Introduction to pharmaceutical legislations in India MCQs With Answer

Introduction:

Understanding pharmaceutical legislations in India is essential for B.Pharm students. This introduction covers key regulations such as the Drugs and Cosmetics Act, CDSCO/DCGI controls, Schedule M (GMP), Schedule H/H1/X classifications, Schedule Y clinical trial rules, pharmacovigilance, drug licensing, labeling, import/export, and price control by NPPA. Grasping these laws helps students ensure drug safety, quality, efficacy, ethics in clinical trials, and regulatory compliance in manufacturing and distribution. Clear knowledge of documentation, licensing procedures, adverse event reporting, and regulatory authorities prepares you for careers in industry, quality assurance, regulatory affairs, and research. ‘Now let’s test your knowledge with 30 MCQs on this topic.’

Q1. Which primary legislation governs manufacture, sale and distribution of drugs and cosmetics in India?

  • Drugs and Cosmetics Act, 1940
  • Indian Medical Council Act, 1956
  • Pharmacy Act, 1948
  • Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954

Correct Answer: Drugs and Cosmetics Act, 1940

Q2. Which organization is the central regulatory authority for approval and regulation of drugs and medical devices in India?

  • Central Drugs Standard Control Organization (CDSCO)
  • State Drug Control Department
  • National Pharmaceutical Pricing Authority (NPPA)
  • Indian Pharmacopoeia Commission (IPC)

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q3. Which schedule of the Drugs and Cosmetics Rules deals primarily with Good Manufacturing Practices (GMP) for pharmaceutical manufacturers?

  • Schedule M
  • Schedule Y
  • Schedule H
  • Schedule X

Correct Answer: Schedule M

Q4. Which schedule lists prescription-only medicines that must bear the warning ‘To be sold by retail on the prescription of a Registered Medical Practitioner only’?

  • Schedule H
  • Schedule X
  • Schedule M
  • Schedule C

Correct Answer: Schedule H

Q5. Which schedule provides regulatory requirements and guidance for clinical trials and approval of new drugs in India?

  • Schedule Y
  • Schedule H1
  • Schedule M
  • Schedule C

Correct Answer: Schedule Y

Q6. Which agency coordinates the national pharmacovigilance program (PvPI) in India?

  • Indian Pharmacopoeia Commission (IPC)
  • National Pharmaceutical Pricing Authority (NPPA)
  • Drug Controller General of India (DCGI)
  • Pharmacy Council of India (PCI)

Correct Answer: Indian Pharmacopoeia Commission (IPC)

Q7. Which authority enforces price control of essential medicines under the Drug Price Control Order (DPCO)?

  • National Pharmaceutical Pricing Authority (NPPA)
  • Central Drugs Standard Control Organization (CDSCO)
  • Food Safety and Standards Authority of India (FSSAI)
  • Ministry of Health and Family Welfare only

Correct Answer: National Pharmaceutical Pricing Authority (NPPA)

Q8. Under the Drugs and Cosmetics Act, which term refers to a drug that is sold with false or misleading labeling or claims?

  • Misbranded drug
  • Adulterated drug
  • Spurious drug
  • Proprietary drug

Correct Answer: Misbranded drug

Q9. Who is the licensing authority for issuing manufacturing licenses for drugs within a state?

  • State Drug Control Authority (State Licensing Authority)
  • Central Drugs Standard Control Organization (CDSCO)
  • National Pharmaceutical Pricing Authority (NPPA)
  • Indian Pharmacopoeia Commission (IPC)

Correct Answer: State Drug Control Authority (State Licensing Authority)

Q10. Which authority grants import licenses for pharmaceutical products into India?

  • Central Drugs Standard Control Organization (CDSCO)
  • State Licensing Authority
  • National Pharmaceutical Pricing Authority (NPPA)
  • Pharmacy Council of India (PCI)

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q11. Which schedule requires manufacturers to maintain a quality control department with trained personnel and appropriate facilities?

  • Schedule M
  • Schedule H
  • Schedule Y
  • Schedule X

Correct Answer: Schedule M

Q12. What is the primary ethical requirement before enrolling a subject into a clinical trial?

  • Obtaining informed consent from the subject
  • Publishing the trial protocol in a journal
  • Ensuring the subject has health insurance
  • Paying the ethics committee beforehand

Correct Answer: Obtaining informed consent from the subject

Q13. Which schedule was introduced to control the sale of certain antibiotics and requires a separate retail record for these drugs?

  • Schedule H1
  • Schedule H
  • Schedule X
  • Schedule M

Correct Answer: Schedule H1

Q14. The Drugs Controller General of India (DCGI) is the head of which entity?

  • Central Drugs Standard Control Organization (CDSCO)
  • National Pharmaceutical Pricing Authority (NPPA)
  • Indian Pharmacopoeia Commission (IPC)
  • Pharmacy Council of India (PCI)

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q15. Which labeling information is mandatory on all packaged pharmaceutical products in India?

  • Batch number, manufacturing date and expiry date
  • Recommended retail price only
  • Distributor’s bank details
  • Physician’s name

Correct Answer: Batch number, manufacturing date and expiry date

Q16. Where must a clinical trial conducted in India be registered before enrolling the first participant?

  • Clinical Trials Registry – India (CTRI)
  • World Health Organization database only
  • Central Drugs Standard Control Organization website without formal registration
  • Ethics committee internal log only

Correct Answer: Clinical Trials Registry – India (CTRI)

Q17. For approval of generic immediate-release oral dosage forms, regulatory authorities typically require which study?

  • Bioequivalence study
  • Phase I safety study
  • Long-term carcinogenicity study
  • Comparative efficacy trial in thousands of patients

Correct Answer: Bioequivalence study

Q18. Which Act regulates narcotic drugs and psychotropic substances in India?

  • Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985
  • Drugs and Cosmetics Act, 1940
  • Pharmacy Act, 1948
  • Food Safety and Standards Act, 2006

Correct Answer: Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985

Q19. Which body publishes the official standards of quality for drugs in India known as the Indian Pharmacopoeia?

  • Indian Pharmacopoeia Commission (IPC)
  • Central Drugs Standard Control Organization (CDSCO)
  • National Pharmaceutical Pricing Authority (NPPA)
  • Pharmacy Council of India (PCI)

Correct Answer: Indian Pharmacopoeia Commission (IPC)

Q20. Schedule C and C1 of the Drugs and Cosmetics Rules relate primarily to which category?

  • Biological products like vaccines, sera and toxins
  • Over-the-counter (OTC) herbal remedies
  • Cosmetic preparations only
  • Homeopathic medicines only

Correct Answer: Biological products like vaccines, sera and toxins

Q21. Who is primarily responsible for payment of compensation to a subject suffering trial-related injury or death?

  • Sponsor of the clinical trial
  • Principal investigator
  • Ethics committee
  • Central Drugs Standard Control Organization (CDSCO)

Correct Answer: Sponsor of the clinical trial

Q22. Which Act restricts misleading advertisements of drugs and magic remedies in India?

  • Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954
  • Drugs and Cosmetics Act, 1940
  • Information Technology Act, 2000
  • Consumer Protection Act, 1986

Correct Answer: Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954

Q23. Which authority can order the recall of a marketed drug in India if it is found unsafe?

  • Central Drugs Standard Control Organization (CDSCO)
  • National Pharmaceutical Pricing Authority (NPPA)
  • Pharmacy Council of India (PCI)
  • District Consumer Forum

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q24. Which phase of clinical trials is primarily designed to evaluate safety and pharmacokinetics in a small group of healthy volunteers?

  • Phase I
  • Phase II
  • Phase III
  • Phase IV

Correct Answer: Phase I

Q25. Which schedule includes drugs that are highly restricted and require special record-keeping and preservation of prescriptions for a set period?

  • Schedule X
  • Schedule H
  • Schedule M
  • Schedule Y

Correct Answer: Schedule X

Q26. Which document must a manufacturer obtain from CDSCO for marketing a “new drug” in India?

  • New Drug Approval/Marketing Authorization from DCGI
  • State GST registration certificate
  • Pharmacist employment records
  • Export-import code only

Correct Answer: New Drug Approval/Marketing Authorization from DCGI

Q27. Under Schedule H1, pharmacists are required to maintain which of the following?

  • A separate register recording patient name, address, prescribing doctor and drug dispensed
  • A monthly sales advertisement logbook
  • A copy of the CDSCO website printout
  • Only a cash memo with no patient details

Correct Answer: A separate register recording patient name, address, prescribing doctor and drug dispensed

Q28. What constitutes an ‘adulterated drug’ under regulatory definitions?

  • A drug whose purity or quality is compromised by contamination or substitution
  • A drug with a mislabeled color on the outer pack only
  • A drug sold below the Maximum Retail Price
  • A drug produced by a foreign manufacturer

Correct Answer: A drug whose purity or quality is compromised by contamination or substitution

Q29. Which of the following is a mandatory requirement before initiating a clinical trial site inspection by regulators?

  • Approval from DCGI and a registered Ethics Committee approval
  • Publication of study results
  • Presence of a sales representative
  • Prior approval from NPPA

Correct Answer: Approval from DCGI and a registered Ethics Committee approval

Q30. Under Indian regulations, who issues guidelines for bioavailability and bioequivalence studies required for generic approvals?

  • Central Drugs Standard Control Organization (CDSCO) / DCGI
  • State Licensing Authority only
  • Pharmacy Council of India (PCI)
  • Food Safety and Standards Authority of India (FSSAI)

Correct Answer: Central Drugs Standard Control Organization (CDSCO) / DCGI

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