MCQ on Drug Laws and Regulatory Affairs

🟢 Easy Level (1–20)

1. Which Act regulates the import, manufacture, and distribution of drugs in India?
   A. NDPS Act
   B. Drug and Magic Remedies Act
   C. Drugs and Cosmetics Act, 1940 ✅
   D. Pharmacy Act, 1948
   Explanation: This is the principal legislation for drug regulation in India.
2. Which body governs the approval of new drugs in India?
   A. WHO
   B. DCGI ✅
   C. PCI
   D. FSSAI
   Explanation: The Drug Controller General of India approves new drug applications.
3. Schedule H drugs are dispensed only with:
   A. Food license
   B. Verbal request
   C. Written prescription ✅
   D. Doctor’s signature on file
   Explanation: These are prescription-only drugs.
4. What does GMP stand for?
   A. General Medicine Policy
   B. Good Manufacturing Practices ✅
   C. General Management Plan
   D. Global Marketing Practices
   Explanation: GMP ensures quality and safety in drug manufacturing.
5. Which Act regulates narcotic drugs in India?
   A. D&C Act
   B. NDPS Act, 1985 ✅
   C. FSSAI Act
   D. PCI Act
   Explanation: NDPS Act governs control and regulation of narcotic substances.
6. The Pharmacy Act was enacted in:
   A. 1955
   B. 1948 ✅
   C. 1962
   D. 1935
   Explanation: This Act established the PCI and regulated pharmacy profession.
7. Which Schedule covers GMP for pharmaceutical industries?
   A. Schedule H
   B. Schedule M ✅
   C. Schedule Y
   D. Schedule X
   Explanation: Schedule M outlines GMP guidelines for manufacturers.
8. Schedule Y deals with:
   A. OTC drugs
   B. Drug labeling
   C. Clinical trials ✅
   D. Drug import
   Explanation: Schedule Y provides guidelines for clinical trials.
9. What does DPCO stand for?
   A. Drug Product Classification Order
   B. Drug Price Control Order ✅
   C. Drug Packaging Control Order
   D. Direct Pharmaceutical Control Order
   Explanation: DPCO regulates drug prices to ensure affordability.
10. Which body regulates food safety and labeling in India?
    A. CDSCO
    B. FSSAI ✅
    C. PCI
    D. ICMR
    Explanation: FSSAI oversees food safety, including dietary supplements.
11. Drugs requiring strict documentation and records are under:
    A. Schedule G
    B. Schedule H
    C. Schedule X ✅
    D. Schedule P
    Explanation: Schedule X includes habit-forming drugs.
12. The primary goal of regulatory affairs in pharmacy is to ensure:
    A. Marketing
    B. Legal compliance ✅
    C. Drug pricing
    D. Medical sales
    Explanation: Regulatory affairs ensure products meet legal and safety requirements.
13. Patent rights in India last for:
    A. 10 years
    B. 15 years
    C. 20 years ✅
    D. Lifetime
    Explanation: The Indian Patent Act grants patents for 20 years.
14. The term ADR refers to:
    A. Alternate Drug Regulation
    B. Adverse Drug Reaction ✅
    C. Automated Drug Report
    D. Annual Drug Review
    Explanation: ADRs are harmful or unintended effects of a drug.
15. Which agency maintains the Indian Pharmacopoeia?
    A. PCI
    B. IPC ✅
    C. FSSAI
    D. ICMR
    Explanation: The Indian Pharmacopoeia Commission publishes the official standards.
16. Which Schedule includes labeling requirements?
    A. Schedule P ✅
    B. Schedule Y
    C. Schedule M
    D. Schedule G
    Explanation: Schedule P provides labeling and shelf-life requirements.
17. The uniform code for ethical marketing is known as:
    A. UCPMP ✅
    B. GMP
    C. DPCO
    D. CSR
    Explanation: The Uniform Code of Pharmaceutical Marketing Practices guides ethical promotion.
18. Which law regulates misleading advertisements for drugs?
    A. Patent Act
    B. Pharmacy Act
    C. Drugs and Magic Remedies Act ✅
    D. DPCO
    Explanation: This Act prohibits false therapeutic claims.
19. Which law is applicable to Ayurvedic and Unani drugs?
    A. Schedule M
    B. D&C Act, 1940 ✅
    C. NDPS Act
    D. UCPMP
    Explanation: The D&C Act also covers traditional systems of medicine.
20. PCI stands for:
    A. Pharmacovigilance Council of India
    B. Pharmacy Council of India ✅
    C. Pharmaceutical Commission of India
    D. Public Chemistry Institute
    Explanation: PCI regulates pharmacy education and registration.

🟡 Moderate Level (21–40)

21. Which schedule includes biological and special products?
    A. Schedule C ✅
    B. Schedule S
    C. Schedule Y
    D. Schedule R
    Explanation: Schedule C covers biologicals like sera, vaccines, etc.
22. Pharmacovigilance in India is regulated by:
    A. CDSCO and IPC ✅
    B. PCI
    C. FDA
    D. AIIMS
    Explanation: CDSCO and IPC jointly manage pharmacovigilance programs.
23. The national pharmacovigilance program is known as:
    A. PVPI ✅
    B. NLEM
    C. NPPA
    D. ADRP
    Explanation: Pharmacovigilance Programme of India monitors drug safety.
24. Which organization handles drug recalls in India?
    A. WHO
    B. CDSCO ✅
    C. PCI
    D. FSSAI
    Explanation: CDSCO oversees recalls of unsafe drugs.
25. The drug regulatory system in India is a:
    A. Central system
    B. State-only system
    C. Dual system ✅
    D. Private system
    Explanation: Central and State governments share responsibilities.
26. Which Schedule contains drugs that are dangerous if taken without supervision?
    A. Schedule G ✅
    B. Schedule M
    C. Schedule Y
    D. Schedule P
    Explanation: These drugs must be taken under medical supervision.
27. Which international guideline harmonizes pharmaceutical regulations?
    A. FDA
    B. ICH ✅
    C. CDSCO
    D. NDPS
    Explanation: International Council for Harmonisation (ICH) harmonizes drug regulations.
28. The CDSCO functions under which ministry?
    A. Ministry of Education
    B. Ministry of Finance
    C. Ministry of Health and Family Welfare ✅
    D. Ministry of Home Affairs
    Explanation: CDSCO is part of the MoHFW.
29. Patent protection is governed in India by the:
    A. CDSCO
    B. Patent Act, 1970 ✅
    C. NDPS Act
    D. Drugs and Cosmetics Rules
    Explanation: The Patent Act governs intellectual property.
30. Which document is essential for importing drugs into India?
    A. Drug License
    B. Registration Certificate (RC) ✅
    C. Test Report
    D. Clinical Trial Protocol
    Explanation: RC is mandatory for drug imports.
31. Which act covers drug price regulation?
    A. D&C Act
    B. DPCO ✅
    C. PCI Act
    D. FSSAI Act
    Explanation: DPCO regulates prices of essential medicines.
32. Medical devices in India are regulated under:
    A. Schedule G
    B. Medical Devices Rules, 2017 ✅
    C. D&C Rules only
    D. Patent Act
    Explanation: MDR 2017 lays out rules for device classification and control.
33. Orange Book by US FDA lists:
    A. Pharmacopoeia standards
    B. Therapeutic equivalents ✅
    C. Herbals
    D. Cosmetics
    Explanation: It identifies FDA-approved generics with equivalence.
34. A marketing authorization is granted for a drug when:
    A. It is manufactured
    B. It is patented
    C. Its safety and efficacy are established ✅
    D. It is exported
    Explanation: Authorization ensures the drug can be marketed.
35. ICH Q10 refers to:
    A. Clinical Trials
    B. Drug labeling
    C. Pharmaceutical Quality System ✅
    D. Packaging
    Explanation: Q10 is part of ICH’s quality guidelines.
36. Patent applications in India are handled by:
    A. CDSCO
    B. Patent Office ✅
    C. PCI
    D. FDA
    Explanation: The Indian Patent Office processes patent filings.
37. Which authority can cancel a drug license in case of non-compliance?
    A. PCI
    B. State Drug Control Authority ✅
    C. WHO
    D. ICMR
    Explanation: State authorities monitor compliance locally.
38. Fixed-dose combinations are regulated by:
    A. Schedule H
    B. UCPMP
    C. CDSCO ✅
    D. NPPA
    Explanation: CDSCO approves and monitors FDCs.
39. Which Schedule outlines standards for cosmetics?
    A. Schedule X
    B. Schedule Y
    C. Schedule S ✅
    D. Schedule P
    Explanation: Schedule S deals with cosmetics in India.
40. Labeling for vaccines falls under:
    A. Schedule G
    B. Schedule H
    C. Schedule C ✅
    D. Schedule Y
    Explanation: Schedule C includes vaccines, sera, and toxins.

🔴 Hard Level (41–50)

41. Which ICH guideline is for stability testing of APIs and products?
    A. Q9
    B. Q1A(R2) ✅
    C. Q6
    D. Q3A
    Explanation: Q1A covers stability testing requirements.
42. Clinical trial registration in India is done at:
    A. DCGI
    B. ICMR
    C. CTRI ✅
    D. CDSCO
    Explanation: Clinical Trials Registry – India (CTRI) is mandatory for trial registration.
43. Medical device classification in India follows which framework?
    A. FDA
    B. Risk-based classification ✅
    C. Cosmetic labeling
    D. DPCO
    Explanation: Devices are classified based on their risk to users.
44. WHO GMP certificate is issued by:
    A. PCI
    B. CDSCO
    C. State Drug Control Departments ✅
    D. ICH
    Explanation: States issue WHO GMP certification after inspection.
45. The main objective of drug regulatory affairs is to:
    A. Promote drugs
    B. Ensure compliance and patient safety ✅
    C. Handle prescriptions
    D. Increase sales
    Explanation: Regulatory affairs focus on legal and safety compliance.
46. Which agency enforces pharmacovigilance in Europe?
    A. CDSCO
    B. EMA ✅
    C. FDA
    D. PCI
    Explanation: European Medicines Agency (EMA) handles drug safety.
47. ICH E6 guideline covers:
    A. GMP
    B. Pharmacovigilance
    C. Good Clinical Practice ✅
    D. Packaging
    Explanation: E6 provides international standards for clinical trial conduct.
48. Bioequivalence studies are required for:
    A. Biologicals
    B. Cosmetics
    C. Generic drugs ✅
    D. OTC drugs
    Explanation: These studies prove that generics perform similarly to branded drugs.
49. The Yellow Book is issued by:
    A. WHO
    B. CDSCO
    C. US CDC ✅
    D. EMA
    Explanation: CDC’s Yellow Book provides travel medicine guidelines.
50. Which global system reports adverse drug reactions?
    A. ADR India
    B. MedWatch
    C. VigiBase ✅
    D. Orange Book
    Explanation: VigiBase is the WHO’s international ADR database.