Applicable regulations and guidelines for biologics in India MCQs With Answer

Applicable regulations and guidelines for biologics in India MCQs With Answer

This quiz-focused blog provides M.Pharm students with targeted multiple-choice questions on the regulatory framework that governs biologics in India. Covering key laws, regulatory authorities, national guidelines (such as the CDSCO–DBT “Guidance on Similar Biologics”), clinical trial requirements, manufacturing standards (GMP/Schedule M), and international harmonisation (WHO/ICH), the questions emphasise practical knowledge required for regulatory affairs, quality assurance and clinical development. Each MCQ is designed to test understanding of approval pathways, comparability principles for biosimilars, immunogenicity assessment, post-marketing obligations and relevant institutional guidelines (ICMR, DBT), helping students prepare for exams and real-world regulatory tasks.

Q1. Which primary legislation governs the regulation of biologic drugs and vaccines in India?

• The Drugs and Cosmetics Act, 1940 and Rules, 1945
• The Pharmacy Act, 1948
• The Biologicals Control Act, 1965
• The National Biotechnology Regulatory Authority Act

Correct Answer: The Drugs and Cosmetics Act, 1940 and Rules, 1945

Q2. Which authority is principally responsible for approval and regulation of biologics and biosimilars in India?

• Central Drugs Standard Control Organization (CDSCO) under DCGI
• Indian Council of Medical Research (ICMR)
• Department of Biotechnology (DBT) alone
• Ministry of Agriculture

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

Q3. What is the title of the national guidance document jointly issued by CDSCO and DBT for biosimilar development?

• Guidance on Similar Biologics
• Biologics Manufacturing Manual
• National Vaccine Development Guide
• Clinical Trial Safety Protocol

Correct Answer: Guidance on Similar Biologics

Q4. Which Schedule of the Drugs and Cosmetics Rules specifies Good Manufacturing Practices (GMP) for biological products manufacturing facilities in India?

• Schedule M
• Schedule Y
• Schedule P
• Schedule D

Correct Answer: Schedule M

Q5. Which set of rules governs clinical trial approvals, conduct and reporting for new drugs and biologics in India since 2019?

• New Drugs and Clinical Trials Rules, 2019
• Schedule Y, 1990
• Pharmacy Practice Rules, 2018
• Biologics Clinical Guidelines, 2005

Correct Answer: New Drugs and Clinical Trials Rules, 2019

Q6. Which ICH guideline specifically addresses viral safety evaluation of biotechnology-derived products?

• ICH Q5A
• ICH Q1A
• ICH Q6A
• ICH M4

Correct Answer: ICH Q5A

Q7. According to Indian guidance, what is the fundamental requirement for approval of a similar biologic (biosimilar)?

• Demonstration of comparability with a reference biologic in quality, safety and efficacy
• Only cost-effectiveness data compared with reference product
• Non-clinical testing only with no clinical comparability
• Post-marketing data from other countries without any local studies

Correct Answer: Demonstration of comparability with a reference biologic in quality, safety and efficacy

Q8. Which type of clinical study is essential to evaluate immunogenicity of a biologic or biosimilar?

• Comparative immunogenicity assessment during clinical trials
• Only animal immunogenicity testing
• Population pharmacokinetic meta-analysis without assays
• Stability testing under accelerated conditions

Correct Answer: Comparative immunogenicity assessment during clinical trials

Q9. For selection of a reference product in biosimilar development, what is the recommended practice under Indian guidance?

• Use a well-characterized, licensed reference biologic (preferably marketed in India) with justification if a foreign comparator is used
• Always use the cheapest available biologic as reference
• Only use reference products from a single global manufacturer without local justification
• Use an unrelated biological product as a surrogate reference

Correct Answer: Use a well-characterized, licensed reference biologic (preferably marketed in India) with justification if a foreign comparator is used

Q10. Which programme is primarily responsible for adverse drug reaction (ADR) reporting and pharmacovigilance for biologics in India?

• Pharmacovigilance Programme of India (PvPI)
• National Immunization Programme
• Indian Biosafety Authority
• Clinical Trial Registry of India

Correct Answer: Pharmacovigilance Programme of India (PvPI)

Q11. Which of the following is a mandatory requirement on labeling and transport of many biological products?

• Cold chain maintenance with clear storage temperature and handling instructions
• No specific temperature or storage instruction is necessary
• Labeling only in local languages without scientific details
• Stability label valid for five years irrespective of product type

Correct Answer: Cold chain maintenance with clear storage temperature and handling instructions

Q12. Stability studies for biologics submitted in India are expected to follow which international guideline framework?

• ICH Q1A: Stability Testing of New Drug Substances and Products
• ICH Q3C only
• WHO GMP Annex 4 solely
• No stability data are required for biologics

Correct Answer: ICH Q1A: Stability Testing of New Drug Substances and Products

Q13. Typical clinical development pathway for a biosimilar in India includes which sequence of studies?

• Comparative analytical and non‑clinical studies, PK/PD (phase I), followed by confirmatory comparative clinical efficacy/safety (phase III)
• Phase III only without prior PK/PD or analytical comparability
• Only animal studies and then immediate market approval
• Post-marketing clinical trials only

Correct Answer: Comparative analytical and non‑clinical studies, PK/PD (phase I), followed by confirmatory comparative clinical efficacy/safety (phase III)

Q14. Which national body issues ethical and scientific guidelines specifically for biomedical research including stem cells in India?

• Indian Council of Medical Research (ICMR)
• Central Drugs Standard Control Organization (CDSCO) exclusively
• Department of Pharmaceuticals
• Ministry of Home Affairs

Correct Answer: Indian Council of Medical Research (ICMR)

Q15. Under Indian regulatory practice, which committee or mechanism typically reviews scientific and clinical trial applications for complex biologics?

• Subject Expert Committee (SEC) or expert panels under CDSCO
• Local hospital ethics committee alone without CDSCO input
• State pollution control board
• Ministry of Finance review board

Correct Answer: Subject Expert Committee (SEC) or expert panels under CDSCO

Q16. The Indian Pharmacopoeia (IP) plays what role in regulation of biologics?

• Provides official monographs and quality standards for many biological medicines used in India
• Regulates clinical trial conduct exclusively
• Issues marketing authorizations directly
• Enforces cold chain operations in hospitals

Correct Answer: Provides official monographs and quality standards for many biological medicines used in India

Q17. Which of the following is the first critical step in the regulatory comparability pathway for a biosimilar according to Indian guidance?

• Extensive analytical (physicochemical and biological) comparability assessment
• Large phase III trial without analytical data
• Marketing application submission before any studies
• Only post-marketing surveillance

Correct Answer: Extensive analytical (physicochemical and biological) comparability assessment

Q18. Which international organisation’s guidance is frequently referenced by Indian regulators for quality and safety of biological products?

• World Health Organization (WHO)
• World Trade Organization (WTO)
• International Monetary Fund (IMF)
• International Civil Aviation Organization (ICAO)

Correct Answer: World Health Organization (WHO)

Q19. What is the expected regulatory assessment of a manufacturing change in a licensed biologic product in India?

• Assessment of potential impact on quality, safety and efficacy with comparability data as required
• Automatic approval without data submission
• Only a fee payment is required with no technical review
• Immediate recall of all marketed batches

Correct Answer: Assessment of potential impact on quality, safety and efficacy with comparability data as required

Q20. Which type of assay is mandatory to include in regulatory dossiers to demonstrate the biological activity of a biologic product?

• Validated potency (biological activity) assay
• Only identity by colorimetry is sufficient
• Unvalidated exploratory assays with no validation
• Only microbiological contamination assays without potency

Correct Answer: Validated potency (biological activity) assay

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