Objectives of Drugs and Cosmetics Act 1940 MCQs With Answer

Introduction: The Objectives of Drugs and Cosmetics Act 1940 MCQs With Answer offers B. Pharm students a focused review of the law that governs drug and cosmetic safety, quality control, licensing, labeling, and distribution in India. This introduction explains core objectives—ensuring efficacy, purity, safe manufacture, preventing adulteration and misbranding, and establishing regulatory authorities and penalties. Understanding the Act’s scope, schedules (like GMP requirements), inspection powers, and legal framework helps pharmacy students apply regulatory principles during drug development, quality assurance, and clinical practice. This resource reinforces key terms such as drug regulation, cosmetics standards, licensing, compliance, and enforcement. ‘Now let’s test your knowledge with 30 MCQs on this topic.’

Q1. What is the primary objective of the Drugs and Cosmetics Act, 1940?

• To promote sales of pharmaceutical companies
• To regulate import, manufacture, distribution and sale of drugs and cosmetics
• To standardize medical education
• To control prices of medicines

Correct Answer: To regulate import, manufacture, distribution and sale of drugs and cosmetics

Q2. Which of the following is included in the definition of “drug” under the Act?

• Only herbal medicines
• Substances intended for use in diagnosis, treatment, mitigation or prevention of disease
• Only injectable formulations
• Household cleaning agents

Correct Answer: Substances intended for use in diagnosis, treatment, mitigation or prevention of disease

Q3. One key objective of the Act is to prevent which of the following?

• Export of pharmaceuticals
• Adulteration and misbranding of drugs
• Clinical research
• Medical advertising

Correct Answer: Adulteration and misbranding of drugs

Q4. Which authority is responsible for regulation of drugs at the central level under the Act?

• State Drug Control Authority
• Municipal Health Board
• Central Drug Authority/Drugs Controller (subject to rules)
• World Health Organization

Correct Answer: Central Drug Authority/Drugs Controller (subject to rules)

Q5. The Act provides powers to appoint which officials for enforcement?

• Pharmacy sales representatives
• Drug Inspectors
• Medical college deans
• Insurance auditors

Correct Answer: Drug Inspectors

Q6. Which of these is a regulatory objective related to cosmetics under the Act?

• Regulating hairdressing salons
• Ensuring cosmetic safety, labeling and preventing harmful ingredients
• Standardizing fashion trends
• Licensing beauty parlors

Correct Answer: Ensuring cosmetic safety, labeling and preventing harmful ingredients

Q7. For manufacture of drugs, the Act emphasizes compliance with which of the following?

• Marketing strategies
• Good Manufacturing Practices and prescribed standards
• Retail display arrangements
• International pricing norms

Correct Answer: Good Manufacturing Practices and prescribed standards

Q8. Which schedule in the Rules (related to the Act) primarily deals with Good Manufacturing Practices?

• Schedule A
• Schedule M
• Schedule Z
• Schedule C

Correct Answer: Schedule M

Q9. One objective of the Act is to ensure proper labeling. Which information is essential on drug labels?

• Manufacturer’s profit margin
• Name, batch no., expiry date, composition and storage instructions
• Retailer contact details only
• Celebrity endorsements

Correct Answer: Name, batch no., expiry date, composition and storage instructions

Q10. Which action is considered an offense under the Act?

• Manufacturing drugs with prescribed quality
• Selling misbranded or adulterated drugs
• Applying for a manufacturing license
• Registering a cosmetic product

Correct Answer: Selling misbranded or adulterated drugs

Q11. The Act helps in establishing standards for drugs by referring to which sources?

• Local newspaper ads
• Pharmacopoeial standards and specified test methods
• Social media reviews
• Company brochures

Correct Answer: Pharmacopoeial standards and specified test methods

Q12. Licensing under the Act is required primarily for which activity?

• Advertising over-the-counter herbal remedies
• Manufacture and sale of scheduled drugs
• Importing medical textbooks
• Setting up a medical college

Correct Answer: Manufacture and sale of scheduled drugs

Q13. The Act empowers inspectors to do which of the following for enforcement?

• Issue patents
• Seize samples, inspect premises and take samples for analysis
• Prescribe drugs to patients
• Set retail prices

Correct Answer: Seize samples, inspect premises and take samples for analysis

Q14. Which of the following is a primary consumer protection objective of the Act?

• To promote clinical trial advertising
• To ensure safety, quality and efficacy of marketed drugs and cosmetics
• To restrict access to medicines
• To subsidize pharmaceutical companies

Correct Answer: To ensure safety, quality and efficacy of marketed drugs and cosmetics

Q15. The Act contains provisions for penalties. Penalties are imposed for which reasons?

• Failure to register staff
• Breach of regulations such as manufacture of adulterated drugs or false labeling
• Late submission of advertisements
• Failure to attend conferences

Correct Answer: Breach of regulations such as manufacture of adulterated drugs or false labeling

Q16. Under the Act, “misbranded” drug refers to which situation?

• Drug in a damaged package only
• When label information is false or misleading or does not meet statutory requirements
• Drug sold below cost price
• Product without a barcode

Correct Answer: When label information is false or misleading or does not meet statutory requirements

Q17. Which function supports the Act’s objective of standardizing drug quality?

• Allowing unregulated imports
• Mandatory quality testing and adherence to pharmacopoeial standards
• Promoting brand advertising
• Encouraging sales discounts

Correct Answer: Mandatory quality testing and adherence to pharmacopoeial standards

Q18. The Act helps regulate clinical trials through rules. Which schedule in Rules addresses clinical trial requirements?

• Schedule M
• Schedule Y
• Schedule X
• Schedule T

Correct Answer: Schedule Y

Q19. One objective is to control distribution channels. Which measure does the Act promote?

• Unrecorded wholesale trade
• Licensing of wholesalers and retailers and record keeping
• Open sale of prescription drugs
• Import-only distribution

Correct Answer: Licensing of wholesalers and retailers and record keeping

Q20. Why is proper record-keeping an objective under the Act?

• To increase paperwork for companies
• To enable traceability, accountability and regulatory audits
• To enable aggressive marketing
• To track consumer preferences

Correct Answer: To enable traceability, accountability and regulatory audits

Q21. Which of the following is controlled under the Act to prevent distribution of counterfeit drugs?

• Packaging aesthetics only
• Manufacturing licenses, labeling, and quality testing
• Insurance coverage for pharmacies
• Physician prescribing patterns

Correct Answer: Manufacturing licenses, labeling, and quality testing

Q22. The Act’s objective to regulate imports ensures what?

• All foreign drugs are automatically approved
• Imported drugs meet Indian standards for safety and quality
• Foreign drugs are exempt from inspection
• Imports are banned entirely

Correct Answer: Imported drugs meet Indian standards for safety and quality

Q23. Under the Act, which is an expected outcome for patients and public health?

• Wider availability of untested formulations
• Protection from harmful or ineffective drugs and cosmetics
• Guaranteed lowest price for all medicines
• Mandatory use of traditional remedies only

Correct Answer: Protection from harmful or ineffective drugs and cosmetics

Q24. Which aspect of pharmaceutical industry conduct does the Act seek to regulate?

• Corporate tax policy
• Manufacturing practices, labeling, advertising and distribution
• Executive compensation
• Export tariffs

Correct Answer: Manufacturing practices, labeling, advertising and distribution

Q25. The Act’s objective to set standards is enforced through which mechanism?

• Voluntary compliance by companies only
• Statutory standards, schedules and inspection by authorities
• Consumer voting
• Market competition alone

Correct Answer: Statutory standards, schedules and inspection by authorities

Q26. Which of the following best describes “adulteration” under the Act?

• Packaging in unattractive colors
• Presence of inferior or harmful substances or deviation from prescribed strength or purity
• High retail margin
• Sale through online platforms

Correct Answer: Presence of inferior or harmful substances or deviation from prescribed strength or purity

Q27. The Act requires which action when a drug is found unsafe or not of standard quality?

• Continue sale without change
• Recall, seizure or prohibition of sale and corrective regulatory action
• Rename the product
• Offer discounts to consumers

Correct Answer: Recall, seizure or prohibition of sale and corrective regulatory action

Q28. Training and qualifications of personnel in manufacturing relate to which objective of the Act?

• Marketing outreach
• Ensuring competent staff to maintain quality and GMP compliance
• Maximizing profit through layoffs
• Designing packaging

Correct Answer: Ensuring competent staff to maintain quality and GMP compliance

Q29. The Drugs and Cosmetics Act supports public health by doing which of the following?

• Encouraging sale of unregulated supplements
• Providing a legal framework to check harmful products and assure therapeutic quality
• Reducing regulatory oversight of manufacturers
• Allowing unrestricted import of cosmetics

Correct Answer: Providing a legal framework to check harmful products and assure therapeutic quality

Q30. Familiarity with the Act is important for B. Pharm students primarily because:

• It ensures they can sell medicines door-to-door
• It equips them to ensure regulatory compliance, patient safety and quality assurance in practice
• It guarantees employment in industry
• It replaces the need for clinical knowledge

Correct Answer: It equips them to ensure regulatory compliance, patient safety and quality assurance in practice

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