Import of drugs under license or permit is an essential subject for B. Pharm students, focusing on regulatory compliance, documentation, and quality assurance. This topic covers national and international frameworks such as the Drugs and Cosmetics Act, the role of the Central Drugs Standard Control Organization (CDSCO)/DCGI, import licenses and permits, Certificates of Pharmaceutical Product (CPP), WHO-GMP certificates, and customs clearance processes. You will learn application procedures, responsibilities of importers, sample testing, batch release, labeling and storage requirements, and legal consequences of non-compliance. Practical knowledge strengthens skills in regulatory affairs, quality control, and safe pharmaceutical supply chain management. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary purpose of an import license for drugs?
- To reduce customs duties on pharmaceutical consignments
- To authorize and regulate the legal import of medicinal products
- To certify clinical trial designs for imported drugs
- To set retail prices for imported medicines
Correct Answer: To authorize and regulate the legal import of medicinal products
Q2. Which central authority is primarily responsible for granting drug import permissions in India?
- Food Safety and Standards Authority of India (FSSAI)
- Central Drugs Standard Control Organization (CDSCO)
- Directorate General of Foreign Trade (DGFT)
- Pharmaceutical Export Promotion Council (Pharmexcil)
Correct Answer: Central Drugs Standard Control Organization (CDSCO)
Q3. Which document commonly demonstrates that a foreign manufacturer meets international manufacturing standards?
- Certificate of Analysis (CoA)
- WHO-GMP certificate
- Free Trade Agreement (FTA)
- Export Packing List
Correct Answer: WHO-GMP certificate
Q4. What is a Certificate of Pharmaceutical Product (CPP) used for in drug import?
- Evidence of marketing authorization in the exporting country
- Proof of payment of import duties
- Clinical trial approval in the importing country
- Certificate of chemical purity only
Correct Answer: Evidence of marketing authorization in the exporting country
Q5. Who holds the primary legal responsibility for ensuring imported drugs comply with local regulations?
- The foreign manufacturer only
- The customs officer at the port
- The designated importer or importer-licence holder
- The retail pharmacist who sells the product
Correct Answer: The designated importer or importer-licence holder
Q6. Which of the following is a common regulatory requirement before releasing an imported drug batch?
- Clinical efficacy trials in the importing country for all drugs
- Laboratory testing and sample analysis by the national regulator
- Automatic market authorization without testing
- Only payment of a fixed fee to customs
Correct Answer: Laboratory testing and sample analysis by the national regulator
Q7. Which document is essential for customs clearance of an imported pharmaceutical consignment?
- Manufacturing SOPs
- Commercial invoice and bill of lading
- Internal audit reports of importer
- Employee training certificates
Correct Answer: Commercial invoice and bill of lading
Q8. Import of a “new drug” generally requires which additional approval?
- Only a customs declaration
- Special permission from the drug regulatory authority for marketing
- Approval from the municipal corporation
- Certificate from local pharmacies
Correct Answer: Special permission from the drug regulatory authority for marketing
Q9. What is the role of a Free Sale Certificate (FSC) in drug importation?
- It replaces any need for local regulatory approval
- It indicates the product is freely sold in the exporting country
- It certifies the product has no patent restrictions
- It guarantees zero customs duty
Correct Answer: It indicates the product is freely sold in the exporting country
Q10. Which practice helps ensure quality during storage of imported drugs before distribution?
- Storing all pharmaceuticals at ambient temperature regardless of label
- Following labeled storage conditions and good warehousing practices
- Mixing batches to reduce inspection needs
- Keeping imports unlabelled to avoid regulatory scrutiny
Correct Answer: Following labeled storage conditions and good warehousing practices
Q11. What is pharmacovigilance in the context of imported medicines?
- Testing raw materials at the manufacturer only
- Monitoring, detecting, and preventing adverse drug reactions after marketing
- Assessing customs duties on pharmaceuticals
- Guaranteeing product efficacy in preclinical studies
Correct Answer: Monitoring, detecting, and preventing adverse drug reactions after marketing
Q12. Which criterion is important when registering a foreign manufacturer for drug import?
- The manufacturer’s logo design
- Evidence of GMP compliance and regulatory standing
- Number of employees at the manufacturing plant
- Distance from port to factory
Correct Answer: Evidence of GMP compliance and regulatory standing
Q13. What is a common consequence of importing drugs without the required license?
- Enhanced marketing privileges
- Regulatory action including seizure, fines or prosecution
- Automatic approval after a grace period
- Lower customs duties
Correct Answer: Regulatory action including seizure, fines or prosecution
Q14. Which body issues customs clearance for pharmaceuticals at the port?
- Local hospital authority
- Customs and port health authorities in coordination with drug regulator
- National pharmacy association
- Trade unions of transport workers
Correct Answer: Customs and port health authorities in coordination with drug regulator
Q15. For emergency import of essential medicines during a public health crisis, regulators often provide:
- Permanent exemption from quality checks
- Expedited or provisional import permissions with conditions
- Automatic market authorization without documentation
- Unlimited import quantities without reporting
Correct Answer: Expedited or provisional import permissions with conditions
Q16. Which of the following is typically reviewed in the import license application?
- Marketing plan for domestic sales only
- Product composition, manufacturing site details, and quality data
- Personal details of retail pharmacists
- Historical sales data in the importing country only
Correct Answer: Product composition, manufacturing site details, and quality data
Q17. What is the importance of batch numbering on imported drug packages?
- It is used solely for aesthetic purposes
- Enables traceability, recalls, and batch-specific quality control
- Prevents customs inspections
- Indicates wholesale pricing tiers
Correct Answer: Enables traceability, recalls, and batch-specific quality control
Q18. Which action should an importer take if an imported batch fails quality testing?
- Release it immediately to meet demand
- Quarantine the batch and notify the regulatory authority
- Relabel the batch to a different expiry date
- Mix it with approved batches to dilute the defect
Correct Answer: Quarantine the batch and notify the regulatory authority
Q19. What role does the Drug Controller General of India (DCGI) play in imports?
- Sets import tariffs for pharmaceuticals
- Oversees regulatory approvals and grants import permissions for drugs
- Manages retail pharmacy licensing exclusively
- Conducts hospital inspections for drug usage
Correct Answer: Oversees regulatory approvals and grants import permissions for drugs
Q20. Which document provides laboratory test results for a specific imported batch?
- Certificate of Analysis (CoA)
- Marketing Authorization Letter
- Certificate of Free Sale
- Bill of Entry
Correct Answer: Certificate of Analysis (CoA)
Q21. What is parallel import in pharmaceuticals?
- Importing patented goods with the patent holder’s consent only
- Bringing in genuine products from another market without the authorization of the local marketer
- Importing only active pharmaceutical ingredients
- Importing expired drugs for disposal
Correct Answer: Bringing in genuine products from another market without the authorization of the local marketer
Q22. Why is labeling in the local language important for imported drugs?
- Local language labels are optional and irrelevant
- To ensure proper use, safety, and regulatory compliance for patients and healthcare providers
- It increases the retail price automatically
- It exempts the product from testing
Correct Answer: To ensure proper use, safety, and regulatory compliance for patients and healthcare providers
Q23. Which is a key step in risk-based import control for pharmaceuticals?
- Inspecting every single consignment regardless of risk
- Prioritizing inspections based on manufacturer history and product risk
- Avoiding any inspection to speed imports
- Relying solely on foreign regulator approvals
Correct Answer: Prioritizing inspections based on manufacturer history and product risk
Q24. What is the significance of shelf-life and expiry checks on imported drugs?
- They are only marketing concepts
- They ensure the product remains stable and efficacious until use
- They determine import duty rates
- They are not required for imported medical devices
Correct Answer: They ensure the product remains stable and efficacious until use
Q25. Which practice helps prevent illegal diversion of imported controlled substances?
- Minimal record-keeping to protect business privacy
- Strict licensing, record-keeping, and regulatory monitoring
- Allowing open distribution without prescriptions
- Registering products only after sale
Correct Answer: Strict licensing, record-keeping, and regulatory monitoring
Q26. What is an importer’s obligation after receiving regulatory approval to import a drug?
- Import without any quality oversight
- Maintain records, ensure compliance with conditions, and facilitate inspections
- Sell the product immediately without labeling
- Transfer the responsibility entirely to distributors
Correct Answer: Maintain records, ensure compliance with conditions, and facilitate inspections
Q27. Which factor is least relevant when assessing the safety of an imported drug?
- Stability data under recommended storage
- Clinical safety data and adverse event reports
- Manufacturer’s GMP certification
- Color of the shipping container
Correct Answer: Color of the shipping container
Q28. Which process addresses the return or recall of unsafe imported medicines?
- Batch release without documentation
- Recall procedure coordinated by regulator and importer
- Immediate resale at a discount
- Sending samples to retailers
Correct Answer: Recall procedure coordinated by regulator and importer
Q29. How do regulators typically verify claims on imported drug labels?
- Through literature marketing only
- By reviewing dossiers, certificates, and sample analysis
- By accepting foreign labels without review
- By user testimonials alone
Correct Answer: By reviewing dossiers, certificates, and sample analysis
Q30. What is a practical skill B. Pharm students should master regarding drug importation?
- Designing shipping containers solely for aesthetics
- Preparing regulatory dossiers, understanding GMP, and interpreting quality data
- Negotiating retail margins with pharmacies
- Avoiding all regulatory paperwork to save time
Correct Answer: Preparing regulatory dossiers, understanding GMP, and interpreting quality data
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