered pharmacist and prescribed premises documents
Q10. How is renewal of a restricted drug sale license typically handled?
- Once issued, the license never needs renewal
- Renewal is performed periodically as specified by the State Licensing Authority
- Renewal is done by national voter list verification
- License renews automatically when tax is paid
Correct Answer: Renewal is performed periodically as specified by the State Licensing Authority
Q11. Can a restricted drug sale license be transferred to another person or premises?
- No, transfer is strictly prohibited in all cases
- Yes, freely without any permission
- Yes, but only with permission of the State Licensing Authority
- Yes, by informing local police only
Correct Answer: Yes, but only with permission of the State Licensing Authority
Q12. What are typical consequences of selling restricted drugs without a proper license?
- No consequence if sale is small scale
- Warning letter only, no further action
- Penalties including fines, imprisonment, and possible license cancellation
- Automatic upgrade to a wholesale license
Correct Answer: Penalties including fines, imprisonment, and possible license cancellation
Q13. Where should the valid restricted sale license be displayed at a pharmacy?
- Hidden in a locked drawer
- On the pharmacy counter in full view of the public
- Only on the owner’s mobile phone
- Not required to be displayed
Correct Answer: On the pharmacy counter in full view of the public
Q14. Who may legally dispense restricted drugs at a licensed outlet?
- Any family member of the owner
- Subcontracted marketing agents
- Qualified and licensed pharmacist operating under a valid restricted license
- Security personnel at the outlet
Correct Answer: Qualified and licensed pharmacist operating under a valid restricted license
Q15. What records must be maintained for dispensing restricted drugs?
- No records are necessary for restricted drugs
- Only cash receipts are required
- Drug sale register and retention of prescriptions for restricted categories
- Social media records of customers
Correct Answer: Drug sale register and retention of prescriptions for restricted categories
Q16. How is online sale of restricted drugs treated under regulations?
- Online sale is unrestricted and unregulated
- Online sale is banned worldwide
- Online sale is regulated and requires specific compliance and licensing
- Online pharmacies need only a business license, no drug license
Correct Answer: Online sale is regulated and requires specific compliance and licensing
Q17. Is emergency supply of a restricted drug without a prescription generally permitted?
- Yes, always permitted for any patient
- No, restricted drugs generally require a valid prescription except in narrow legally defined emergencies
- Yes, if the pharmacy owner permits it
- Only if the manufacturer provides consent
Correct Answer: No, restricted drugs generally require a valid prescription except in narrow legally defined emergencies
Q18. What is the role of a licensed seller in pharmacovigilance regarding restricted drugs?
- No role; only manufacturers report adverse events
- Licensed sellers must report adverse drug reactions and cooperate with pharmacovigilance systems
- Pharmacovigilance is handled exclusively by hospitals
- Customers must report directly; sellers are exempt
Correct Answer: Licensed sellers must report adverse drug reactions and cooperate with pharmacovigilance systems
Q19. Are restricted drugs generally allowed to be advertised to the general public?
- Yes, unrestricted advertising is allowed
- Advertising is restricted; many restricted drugs cannot be advertised to the public
- Only radio ads are permitted
- Advertising is allowed if price is not shown
Correct Answer: Advertising is restricted; many restricted drugs cannot be advertised to the public
Q20. What are common storage requirements for restricted drugs at a licensed outlet?
- Stored on an open shelf with general items
- Separate secure storage with controlled temperature and restricted access
- Keep them in the shopkeeper’s personal bag
- No special storage conditions are required
Correct Answer: Separate secure storage with controlled temperature and restricted access
Q21. How do regulatory authorities usually conduct inspections of licensed pharmacies?
- Only by appointment on the last day of the year
- By routine scheduled visits and surprise inspections as needed
- Inspections are not permitted by law
- Inspections are conducted by consumer groups only
Correct Answer: By routine scheduled visits and surprise inspections as needed
Q22. What information must a prescription contain to be valid for dispensing restricted drugs?
- Only the patient’s signature
- Registered practitioner’s name, signature and registration number with date
- Only the drug price and pharmacy stamp
- Prescription can be verbal with no details
Correct Answer: Registered practitioner’s name, signature and registration number with date
Q23. How should sample medicines be handled under restricted licensing rules?
- Samples may be sold freely to customers
- Samples are regulated; distribution is controlled and should follow manufacturer and legal guidelines
- Samples are exempt from all legal requirements
- Samples must be advertised as free items to the public
Correct Answer: Samples are regulated; distribution is controlled and should follow manufacturer and legal guidelines
Q24. For how long should records of sale of restricted drugs typically be retained?
- No retention is necessary
- Retain records for a period as mandated by law (commonly two to three years)
- Records must be destroyed weekly
- Keep records forever in physical form only
Correct Answer: Retain records for a period as mandated by law (commonly two to three years)
Q25. What action is required if a licensed seller discovers counterfeit restricted drugs in stock?
- Continue selling to avoid loss
- Report to regulatory authorities and quarantine the stock for investigation
- Destroy them without any record
- Mix with genuine stock to dilute the counterfeit
Correct Answer: Report to regulatory authorities and quarantine the stock for investigation
Q26. Under which act are psychotropic substances regulated requiring special licensure and controls?
- The Indian Forest Act
- Narcotic Drugs and Psychotropic Substances (NDPS) Act
- Right to Information Act
- Income Tax Act
Correct Answer: Narcotic Drugs and Psychotropic Substances (NDPS) Act
Q27. What is the correct procedure for disposal of expired restricted drugs?
- Flush down the drain without documentation
- Return to manufacturer only, no records needed
- Follow prescribed disposal procedures with proper documentation and witness as required by law
- Sell at discounted rates before expiry
Correct Answer: Follow prescribed disposal procedures with proper documentation and witness as required by law
Q28. How can hospitals legally procure restricted drugs for inpatient use?
- By informal verbal agreements with suppliers
- Hospitals may procure with proper documentation, authorized licenses and adherence to regulations
- Hospitals cannot procure restricted drugs at all
- By importing directly without permissions
Correct Answer: Hospitals may procure with proper documentation, authorized licenses and adherence to regulations
Q29. What is the role of pharmacy assistants or technicians in sale of restricted drugs?
- They can independently prescribe restricted drugs
- They may assist in dispensing but final supply must be supervised by the registered pharmacist
- They are not allowed to touch any stock
- They can approve license renewals
Correct Answer: They may assist in dispensing but final supply must be supervised by the registered pharmacist
Q30. How should a licensee respond to a drug recall affecting restricted products?
- Ignore recall notices and continue sale
- Immediately cooperate with authorities, quarantine affected stock and implement recall procedures
- Sell recalled products only to select customers
- Dispose of recall notices without action
Correct Answer: Immediately cooperate with authorities, quarantine affected stock and implement recall procedures
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