Rules, regulations, guidelines and standards for regulatory filing in India MCQs With Answer

Introduction

This quiz collection covers the rules, regulations, guidelines and standards required for regulatory filing in India, tailored for M.Pharm students. It focuses on legal frameworks (Drugs & Cosmetics Act, Food Safety Act, Medical Devices Rules), regulatory authorities (CDSCO, FSSAI, Ministry of AYUSH), key schedules and guidance documents (Schedule M, Schedule Y, Similar Biologics guidance), submission formats (CTD/eCTD, SUGAM portal), and relevant IPR basics (patent term, Section 3(d), compulsory licensing). Questions are designed to reinforce practical knowledge needed for preparing regulatory dossiers, clinical trial compliance, quality systems and post-approval obligations in the Indian regulatory landscape.

Q1. Which primary legislation governs the manufacture, sale and distribution of drugs and cosmetics in India?

• Drugs and Cosmetics Act, 1940
• Pharmaceuticals Regulation Act, 1956
• Food Safety and Standards Act, 2006
• Medical Devices Act, 2017

Correct Answer: Drugs and Cosmetics Act, 1940

Q2. Who is the head of the Central Drugs Standard Control Organization (CDSCO) and the national regulatory authority for drugs in India?

• Drug Controller General of India (DCGI)
• Director General of Health Services (DGHS)
• Secretary, Ministry of Health and Family Welfare
• Chairperson, Indian Pharmacopoeia Commission

Correct Answer: Drug Controller General of India (DCGI)

Q3. Which Schedule of the Drugs and Cosmetics Rules lays down Good Manufacturing Practices (GMP) requirements for pharmaceutical manufacturers in India?

• Schedule M
• Schedule Y
• Schedule D
• Schedule H

Correct Answer: Schedule M

Q4. The regulatory framework that specifically modernized clinical trial approvals and new drug procedures in India in 2019 is called:

• New Drugs and Clinical Trials Rules, 2019
• Clinical Trials Regulation Act, 2019
• Drugs and Cosmetics Amendment Rules, 2019
• Medical Device Regulation Rules, 2019

Correct Answer: New Drugs and Clinical Trials Rules, 2019

Q5. Where must all clinical trials in India be prospectively registered before subject enrollment?

• Clinical Trials Registry – India (CTRI)
• Indian Pharmacopoeia Commission Registry
• Central Drugs Laboratory Portal
• National Biosafety Board

Correct Answer: Clinical Trials Registry – India (CTRI)

Q6. What is the internationally harmonized dossier format recommended for regulatory submissions to facilitate global filings?

• Common Technical Document (CTD)
• Module Based Application (MBA)
• Indian Application Format (IAF)
• Regulatory Harmonized Dossier (RHD)

Correct Answer: Common Technical Document (CTD)

Q7. Which Schedule of the Drugs and Cosmetics Rules contains specific provisions and requirements for clinical trials, notifications and approvals?

• Schedule Y
• Schedule M
• Schedule G
• Schedule X

Correct Answer: Schedule Y

Q8. Which authority is primarily responsible for regulation and approval of medical devices in India?

• Central Drugs Standard Control Organization (CDSCO)
• Food Safety and Standards Authority of India (FSSAI)
• Indian Council of Medical Research (ICMR)
• Ministry of AYUSH

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q9. For approval of biosimilar (similar biologic) products in India, manufacturers follow guidance issued by:

• Central Drugs Standard Control Organization (CDSCO) – Guidance on Similar Biologics
• Food Safety and Standards Authority of India (FSSAI)
• Ministry of AYUSH
• Indian Pharmacopoeia Commission (IPC)

Correct Answer: Central Drugs Standard Control Organization (CDSCO) – Guidance on Similar Biologics

Q10. Which online portal is commonly used for submission of licensing applications and certain regulatory filings to CDSCO?

• SUGAM portal
• CESTAT portal
• TRIPS portal
• eNTRy portal

Correct Answer: SUGAM portal

Q11. Which legislation governs food products, nutraceuticals and functional foods in India?

• Food Safety and Standards Act, 2006 (FSSAI)
• Drugs and Cosmetics Act, 1940
• Prevention of Food Adulteration Act, 1954
• Pharmacopeial Standards Act, 2002

Correct Answer: Food Safety and Standards Act, 2006 (FSSAI)

Q12. Which ministry is the nodal authority for regulation and policy of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homeopathy systems in India?

• Ministry of AYUSH
• Ministry of Health and Family Welfare
• Department of Biotechnology
• Ministry of Science & Technology

Correct Answer: Ministry of AYUSH

Q13. Who publishes and maintains the official Indian Pharmacopoeia standards used for quality specification of drugs?

• Indian Pharmacopoeia Commission (IPC)
• Central Drugs Laboratory (CDL)
• Central Drug Research Institute (CDRI)
• National Institute of Pharmaceutical Education and Research (NIPER)

Correct Answer: Indian Pharmacopoeia Commission (IPC)

Q14. In India, what is the standard term of patent protection from the date of filing?

• 20 years from the filing date
• 10 years from the grant date
• 14 years from the filing date
• 25 years from the grant date

Correct Answer: 20 years from the filing date

Q15. Which section of the Indian Patents Act restricts patentability of mere new forms of known substances unless enhanced efficacy is demonstrated?

• Section 3(d)
• Section 8
• Section 25
• Section 66

Correct Answer: Section 3(d)

Q16. Under Indian patent law, after how long from the grant of a patent can a third party seek compulsory licensing under Section 84?

• After three years from grant of the patent
• Immediately upon grant
• After ten years from grant
• Only after patent expiry

Correct Answer: After three years from grant of the patent

Q17. Which international quality management standard is widely accepted for medical device manufacturers and often referenced in regulatory filings?

• ISO 13485 (Medical device QMS)
• ISO 9001 (General QMS)
• ISO 14001 (Environmental)
• ISO 27001 (Information Security)

Correct Answer: ISO 13485 (Medical device QMS)

Q18. The office responsible for patents, designs and trademarks administration in India is called:

• Controller General of Patents, Designs & Trademarks (CGPDTM)
• Intellectual Property Board of India (IPBI)
• National Patent Authority (NPA)
• Patent Regulatory Commission (PRC)

Correct Answer: Controller General of Patents, Designs & Trademarks (CGPDTM)

Q19. What does eCTD stand for in the context of electronic regulatory submissions?

• Electronic Common Technical Document
• Enhanced Clinical Trial Dossier
• Electronic Clinical Trial Data
• Encoded Chemical and Toxicology Dossier

Correct Answer: Electronic Common Technical Document

Q20. For approval of generic immediate-release oral solid dosage forms in India, regulators typically require which of the following to demonstrate equivalence with the reference product?

• Bioequivalence studies as per CDSCO guidance
• Only comparative dissolution testing without in vivo studies
• No studies if the formulation is the same
• Only stability studies for six months

Correct Answer: Bioequivalence studies as per CDSCO guidance

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