Regulatory provisions for manufacture of herbal cosmetics MCQs With Answer

This blog offers a focused set of 20 multiple-choice questions with answers on regulatory provisions for the manufacture of herbal cosmetics, tailored for M.Pharm students studying Herbal Cosmetics (MPG 204T). Questions cover the Indian regulatory framework, distinguishing drugs from cosmetics, licensing and GMP expectations, labeling and claims, stability and safety testing, post‑marketing surveillance, and the interface with AYUSH for traditional preparations. Each question is designed to deepen understanding of practical regulatory requirements and to prepare students for examinations and professional practice. Answers are provided for quick self-assessment and to reinforce key regulatory concepts necessary for compliant herbal cosmetic manufacturing.

Q1. Which Act is the primary legal framework governing cosmetics in India?

• Drugs and Cosmetics Act, 1940
• Indian Cosmetic Safety Act, 1986
• Food Safety and Standards Act, 2006
• Ministry of AYUSH Act, 2014

Correct Answer: Drugs and Cosmetics Act, 1940

Q2. Which central organization is principally responsible for regulation of cosmetics in India?

• Central Drugs Standard Control Organization (CDSCO)
• Food Safety and Standards Authority of India (FSSAI)
• Ministry of AYUSH
• Bureau of Indian Standards (BIS)

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q3. Who normally issues a manufacturing licence for a cosmetic manufacturing facility in India?

• State Licensing Authority
• CDSCO exclusively at central level
• Ministry of AYUSH
• Food Safety and Standards Authority of India (FSSAI)

Correct Answer: State Licensing Authority

Q4. The regulatory distinction between a drug and a cosmetic is primarily based on which factor?

• Intended use and claims made for the product
• Source of the active ingredients (plant vs synthetic)
• Location of manufacture (urban vs rural)
• Price and marketing strategy

Correct Answer: Intended use and claims made for the product

Q5. A herbal preparation marketed with a claim to “treat eczema” would be classified as which of the following?

• Cosmetic
• Drug/therapeutic product
• Food supplement
• Medical device

Correct Answer: Drug/therapeutic product

Q6. Compliance with Good Manufacturing Practices (GMP) for cosmetics primarily ensures which outcome?

• Consistent product quality, safety and purity
• Faster approval by the tax authorities
• Reduction in advertising costs
• Mandatory clinical trials for all products

Correct Answer: Consistent product quality, safety and purity

Q7. Are pre‑market clinical trials generally mandatory for cosmetic products in India?

• Yes, for all cosmetics
• No, clinical trials are generally not required for cosmetics
• Only mandatory for herbal cosmetics
• Only mandatory for imported products

Correct Answer: No, clinical trials are generally not required for cosmetics

Q8. Which of the following is a required element on a cosmetic product label?

• Batch number, manufacturing date and expiry/period after opening
• Therapeutic claims such as “cures acne”
• Personal mobile number of the formulator
• Prescriber name and prescription requirement

Correct Answer: Batch number, manufacturing date and expiry/period after opening

Q9. Determination of the shelf life of a herbal cosmetic product is principally based on which type of study?

• Stability testing under defined conditions
• Animal pharmacology studies
• Consumer preference surveys
• Marketing focus groups

Correct Answer: Stability testing under defined conditions

Q10. Which Ministry in India is responsible for regulation and standards of classical Ayurvedic formulations?

• Ministry of AYUSH
• Central Drugs Standard Control Organization (CDSCO)
• Food Safety and Standards Authority of India (FSSAI)
• Ministry of Chemicals and Fertilizers

Correct Answer: Ministry of AYUSH

Q11. In the context of Ayurvedic products, a “proprietary” formulation typically means which of the following?

• A new or modified formulation based on Ayurvedic principles marketed under a brand name
• An unmodified classical formula exactly as in classical texts
• A product regulated only by CDSCO
• An imported traditional medicine

Correct Answer: A new or modified formulation based on Ayurvedic principles marketed under a brand name

Q12. Regulatory assessment of preservatives used in herbal cosmetics focuses mainly on what?

• Safety for intended use and permissible limits
• The color they impart to the formulation
• How easily they dissolve in water
• Their impact on packaging weight

Correct Answer: Safety for intended use and permissible limits

Q13. Why are microbial limit testing and control important for cosmetic products?

• To ensure product safety and protect consumer health
• To improve the fragrance of the product
• To reduce production costs
• To comply with advertising standards

Correct Answer: To ensure product safety and protect consumer health

Q14. Which document type commonly provides detailed guidance on GMP for cosmetics in India?

• Good Manufacturing Practices (GMP) guidelines issued by regulatory authorities
• Indian Pharmacopoeia monographs for cosmetics
• Food Safety and Standards Regulations for cosmetics
• ISO 14001 environmental manuals only

Correct Answer: Good Manufacturing Practices (GMP) guidelines issued by regulatory authorities

Q15. When importing herbal cosmetics into India, the importer must do which of the following?

• Ensure compliance with Indian regulatory requirements and assume responsibility for product compliance
• Only pay customs duty; no regulatory compliance needed
• Register the product exclusively with the Ministry of AYUSH
• Conduct mandatory full clinical trials in India for every product

Correct Answer: Ensure compliance with Indian regulatory requirements and assume responsibility for product compliance

Q16. Label claims such as “cures psoriasis” or “treats eczema” on a topical herbal cream are considered what under cosmetic regulations?

• Permissible cosmetic marketing language
• Therapeutic claims that reclassify the product as a drug and are not allowable for cosmetics
• Allowed if the product is herbal irrespective of claim
• Only allowed for products sold through pharmacies

Correct Answer: Therapeutic claims that reclassify the product as a drug and are not allowable for cosmetics

Q17. Post‑marketing surveillance of cosmetic safety in India is primarily the responsibility of which bodies?

• CDSCO in coordination with State Drug Control Authorities
• Ministry of AYUSH exclusively
• Individual retailers only
• Consumer associations without regulatory involvement

Correct Answer: CDSCO in coordination with State Drug Control Authorities

Q18. Stability testing for cosmetics typically includes which of the following conditions?

• Both accelerated and long‑term storage conditions to establish shelf life
• Only room temperature exposure for 24 hours
• Only exposure to direct sunlight for one day
• Only freezing conditions to test solidification

Correct Answer: Both accelerated and long‑term storage conditions to establish shelf life

Q19. Substantiation of claims for a herbal cosmetic intended to improve skin appearance should be based on which evidence?

• Safety and efficacy data relevant to the cosmetic use and substantiation of non‑therapeutic claims
• A registered patent for the herbal ingredient
• Clinical trials demonstrating cure of dermatological diseases
• A certificate from the manufacturer only

Correct Answer: Safety and efficacy data relevant to the cosmetic use and substantiation of non‑therapeutic claims

Q20. In regulatory terms, “adulteration” of herbal cosmetics most often refers to which situation?

• Presence of undeclared pharmaceutical actives, contaminants or harmful substances
• Use of lower fragrance concentration than claimed
• Smaller package size than competitors
• Higher retail price compared to similar products

Correct Answer: Presence of undeclared pharmaceutical actives, contaminants or harmful substances

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