Schedule G – details and significance MCQs With Answer

Schedule G – details and significance MCQs With Answer

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Schedule G – details and significance MCQs With Answer

Schedule G is a regulatory provision under the Drugs and Cosmetics Rules that requires specified potent medicines to carry a mandatory cautionary label and be used under medical supervision. For B.Pharm students, mastering Schedule G involves understanding the exact warning text, drug classification criteria, pharmacist responsibilities for dispensing and labeling, implications for patient counselling, and compliance with legal and quality standards. This topic links pharmacology, pharmacy practice, regulatory affairs, and public health by identifying products needing careful supervision to prevent misuse, adverse effects, and regulatory violations. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary requirement of Schedule G in the Drugs and Cosmetics Rules?

  • Mandatory export documentation for listed drugs
  • Mandatory cautionary labeling indicating use only under medical supervision
  • Mandatory over‑the‑counter availability for listed drugs
  • Mandatory clinical trial data submission for listed drugs

Correct Answer: Mandatory cautionary labeling indicating use only under medical supervision

Q2. What is the exact cautionary statement usually associated with Schedule G labels?

  • “For external use only”
  • “Keep out of reach of children”
  • “Caution: It is dangerous to take this preparation except under medical supervision.”
  • “To be sold by retail without prescription”

Correct Answer: “Caution: It is dangerous to take this preparation except under medical supervision.”

Q3. Which of the following best describes the regulatory purpose of Schedule G?

  • To classify foods and nutraceuticals
  • To indicate medicines that require technical storage only
  • To warn consumers about medicines that require medical supervision and counselling
  • To list medicines banned from manufacture

Correct Answer: To warn consumers about medicines that require medical supervision and counselling

Q4. Which schedule is primarily known for requiring a prescription for sale in India?

  • Schedule G
  • Schedule H
  • Schedule M
  • Schedule P

Correct Answer: Schedule H

Q5. Which professional responsibility is directly emphasized for pharmacists regarding Schedule G drugs?

  • Preparing clinical trial protocols
  • Ensuring correct cautionary labeling and providing patient counselling
  • Manufacturing the active pharmaceutical ingredient
  • Conducting community health surveys

Correct Answer: Ensuring correct cautionary labeling and providing patient counselling

Q6. Compared to Schedule H, a key difference of Schedule G is that it specifically focuses on:

  • Stricter storage temperature controls
  • Mandatory cautionary labelling about medical supervision rather than prescription-only status
  • Requirements for clinical efficacy data
  • Ban on advertising in print media

Correct Answer: Mandatory cautionary labelling about medical supervision rather than prescription-only status

Q7. Which type of drugs are commonly included in Schedule G lists?

  • Vitamin supplements and minerals
  • Hormones, steroids and other potent systemic agents
  • Topical cosmetic fragrances
  • Herbal teas and home remedies

Correct Answer: Hormones, steroids and other potent systemic agents

Q8. How does Schedule G labeling support patient safety?

  • By guaranteeing generic substitution
  • By alerting patients and pharmacists that medical supervision and counselling are necessary to reduce risks
  • By removing the need for patient information leaflets
  • By extending shelf life of the medicine

Correct Answer: By alerting patients and pharmacists that medical supervision and counselling are necessary to reduce risks

Q9. Which action would be non‑compliant with Schedule G requirements?

  • Dispensing a Schedule G drug with the prescribed cautionary label and counselling
  • Selling a Schedule G drug without the mandatory cautionary statement on the label
  • Referring a patient to a prescriber when uncertain about therapy
  • Maintaining records of counselling given for potent medicines

Correct Answer: Selling a Schedule G drug without the mandatory cautionary statement on the label

Q10. In pharmacy practice, documenting Schedule G dispensing helps primarily to:

  • Increase drug prices
  • Provide audit trail for regulatory compliance and patient safety
  • Replace the need for a prescription completely
  • Eliminate the need for counselling

Correct Answer: Provide audit trail for regulatory compliance and patient safety

Q11. Which regulatory activity ensures manufacturers comply with Schedule G labeling?

  • Periodic nutritional audits
  • Drug regulatory inspections and label review during licensing
  • Clinical trial ethics committee approval
  • Patent office clearance

Correct Answer: Drug regulatory inspections and label review during licensing

Q12. For B.Pharm students, why is understanding Schedule G important in pharmacovigilance?

  • Because Schedule G drugs are immune to adverse effects
  • Because these drugs often require monitoring and reporting of adverse events due to higher risk profiles
  • Because Schedule G eliminates the need for patient follow-up
  • Because Schedule G drugs do not require labeling

Correct Answer: Because these drugs often require monitoring and reporting of adverse events due to higher risk profiles

Q13. Which statement about advertising Schedule G drugs is correct?

  • They can be freely advertised as OTC remedies
  • Advertising must not mislead and should conform to regulatory limits because these drugs need medical supervision
  • Advertising is encouraged without restrictions
  • Schedule G drugs are exclusively promoted through televised ads

Correct Answer: Advertising must not mislead and should conform to regulatory limits because these drugs need medical supervision

Q14. Which practice is essential when dispensing a Schedule G medicine to a patient?

  • Omitting the patient counseling to save time
  • Providing clear verbal counselling on risks, dosage, and need for medical supervision
  • Allowing sale without any label if patient is familiar
  • Suggesting off‑label uses to the patient

Correct Answer: Providing clear verbal counselling on risks, dosage, and need for medical supervision

Q15. What is the likely consequence for a manufacturer if Schedule G labeling is missing on a listed product?

  • Increased market share
  • Regulatory warning, possible recall, and legal penalties
  • Automatic approval for export
  • Tax exemption

Correct Answer: Regulatory warning, possible recall, and legal penalties

Q16. How does Schedule G interact with patient information leaflets (PILs)?

  • PILs are prohibited for Schedule G drugs
  • PILs should complement the cautionary label by providing detailed safety and monitoring information
  • PILs replace the need for pharmacist counselling
  • PILs are only required for herbal products

Correct Answer: PILs should complement the cautionary label by providing detailed safety and monitoring information

Q17. In academic teaching, Schedule G is most relevant to which subjects for B.Pharm students?

  • Physical pharmacy and pharmaceutical engineering only
  • Pharmacology, pharmacy law, pharmaceutics, and clinical pharmacy
  • Botany and agricultural science
  • Mathematics and statistics exclusively

Correct Answer: Pharmacology, pharmacy law, pharmaceutics, and clinical pharmacy

Q18. Which documentation at a retail pharmacy helps demonstrate compliance with Schedule G requirements?

  • Stock photos of products only
  • Label copies, dispensing records, and counselling logs
  • Only annual sales totals without details
  • Patient identity documents only

Correct Answer: Label copies, dispensing records, and counselling logs

Q19. If a physician prescribes a Schedule G medicine, what is the pharmacist’s role before dispensing?

  • Ignore the prescription and sell a substitute
  • Verify prescription, ensure correct labeling, counsel the patient regarding supervision and risks
  • Suggest an unsupervised home remedy instead
  • Dispense without any label to protect patient privacy

Correct Answer: Verify prescription, ensure correct labeling, counsel the patient regarding supervision and risks

Q20. From a public health perspective, why are Schedule G regulations significant?

  • They reduce access to life‑saving medicines
  • They help minimize misuse and adverse outcomes of potent drugs by requiring warnings and supervision
  • They promote unregulated self‑medication
  • They eliminate the need for healthcare practitioners

Correct Answer: They help minimize misuse and adverse outcomes of potent drugs by requiring warnings and supervision

Q21. Which of the following is a correct pharmacist action when encountering an unlabelled Schedule G product on the shelf?

  • Immediately dispense it to customers
  • Quarantine the stock, inform the supplier and regulatory authority if required
  • Remove all labels and resell at discount
  • Ignore and continue normal operations

Correct Answer: Quarantine the stock, inform the supplier and regulatory authority if required

Q22. How should Schedule G labelling appear on the primary pack?

  • In invisible ink only
  • Clearly legible, conspicuous and containing the mandated cautionary statement
  • Only on the outer carton and not on the primary container
  • Only on the invoice, not on the medicine

Correct Answer: Clearly legible, conspicuous and containing the mandated cautionary statement

Q23. In comparing international regulatory systems, Schedule G most closely aligns with which concept?

  • Unregulated supplements category
  • Prescription‑only or pharmacovigilance‑sensitive classifications that require medical oversight
  • Cosmetic labeling rules
  • Over‑the‑counter unrestricted sale

Correct Answer: Prescription‑only or pharmacovigilance‑sensitive classifications that require medical oversight

Q24. Which pharmacy curriculum activity helps students apply Schedule G principles?

  • Memorizing drug prices only
  • Practical dispensing exercises including labeling, record‑keeping, and patient counselling scenarios
  • Only attending guest lectures without practice
  • Studying botanical names of herbs exclusively

Correct Answer: Practical dispensing exercises including labeling, record‑keeping, and patient counselling scenarios

Q25. If a regulatory inspector finds Schedule G drugs sold without required warnings, the inspector may:

  • Grant a marketing award
  • Issue notices, demand corrective action, or initiate penalties/recall
  • Ignore the violation as insignificant
  • Provide extra stock to the pharmacy

Correct Answer: Issue notices, demand corrective action, or initiate penalties/recall

Q26. Which element should a pharmacist emphasize during counselling for a Schedule G drug?

  • That the drug has no side effects
  • Indications, adverse effects, need for medical supervision and follow‑up
  • Only the brand logo
  • That the drug can be shared with family members

Correct Answer: Indications, adverse effects, need for medical supervision and follow‑up

Q27. For manufacturers, which document should reflect Schedule G requirements when applying for product approval?

  • Marketing brochure only
  • Labelling and package insert details in the product dossier
  • Unofficial email notes
  • Only the sales forecast

Correct Answer: Labelling and package insert details in the product dossier

Q28. Which practice helps reduce misuse of Schedule G drugs at community pharmacies?

  • Ignoring patient queries
  • Active patient counselling, verifying prescriber intent, and documenting dispensing
  • Promoting unsupervised use through discounts
  • Removing labels to improve packaging aesthetics

Correct Answer: Active patient counselling, verifying prescriber intent, and documenting dispensing

Q29. What role does continuing education play in Schedule G compliance for pharmacists?

  • It is irrelevant to compliance
  • It updates pharmacists on regulation changes, safe use guidance and counselling techniques
  • It replaces the need for legal inspections
  • It solely focuses on marketing strategies

Correct Answer: It updates pharmacists on regulation changes, safe use guidance and counselling techniques

Q30. Which is the best immediate response if a patient reports unexpected severe adverse effects from a Schedule G medicine?

  • Advise to continue medication without consulting anyone
  • Advise discontinuation if appropriate, refer to prescriber urgently and report the adverse event as per pharmacovigilance procedures
  • Suggest doubling the dose to overcome side effects
  • Ignore the report as non‑serious

Correct Answer: Advise discontinuation if appropriate, refer to prescriber urgently and report the adverse event as per pharmacovigilance procedures

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