1. If any difficulty arises in giving effect to any provision of the DRAP Act, who has the authority to remove the difficulty?
2. For veterinary drugs, what is the source of specifications if they are not approved by the Registration Board?
3. What is the short title of the rules that govern the Drugs Appellate Board?
4. Who may physically inspect an imported consignment, draw samples, and order the importer not to sell or dispose of the drug for a specific period?
5. Which of the following statements about advertisement material is NOT true?
6. What does an Inspector require from a person during a search or seizure under Schedule-V?
7. What is the maximum quantity of a single drug that can be imported for personal use without exceeding the limit?
8. What is the purpose of an "airlock" in pharmaceutical manufacturing?
9. Under what circumstance can an exporter withdraw a batch of drugs from export after being informed by the licensing authority?
10. Which power of the Inspector requires specific authorization by the Government?
11. What is the punishment for violating any prohibitions specified in Schedule-II of the DRAP Act?
12. What is the purpose of the Drug Regulatory Authority of Pakistan Fund?
13. What is the penalty for a person who obstructs an Inspector in the exercise of any power conferred upon him under the Act?
14. Which of the following is NOT included in the definition of "Biologicals" under Schedule-I?
15. What provision allows an exporter to recall issues already made from a batch of drugs that have been found to be in contravention of the Act or rules of 1976?
16. What should an Inspector do if he finds that the therapeutic good does not contravene any provisions of the Act?
17. What is the purpose of Schedule-III of the DRAP Act?
18. What is the punishment for a person who exports, imports, manufactures for sale, or sells any spurious therapeutic good or any unregistered therapeutic good?
19. What is the role of the Appellate Board under The Drug Regulatory Authority of Pakistan Act, 2012?
20. Under what conditions are drug advertisements to the general public generally permitted?
21. What is the definition of "Biological Drugs (Ready-to-fill form)" under Schedule-I?
22. What is the purpose of a separate application for manufacturing drugs on more than one set of premises?
23. In what circumstances shall a drug not be deemed misbranded or adulterated?
24. Which of the following criteria should promotional claims about drugs adhere to?
25. What is the meaning of "Reference Biotherapeutic Product (RBP)" under ScheduleI?
26. The Drugs Act, 1976 extends to which of the following areas?
27. What is the age requirement for the Chief Executive Officer (CEO) of the Authority?
28. What kind of offense is non-cognizable under the Drugs Act 1976?
29. What is the purpose of Form 6?
30. What is the purpose of the Drugs (Research) Rules, 1978?
31. What information should be included in the written contract between the contract giver and contract acceptor for contract manufacture?
32. What is the procedure for appealing the suspension or cancellation of a license under Drugs Import & Export Rules 1976?
33. What is the role of the Quality Control Department in the manufacturing process?
34. What are the types of licences to manufacture drugs under Drugs Licensing, Registering & Advertising rules 1976?
35. What is the primary focus of basic research in the context of the Drugs (Research) Rules?
36. What is the penalty for a person who fails to provide information requested by the Authority?
37. What is the primary function of the Federal Drug Laboratory as stated in the rules?
38. What is the purpose of The Drug Regulatory Authority of Pakistan Act, 2012?
39. In case an exporter's license is suspended or canceled, what recourse does the licensee have?
40. What degree qualifications are required for the competent technical staff involved in the manufacture of drugs by way of basic or semi-basic manufacture?
41. Who is considered an "investigator" under the Drugs (Research) Rules?
42. What is the condition under which printing of labeling for therapeutic goods is allowed under Schedule-II?
43. What type of containers are ophthalmic solutions and suspensions required to be contained in?
44. Which of the following offenses punishable under Schedule-III is non-cognizable?
45. What is the purpose of the criteria regarding medical representatives?
46. What does the term "batch number (or lot number)" refer to?
47. What is the purpose of the license to manufacture drugs for experimental purposes?
48. Who has the authority to make rules for carrying out the purposes of the DRAP Act 2012?
49. In what situations can a drug or substance be advertised to the medical, pharmaceutical, and allied professions without referring to the Federal Government?
50. In case of inconsistency between the provisions of the DRAP Act and any other law, what takes precedence?
51. Within what time frame should the Authority submit its annual report to the Federal Government?
52. In case of inconsistency between the provisions of the DRAP Act and any other law, what takes precedence?
53. What action should the Authority take in response to objections raised by the Auditor-General?
54. Which of the following actions related to therapeutic goods is PROHIBITED under Schedule-II?
55. Which Division is responsible for the evaluation, assessment, and registration of pharmaceutical drugs for human beings and animals?
56. What substances are NOT included in the definition of "Drug" under Schedule-I?
57. What is the penalty for giving a false warranty in respect of any therapeutic good or applying a warranty given for another therapeutic good?
58. Who serves as the ex-officio Chairman of the Appellate Board?
59. When does an Inspector need to divide a sample into three portoons instead of four?
60. What is the purpose of the Drug Regulatory Authority of Pakistan Fund?
61. Which of the following substances would NOT be considered a "Medicated Cosmetic"?
62. What condition must be met for an application for renewal of a licence to be entertained?
63. What is the penalty for selling a drug in the finished form over and above the maximum retail price fixed by the Federal Government?
64. Who has the authority to make rules for carrying out the purposes of the DRAP Act 2012?
65. What are "Medical Devices" under Schedule-I?
66. Which term refers to the set of operations that establish the relationship between values indicated by an instrument and known reference standards?
67. What form should be used for applying for the grant or renewal of a licence to manufacture drugs?
68. Which of the following is NOT a source of financing the Drug Regulatory Authority Fund?
69. What is the consequence of violating the conditions of a license to import drugs or the provisions of the Act?
70. According to the schedule in the Drugs (Specifications) Rules, what specifications should drugs bear that reference publications specified under sub-clause (ii) of clause (z) of Section 3?
71. Who qualifies as a Federal Inspector according to these rules?
72. Which type of research involves intervention, treatment, or medication programs using human subjects?
73. Which authority may authorize a Federal Inspector to disclose information acquired during official duties?
74. What is the maximum time limit for submieng an appeal to the Appellate Board after receiving a decision?
75. Which of the following offenses punishable under Schedule-III is non-cognizable?
76. Who is responsible for carrying out the audit of the Authority's accounts?
77. What is the maximum period for which an Inspector can forbid a person in charge of premises from removing or dispensing therapeutic goods?
78. The Central Research Fund fee collected by the Authority will be utilized for:
79. What is the primary purpose of the Committee of Experts on Drug Research?
80. According to the Drug Licensing, Registering & Advertisement rules 1976, what type of information should advertisements to physicians and health-related professionals be consistent with?
81. Who has the authority to physically inspect consignments of exported drugs and draw samples for testing?
82. The Authority shall levy and collect fees for its functions at rates determined by:
83. Which type of ophthalmic preparations is allowed to have a preservative?
84. What stage of investigation on human beings involves determining safety, effectiveness, and common side effects of a drug?
85. In what type of premises should the manufacturing of drugs by way of basic or semi-basic manufacture take place?
86. What are "Medicated Cosmetics" under Schedule-I?
87. Who is responsible for maintaining records of quarterly production and disposal of a drug?
88. Under what condition can finished drugs be imported?
89. What is the fee for submitting an appeal to the Appellate Board, as mentioned in the rules?
90. The Authority may open its accounts with:
91. What is the penalty for a person who obstructs an Inspector in the exercise of any power conferred upon him under the Act?
92. In which circumstances may the Registration Board register a drug on its own motion?
93. When a Federal Inspector is not competent to take action under Schedule-IV, what should he do?
94. What is the penalty for a subsequent offense under Clause (1) of Schedule-III?
95. When does an Inspector need to divide a sample into three portoons instead of four?
96. Who shall not be liable for a contravention of Section 23 of the Drugs Act 1976?
97. When can deviations be made from the information submitted during the registration of a drug?
98. What authority is responsible for inspecting and regulaying the manufacturing of drugs under 1976 rules?
99. What does the term "Advertise" mean under Schedule-II?
100. What is the maximum duration of a licence issued under Drugs Licensing, Registering & Advertising rules 1976?
