Introduction: IPR Types & Indian Regulatory Bodies MCQs With Answer is designed for M.Pharm students preparing for exams and competitive assessments. This set focuses on core intellectual property rights relevant to pharmaceuticals—patents, trademarks, designs, copyrights, trade secrets, geographical indications and sui generis systems—alongside Indian regulatory authorities that govern drug approval, pricing, and biosafety. Questions emphasize legal provisions such as patentability criteria, Section 3(d), compulsory licensing, the Patent Office structure, CDSCO/DCGI roles, NPPA, National Biodiversity Authority, and interfaces between IPR and public health. The MCQs target conceptual clarity and application to drug development, regulatory strategy, and IP management in India.
Q1. Which Indian office is primarily responsible for granting patents, trademarks and designs?
- Central Drugs Standard Control Organization (CDSCO)
- Controller General of Patents, Designs & Trade Marks (CGPDTM)
- National Pharmaceutical Pricing Authority (NPPA)
- National Biodiversity Authority (NBA)
Correct Answer: Controller General of Patents, Designs & Trade Marks (CGPDTM)
Q2. Under the Indian Patents Act, 1970, which section addresses the prohibition of patenting new forms of known substances unless increased efficacy is shown?
- Section 3(b)
- Section 3(d)
- Section 10
- Section 84
Correct Answer: Section 3(d)
Q3. Which authority is the national regulator for approval of drugs and clinical trials in India?
- Department of Biotechnology (DBT)
- Central Drugs Standard Control Organization (CDSCO)
- Indian Patent Office
- National Biodiversity Authority (NBA)
Correct Answer: Central Drugs Standard Control Organization (CDSCO)
Q4. What is the primary international agreement that sets minimum standards for intellectual property protection, including pharmaceuticals, that India is a signatory to?
- Paris Convention
- Berne Convention
- TRIPS Agreement (WTO)
- Budapest Treaty
Correct Answer: TRIPS Agreement (WTO)
Q5. Which Indian body is responsible for regulating the prices of scheduled drugs to ensure affordability?
- Central Drugs Standard Control Organization (CDSCO)
- National Pharmaceutical Pricing Authority (NPPA)
- Controller General of Patents, Designs & Trade Marks (CGPDTM)
- Pharmacy Council of India (PCI)
Correct Answer: National Pharmaceutical Pricing Authority (NPPA)
Q6. The concept of “compulsory licensing” in India allows which of the following?
- Patent holder to extend patent term automatically
- Government to authorize third parties to produce patented product without patentee’s consent under specific conditions
- Complete revocation of patent rights for any reason
- Exclusive licensing to a private company for export only
Correct Answer: Government to authorize third parties to produce patented product without patentee’s consent under specific conditions
Q7. Which Indian legislation governs protection of plant varieties and farmers’ rights as a sui generis system?
- Plant Variety Protection Act, 1972
- Protection of Plant Varieties and Farmers’ Rights Act, 2001 (PPVFR)
- The Biological Diversity Act, 2002
- The Seed Act, 1966
Correct Answer: Protection of Plant Varieties and Farmers’ Rights Act, 2001 (PPVFR)
Q8. Which of the following is NOT typically patentable in India?
- A new chemical entity with inventive step
- A novel method of treatment of the human body
- A new manufacturing process for a drug
- A genetically modified microorganism with novelty and inventive step
Correct Answer: A novel method of treatment of the human body
Q9. What is the standard term of a patent in India from the date of filing?
- 14 years
- 16 years
- 20 years
- 25 years
Correct Answer: 20 years
Q10. The Traditional Knowledge Digital Library (TKDL) in India primarily serves to:
- Grant patents for traditional medicines
- Document traditional knowledge to prevent wrongful patents and aid prior art searches
- Provide clinical trial data for herbal products
- License traditional knowledge to pharmaceutical companies
Correct Answer: Document traditional knowledge to prevent wrongful patents and aid prior art searches
Q11. Which Indian authority must be consulted for access to biological resources and associated traditional knowledge for commercial use?
- National Biodiversity Authority (NBA)
- Central Drugs Standard Control Organization (CDSCO)
- Controller General of Patents, Designs & Trade Marks (CGPDTM)
- National Pharmaceutical Pricing Authority (NPPA)
Correct Answer: National Biodiversity Authority (NBA)
Q12. Under the Indian Patents Act, which provision allows regulatory authorities to approve generic versions of drugs during patent term for the purpose of marketing immediately after patent expiry?
- Section 3(d)
- Bolar exemption
- Compulsory license provision
- Evergreening clause
Correct Answer: Bolar exemption
Q13. Which Indian regulator issues No Objection Certificate (NOC) or permissions related to clinical trials for new drugs?
- National Biodiversity Authority (NBA)
- Central Drugs Standard Control Organization (CDSCO) / DCGI
- Controller General of Patents, Designs & Trade Marks (CGPDTM)
- Indian Council of Medical Research (ICMR)
Correct Answer: Central Drugs Standard Control Organization (CDSCO) / DCGI
Q14. Which instrument allows an applicant to file a single international patent application that can later enter national phases in multiple countries?
- TRIPS national filing
- Patent Cooperation Treaty (PCT)
- Berne Application
- Madison Protocol
Correct Answer: Patent Cooperation Treaty (PCT)
Q15. What kind of intellectual property protects the shape, configuration or ornamentation of a product in India?
- Trademark
- Patent
- Design
- Geographical Indication
Correct Answer: Design
Q16. Which agency provides guidance on ethical, scientific design of human trials and often issues guidelines used by CDSCO?
- National Pharmaceutical Pricing Authority (NPPA)
- Indian Council of Medical Research (ICMR)
- Controller General of Patents, Designs & Trade Marks (CGPDTM)
- National Biodiversity Authority (NBA)
Correct Answer: Indian Council of Medical Research (ICMR)
Q17. In India, data exclusivity that blocks generic approval based solely on originator clinical data is:
- explicitly provided under the Patents Act
- non-existent as a statutory right; approval largely relies on regulator discretion and public health rules
- automatically granted for 5 years to all new drugs
- handled by NPPA
Correct Answer: non-existent as a statutory right; approval largely relies on regulator discretion and public health rules
Q18. Which authority handles pre-grant and post-grant oppositions and appeals related to patents in India?
- Intellectual Property Appellate Board (IPAB) — previously; now high courts and IPAB functions folded to courts
- National Biodiversity Authority (NBA)
- Central Drugs Standard Control Organization (CDSCO)
- National Pharmaceutical Pricing Authority (NPPA)
Correct Answer: Intellectual Property Appellate Board (IPAB) — previously; now high courts and IPAB functions folded to courts
Q19. Geographical Indications (GI) in India are used to protect:
- The molecular structure of a drug
- Names and qualities of products originating from a specific region (e.g., Darjeeling tea)
- Clinical trial protocols
- Patentable algorithms
Correct Answer: Names and qualities of products originating from a specific region (e.g., Darjeeling tea)
Q20. Which Indian authority is primarily concerned with access and benefit sharing when biological resources are used for research leading to commercial products?
- National Biodiversity Authority (NBA)
- Central Drugs Standard Control Organization (CDSCO)
- Controller General of Patents, Designs & Trade Marks (CGPDTM)
- National Pharmaceutical Pricing Authority (NPPA)
Correct Answer: National Biodiversity Authority (NBA)
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
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