Regulatory Affairs & Quality Assurance PYQs – Set 169
Subject : Regulatory Affairs & Quality Assurance
3361. Maximum number of Abbreviated New Drug Approvals in 2013 are granted by US-FDA to which of the Indian company?
Regulatory Affairs & Quality Assurance • • NIPER 2014
3362. Sanofi-Synthélabo merged with Aventis and formed Sanofi-Aventis. It is renamed in 2011 as:
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3363. Novartis lost patent right over its anti-cancer drug Glivec in India, because ____.
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3364. The first compulsory license is granted to NATCO for Nexavar. What is the active ingredient of it?
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3365. Declaration of Helsinki is related to:
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3366. Who is the chairman for Drugs Technical Advisory Board?
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3367. For adults, the ethanol content limit for oral OTC solution products is:
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3368. The Intellectual Property Appellate Board, a statutory body under the Indian Patent Act:
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3369. As per DPCO 2013, new drug/formulation/processes developed by domestic research and development and patented is exempted from price control for a period of:
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3370. Drug Price Control Order 2013 imposes MRP restriction on _____ essential drugs.
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3371. The acronym CDSCO stands for:
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3372. Which of the following words does not appear in the official definition of 'drug' in India?
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3373. The Consumer Protection Act was passed in the year:
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3374. The requirement and guidelines for contract research come in which Schedule?
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3375. Drug prices in India are decided by which regulatory agency?
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3376. Indian Patent Controller General gave a compulsory license to NATCO to manufacture Bayer Pharma’s anti-cancer drug ‘Nexavar’ because Bayer Pharma ______.
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3377. Which schedule is related to the shelf life of drug formulations:
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3378. An amendment was introduced in the Drugs & Cosmetics Act 1940 to prohibit advertisement of drugs specified in Schedule H, Schedule H1, or Schedule X. When was this amendment introduced?
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3379. Blood and blood products are governed by which Schedule of the Drugs & Cosmetics Act 1940?
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3380. What is the maximum shelf life in months permissible under the Drugs and Cosmetics Act?
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