Quality control as per Drugs & Cosmetics Act MCQs With Answer

Introduction: Quality control as per Drugs & Cosmetics Act MCQs With Answer is designed for M.Pharm students specializing in herbal cosmetics to strengthen their understanding of statutory quality requirements. This short quiz-based guide highlights key regulatory concepts from the Drugs & Cosmetics Act and associated rules, focusing on labeling, licensing, manufacturing controls, testing requirements, contamination limits, and documentation required for herbal cosmetic products. Each question emphasizes practical aspects of quality assurance and laboratory controls relevant to herbal formulations, including microbial limits, stability testing, raw material identification and prohibited claims. The objective is to build exam-ready knowledge and promote accurate application of regulatory norms in product development and batch release.

Q1. What primarily distinguishes a cosmetic from a drug under the Drugs & Cosmetics Act?

• An article intended to be applied to the human body for cleansing, beautifying or altering appearance
• An article intended to diagnose, cure, mitigate, treat or prevent disease
• A product requiring prescription from a qualified practitioner
• A substance formulated only from synthetic chemicals

Correct Answer: An article intended to be applied to the human body for cleansing, beautifying or altering appearance

Q2. Which authority issues manufacturing licenses for cosmetics in India?

• Central Drugs Standard Control Organization (CDSCO) only
• State Licensing Authority/State Drug Control Department
• Ministry of AYUSH
• Food Safety and Standards Authority of India (FSSAI)

Correct Answer: State Licensing Authority/State Drug Control Department

Q3. Which of the following is a mandatory label requirement for cosmetic products under the Drugs & Cosmetics Rules?

• Complete clinical data from human trials
• Therapeutic indications for internal diseases
• Batch number, manufacturing and expiry date, net contents and name & address of manufacturer
• Physician’s prescription

Correct Answer: Batch number, manufacturing and expiry date, net contents and name & address of manufacturer

Q4. Which microbial tests are standard for routine quality control of cosmetic formulations?

• Minimum Inhibitory Concentration (MIC) only
• Total Aerobic Microbial Count (TAMC) and Total Yeast & Mold Count (TYMC)
• Viral load assay and endotoxin quantification
• Petri dish diffusion and Ames test

Correct Answer: Total Aerobic Microbial Count (TAMC) and Total Yeast & Mold Count (TYMC)

Q5. The preservative efficacy test (challenge test) in cosmetics is performed primarily to assess:

• The fragrance stability over time
• The ability of the formulation to resist microbial contamination during use and storage
• Heavy metal content in finished product
• The caloric value of herbal extracts

Correct Answer: The ability of the formulation to resist microbial contamination during use and storage

Q6. Which heavy metals are commonly tested as part of quality control for herbal cosmetics?

• Iron, calcium, potassium, sodium
• Lead, arsenic, mercury and cadmium
• Chromium, cobalt, manganese and nickel only for inorganic pigments
• Gold and silver as part of decorative cosmetics only

Correct Answer: Lead, arsenic, mercury and cadmium

Q7. What is the primary objective of stability testing for a cosmetic product?

• To determine the active pharmaceutical ingredient potency
• To establish shelf life, storage conditions and ensure product retains intended quality attributes over time
• To replace preservative efficacy testing
• To measure the product’s nutritional content

Correct Answer: To establish shelf life, storage conditions and ensure product retains intended quality attributes over time

Q8. Under the Act, a cosmetic is termed ‘misbranded’ if:

• It is contaminated with environmental microbes
• Its labeling is false or misleading in any particular way, including false claims
• It contains natural herbal ingredients
• It is packed in non-recyclable material

Correct Answer: Its labeling is false or misleading in any particular way, including false claims

Q9. Which of the following is an essential component of Good Manufacturing Practices (GMP) for cosmetic manufacture?

• Absence of any written procedures to allow flexible operations
• Written Standard Operating Procedures (SOPs) and documented batch records
• Use of unqualified personnel to reduce costs
• Random disposal of QC samples after manufacture

Correct Answer: Written Standard Operating Procedures (SOPs) and documented batch records

Q10. Who is empowered to inspect cosmetics manufacturing premises and take samples under the Drugs & Cosmetics Act?

• Food safety inspector from FSSAI
• Municipal health officer only
• Drugs Inspector appointed under the Act
• Quality manager of a competing company

Correct Answer: Drugs Inspector appointed under the Act

Q11. Assignment of shelf life for a cosmetic batch is primarily based on:

• Color preference of the marketing team
• Results from stability studies including real-time and accelerated testing
• Price point and packaging design
• Manufacturer’s production capacity

Correct Answer: Results from stability studies including real-time and accelerated testing

Q12. Which analytical method is most suitable for routine detection of pesticide residues in herbal raw materials used for cosmetics?

• High-performance thin-layer chromatography (HPTLC)
• Gas chromatography–mass spectrometry (GC-MS)
• UV-visible spectrophotometry at 254 nm
• Titration with standard alkali

Correct Answer: Gas chromatography–mass spectrometry (GC-MS)

Q13. Import of cosmetic products into India requires which of the following?

• Registration with Ministry of AYUSH only
• Import license and clearance from Central Drugs Standard Control Organization (CDSCO)
• No documentation if products are labelled in English
• Only a commercial invoice and packing list

Correct Answer: Import license and clearance from Central Drugs Standard Control Organization (CDSCO)

Q14. For identity and purity tests of herbal raw materials, which combination of tests gives a robust botanical verification?

• Organoleptic evaluation, microscopy and chromatographic fingerprinting (e.g., HPTLC)
• Only taste and odor assessment
• Exclusive use of DNA barcoding without macroscopic study
• Measurement of pH and conductivity alone

Correct Answer: Organoleptic evaluation, microscopy and chromatographic fingerprinting (e.g., HPTLC)

Q15. Which claim on a cosmetic label would convert the product into a ‘drug’ under regulatory interpretation?

• “Improves skin’s radiance”
• “Prevents and cures eczema”
• “Natural aloe for moisturizing”
• “Dermatologically tested”

Correct Answer: “Prevents and cures eczema”

Q16. Which parameter is particularly important to monitor in emulsion-type herbal creams during stability testing?

• Melting point of a pure herb extract
• Viscosity, phase separation and droplet size distribution
• Amount of dissolved carbon dioxide
• Electrical conductivity of the packaging material

Correct Answer: Viscosity, phase separation and droplet size distribution

Q17. Eye-area cosmetics require special microbial control because:

• The eye area is highly tolerant of microbial contamination
• Even low levels of certain microbes can cause serious eye infections
• They are always preserved with heavy metals
• They are not applied daily

Correct Answer: Even low levels of certain microbes can cause serious eye infections

Q18. What is the purpose of issuing a Certificate of Analysis (CoA) for a cosmetic batch?

• To provide a marketing description for the sales team
• To document test results and confirm that the batch meets predefined specifications before release
• To avoid performing any laboratory testing
• To register the product with local municipal authorities

Correct Answer: To document test results and confirm that the batch meets predefined specifications before release

Q19. Which of the following contaminants is of special concern for herbal ingredients and must be tested during QC?

• Plasticizer migration only
• Aflatoxins and microbial toxins
• Color fastness to sunlight
• Paper fiber content

Correct Answer: Aflatoxins and microbial toxins

Q20. In the context of the Drugs & Cosmetics Act, which practice helps ensure traceability of a cosmetic product batch?

• Omitting batch numbers to prevent competitor analysis
• Maintaining complete batch manufacturing records, raw material lot numbers and CoAs
• Discarding production records after one month
• Labeling all batches with the same generic code

Correct Answer: Maintaining complete batch manufacturing records, raw material lot numbers and CoAs

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