Regulatory aspects of QUM in India: scheduling and OTC regulation MCQs With Answer

Introduction

This quiz collection focuses on the regulatory aspects of Quality Use of Medicines (QUM) in India, emphasizing scheduling and over‑the‑counter (OTC) regulation relevant to M.Pharm students. It covers central regulatory bodies, schedules under the Drugs and Cosmetics Rules (such as Schedule H, H1 and X), pharmacist responsibilities, labeling and record‑keeping requirements, and current gaps in OTC classification. The questions are aimed to deepen understanding of how regulation shapes appropriate medicine use, safety monitoring and antimicrobial stewardship in India, and to prepare students for regulatory, clinical and community pharmacy roles.

Q1. Which authority is primarily responsible for approval of new drugs and regulation of clinical trials at the central level in India?

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

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q2. Under the Drugs and Cosmetics Rules, which schedule designates medicines that must be sold only on prescription and carry a specific legend for retail sale?

• Schedule M
• Schedule H
• Schedule Y
• Schedule K

Correct Answer: Schedule H

Q3. Which schedule was introduced to strengthen control over certain antibiotics and other drugs by mandating record‑keeping at the pharmacy level?

• Schedule X
• Schedule M
• Schedule H1
• Schedule G

Correct Answer: Schedule H1

Q4. Which schedule covers habit‑forming or narcotic drugs that are subject to stricter control, including special prescription handling and pharmacist record retention?

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

Correct Answer: Schedule X

Q5. In India, which statement best describes the legal status of an official OTC (over‑the‑counter) category within the Drugs and Cosmetics Act and Rules?

• There is a clearly defined and fully implemented national OTC schedule in the D&C Rules
• OTC medicines are regulated by NPPA only
• There is no formal legally defined OTC category in the D&C Act; medicines not under prescription schedules are practically available OTC
• All non‑scheduled drugs are banned from retail sale without prescription

Correct Answer: There is no formal legally defined OTC category in the D&C Act; medicines not under prescription schedules are practically available OTC

Q6. Which of the following is a primary responsibility of the Drugs Controller General of India (DCGI)?

• Setting retail prices for essential medicines
• Approving import, manufacture and clinical trials of new drugs
• Conducting post‑marketing surveillance exclusively in states
• Issuing state pharmacy licences

Correct Answer: Approving import, manufacture and clinical trials of new drugs

Q7. What is a key labeling requirement for Schedule H medicines sold in India?

• They must display the phrase “OTC: Safe for self‑medication”
• They must carry the legend indicating sale only on the prescription of a Registered Medical Practitioner
• They are exempt from manufacturer batch numbering
• They must be labelled with the price fixed by NPPA

Correct Answer: They must carry the legend indicating sale only on the prescription of a Registered Medical Practitioner

Q8. For Schedule H1 medicines, what additional pharmacy practice measure is commonly required compared to general Schedule H drugs?

• No prescription is needed for Schedule H1
• Pharmacies must maintain a special register recording patient and prescriber details for each sale
• Schedule H1 drugs can only be sold in hospitals
• Manufacturers must provide free samples to pharmacists

Correct Answer: Pharmacies must maintain a special register recording patient and prescriber details for each sale

Q9. Which central body is primarily responsible for regulating drug prices and monitoring availability under government policy?

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

Correct Answer: National Pharmaceutical Pricing Authority (NPPA)

Q10. Which schedule of the Drugs and Cosmetics Rules deals mainly with standards for manufacturing premises and Good Manufacturing Practices (GMP)?

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

Correct Answer: Schedule M

Q11. What is the regulatory implication of a medicine being outside Schedules H, H1 and X in India?

• It automatically becomes a controlled narcotic
• It is treated as subject to prescription‑only sales
• It may be available for sale without prescription unless other laws restrict it
• It is banned from retail sale

Correct Answer: It may be available for sale without prescription unless other laws restrict it

Q12. Under Indian regulation, which act restricts misleading advertisements relating to cures for certain diseases and health conditions?

• Drugs and Cosmetics Act
• Medical Termination of Pregnancy Act
• Drugs and Magic Remedies (Objectionable Advertisements) Act
• Pharmacy Act

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

Q13. Which regulatory requirement supports antimicrobial stewardship by controlling sale of key antimicrobials?

• Inclusion of antibiotics in Schedule H1 with pharmacy record‑keeping
• Exemption of antibiotics from all schedules
• Allowing free advertising of all antibiotics
• Mandating home delivery of all antimicrobials

Correct Answer: Inclusion of antibiotics in Schedule H1 with pharmacy record‑keeping

Q14. Which of the following is true about retention of prescriptions for certain controlled drugs under Indian rules?

• Pharmacies are never required to retain prescriptions
• Pharmacies must retain prescriptions for certain controlled schedules as specified by the Rules
• Only manufacturers retain prescriptions, not pharmacists
• Prescription retention is optional and left to pharmacist discretion

Correct Answer: Pharmacies must retain prescriptions for certain controlled schedules as specified by the Rules

Q15. Which regulatory document is primarily referred to for specific requirements on labelling, packaging and contents of drug containers in India?

• Pharmacopoeia of the United States
• Schedules of the Drugs and Cosmetics Rules
• World Health Organization guidelines only
• Indian Penal Code

Correct Answer: Schedules of the Drugs and Cosmetics Rules

Q16. If a pharmacist dispenses a Schedule H medicine without a prescription, which of the following is correct?

• This practice is permitted for first‑time patients only
• It is an offence under the Drugs and Cosmetics Rules and can attract penal action
• It is mandatory to dispense without prescription for emergency care
• The pharmacist is entitled to a warning but no legal consequence

Correct Answer: It is an offence under the Drugs and Cosmetics Rules and can attract penal action

Q17. How does the regulatory framework encourage rational use of medicines via scheduling in India?

• By classifying all medicines as Schedule X
• By using schedules to restrict supply of potentially harmful drugs and promote prescription control
• By allowing unrestricted advertising of prescription medicines
• By prohibiting generic substitution entirely

Correct Answer: By using schedules to restrict supply of potentially harmful drugs and promote prescription control

Q18. Which of the following best describes the State Licensing Authority’s role in medicines regulation?

• Approving new drug applications at national level
• Issuing retail and wholesale drug licences and local enforcement of the Rules
• Setting national drug prices
• Banning all imports of medicines

Correct Answer: Issuing retail and wholesale drug licences and local enforcement of the Rules

Q19. For fixed‑dose combinations (FDCs), what is the usual regulatory concern addressed by CDSCO before marketing approval?

• Whether the combination has a justified therapeutic rationale and safety/efficacy data
• Whether the FDC has the most expensive components
• Whether the FDC is preferred by pharmacists for profit
• Whether the combination has more than five active ingredients regardless of evidence

Correct Answer: Whether the combination has a justified therapeutic rationale and safety/efficacy data

Q20. Which practice enhances transparency and consumer awareness for medicines available without prescription in India?

• Clear labelling of indications, dose, precautions and warnings on over‑the‑counter product labels
• Removing expiry dates from OTC products
• Prohibiting ingredient lists on packaging
• Mandating physician signature on every OTC pack

Correct Answer: Clear labelling of indications, dose, precautions and warnings on over‑the‑counter product labels

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