Introduction to regulatory requirements for biologics and vaccines in India MCQs With Answer

Introduction: This quiz set on “Introduction to regulatory requirements for biologics and vaccines in India” is tailored for M.Pharm students preparing for examinations in Regulatory Aspects of Herbal and Biologicals (MRA202T). It summarizes the core Indian regulatory framework, including the roles of CDSCO and DCGI, clinical trial and licensing pathways, biosimilar comparability, lot release, GMP/GLP/GCP expectations, cold-chain and stability considerations, and post-marketing pharmacovigilance. Questions focus on applied knowledge required to evaluate regulatory dossiers, design compliant studies, and understand manufacturing and quality control obligations specific to biologicals and vaccines in India. Use these MCQs to reinforce concepts, identify gaps, and practice exam-style reasoning.

Q1. Which organization is the primary national regulator responsible for approval and oversight of biologics and vaccines in India?

• Central Drugs Standard Control Organization (CDSCO)
• Indian Council of Medical Research (ICMR)
• National Institute of Virology (NIV)
• Ministry of Ayush

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q2. Who is the statutory head responsible for overall regulatory decisions on clinical trials and approvals of biologicals in India?

• Drug Controller General of India (DCGI)
• Director General of Health Services (DGHS)
• Secretary, Department of Biotechnology
• Chairperson, ICMR

Correct Answer: Drug Controller General of India (DCGI)

Q3. Which part of the Drugs and Cosmetics Rules primarily governs clinical trial requirements for new biologicals and vaccines?

• Schedule Y of the Drugs and Cosmetics Rules
• Schedule M of the Drugs and Cosmetics Rules
• Schedule T of the Drugs and Cosmetics Rules
• Indian Pharmacopoeia Commission guidelines

Correct Answer: Schedule Y of the Drugs and Cosmetics Rules

Q4. Which approvals are generally required before initiating a vaccine clinical trial at an Indian site?

• Approval from CDSCO/DCGI and a registered Institutional Ethics Committee
• Only Institutional Ethics Committee approval
• Market authorization from State Licensing Authority
• Approval from WHO only

Correct Answer: Approval from CDSCO/DCGI and a registered Institutional Ethics Committee

Q5. What standardized dossier format is expected for submission of quality, non‑clinical and clinical data for biological products in India?

• Common Technical Document (CTD) format
• Modular Technical Dossier (MTD)
• Biologics Single File (BSF)
• Pharmacopoeial Monograph Only

Correct Answer: Common Technical Document (CTD) format

Q6. Key regulatory requirement for licensure of a biosimilar in India includes which of the following?

• Comparability exercises including analytical, non‑clinical and clinical studies with immunogenicity assessment
• Only analytical similarity without clinical data
• Only clinical trials without analytical comparability
• Bioequivalence studies using generic tablet metrics

Correct Answer: Comparability exercises including analytical, non‑clinical and clinical studies with immunogenicity assessment

Q7. Who is typically responsible for independent national lot release testing of vaccine batches in India?

• National Control Laboratory designated by CDSCO
• Manufacturer’s in‑house QC lab only
• State Licensing Authority laboratory
• ICMR regional office

Correct Answer: National Control Laboratory designated by CDSCO

Q8. Good Manufacturing Practices for biological products in India are specified under which regulatory instrument?

• Schedule M of the Drugs and Cosmetics Rules together with CDSCO biological product guidelines
• Schedule Y only
• Indian GCP guidelines only
• Clinical trial protocol templates

Correct Answer: Schedule M of the Drugs and Cosmetics Rules together with CDSCO biological product guidelines

Q9. Regulatory stability expectations for vaccines typically include which elements?

• Real‑time and accelerated stability studies plus validated cold chain and in‑use stability data
• Only accelerated stability at high temperature
• No stability data if producer is WHO prequalified
• Only annual visual inspection of vials

Correct Answer: Real‑time and accelerated stability studies plus validated cold chain and in‑use stability data

Q10. In vaccine clinical development, immunogenicity endpoints most commonly measure:

• Serological immune responses such as antibody titers and seroconversion rates
• Only local reactogenicity at injection site
• Manufacturing process impurities
• Packaging integrity under transport

Correct Answer: Serological immune responses such as antibody titers and seroconversion rates

Q11. Which national program is responsible for collecting and analyzing adverse drug reactions for marketed biologics and vaccines in India?

• Pharmacovigilance Programme of India (PvPI)
• National Immunization Programme (NIP)
• Clinical Trials Registry – India (CTRI)
• National Adverse Event Monitoring Board (NAEMB)

Correct Answer: Pharmacovigilance Programme of India (PvPI)

Q12. For import of a vaccine into India the regulatory requirement typically includes which of the following?

• Import license from CDSCO and registration or permission for the foreign manufacturer
• Only a commercial invoice and airway bill
• No regulatory paperwork if for clinical research
• Approval from State Licensing Authority alone

Correct Answer: Import license from CDSCO and registration or permission for the foreign manufacturer

Q13. Which international guidance is commonly referenced by Indian regulators for non‑clinical evaluation of vaccines and biologics?

• World Health Organization (WHO) guidelines on non‑clinical evaluation of vaccines
• European Pharmacopeia monograph only
• FAO animal feed standards
• United States EPA pesticide guidelines

Correct Answer: World Health Organization (WHO) guidelines on non‑clinical evaluation of vaccines

Q14. Accreditation body relevant for laboratories performing quality control testing for vaccines in India is:

• National Accreditation Board for Testing and Calibration Laboratories (NABL)
• Food Safety and Standards Authority of India (FSSAI)
• Indian Council of Agricultural Research (ICAR)
• Reserve Bank of India (RBI)

Correct Answer: National Accreditation Board for Testing and Calibration Laboratories (NABL)

Q15. Ethics committees that review vaccine clinical trials in India are required to be:

• Registered with CDSCO and follow Indian GCP
• Informal committees appointed by the sponsor
• Only locally convened with no formal registration
• Subcommittees of the National Human Rights Commission

Correct Answer: Registered with CDSCO and follow Indian GCP

Q16. Which statement correctly describes a biological product?

• A medicine derived from living organisms or their components, such as proteins, nucleic acids, or cells
• A chemically synthesized small molecule with defined structure
• A herbal extract standardized by appearance only
• A cosmetic product regulated under consumer laws

Correct Answer: A medicine derived from living organisms or their components, such as proteins, nucleic acids, or cells

Q17. Are biosimilars automatically deemed interchangeable with the reference biologic in India without additional evidence?

• No, interchangeability requires specific evidence and is subject to regulatory and prescriber discretion
• Yes, they are automatically interchangeable upon approval
• Yes, but only for pediatric indications
• Only after five years of market presence

Correct Answer: No, interchangeability requires specific evidence and is subject to regulatory and prescriber discretion

Q18. A complete regulatory dossier for vaccine licensure in India must include which of the following categories of information?

• Quality, non‑clinical and clinical data including product characterization, manufacturing process and stability data
• Only clinical trial protocols and investigator brochures
• Only batch release certificates without manufacturing details
• Market analysis and pricing strategy only

Correct Answer: Quality, non‑clinical and clinical data including product characterization, manufacturing process and stability data

Q19. Which authority typically issues the manufacturing licence for a pharmaceutical manufacturing site (including biologicals) in India?

• State Licensing Authority (for grant of manufacturing licence for sale in that state)
• Central Drugs Standard Control Organization (CDSCO) for all manufacturing licences
• Ministry of Environment and Forests
• National Biodiversity Authority

Correct Answer: State Licensing Authority (for grant of manufacturing licence for sale in that state)

Q20. Which document is required at the time of market authorization to outline planned safety monitoring and risk mitigation for a newly approved vaccine?

• Risk Management Plan (RMP) describing safety monitoring and mitigation measures
• Certificate of Pharmaceutical Product (CPP) only
• Market authorization without any post‑market plan
• Only the product insert with no additional safety commitments

Correct Answer: Risk Management Plan (RMP) describing safety monitoring and mitigation measures

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