Legal requirements to start a community pharmacy MCQs With Answer

Introduction

Legal requirements to start a community pharmacy is a crucial area of understanding for M.Pharm students preparing to enter practice or management roles. This blog-style quiz set focuses on statutory frameworks, mandatory registrations, licensing authorities, record-keeping, controlled-drug regulations and Good Pharmacy Practice essentials specific to community pharmacies. Each question is designed to reinforce knowledge of Indian pharmacy laws and operational obligations—such as the Drugs & Cosmetics Act, Pharmacy Act, NDPS provisions, and state licensing rules—while emphasizing practical compliance steps like employment of a registered pharmacist, maintaining required registers, proper storage and documentation, and limits on activities without manufacturing licenses. Use these MCQs to assess and sharpen your regulatory competence before establishing or managing a community pharmacy.

Q1. Which legislation primarily governs the manufacture, sale and distribution of drugs in India?

• Pharmacy Act, 1948
• Drugs and Cosmetics Act, 1940
• Narcotic Drugs and Psychotropic Substances Act, 1985
• Indian Medical Council Act, 1956

Correct Answer: Drugs and Cosmetics Act, 1940

Q2. What statutory registration is mandatory for an individual to practice as a pharmacist in India?

• Registration with State Pharmacy Council
• License from Central Drugs Standard Control Organization (CDSCO)
• Registration with Medical Council of India
• Shop establishment certificate only

Correct Answer: Registration with State Pharmacy Council

Q3. Which authority normally issues a retail community pharmacy licence?

• Central Drugs Standard Control Organization (CDSCO)
• State Licensing Authority / State Drug Control Department
• Pharmacy Council of India
• Municipal Corporation Health Department only

Correct Answer: State Licensing Authority / State Drug Control Department

Q4. Is the presence of a registered pharmacist during business hours a legal requirement for a community pharmacy?

• No, a registered pharmacist is not required
• Yes, a registered pharmacist must be on duty during business hours
• Only at the time of inspection
• Only for pharmacies selling Schedule X drugs

Correct Answer: Yes, a registered pharmacist must be on duty during business hours

Q5. Which schedule in the Drugs & Cosmetics Rules lists prescription-only drugs that cannot be sold without a valid prescription?

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

Correct Answer: Schedule H

Q6. Which schedule was introduced to impose stricter controls, record keeping and prescription retention for a subset of antibiotics and certain drugs?

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

Correct Answer: Schedule H1

Q7. The handling, sale and distribution of narcotic and psychotropic substances in a community pharmacy are regulated under which Act?

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

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

Q8. Who is authorized to own a community retail pharmacy under general practice in India?

• Only a registered pharmacist may own a pharmacy
• Only medical practitioners may own pharmacies
• Any person or entity may own, provided a registered pharmacist is employed
• Only pharmaceutical companies may own retail pharmacies

Correct Answer: Any person or entity may own, provided a registered pharmacist is employed

Q9. Which of the following records is specifically required for sales of Schedule H1 drugs in a community pharmacy?

• No special record is required
• Separate register with patient name, prescriber, drug details and retention of prescription copy
• Only retail invoices need to be kept
• Only purchase invoices from suppliers need to be maintained

Correct Answer: Separate register with patient name, prescriber, drug details and retention of prescription copy

Q10. Who typically performs inspections and enforcement visits for community pharmacy licensing and compliance?

• Pharmacy Council of India inspectors
• Local police only
• State Drug Inspectors from the State Drug Control Department
• Central Bureau of Investigation (CBI)

Correct Answer: State Drug Inspectors from the State Drug Control Department

Q11. Which of the following is a mandatory display requirement at a licensed community pharmacy?

• Only business hours need be displayed
• Display a copy of the valid pharmacy licence and the name of the registered pharmacist on duty
• No display of licence is required
• Only the owner’s identity card must be displayed

Correct Answer: Display a copy of the valid pharmacy licence and the name of the registered pharmacist on duty

Q12. Which document proves the professional qualification entitlement of the dispensing pharmacist?

• Pharmacist’s degree certificate only
• Registration certificate issued by the State Pharmacy Council
• Shop establishment certificate
• Owner’s PAN card

Correct Answer: Registration certificate issued by the State Pharmacy Council

Q13. Which activity cannot be carried out in a community retail pharmacy without obtaining a separate manufacturing licence?

• Dispensing and counselling to patients
• Selling over-the-counter medicines
• Manufacture of sterile injectables or large‑scale formulation production
• Maintaining patient medication records

Correct Answer: Manufacture of sterile injectables or large‑scale formulation production

Q14. Good Pharmacy Practice (GPP) guidelines primarily aim to ensure which of the following in community pharmacies?

• Maximum profit with minimum staff
• Safe, effective and rational use of medicines including appropriate dispensing and patient counselling
• Abolition of prescriptions for antibiotics
• Exclusive sale of branded medicines

Correct Answer: Safe, effective and rational use of medicines including appropriate dispensing and patient counselling

Q15. What is a legal and practical requirement for storing vaccines and other thermolabile medicines in a community pharmacy?

• Store at room temperature with no records
• Maintain a calibrated refrigerator with continuous temperature monitoring and temperature log
• Keep in any cool place without documentation
• Only manufacturer needs to ensure cold chain; pharmacy has no responsibility

Correct Answer: Maintain a calibrated refrigerator with continuous temperature monitoring and temperature log

Q16. Retention of prescription copies and related records for controlled prescription drugs is mandated under which rules or legislation?

• Pharmacy Act, 1948 only
• Drugs and Cosmetics Rules framed under the Drugs and Cosmetics Act
• Income Tax Act
• Consumer Protection Act

Correct Answer: Drugs and Cosmetics Rules framed under the Drugs and Cosmetics Act

Q17. Sale of drugs without a valid retail licence or by an unregistered outlet is an offence under which law?

• Indian Penal Code only
• Drugs and Cosmetics Act, 1940
• Pharmacy Act, 1948
• Trade Marks Act

Correct Answer: Drugs and Cosmetics Act, 1940

Q18. Community pharmacies are encouraged and often expected to participate in which national patient-safety activity?

• Pharmacovigilance Programme of India (PvPI) reporting of adverse drug reactions
• Only manufacturing quality control
• Issuing drug manufacturing licences
• None; pharmacies have no role in patient safety programs

Correct Answer: Pharmacovigilance Programme of India (PvPI) reporting of adverse drug reactions

Q19. How should Schedule X and other tightly controlled drugs be stored in a compliant community pharmacy?

• In an openly accessible shelf with other OTC medicines
• In a separate, lockable facility/cabinet with strict key control and record of access
• Inside the billing counter drawer without any register
• In the shop owner’s private home

Correct Answer: In a separate, lockable facility/cabinet with strict key control and record of access

Q20. Which document or permission is commonly required to demonstrate suitability of premises when applying for a retail pharmacy licence?

• No documents are required on premises
• Local approvals such as trade licence / municipal NOC in addition to layout complying with State rules
• Only the pharmacist’s degree certificate
• Only a bank statement

Correct Answer: Local approvals such as trade licence / municipal NOC in addition to layout complying with State rules

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