Drugs and Cosmetics Act 1940 and Rules 1945 – scope and key provisions MCQs With Answer

Introduction
The Drugs and Cosmetics Act, 1940 and Rules, 1945 form the primary legal framework governing the manufacture, import, distribution and sale of drugs and cosmetics in India. This blog provides M.Pharm students with targeted multiple-choice questions designed to reinforce understanding of the Act’s scope, licensing requirements, schedules (such as Schedule M, H, H1, X, and D(II)), regulatory authorities (CDSCO, DCGI, State Licensing Authorities), powers of drug inspectors, and key concepts like adulteration, misbranding and clinical trial approvals. The questions focus on practical regulatory provisions and compliance obligations encountered in industry and academia, helping students prepare for exams and professional regulatory responsibilities.

Q1. Which authority is primarily responsible for regulating the import of drugs into India?

• State Licensing Authority
• Central Drugs Standard Control Organization (CDSCO)
• Drug Controllers of individual states acting independently
• Pharmacopoeia Commission

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q2. Which schedule of the Drugs and Cosmetics Rules prescribes Good Manufacturing Practices (GMP) for pharmaceutical manufacturing?

• Schedule H
• Schedule M
• Schedule X
• Schedule D(II)

Correct Answer: Schedule M

Q3. Which body issues approval for clinical trials of new drugs in India?

• State Licensing Authority after local review
• Central Drugs Standard Control Organization (CDSCO) / DCGI
• National Pharmaceutical Pricing Authority (NPPA)
• Indian Council of Medical Research (ICMR) exclusively

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

Q4. Which schedule contains drugs that can be sold only on the prescription of a registered medical practitioner?

• Schedule H
• Schedule M
• Schedule X
• Schedule K

Correct Answer: Schedule H

Q5. Schedule X drugs are subject to which special requirement at the point of retail sale?

• No prescription is required for sale
• Prescription must be retained and records maintained for a specified period
• They can be sold over-the-counter only during emergency
• Sale is restricted to hospital pharmacies only

Correct Answer: Prescription must be retained and records maintained for a specified period

Q6. Which schedule pertains specifically to biological products such as vaccines and sera under the Rules?

• Schedule H1
• Schedule D(II)
• Schedule M
• Schedule Y

Correct Answer: Schedule D(II)

Q7. Who is the competent authority to grant a manufacturing license for most drugs (excluding certain central matters) in India?

• Central Government only
• State Licensing Authority
• National Accreditation Board
• District Magistrate

Correct Answer: State Licensing Authority

Q8. Under the Act, which of the following best describes “misbranded” drug?

• A drug whose color is faded
• A drug labeled with false or misleading information
• A drug stored in an unventilated area
• A drug imported from abroad

Correct Answer: A drug labeled with false or misleading information

Q9. Which officer has statutory powers to inspect manufacturing premises, take samples and seize contraband under the Act?

• Drug Inspector
• Food Safety Officer
• Customs Broker
• Registrar of Companies

Correct Answer: Drug Inspector

Q10. The term “adulterated drug” under the Act commonly refers to a drug that:

• Has been repackaged with new expiry
• Contains impurities or undeclared foreign substances
• Is sold at a discounted price
• Has been approved by CDSCO

Correct Answer: Contains impurities or undeclared foreign substances

Q11. Which schedule was introduced to control over-the-counter sales of certain antibiotics and other drugs by mandating prescription retention and additional safeguards?

• Schedule M
• Schedule H1
• Schedule K
• Schedule C

Correct Answer: Schedule H1

Q12. The Drugs and Cosmetics Act principally does NOT regulate which of the following?

• Prescription and non-prescription drugs
• Cosmetics
• Foods and nutraceuticals broadly defined as food
• Biological products such as vaccines

Correct Answer: Foods and nutraceuticals broadly defined as food

Q13. Who heads the Central Drugs Standard Control Organization (CDSCO)?

• Secretary of Health
• Drugs Controller General of India (DCGI)
• Chairperson of National Medical Commission
• Director General of Indian Council of Medical Research

Correct Answer: Drugs Controller General of India (DCGI)

Q14. Which of the following is a primary objective of Schedule M requirements?

• To list drugs that can be sold without prescription
• To mandate specific pricing for essential medicines
• To ensure proper premises, equipment and quality assurance systems in manufacturing
• To regulate advertising claims by manufacturers

Correct Answer: To ensure proper premises, equipment and quality assurance systems in manufacturing

Q15. What is the typical validity period for a drug manufacturing license issued by most State Licensing Authorities (unless varied by rules)?

• 1 year
• 5 years
• 10 years
• Lifetime

Correct Answer: 5 years

Q16. For import of a new drug into India for clinical trials or marketing, approval must be obtained from:

• State Drug Controller of the importing state only
• Central licensing authority (CDSCO) / DCGI
• Local municipal corporation
• No approval is required for imports

Correct Answer: Central licensing authority (CDSCO) / DCGI

Q17. Which of the following is true about cosmetics under the Act and Rules?

• They are regulated under the same Act and have labeling and safety requirements
• They are completely unregulated and require no compliance
• They can be marketed only after clinical trials
• They are regulated by the Ministry of Agriculture

Correct Answer: They are regulated under the same Act and have labeling and safety requirements

Q18. Which document or requirement is commonly expected at the time of inspection to demonstrate control over manufacture of controlled substances (Schedule X)?

• Certificate of analysis and controlled substance register with prescriptions
• Only the company’s annual report
• Marketing brochures for the drug
• Employee resumes

Correct Answer: Certificate of analysis and controlled substance register with prescriptions

Q19. Misbranding and adulteration offences under the Act can lead to which regulatory consequences?

• No action other than a warning
• Penalties including fines, imprisonment and possible cancellation of license
• Only product recall without legal penalty
• Transfer of license to another company automatically

Correct Answer: Penalties including fines, imprisonment and possible cancellation of license

Q20. Which organization is primarily responsible for coordination and oversight of national drug testing laboratories and official drug analysis in India?

• Central Drugs Laboratory / CDSCO network
• World Health Organization office in India
• National Accreditation Board for Testing and Calibration Laboratories (NABL) exclusively
• Pharmaceutical Importers Association

Correct Answer: Central Drugs Laboratory / CDSCO network

Download