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
