Indian Pharmacopoeial standards, BIS and ISO standards – applicability MCQs With Answer

Introduction: The following quiz focuses on Indian Pharmacopoeial standards and the applicability of BIS and ISO standards as they relate to drugs, medical devices, biologicals, herbals and associated testing in India. It is designed for M.Pharm students to reinforce regulatory knowledge and practical application: when pharmacopoeial monographs are legally binding, how BIS standards interact with pharmaceutical requirements, and which ISO standards govern quality systems, laboratory competence, sterilization, biocompatibility and device labeling. Each question emphasizes regulatory context, standard bodies and the practical consequences for manufacturing, testing and market authorization in India. Use this to prepare for exams and regulatory practice.

Q1. What is the Indian Pharmacopoeia (IP)?

• A voluntary collection of drug monographs prepared by the pharmaceutical industry
• The national officially recognized compendium of standards for drugs and pharmaceutical substances in India
• An international guideline issued by WHO only for herbal medicines
• A set of manufacturing best practices unrelated to legal compliance

Correct Answer: The national officially recognized compendium of standards for drugs and pharmaceutical substances in India

Q2. Which legal instrument gives the Indian Pharmacopoeia its statutory authority in India?

• The Drugs and Cosmetics Act, 1940 and Rules, 1945
• The Bureau of Indian Standards Act, 2016
• The Food Safety and Standards Act, 2006
• The World Health Organization regulations

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

Q3. For a pharmaceutical product with an existing IP monograph, which statement is correct?

• Compliance with the Indian Pharmacopoeia monograph is mandatory for market approval in India
• Compliance with IP is optional and replaced by any foreign pharmacopoeia
• Only BIS standards apply; pharmacopoeias are advisory
• Manufacturers can choose any specification without regulatory oversight

Correct Answer: Compliance with the Indian Pharmacopoeia monograph is mandatory for market approval in India

Q4. What is the primary role of the Bureau of Indian Standards (BIS)?

• To regulate clinical trials for medical devices
• To develop and publish national standards across products and industrial sectors in India
• To issue marketing authorizations for drugs
• To manufacture pharmaceutical reference standards

Correct Answer: To develop and publish national standards across products and industrial sectors in India

Q5. Are BIS standards automatically mandatory for pharmaceutical products?

• Yes — all BIS standards are legally mandatory for every product
• No — BIS standards are generally voluntary unless made mandatory by government notification
• Only pharmaceutical manufacturers can opt out of BIS standards
• BIS standards apply only to exports and never to domestic products

Correct Answer: No — BIS standards are generally voluntary unless made mandatory by government notification

Q6. What is ISO 13485 intended for?

• Requirements for environmental management systems
• Requirements for a Quality Management System specific to medical device manufacturers
• Clinical trial conduct for pharmaceuticals
• Laboratory accreditation for chemical testing

Correct Answer: Requirements for a Quality Management System specific to medical device manufacturers

Q7. Which ISO/IEC standard defines competence requirements for testing and calibration laboratories?

• ISO 9001
• ISO 13485
• ISO/IEC 17025
• ISO 14971

Correct Answer: ISO/IEC 17025

Q8. The ISO 10993 series addresses what topic important for medical devices?

• Packaging requirements
• Biological evaluation and biocompatibility testing of medical devices
• Electrical safety only for in vitro diagnostics
• Clinical trial statistical methods

Correct Answer: Biological evaluation and biocompatibility testing of medical devices

Q9. Which standard provides a systematic process for risk management of medical devices?

• ISO 11607
• ISO 14971
• ISO 9001
• ISO/IEC 17025

Correct Answer: ISO 14971

Q10. ISO 11607 is primarily concerned with which aspect of medical devices?

• Software lifecycle management
• Packaging for terminally sterilized medical devices
• Clinical trial reporting
• Good Laboratory Practices

Correct Answer: Packaging for terminally sterilized medical devices

Q11. Which standard does NABL use as the basis for accrediting testing laboratories in India?

• ISO 9001
• ISO 13485
• ISO/IEC 17025
• ISO 14971

Correct Answer: ISO/IEC 17025

Q12. For regulatory submissions of medical devices in India, which QMS certification is most commonly expected or accepted?

• ISO 9001 quality management system
• ISO 13485 medical devices quality management system
• GLP certification only
• ISO/IEC 17025 laboratory accreditation

Correct Answer: ISO 13485 medical devices quality management system

Q13. If an Indian drug lacks an IP monograph, which alternative pharmacopoeias are commonly accepted subject to regulator approval?

• British Pharmacopoeia (BP) or United States Pharmacopeia (USP) as accepted by the regulator
• Only the European Pharmacopoeia (Ph. Eur.) without further checks
• No alternative is permitted under any circumstances
• Any manufacturer’s internal specification automatically suffices

Correct Answer: British Pharmacopoeia (BP) or United States Pharmacopeia (USP) as accepted by the regulator

Q14. Who issues Indian Pharmacopoeia Reference Substances used for assay and identification?

• Bureau of Indian Standards (BIS)
• Indian Pharmacopoeia Commission (IPC)
• Central Drugs Standard Control Organization (CDSCO)
• National Accreditation Board for Testing and Calibration Laboratories (NABL)

Correct Answer: Indian Pharmacopoeia Commission (IPC)

Q15. When an IP monograph for a pharmaceutical excipient conflicts with a BIS standard, which should be followed for drug quality?

• The BIS standard always overrides pharmacopoeial monographs
• The Indian Pharmacopoeia monograph applies for pharmaceutical quality and prevails for drug substances and products
• The manufacturer may choose either one arbitrarily
• The World Health Organization decides on conflict resolution

Correct Answer: The Indian Pharmacopoeia monograph applies for pharmaceutical quality and prevails for drug substances and products

Q16. Which ISO standard governs conduct of clinical investigations of medical devices?

• ISO 13485
• ISO 14155
• ISO 10993
• ISO 11607

Correct Answer: ISO 14155

Q17. Which ISO defines symbols to be used on medical device labels and accompanying documents?

• ISO 13485
• ISO 15223-1
• ISO 9001
• ISO 17665

Correct Answer: ISO 15223-1

Q18. Which ISO standard covers moist heat sterilization of healthcare products?

• ISO 11137 (radiation sterilization)
• ISO 17665 (moist heat sterilization)
• ISO 11607 (packaging for sterilized products)
• ISO 10993 (biocompatibility)

Correct Answer: ISO 17665 (moist heat sterilization)

Q19. Which pharmacopoeia specifically addresses Ayurvedic and herbal drug standards in India?

• Indian Pharmacopoeia (IP) exclusively
• Ayurvedic Pharmacopoeia of India (API)
• United States Pharmacopeia (USP) Herbal Supplement
• European Pharmacopoeia herbal monographs

Correct Answer: Ayurvedic Pharmacopoeia of India (API)

Q20. Which authorities enforce compliance with pharmacopoeial standards and related drug regulations in India?

• Bureau of Indian Standards (BIS) only
• Central Drugs Standard Control Organization (CDSCO) and State Drug Controllers
• World Health Organization inspectors
• National Accreditation Board for Testing and Calibration Laboratories (NABL) only

Correct Answer: Central Drugs Standard Control Organization (CDSCO) and State Drug Controllers

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