Regulatory Affairs & Quality Assurance PYQs – Set 168
Subject : Regulatory Affairs & Quality Assurance
3341. Exclusivity granted to the first generic applicant after FDA approval:
Regulatory Affairs & Quality Assurance • • NIPER 2012
3342. Which are the THREE R's followed by the animal ethics committee? (P: Replacement; Q: Reduction; R: Refinement; S: Rehabilitation)
Regulatory Affairs & Quality Assurance • • NIPER 2012
3343. Which of the following does not appear in the official definition of drugs in India?
Regulatory Affairs & Quality Assurance • • NIPER 2012
3344. Using the FDA bioequivalence rule, how much variation could a generic drug potentially have from an innovator and still be considered equivalent?
Regulatory Affairs & Quality Assurance • • NIPER 2012
3345. Central Pharma Public Sector Undertakings are: P) Indian Drugs & Pharmaceuticals Limited, Gurgaon; Q) Hindustan Antibiotics Limited, Pimpri, Pune; R) Bengal Chemicals & Pharmaceuticals Limited, Kolkata; S) Karnataka Antibiotics & Pharmaceuticals Limited, Bangalore & Rajasthan Drugs & Pharmaceuticals Limited, Jaipur.
Regulatory Affairs & Quality Assurance • • NIPER 2012
3346. Which of the following is nonpatentable as per Indian Patents ACT, 1970?
Regulatory Affairs & Quality Assurance • • NIPER 2012
3347. Indian Medicine Pharmaceutical Corporation Limited (IMPCL), a public sector undertaking by AYUSH is located in:
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3348. An information gathering and managing tool that can be used to help identify potential causes of a certain problem or event is/are:
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3349. The provisional specification of a patent application does not contain:
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3350. International Bureau of World Intellectual Property Organisation is:
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3351. For imported formulations, the margin to cover selling and distribution expenses including interest and importer’s profit shall not exceed ___ of the landed cost.
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3352. The Chairman of the Investigational New Drug (IND) Committee in India is:
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3353. The first product patent in India was granted to:
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3354. The IPR in India is implemented with:
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3355. SCCO works under the Ministry of:
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3356. In March 2012, India granted its first compulsory license for anti-cancer drug by Indian Patent office to:
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3357. DPCO is issued under which act?
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3358. US-FDA opened office in New Delhi in:
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3359. Drugs (Prices Control) Order, 2013 is issued by:
Regulatory Affairs & Quality Assurance • • NIPER 2012
3360. Least-developed countries have time given till _____ to ensure that their laws and practices conform to the TRIPS agreement for pharmaceutical patents.
Regulatory Affairs & Quality Assurance • • NIPER 2012
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