Retail sale of drugs – licensing and control is an essential topic for B.Pharm students, covering legal framework, permits, and regulatory oversight that ensure safe dispensing. This module explains drug retail licensing, the Drugs and Cosmetics Act and Rules, roles of State Drug Authorities and drug inspectors, requirements for registered pharmacists, prescription-only categories (Schedule H, Schedule X), record-keeping, storage, labeling, and Good Pharmacy Practice. Understanding license application, renewal, transfer, inspections, and penalties for non-compliance prepares you for professional responsibilities in community pharmacies and hospital dispensaries. Mastering these concepts strengthens patient safety, rational drug use, and regulatory compliance. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is meant by retail sale of drugs?
- Sale of drugs to the ultimate consumer for personal use
- Sale of drugs exclusively to hospitals and clinics
- Wholesale distribution to medical stores and distributors
- Manufacturing of drugs for export only
Correct Answer: Sale of drugs to the ultimate consumer for personal use
Q2. Which authority primarily issues retail drug licences in India?
- State Licensing Authority / State Drug Control Department
- Central Drugs Standard Control Organization (CDSCO)
- Pharmacy Council of India
- National Pharmaceutical Pricing Authority
Correct Answer: State Licensing Authority / State Drug Control Department
Q3. Which law is the principal statute governing licensing and control of retail sale of drugs?
- Indian Penal Code
- Drugs and Cosmetics Act, 1940
- Sale of Goods Act
- Food Safety and Standards Act
Correct Answer: Drugs and Cosmetics Act, 1940
Q4. Who must be on duty at a retail pharmacy to legally dispense prescription drugs?
- A registered pharmacist holding recognized qualification
- An MBBS doctor only
- A sales representative from the manufacturer
- A licensed wholesaler
Correct Answer: A registered pharmacist holding recognized qualification
Q5. Which schedule contains drugs that are to be sold only on a prescription?
- Schedule H
- Schedule M
- Schedule J
- Schedule P
Correct Answer: Schedule H
Q6. Which schedule imposes stricter control and separate record-keeping requirements and includes severe restrictions on sale and storage?
- Schedule X
- Schedule Y
- Schedule G
- Schedule M
Correct Answer: Schedule X
Q7. Which central body is primarily responsible for approval of new drugs and national standards?
- Central Drugs Standard Control Organization (CDSCO)
- State Drug Control Department
- Pharmacy Council of India
- Medical Council of India
Correct Answer: Central Drugs Standard Control Organization (CDSCO)
Q8. Which of the following is a key component of Good Pharmacy Practice (GPP) in retail sale?
- Patient counselling and appropriate dispensing
- Maximizing sales irrespective of prescription
- Replacing medicines without informing prescriber
- Refusing to maintain any dispensing records
Correct Answer: Patient counselling and appropriate dispensing
Q9. Sale of narcotic and psychotropic substances at retail requires compliance with which legislation in addition to drug licensing rules?
- Narcotic Drugs and Psychotropic Substances (NDPS) Act
- Consumer Protection Act
- Indian Evidence Act
- Companies Act
Correct Answer: Narcotic Drugs and Psychotropic Substances (NDPS) Act
Q10. Which professional body registers pharmacists at the state level?
- State Pharmacy Council
- Pharmacists Guild of India
- National Drugs Authority
- State Medical Council
Correct Answer: State Pharmacy Council
Q11. What information must be present on labels of dispensed medicines from a retail pharmacy?
- Batch number, manufacturing date, expiry date and storage instructions
- Only brand logo and price
- Patient’s financial details
- Manufacturer’s proprietary research data
Correct Answer: Batch number, manufacturing date, expiry date and storage instructions
Q12. Is it permissible to sell Schedule H drugs without a valid prescription?
- No, Schedule H drugs must be dispensed only against a valid prescription
- Yes, if the patient requests them verbally
- Yes, during weekends only
- Only if the drug is in low quantity
Correct Answer: No, Schedule H drugs must be dispensed only against a valid prescription
Q13. For Schedule X drugs at retail level, which practice is mandatory?
- Maintain a separate register with strict record of sale
- Sell without prescription during emergencies only
- Mix them with OTC stock on shelves
- Return all sales records monthly to manufacturer
Correct Answer: Maintain a separate register with strict record of sale
Q14. Where should the retail drug licence be displayed in the pharmacy?
- Conspicuously at the licensed premises
- Only on the manager’s private desk
- Nowhere; it must be kept confidential
- At the local municipal office only
Correct Answer: Conspicuously at the licensed premises
Q15. Can a retail drug licence be transferred to another person or place without permission?
- No, transfer requires prior permission from the licensing authority
- Yes, transfer is always automatic
- Yes, if the buyer is a relative
- No, licences are permanently tied to the first owner and cannot be transferred
Correct Answer: No, transfer requires prior permission from the licensing authority
Q16. What should a retail pharmacist do with expired or damaged drugs?
- Quarantine and follow statutory procedures for return or disposal
- Discount and sell them quickly
- Mix with new stock to dilute expiry issues
- Donate directly to patients in need
Correct Answer: Quarantine and follow statutory procedures for return or disposal
Q17. Who inspects retail pharmacies for compliance with drug laws?
- Drug Inspector / Authorized official of the State Drug Control Department
- Local school board representatives
- Manufacturer’s marketing personnel
- Insurance assessors only
Correct Answer: Drug Inspector / Authorized official of the State Drug Control Department
Q18. Which educational qualifications are typically recognized for registration as a pharmacist at retail level?
- D.Pharm or B.Pharm with registration in the State Pharmacy Council
- Only MBBS degree holders
- High school certificate with on-the-job training
- Any graduate degree without registration
Correct Answer: D.Pharm or B.Pharm with registration in the State Pharmacy Council
Q19. What is a core requirement for storage of temperature-sensitive medicines at retail pharmacies?
- Maintain appropriate cold chain and temperature logs
- Store them on open racks with sunlight exposure
- Keep them in unlabeled containers
- Ignore temperature if stock turnover is high
Correct Answer: Maintain appropriate cold chain and temperature logs
Q20. For online sale of prescription drugs by a retail pharmacy, which condition is essential?
- Valid prescription and appropriate licensing for online retailing
- Only a social media account is sufficient
- No licence is required if sales are below a threshold
- Prescription can be ignored for repeat customers
Correct Answer: Valid prescription and appropriate licensing for online retailing
Q21. What does OTC (over-the-counter) medication mean?
- Medicines available without a prescription for self-care
- Drugs that require hospitalization to administer
- Only habit-forming drugs
- Drugs banned for public sale
Correct Answer: Medicines available without a prescription for self-care
Q22. Which practice is considered illegal at a licensed retail pharmacy?
- Selling Schedule H drugs without valid prescription
- Providing patient counselling for safe use
- Maintaining proper cold chain for vaccines
- Displaying the licence at the premises
Correct Answer: Selling Schedule H drugs without valid prescription
Q23. Who is authorized to write prescriptions that enable dispensing of prescription-only medicines?
- Registered medical practitioners and authorized prescribers
- Any pharmacist at the retail counter
- Salespersons of pharmaceutical companies
- Non-medical family members of the patient
Correct Answer: Registered medical practitioners and authorized prescribers
Q24. Which of the following actions can lead to suspension or cancellation of a retail drug licence?
- Repeated non-compliance with licensing conditions and legal provisions
- Offering discounts on branded medicines
- Hiring a qualified registered pharmacist
- Maintaining records and temperature logs
Correct Answer: Repeated non-compliance with licensing conditions and legal provisions
Q25. During inspection, why must a pharmacist keep invoices and sale records available?
- To enable verification of source, sale and regulatory compliance by authorities
- Only for tax audits and not for drug control purposes
- They are not required and can be discarded monthly
- To share confidential patient information publicly
Correct Answer: To enable verification of source, sale and regulatory compliance by authorities
Q26. Which of the following is a prohibited practice at retail pharmacies?
- Selling adulterated or spurious drugs
- Providing generic substitution information when permitted
- Maintaining temperature records for cold chain products
- Keeping prescription records as required
Correct Answer: Selling adulterated or spurious drugs
Q27. Who is responsible for classification and scheduling of drugs (e.g., Schedules H, X) in India?
- Central Government through rules framed under the Drugs and Cosmetics Act
- Local municipal corporations exclusively
- Private pharmaceutical companies
- Individual retail pharmacists
Correct Answer: Central Government through rules framed under the Drugs and Cosmetics Act
Q28. What is the primary public health purpose of retail drug licensing and control?
- To ensure safe, rational and legal dispensing of medicines to the public
- To maximize profits of pharmaceutical manufacturers
- To restrict access to basic healthcare
- To centralize all drug sales to a single vendor
Correct Answer: To ensure safe, rational and legal dispensing of medicines to the public
Q29. Inspections of retail pharmacies by drug control authorities can be which of the following?
- Routine or surprise (unannounced) inspections
- Only annual audits with prior notice always
- Conducted only by manufacturer representatives
- Required only when a crime is reported
Correct Answer: Routine or surprise (unannounced) inspections
Q30. Which document is essential to operate legally as a retail pharmacy?
- Valid retail drug licence issued by the competent authority
- Only a sales tax registration certificate
- A personal recommendation letter from a doctor
- A temporary stall permit from the market association
Correct Answer: Valid retail drug licence issued by the competent authority
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