Documentation for new drug applications and export registration for ISM MCQs With Answer

Introduction: Documentation for new drug applications and export registration for Indian Systems of Medicine (ISM) is a critical topic for M.Pharm students specializing in traditional medicines. This blog provides a concise, practical guide to the types of dossiers, essential documents, quality and safety data, and regulatory expectations for both domestic marketing authorization and international export. Emphasis is placed on classical versus proprietary formulations, pharmacopoeial standards, GMP and stability requirements, and key export certificates such as Certificate of Pharmaceutical Product and Free Sale Certificate. The questions that follow test comprehension of documentation structure, CTD concepts adapted for ISM, and export-specific documentation needs relevant to contemporary regulatory practice.

Q1. Which of the following lists the primary components of a new drug application dossier for an ISM product?

• Administrative documents, Quality data, Safety and efficacy data, Stability data
• Only traditional texts and recipes
• Marketing plan and pricing strategy only
• Clinical trial protocol only

Correct Answer: Administrative documents, Quality data, Safety and efficacy data, Stability data

Q2. In the Common Technical Document (CTD) format, which module primarily contains the detailed pharmaceutical quality (chemistry, manufacturing and controls) information?

• Module 1
• Module 2
• Module 3
• Module 5

Correct Answer: Module 3

Q3. For classical Ayurvedic formulations, documentation for marketing often relies heavily on which type of evidence?

• Authoritative traditional texts, pharmacopeial monographs and documented historical use
• Only modern randomized controlled trials
• Only animal toxicology studies
• Patent filings and commercial branding materials

Correct Answer: Authoritative traditional texts, pharmacopeial monographs and documented historical use

Q4. Which document is routinely required by importing regulatory authorities to demonstrate that a manufacturing site complies with Good Manufacturing Practices?

• Certificate of Pharmaceutical Product (CPP)
• Good Manufacturing Practice (GMP) certificate or GMP inspection report
• Clinical Study Report (CSR)
• Marketing Authorization Letter

Correct Answer: Good Manufacturing Practice (GMP) certificate or GMP inspection report

Q5. What is the purpose of a Certificate of Pharmaceutical Product (CPP) in export registration?

• It certifies clinical trial design is acceptable
• It documents local market sales figures
• It provides evidence the product is authorized for sale in the exporting country and summarizes regulatory status
• It replaces the need for any stability data

Correct Answer: It provides evidence the product is authorized for sale in the exporting country and summarizes regulatory status

Q6. Which stability testing conditions are commonly used for accelerated stability studies referenced in many regulatory guidelines?

• 25°C / 40% RH
• 30°C / 65% RH
• 40°C / 75% RH
• 5°C / ambient RH

Correct Answer: 40°C / 75% RH

Q7. For ISM product dossiers, testing and documentation of which contaminants is typically mandatory or highly recommended?

• Heavy metals, pesticide residues and microbial limits
• Only water content
• Only color and odor description
• Only tablet hardness

Correct Answer: Heavy metals, pesticide residues and microbial limits

Q8. Which source is most appropriate to cite for official monographs and standard specifications of ISM raw materials and finished products?

• Local newspaper articles
• Recognized pharmacopoeias and Ayurvedic pharmacopoeial monographs
• Manufacturer advertisements
• Social media posts

Correct Answer: Recognized pharmacopoeias and Ayurvedic pharmacopoeial monographs

Q9. For a new proprietary polyherbal formulation intended for marketing, what type of clinical or bioavailability evidence is generally expected?

• No evidence is ever required
• Clinical safety and efficacy data or supportive bioavailability/bioequivalence data as applicable
• Only manufacturing cost breakdown
• Only traditional text citation without any modern data

Correct Answer: Clinical safety and efficacy data or supportive bioavailability/bioequivalence data as applicable

Q10. Which of the following is an essential batch-specific document that accompanies export consignments and summarizes analytical test results for that batch?

• Marketing Authorization Certificate
• Certificate of Analysis (CoA)
• Pharmacopoeial monograph
• Clinical Trial Application

Correct Answer: Certificate of Analysis (CoA)

Q11. Which document contains summarized nonclinical and clinical overviews when submitting a CTD-style dossier?

• Module 1 administrative forms
• Module 2 summaries (quality, nonclinical and clinical overviews)
• Module 4 full reports only
• Marketing material brochure

Correct Answer: Module 2 summaries (quality, nonclinical and clinical overviews)

Q12. For export registration, which certificate indicates that the product is sold freely in the exporting country and is often requested by importing authorities?

• Free Sale Certificate (FSC)
• Patent Certificate
• Environmental Clearance Certificate
• Clinical Trial Approval

Correct Answer: Free Sale Certificate (FSC)

Q13. Which document provides a detailed description of an active ingredient’s manufacturing, controls and specifications that can be submitted confidentially by a supplier?

• Drug Master File (DMF)
• Certificate of Analysis (CoA)
• Label mock-up
• Marketing strategy plan

Correct Answer: Drug Master File (DMF)

Q14. When preparing an export dossier for an ISM formulation, which of the following labeling elements is generally required by many importing countries?

• Manufacturer’s trade secrets and proprietary formulas printed prominently
• Essential label elements: product name, composition, indications, dosage, manufacturer details, batch number and expiry date in the required language
• Only decorative logos
• Only price and distributor profit margin

Correct Answer: Essential label elements: product name, composition, indications, dosage, manufacturer details, batch number and expiry date in the required language

Q15. Which of the following best describes documentation of traditional knowledge for classical ISM products?

• Random internet blogs are sufficient evidence
• Documentation should include citations from recognized classical texts, historical usage records and pharmacopeial references
• Only modern clinical trials are acceptable and classical texts are irrelevant
• Only photographs of herbs are required

Correct Answer: Documentation should include citations from recognized classical texts, historical usage records and pharmacopeial references

Q16. What is the role of a Site Master File (SMF) in a dossier for both marketing authorization and export?

• To list only the company’s marketing channels
• To provide detailed facility information, quality systems, personnel and manufacturing practices for regulator evaluation
• To replace batch records entirely
• To serve as a product monograph

Correct Answer: To provide detailed facility information, quality systems, personnel and manufacturing practices for regulator evaluation

Q17. Which type of analytical validation data should be included in the quality section of an ISM product dossier?

• Validation of analytical methods including specificity, accuracy, precision, linearity and robustness
• Only graphical images of herbs
• Only vendor certificates without method validation
• Only marketing claims about purity

Correct Answer: Validation of analytical methods including specificity, accuracy, precision, linearity and robustness

Q18. For export, many importing countries require assurance about residues. Which of the following residue tests are commonly requested for herbal-origin products?

• Radiological contamination only
• Pesticide residues and aflatoxins in addition to heavy metals
• Only sugar content
• Only color fastness tests

Correct Answer: Pesticide residues and aflatoxins in addition to heavy metals

Q19. Good Clinical Practice (GCP) compliance documentation for clinical studies in an ISM dossier should include which element?

• Signed informed consent forms, protocol, investigator brochures and ethics committee approvals
• Only product photographs
• Only the clinical site’s commercial profile
• Only patient names without consent

Correct Answer: Signed informed consent forms, protocol, investigator brochures and ethics committee approvals

Q20. Which of the following best describes the Certificate of Analysis (CoA) role versus the GMP certificate in export documentation?

• CoA documents batch analytical results; GMP certificate demonstrates the manufacturing system meets regulatory GMP standards
• CoA is the same as GMP certificate
• GMP certificate replaces need for CoA
• Both are marketing documents with no regulatory value

Correct Answer: CoA documents batch analytical results; GMP certificate demonstrates the manufacturing system meets regulatory GMP standards

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