1. What is the purpose of the Drugs (Research) Rules, 1978?
2. What is the purpose of an "airlock" in pharmaceutical manufacturing?
3. What is the maximum time limit for submieng an appeal to the Appellate Board after receiving a decision?
4. What is the definition of "promotion" for the purposes of Schedule G of 1976 Rules?
5. What is the maximum duration for which the approval of an advertisement under sub-rule (1) is valid?
6. According to the Drugs (Specifications) Rules, 1978, what is the requirement for ophthalmic ointments?
7. What is the role of the Quality Control Department in the manufacturing process?
8. What is the purpose of an "airlock" in pharmaceutical manufacturing?
9. Within what time frame should the Authority submit its annual report to the Federal Government?
10. 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?
11. How often must records of quarterly production and disposal of a drug be supplied to the Chairman of the Registration Board?
12. What is the age requirement for the Chief Executive Officer (CEO) of the Authority?
13. If any difficulty arises in giving effect to any provision of the DRAP Act, who has the authority to remove the difficulty?
14. Which of the following actions related to therapeutic goods is PROHIBITED under Schedule-II?
15. What type of containers are ophthalmic solutions and suspensions required to be contained in?
16. Which of the following criteria should promotional claims about drugs adhere to?
17. What is the purpose of the license to manufacture drugs for experimental purposes?
18. What is the meaning of "Reference Biotherapeutic Product (RBP)" under ScheduleI?
19. What substances are NOT included in the definition of "Drug" under Schedule-I?
20. Who has the power to institute a prosecution for a contravention of any provision of the DRAP Act, 2012, and The Drugs Act, 1976?
21. When does an Inspector need to divide a sample into three portoons instead of four?
22. What is the fee for submitting an appeal to the Appellate Board, as mentioned in the rules?
23. What is the punishment for a person who exports, imports, manufactures for sale, or sells any spurious therapeutic good or any unregistered therapeutic good?
24. Which authority is responsible for issuing licences to manufacture drugs by way of repacking under section 18 of ordinance in a province?
25. What stage of investigation on human beings involves determining safety, effectiveness, and common side effects of a drug?
26. Which court shall try an offense punishable under the DRAP Act, 2012, and The Drugs Act, 1976?
27. What is the punishment for a person who exports, imports, manufactures for sale, or sells any spurious therapeutic good or any unregistered therapeutic good?
28. What is the penalty for a person who obstructs an Inspector in the exercise of any power conferred upon him under the Act?
29. What does an Inspector require from a person during a search or seizure under Schedule-V?
30. What does the term "batch number (or lot number)" refer to?
31. What authority is responsible for inspecting and regulaying the manufacturing of drugs under 1976 rules?
32. In case an exporter's license is suspended or canceled, what recourse does the licensee have?
33. What is the procedure for appealing the suspension or cancellation of a license under Drugs Import & Export Rules 1976?
34. Under what conditions can the aid from the research fund be withdrawn and a clinical trial terminated?
35. Under Schedule-II, what is allowed in terms of distributing therapeutic goods as samples?
36. Who serves as the ex-officio Chairman of the Appellate Board?
37. What is the purpose of Form 10 in the export of drugs?
38. When does an Inspector need to divide a sample into three portoons instead of four?
39. What is the duration of a license to import drugs, unless suspended or canceled?
40. Which of the following is NOT a source of financing the Drug Regulatory Authority Fund?
41. What ethical criteria should be followed for medical drug promotion?
42. What labeling requirements apply to drugs manufactured for experimental purposes?
43. What is the consequence of violating the conditions of a license to import drugs or the provisions of the Act?
44. What is the primary purpose of the Committee of Experts on Drug Research?
45. If any difficulty arises in giving effect to any provision of the DRAP Act, who has the authority to remove the difficulty?
46. What is the purpose of The Drug Regulatory Authority of Pakistan Act, 2012?
47. Which type of research involves intervention, treatment, or medication programs using human subjects?
48. What is the role of the Appellate Board under The Drug Regulatory Authority of Pakistan Act, 2012?
49. What are the types of licences to manufacture drugs under Drugs Licensing, Registering & Advertising rules 1976?
50. What action should the Authority take in response to objections raised by the Auditor-General?
51. What form should be used for applying for the grant or renewal of a licence to manufacture drugs?
52. What condition must be met for a drug or substance to be advertised through press without reference to the Federal Government?
53. In which circumstances may the Registration Board register a drug on its own motion?
54. What should an Inspector do if he finds that the therapeutic good does not contravene any provisions of the Act?
55. What are "Medicated Cosmetics" under Schedule-I?
56. In what type of premises should the manufacturing of drugs by way of basic or semi-basic manufacture take place?
57. What is the purpose of Schedule-III of the DRAP Act?
58. Who has the authority to establish the Drug Regulatory Authority of Pakistan?
59. What is the definition of "Biological Drugs (Ready-to-fill form)" under Schedule-I?
60. Who shall not be liable for a contravention of Section 23 of the Drugs Act 1976?
61. In what circumstances shall a drug not be deemed misbranded or adulterated?
62. Who is responsible for maintaining records of quarterly production and disposal of a drug?
63. Where should one portion of a sample taken by an Inspector be sent for test and analysis?
64. What condition must be met for an application for renewal of a licence to be entertained?
65. What is the meaning of "Reference Biotherapeutic Product (RBP)" under ScheduleI?
66. What is the maximum period for which an Inspector can forbid a person in charge of premises from removing or dispensing therapeutic goods?
67. What is the purpose of a separate application for manufacturing drugs on more than one set of premises?
68. What kind of offense is non-cognizable under the Drugs Act 1976?
69. What is the purpose of Schedule-III of the DRAP Act?
70. What is the purpose of Form 6?
71. What is the penalty for selling a drug in the finished form over and above the maximum retail price fixed by the Federal Government?
72. What is the primary function of the Federal Drug Laboratory as stated in the rules?
73. What information should be included in the written contract between the contract giver and contract acceptor for contract manufacture?
74. Which of the following offenses punishable under Schedule-III is non-cognizable?
75. 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?
76. What is the maximum quantity of a single drug that can be imported for personal use without exceeding the limit?
77. Which of the following is NOT considered as "Therapeutic goods" under the Act?
78. Under Schedule-II, what is allowed in terms of distributing therapeutic goods as samples?
79. What is the role of the Quality Control Department in the manufacturing process?
80. Who has the authority to make rules for carrying out the purposes of the DRAP Act 2012?
81. What is the meaning of "sponsor" in the context of the Drugs (Research) Rules?
82. What substances are NOT included in the definition of "Drug" under Schedule-I?
83. What is the purpose of The Drug Regulatory Authority of Pakistan Act, 2012?
84. When a Federal Inspector is not competent to take action under Schedule-IV, what should he do?
85. What are "Medical Devices" under Schedule-I?
86. Which term refers to the set of operations that establish the relationship between values indicated by an instrument and known reference standards?
87. What is the punishment for violating any prohibitions specified in Schedule-II of the DRAP Act?
88. What is the penalty for selling a drug in the finished form over and above the maximum retail price fixed by the Federal Government?
89. Which power of the Inspector requires specific authorization by the Government?
90. In which situations may the Registration Board provisionally register a drug for a period of two years?
91. Who is considered an "investigator" under the Drugs (Research) Rules?
92. What is the penalty for a subsequent offense under Clause (1) of Schedule-III?
93. Which of the following actions related to therapeutic goods is PROHIBITED under Schedule-II?
94. Which of the following offenses punishable under Schedule-III is non-cognizable?
95. Which of the following substances would NOT be considered a "Medicated Cosmetic"?
96. According to the Drug Licensing, Registering & Advertisement rules 1976, what type of information should advertisements to physicians and health-related professionals be consistent with?
97. Which of the following is NOT included in the definition of "Biologicals" under Schedule-I?
98. When can deviations be made from the information submitted during the registration of a drug?
99. Under what conditions is contract manufacture permissible?
100. Who can revoke an order passed under Section 32 of the DRAP Act, 2012?
