MCQ on Schedule Classifications and Controlled Substances

🟢 Easy Level (1–20)

1. Which Indian law governs the classification of scheduled drugs?
   A. NDPS Act
   B. Indian Penal Code
   C. Drugs and Cosmetics Act, 1940 ✅
   D. Pharmacy Act
   Explanation: Drug classification in India falls under the Drugs and Cosmetics Act.
2. Schedule H drugs require:
   A. No prescription
   B. Veterinary use
   C. A prescription from a registered medical practitioner ✅
   D. Herbal certification
   Explanation: Schedule H drugs are prescription-only.
3. Schedule X drugs are:
   A. Ayurvedic
   B. Highly toxic
   C. Narcotic and psychotropic substances ✅
   D. For external use only
   Explanation: Schedule X includes habit-forming drugs needing special handling.
4. Schedule G drugs require:
   A. No label
   B. Caution label “To be taken under medical supervision” ✅
   C. OTC sale
   D. Temperature-sensitive storage
   Explanation: Schedule G drugs must carry this warning.
5. Which of the following schedules includes OTC drugs?
   A. Schedule H
   B. Schedule G
   C. Schedule K
   D. Schedule K and general sales list ✅
   Explanation: Schedule K includes some exempted and OTC categories.
6. Which schedule deals with standards for cosmetics?
   A. Schedule M
   B. Schedule S ✅
   C. Schedule Y
   D. Schedule H1
   Explanation: Schedule S defines standards for cosmetics.
7. Schedule H1 drugs are regulated for:
   A. Veterinary use
   B. Antibiotic resistance control ✅
   C. Homeopathy
   D. Cosmetics
   Explanation: H1 controls misuse of antibiotics and anti-TB drugs.
8. Schedule P specifies:
   A. Approved vaccines
   B. Life-saving drugs
   C. Storage conditions for drugs ✅
   D. Pricing policy
   Explanation: Schedule P outlines storage and shelf-life.
9. Schedule M relates to:
   A. Hospital design
   B. Good Manufacturing Practices (GMP) ✅
   C. Advertisement rules
   D. Veterinary formulations
   Explanation: Schedule M ensures GMP compliance.
10. Schedule Y relates to:
    A. Drug pricing
    B. Clinical trials regulations ✅
    C. Schedule of vitamins
    D. Drug abuse
    Explanation: Schedule Y outlines clinical trial protocols.
11. Schedule H1 drugs must be recorded in:
    A. Daily logbooks ✅
    B. OTC registers
    C. Hospital discharge summaries
    D. Media reports
    Explanation: H1 mandates proper record maintenance.
12. What is the caution label on Schedule X drugs?
    A. “Dangerous drug”
    B. “Not for sale”
    C. “To be sold by retail on the prescription of a specialist only” ✅
    D. No label required
    Explanation: These drugs are highly regulated.
13. Schedule C and C1 deal with:
    A. Cosmetics
    B. Homeopathy
    C. Biological and special products ✅
    D. Ayurvedic
    Explanation: These cover vaccines and sera.
14. Schedule J contains a list of:
    A. OTC drugs
    B. Banned drugs/diseases that cannot be claimed to be cured ✅
    C. Veterinary drugs
    D. Approved antibiotics
    Explanation: Prohibits certain treatment claims.
15. Drugs in Schedule X must be stored:
    A. In a public display
    B. Without lock
    C. Under double lock system ✅
    D. In room temperature
    Explanation: Double lock ensures restricted access.
16. Which authority schedules drugs in India?
    A. Pharmacy Council
    B. FSSAI
    C. CDSCO and MoHFW ✅
    D. AYUSH
    Explanation: CDSCO under MoHFW regulates drug scheduling.
17. Schedule C drugs must be stored:
    A. Frozen
    B. In sunlight
    C. At 2–8°C ✅
    D. In dry heat
    Explanation: These drugs are biologically active.
18. Schedule Z exists for:
    A. Oncology drugs
    B. Not a valid schedule ✅
    C. HIV treatment
    D. Painkillers
    Explanation: No Schedule Z in Indian regulations.
19. Schedule A includes:
    A. Format of forms ✅
    B. Pharmacopoeial standards
    C. Drug labeling
    D. Veterinary documents
    Explanation: Schedule A covers various forms under D&C Act.
20. Schedule D includes:
    A. Vaccines
    B. Exemptions from import regulations ✅
    C. Dangerous drugs
    D. AYUSH classification
    Explanation: Some drugs are exempted from full compliance.

🟡 Moderate Level (21–40)

21. Controlled substances are regulated in India under:
    A. MTP Act
    B. NDPS Act, 1985 ✅
    C. Pharmacy Act
    D. Clinical Establishment Act
    Explanation: NDPS governs narcotics and psychotropics.
22. Psychotropic substances are listed in:
    A. Schedule H
    B. Schedule I
    C. NDPS Act Schedules ✅
    D. Schedule M
    Explanation: They are controlled under NDPS schedules.
23. Cough syrups with codeine fall under:
    A. Schedule G
    B. Schedule X
    C. Schedule H1 ✅
    D. Schedule K
    Explanation: Codeine is regulated due to potential misuse.
24. Which of these is NOT a controlled substance?
    A. Morphine
    B. Diazepam
    C. Paracetamol ✅
    D. Alprazolam
    Explanation: Paracetamol is not habit-forming.
25. Which body is responsible for narcotics regulation?
    A. PCI
    B. NCB ✅
    C. IMA
    D. WHO
    Explanation: Narcotics Control Bureau oversees NDPS enforcement.
26. Drugs with high abuse potential and no accepted medical use are classified as:
    A. Schedule C
    B. NDPS Schedule I ✅
    C. Schedule M
    D. Schedule H1
    Explanation: These are tightly regulated.
27. Controlled substances require:
    A. Routine labeling
    B. Special licenses for handling ✅
    C. Free distribution
    D. No documentation
    Explanation: Licenses ensure accountability.
28. Narcotic drugs used for pain management are regulated due to:
    A. Shelf-life
    B. Abuse and dependence risk ✅
    C. Cost
    D. Packaging
    Explanation: Risk of addiction mandates control.
29. Drugs listed under Schedule H1 must be preserved for:
    A. 3 months
    B. 6 months
    C. 2 years ✅
    D. 5 years
    Explanation: Records are required to be maintained for 2 years.
30. Tramadol was included in NDPS in which year?
    A. 2005
    B. 2018 ✅
    C. 2010
    D. 2020
    Explanation: It was classified due to rising misuse.
31. Which drug is an example of a Schedule X substance?
    A. Ibuprofen
    B. Methadone ✅
    C. Cefixime
    D. Ranitidine
    Explanation: Methadone is highly regulated.
32. Schedule H1 was introduced to control misuse of:
    A. Cosmetics
    B. Antibiotics and anti-TB drugs ✅
    C. Homeopathy
    D. Sedatives
    Explanation: H1 controls antimicrobial resistance.
33. The NDPS Act penalizes violations including:
    A. Mislabeling
    B. Improper sale of psychotropics ✅
    C. Excess packaging
    D. Price fluctuation
    Explanation: NDPS violations lead to strict penalties.
34. Drug scheduling ensures:
    A. Color uniformity
    B. Legal framework for control and distribution ✅
    C. Medicine flavor
    D. Pricing control
    Explanation: It classifies drugs by regulation needs.
35. Which of these drugs is considered psychotropic?
    A. Metformin
    B. Clonazepam ✅
    C. Dicyclomine
    D. Diclofenac
    Explanation: Clonazepam is a CNS-acting substance.
36. Which act classifies banned substances?
    A. Pharmacy Act
    B. Drugs and Magic Remedies Act
    C. NDPS Act ✅
    D. Clinical Trials Act
    Explanation: NDPS defines narcotic and banned substances.
37. “Schedule” in pharmacy refers to:
    A. Sales data
    B. Packaging routine
    C. Legal classification of drugs ✅
    D. Refill timing
    Explanation: Schedules define how drugs are regulated.
38. Schedule H1 drugs must have which color label strip?
    A. Blue
    B. Red ✅
    C. Green
    D. Yellow
    Explanation: Red strip for visual identification.
39. Which class of drugs requires double-lock storage and strict recording?
    A. Schedule G
    B. Schedule X ✅
    C. Schedule K
    D. Schedule S
    Explanation: These drugs pose high misuse potential.
40. Which is NOT a requirement for dispensing Schedule H1 drugs?
    A. Prescription
    B. Record of sale
    C. Patient signature ✅
    D. Label warning
    Explanation: No signature, but record-keeping and labeling are mandatory.

🔴 Hard Level (41–50)

41. A hospital storing morphine must have:
    A. FSSAI registration
    B. NDPS license ✅
    C. Schedule H1 certificate
    D. Bioequivalence study
    Explanation: NDPS license is compulsory.
42. NDPS violations can lead to imprisonment of:
    A. 3 months
    B. 1 year
    C. 10 years or more ✅
    D. Fine only
    Explanation: Punishment is severe.
43. Fentanyl is classified under:
    A. Schedule H
    B. Schedule G
    C. NDPS-controlled substances ✅
    D. Over-the-counter
    Explanation: It’s a potent opioid.
44. The inclusion of a drug in NDPS schedules is based on:
    A. Cost
    B. Availability
    C. Abuse potential ✅
    D. Brand name
    Explanation: Drugs with high abuse risk are scheduled.
45. Who maintains the list of controlled drugs globally?
    A. WHO
    B. United Nations – INCB ✅
    C. US-FDA
    D. CDSCO
    Explanation: INCB oversees global narcotic control.
46. According to NDPS, “small quantity” defines limits for:
    A. Packaging
    B. Drug trial sizes
    C. Legal possession thresholds ✅
    D. Cold chain limits
    Explanation: It helps determine legal penalty.
47. Red H1 warning on label indicates:
    A. Home use
    B. Safe for OTC
    C. Strict control and prescription-only ✅
    D. Export permitted
    Explanation: It’s a warning to consumers and pharmacists.
48. Which Schedule lists essential narcotic drugs (ENDs)?
    A. NDPS 1
    B. NDPS Rule 2(b) ✅
    C. Schedule H
    D. Schedule K
    Explanation: ENDs are listed under specific NDPS rules.
49. Clonazepam is regulated under:
    A. Schedule K
    B. Schedule X
    C. Schedule H1 and NDPS ✅
    D. OTC drug list
    Explanation: It’s controlled due to its CNS activity.
50. Repeated violation of NDPS can lead to:
    A. Fine only
    B. Warning letter
    C. Life imprisonment ✅
    D. Product withdrawal
    Explanation: Severe repeat offenses are harshly penalized.