Introduction: The wholesale sale of drugs involves regulated distribution, licensing, and stringent control measures to ensure safe supply chains and public health. B. Pharm students must understand licensing procedures, State drug control authorities, Good Distribution Practices (GDP), storage and transportation requirements, record keeping, prescription categories such as Schedule H and Schedule X, inspection protocols, and penalties for non-compliance. Knowledge of license application, renewal, transfer, and suspension processes is essential for managing wholesale operations and ensuring legal distribution to retailers, hospitals, and other licensed entities. This topic bridges pharmacy law and practical distribution safeguards for future pharmacists. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary purpose of requiring a wholesale drug license?
- To control the manufacture of drugs
- To regulate retail pricing of medicines
- To ensure legal and safe distribution of drugs in bulk
- To approve new drug formulations
Correct Answer: To ensure legal and safe distribution of drugs in bulk
Q2. Which authority typically issues wholesale drug licenses in India?
- Central Drug Laboratory
- State Drug Control Authority
- Pharmacy Council of India
- Drug Technical Advisory Board
Correct Answer: State Drug Control Authority
Q3. Good Distribution Practices (GDP) for wholesale dealers primarily address which aspect?
- Clinical trial design
- Supply chain integrity, storage, and transport conditions
- Drug formulation stability studies
- Retail marketing strategies
Correct Answer: Supply chain integrity, storage, and transport conditions
Q4. Which schedule requires strict record keeping and special controls for certain habit-forming drugs?
- Schedule H
- Schedule M
- Schedule X
- Schedule Y
Correct Answer: Schedule X
Q5. A wholesale dealer must maintain records mainly to
- advertise products online
- track transactions, enable recalls, and demonstrate compliance during inspections
- reduce tax liabilities
- increase sales margins
Correct Answer: track transactions, enable recalls, and demonstrate compliance during inspections
Q6. Which one is a typical condition for wholesale premises?
- Proximity to a hospital is mandatory
- Secure storage with adequate space and suitable temperature control
- Mandatory retail counter for customers
- No documentation of stock movement
Correct Answer: Secure storage with adequate space and suitable temperature control
Q7. Who can lawfully purchase drugs from a wholesale dealer?
- Only registered medical practitioners with no license
- Licensed retailers, hospitals, and other authorized wholesale dealers
- Any member of the public
- Only manufacturers
Correct Answer: Licensed retailers, hospitals, and other authorized wholesale dealers
Q8. During an inspection, a wholesale licensee is least likely to be asked about
- Cold chain maintenance records
- Invoices and batch distribution records
- Clinical efficacy data of a drug
- Storage and sanitation of premises
Correct Answer: Clinical efficacy data of a drug
Q9. What is a key responsibility when handling Schedule H drugs at wholesale?
- Sell freely without prescriptions
- Ensure supply only against valid prescriptions and maintain records
- Mix with other drugs to dilute potency
- Export without documentation
Correct Answer: Ensure supply only against valid prescriptions and maintain records
Q10. Which practice helps prevent diversion of controlled medicines from wholesale channels?
- Keeping no records to save space
- Implementing batch-wise distribution records and reconciliation
- Selling expired stocks at discounts
- Allowing anonymous cash purchases
Correct Answer: Implementing batch-wise distribution records and reconciliation
Q11. What is the appropriate action for a wholesale dealer if a defect is found in a drug batch?
- Continue selling to clear stock
- Initiate recall procedures and notify regulatory authority
- Destroy records to hide the defect
- Mix with other batches to dilute defect
Correct Answer: Initiate recall procedures and notify regulatory authority
Q12. Which document is essential to accompany a consignment from a wholesale dealer?
- Sales brochure only
- Invoice and batch-wise dispatch record
- Employee salary slip
- Manufacturer patent certificate
Correct Answer: Invoice and batch-wise dispatch record
Q13. What does “license transfer” in wholesale licensing refer to?
- Changing the brand name of a drug
- Moving the license from one premises to another or transferring to a new owner with regulatory approval
- Switching from retail to manufacturing without permission
- Hiring new staff without notice
Correct Answer: Moving the license from one premises to another or transferring to a new owner with regulatory approval
Q14. How should temperature-sensitive medicines be handled by a wholesale dealer?
- Stored at ambient conditions regardless of label
- Stored and transported according to manufacturer’s recommended temperature ranges with monitoring
- Left in direct sunlight to dry
- Mixed with other commodities to save space
Correct Answer: Stored and transported according to manufacturer’s recommended temperature ranges with monitoring
Q15. Which of the following can lead to suspension of a wholesale license?
- Maintaining proper records
- Non-compliance with licensing conditions or sale of unlicensed drugs
- Hiring qualified staff
- Timely renewal application
Correct Answer: Non-compliance with licensing conditions or sale of unlicensed drugs
Q16. What is the role of batch number documentation in wholesale distribution?
- To identify and trace specific production lots for recall or quality investigation
- To determine retail discounts
- To advertise faster-selling batches
- To avoid paying taxes
Correct Answer: To identify and trace specific production lots for recall or quality investigation
Q17. Online sale of prescription drugs by a wholesale dealer requires
- No regulatory oversight
- Compliance with applicable laws, licensing, and secure prescription verification
- Only a website without a valid license
- Advertising directly to patients to increase sales
Correct Answer: Compliance with applicable laws, licensing, and secure prescription verification
Q18. Which practice is essential for preventing distribution of expired drugs?
- First-expiry-first-out (FEFO) stock rotation and periodic expiry checks
- Stocking large quantities without checks
- Selling expired drugs only to hospitals
- Mixing expired drugs into new batches
Correct Answer: First-expiry-first-out (FEFO) stock rotation and periodic expiry checks
Q19. When is a wholesale dealer allowed to supply Schedule X drugs?
- Without any paperwork to any customer
- Only against valid prescriptions and with strict record-keeping requirements
- Only for export, not domestic sale
- Only to unregistered retailers
Correct Answer: Only against valid prescriptions and with strict record-keeping requirements
Q20. What is a critical element of Good Distribution Practices for vehicles used in transportation?
- No need for cleaning between consignments
- Sanitary condition, temperature control, and protection from contamination
- Only driver’s license is checked
- Loading drugs with food items without segregation
Correct Answer: Sanitary condition, temperature control, and protection from contamination
Q21. Why must wholesale dealers avoid supplying medicines to unlicensed persons?
- To reduce paperwork
- To prevent illegal distribution and protect public health
- Because unlicensed persons pay higher prices
- To avoid customer service queries
Correct Answer: To prevent illegal distribution and protect public health
Q22. What is the importance of periodic self-inspection by wholesale dealers?
- To delay regulatory inspections
- To identify non-compliances, maintain standards, and prepare for regulatory audits
- To increase product prices
- To reduce employee training
Correct Answer: To identify non-compliances, maintain standards, and prepare for regulatory audits
Q23. Which information is typically recorded in a wholesale distribution register?
- Employee personal social media details
- Drug name, batch number, quantity supplied, recipient details and date
- Competitor pricing strategies
- Customer favorite brands only
Correct Answer: Drug name, batch number, quantity supplied, recipient details and date
Q24. What must a wholesale dealer do before accepting returned drugs from a retailer?
- Automatically restock them without checks
- Quarantine, assess quality and expiry status, and follow disposal or return-to-supplier procedures
- Mix returns with current stock
- Sell returns at full price immediately
Correct Answer: Quarantine, assess quality and expiry status, and follow disposal or return-to-supplier procedures
Q25. Which of the following is true about samples distributed by manufacturers to wholesalers?
- Samples can be sold in the market freely
- Samples are subject to regulatory restrictions and must be handled per rules
- Samples require no documentation
- Samples can be mixed with saleable stock
Correct Answer: Samples are subject to regulatory restrictions and must be handled per rules
Q26. A wholesale license application typically requires demonstrating
- Availability of recreational facilities on premises
- Qualified personnel, suitable premises, and compliance with storage norms
- That the applicant has sold drugs informally before
- Ability to manufacture new drugs
Correct Answer: Qualified personnel, suitable premises, and compliance with storage norms
Q27. How should controlled documentation be preserved by wholesale dealers?
- Kept electronically only with no backups
- Maintained securely, with backups and available for regulatory review
- Destroyed monthly to save space
- Shared publicly online
Correct Answer: Maintained securely, with backups and available for regulatory review
Q28. Which action is required when a wholesale dealer suspects counterfeit products in stock?
- Continue selling until proven otherwise
- Segregate suspect stock, inform supplier and regulatory authority, and assist investigation
- Dispose immediately without record
- Mix with genuine stock to dilute risk
Correct Answer: Segregate suspect stock, inform supplier and regulatory authority, and assist investigation
Q29. What distinguishes wholesale distribution from manufacturing in regulatory terms?
- Wholesale deals with bulk supply and distribution, not production or formulation changes
- Wholesale always involves clinical trials
- Manufacturing only sells to patients directly
- Wholesale creates new drug entities
Correct Answer: Wholesale deals with bulk supply and distribution, not production or formulation changes
Q30. Why is staff training important for wholesale dealers?
- To decorate the premises
- To ensure correct handling, compliance with laws, and safe distribution practices
- To reduce the need for record keeping
- To enable staff to manufacture drugs
Correct Answer: To ensure correct handling, compliance with laws, and safe distribution practices
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