Procedure for export of pharmaceutical products from India MCQs With Answer

Understanding the procedure for export of pharmaceutical products from India is essential for B.Pharm students preparing for careers in global pharma trade. This concise guide covers export documentation, IEC registration, DGFT regulations, customs clearance, shipping bills, export licensing, CDSCO approvals, Good Manufacturing Practices (GMP), Schedule M compliance, quality control, international regulatory requirements, labeling and packaging norms, cold chain logistics, sample testing protocols, and export incentives to strengthen practical skills and employability. These MCQs with answers focus on practical export process, customs procedures, documentation formats, and quality assurance for pharmaceutical exports. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What does IEC stand for in the context of Indian exports?

• International Export Certificate
• Importer Exporter Code issued by DGFT
• Indian Export Compliance
• Institute of Export Certification

Correct Answer: Importer Exporter Code issued by DGFT

Q2. Which authority issues the Certificate of Pharmaceutical Product (CPP) in India?

• Pharmaceutical Export Promotion Council (Pharmexcil)
• Central Drugs Standard Control Organization (CDSCO)
• Directorate General of Foreign Trade (DGFT)
• Ministry of Commerce

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q3. Which of the following documents is primarily used to claim export incentives/drawback?

• Commercial Invoice
• Packing List
• Shipping Bill / Bill of Export
• Certificate of Analysis

Correct Answer: Shipping Bill / Bill of Export

Q4. Which schedule of the Drugs and Cosmetics Rules prescribes manufacturing standards relevant for pharmaceutical exports?

• Schedule X
• Schedule M
• Schedule D
• Schedule E

Correct Answer: Schedule M

Q5. A Good Manufacturing Practices (GMP) certificate for export is typically issued by which body or authority?

• Local municipal corporation
• State Drug Control Authority or CDSCO inspection
• Exporter’s internal QA manager
• Directorate General of Foreign Trade (DGFT)

Correct Answer: State Drug Control Authority or CDSCO inspection

Q6. What is the primary purpose of a Certificate of Analysis (CoA) in exports?

• To confirm packing dimensions
• To certify quality and test results of the batch
• To act as a customs declaration
• To provide shipping route details

Correct Answer: To certify quality and test results of the batch

Q7. Which document proves the origin of goods for preferential tariff treatment?

• Commercial Invoice
• Certificate of Pharmaceutical Product (CPP)
• Certificate of Origin
• Packing List

Correct Answer: Certificate of Origin

Q8. For exporting temperature-sensitive drugs, which export requirement is most critical?

• Incoterm selection only
• Cold chain logistics and validated temperature monitoring
• Long commercial invoices
• Minimal labeling information

Correct Answer: Cold chain logistics and validated temperature monitoring

Q9. Which shipping document serves as the contract of carriage for sea shipments?

• Airway Bill
• Bill of Lading
• Commercial Invoice
• Packing List

Correct Answer: Bill of Lading

Q10. What is the role of the Directorate General of Foreign Trade (DGFT) in pharmaceutical exports?

• To test drug potency
• To issue IEC and regulate export policy and licensing
• To handle customs clearance at ports
• To ship the consignment abroad

Correct Answer: To issue IEC and regulate export policy and licensing

Q11. Which one of the following is a common regulatory requirement for exporting APIs (Active Pharmaceutical Ingredients)?

• Proprietary brand registration in India
• Certificate of Analysis and GMP compliance
• Only verbal declaration by exporter
• No documentation required for APIs

Correct Answer: Certificate of Analysis and GMP compliance

Q12. Which incoterm places maximum responsibility on the seller including freight and insurance to the named port?

• EXW (Ex Works)
• FOB (Free On Board)
• CIF (Cost, Insurance and Freight)
• DAP (Delivered At Place)

Correct Answer: CIF (Cost, Insurance and Freight)

Q13. Which agency typically inspects and clears pharmaceutical consignments at Indian ports?

• Food Safety and Standards Authority of India (FSSAI)
• Customs authorities often in coordination with CDSCO and state drug authorities
• Pharmexcil only
• International buyer’s customs only

Correct Answer: Customs authorities often in coordination with CDSCO and state drug authorities

Q14. What is an Export Promotion Council (like Pharmexcil) primarily used for by pharmaceutical exporters?

• Issuing IEC codes
• Providing market information, trade facilitation, and export promotion support
• Customs duty collection
• Quality testing of products

Correct Answer: Providing market information, trade facilitation, and export promotion support

Q15. Which document contains details of package contents, weight, and dimensions?

• Certificate of Origin
• Packing List
• Letter of Credit
• GMP Certificate

Correct Answer: Packing List

Q16. What is the significance of Harmonized System (HS) codes in pharmaceutical exports?

• They determine the manufacturer’s address
• They classify goods for customs, duties, and export statistics
• They are used only for domestic sales
• They validate GMP compliance

Correct Answer: They classify goods for customs, duties, and export statistics

Q17. Which financial instrument is commonly used to ensure payment for exported pharma consignments?

• Bill of Lading
• Letter of Credit (L/C)
• Certificate of Analysis
• Commercial Packing List

Correct Answer: Letter of Credit (L/C)

Q18. For regulatory clearance to export a finished drug product, which of the following is often mandatory?

• Exporter’s internal memo
• Marketing authorization / product registration in destination country or CPP where required
• Only an invoice is mandatory
• No documentation for finished products

Correct Answer: Marketing authorization / product registration in destination country or CPP where required

Q19. What is an Export Declaration or Shipping Bill used for?

• Documenting domestic sales taxes
• Declaring goods to customs for export clearance and benefit claims
• Registering trademarks abroad
• Quality testing of raw materials

Correct Answer: Declaring goods to customs for export clearance and benefit claims

Q20. Which of the following is NOT typically reviewed during regulatory inspection for pharma export readiness?

• Batch manufacturing records
• Quality control test records
• Employee personal email correspondence
• Stability study reports

Correct Answer: Employee personal email correspondence

Q21. What is the purpose of a Free Sale Certificate for pharmaceutical exports?

• To certify that a product is freely sold in the exporting country and meets regulatory standards
• To indicate free shipping
• To declare customs duties paid
• To replace the invoice

Correct Answer: To certify that a product is freely sold in the exporting country and meets regulatory standards

Q22. Which of these is a common export compliance requirement related to labeling?

• Blank labels are preferred
• Labels must include active ingredient, strength, batch number, manufacturing and expiry dates, storage instructions, and manufacturer details
• Labels should omit expiry dates for exports
• Only the brand name is required

Correct Answer: Labels must include active ingredient, strength, batch number, manufacturing and expiry dates, storage instructions, and manufacturer details

Q23. In case of export of clinical trial samples, which approval is often required?

• No approval is required for samples
• Approval from regulatory authority like CDSCO and institutional ethics committee clearance
• Approval only from the foreign buyer
• Approval from the local post office

Correct Answer: Approval from regulatory authority like CDSCO and institutional ethics committee clearance

Q24. Which document provides conclusive evidence of shipment handed over to carrier for air transport?

• Bill of Lading
• Airway Bill (AWB)
• Commercial Invoice
• Export Promotion Copy

Correct Answer: Airway Bill (AWB)

Q25. What is the primary regulatory concern when exporting sterile injectable products?

• Only pricing matters
• Sterility assurance, validated aseptic processes, endotoxin limits, and cold chain where needed
• Only package color matters
• No special concern compared to tablets

Correct Answer: Sterility assurance, validated aseptic processes, endotoxin limits, and cold chain where needed

Q26. Which certificate confirms that the manufacturing facility complies with WHO GMP for international markets?

• Certificate of Free Sale
• WHO GMP Certificate or national GMP certificate recognized by importing country
• Commercial Invoice
• Packing List

Correct Answer: WHO GMP Certificate or national GMP certificate recognized by importing country

Q27. What is the importance of stability data for exported pharmaceutical products?

• It helps in designing the invoice
• It supports shelf-life claims and storage conditions required by regulators of importing countries
• It is only used for marketing brochures
• It replaces GMP certification

Correct Answer: It supports shelf-life claims and storage conditions required by regulators of importing countries

Q28. Which of the following is a common reason for customs detention of pharma exports?

• Overly detailed stability data
• Incomplete or incorrect documentation, mismatched descriptions or missing permits
• Having a GMP certificate
• Exporting within permitted quantities

Correct Answer: Incomplete or incorrect documentation, mismatched descriptions or missing permits

Q29. What is an Export License or NOC in pharmaceutical exports?

• A license to import raw materials only
• A No Objection Certificate or specific export permission from regulatory authority for certain controlled drug categories
• A travel permit for exporters
• A shipping company license

Correct Answer: A No Objection Certificate or specific export permission from regulatory authority for certain controlled drug categories

Q30. For testing and certification prior to export, which quality document ensures batch release by quality unit?

• Export Promotion Copy
• Batch Manufacturing Record (BMR) coupled with a Quality Unit release certificate
• IEC code printout
• Packing List signed by the shipping line

Correct Answer: Batch Manufacturing Record (BMR) coupled with a Quality Unit release certificate

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