1. What is the purpose of an "airlock" in pharmaceutical manufacturing?
2. What form should be used for applying for the grant or renewal of a licence to manufacture drugs?
3. Within what time frame should the Authority submit its annual report to the Federal Government?
4. What ethical criteria should be followed for medical drug promotion?
5. Which of the following is NOT included in the definition of "Biologicals" under Schedule-I?
6. What type of containers are ophthalmic solutions and suspensions required to be contained in?
7. How many members does the Policy Board consist of?
8. What condition must be met for a drug or substance to be advertised through press without reference to the Federal Government?
9. What is the duration of a license to export drugs?
10. What are the conditions that the Central Licensing Board must ensure are complied with before granting or renewing a licence to manufacture drugs by way of basic or semi-basic manufacture?
11. What is the term of office for members of the Registration Board?
12. What is the purpose of the Central Research Fund mentioned in the Drugs Licensing, Registering & Advertising Rules 1976?
13. Which power of the Inspector requires specific authorization by the Government?
14. What is the meaning of "Reference Biotherapeutic Product (RBP)" under ScheduleI?
15. What is the short title of the rules that govern the Drugs Appellate Board?
16. What action should the Authority take in response to objections raised by the Auditor-General?
17. Which of the following statements about advertisement material is NOT true?
18. 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?
19. What is the primary focus of basic research in the context of the Drugs (Research) Rules?
20. When can deviations be made from the information submitted during the registration of a drug?
21. What is the meaning of "Reference Biotherapeutic Product (RBP)" under ScheduleI?
22. What is the penalty for a person who obstructs an Inspector in the exercise of any power conferred upon him under the Act?
23. What is the age requirement for the Chief Executive Officer (CEO) of the Authority?
24. Who can revoke an order passed under Section 32 of the DRAP Act, 2012?
25. What is the purpose of the Committee on Drugs Evaluation?
26. What is the main duty of a Federal Inspector?
27. Which of the following is NOT considered as "Therapeutic goods" under the Act?
28. 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?
29. When a Federal Inspector is not competent to take action under Schedule-IV, what should he do?
30. If any difficulty arises in giving effect to any provision of the DRAP Act, who has the authority to remove the difficulty?
31. What is the commencement date for the Drugs (Specifications) Rules, 1978?
32. How long do members, other than ex-officio members, of the Appellate Board hold office for initially?
33. What does the term "batch number (or lot number)" refer to?
34. In case an exporter's license is suspended or canceled, what recourse does the licensee have?
35. Under what conditions is contract manufacture permissible?
36. The Authority may open its accounts with:
37. Under what conditions can the aid from the research fund be withdrawn and a clinical trial terminated?
38. What should an Inspector do if he finds that the therapeutic good does not contravene any provisions of the Act?
39. What is the maximum allowable retailer's discount for drugs?
40. What is the purpose of Form 10 in the export of drugs?
41. Which type of ophthalmic preparations is allowed to have a preservative?
42. Which of the following offenses punishable under Schedule-III is non-cognizable?
43. Which term refers to the set of operations that establish the relationship between values indicated by an instrument and known reference standards?
44. What labeling requirements apply to drugs manufactured for experimental purposes?
45. Where should one portion of a sample taken by an Inspector be sent for test and analysis?
46. The Central Research Fund fee collected by the Authority will be utilized for:
47. What is the maximum duration of a licence issued under Drugs Licensing, Registering & Advertising rules 1976?
48. Who has the authority to make rules for carrying out the purposes of the DRAP Act 2012?
49. In which circumstances may the Registration Board register a drug on its own motion?
50. What is the maximum period for which an Inspector can forbid a person in charge of premises from removing or dispensing therapeutic goods?
51. What kind of offense is non-cognizable under the Drugs Act 1976?
52. Who is responsible for maintaining records of quarterly production and disposal of a drug?
53. Which power of the Inspector requires specific authorization by the Government?
54. In case of inconsistency between the provisions of the DRAP Act and any other law, what takes precedence?
55. In what situations can a drug or substance be advertised to the medical, pharmaceutical, and allied professions without referring to the Federal Government?
56. What substances are NOT included in the definition of "Drug" under Schedule-I?
57. What action should the Authority take in response to objections raised by the Auditor-General?
58. Which authority may authorize a Federal Inspector to disclose information acquired during official duties?
59. Who is responsible for carrying out the audit of the Authority's accounts?
60. What is the punishment for a person who exports, imports, manufactures for sale, or sells any spurious therapeutic good or any unregistered therapeutic good?
61. What is the purpose of Schedule-III of the DRAP Act?
62. What is the role of the Appellate Board under The Drug Regulatory Authority of Pakistan Act, 2012?
63. What is the maximum duration for which the approval of an advertisement under sub-rule (1) is valid?
64. What is the purpose of the criteria regarding medical representatives?
65. What is the purpose of Form 6?
66. What is the penalty for selling a drug in the finished form over and above the maximum retail price fixed by the Federal Government?
67. What is the purpose of the license to manufacture drugs for experimental purposes?
68. For drugs other than those falling under specific categories, whose approval is required for the specifications?
69. Who has the power to institute a prosecution for a contravention of any provision of the DRAP Act, 2012, and The Drugs Act, 1976?
70. What condition must be met for an application for renewal of a licence to be entertained?
71. What is the purpose of the Drug Regulatory Authority of Pakistan Fund?
72. Which of the following actions related to therapeutic goods is PROHIBITED under Schedule-II?
73. 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?
74. Which type of research involves intervention, treatment, or medication programs using human subjects?
75. What is the penalty for a person who fails to provide information requested by the Authority?
76. Which authority is responsible for issuing licences to manufacture drugs by way of repacking under section 18 of ordinance in a province?
77. What is the condition under which printing of labeling for therapeutic goods is allowed under Schedule-II?
78. What substances are NOT included in the definition of "Drug" under Schedule-I?
79. What is the punishment for a person who exports, imports, manufactures for sale, or sells any spurious therapeutic good or any unregistered therapeutic good?
80. What is the purpose of an "airlock" in pharmaceutical manufacturing?
81. What is the procedure for appealing the suspension or cancellation of a license under Drugs Import & Export Rules 1976?
82. What is the definition of "promotion" for the purposes of Schedule G of 1976 Rules?
83. What is the maximum time limit for submieng an appeal to the Appellate Board after receiving a decision?
84. Which Division is responsible for the evaluation, assessment, and registration of pharmaceutical drugs for human beings and animals?
85. What is the role of the Quality Control Department in the manufacturing process?
86. What is the purpose of Schedule-III of the DRAP Act?
87. Under Schedule-II, what is allowed in terms of distributing therapeutic goods as samples?
88. Which of the following is NOT included in the definition of "Biologicals" under Schedule-I?
89. What is the penalty for giving a false warranty in respect of any therapeutic good or applying a warranty given for another therapeutic good?
90. What are "Medical Devices" under Schedule-I?
91. In what type of premises should the manufacturing of drugs by way of basic or semi-basic manufacture take place?
92. What degree qualifications are required for the competent technical staff involved in the manufacture of drugs by way of basic or semi-basic manufacture?
93. What are "Medicated Cosmetics" under Schedule-I?
94. If any difficulty arises in giving effect to any provision of the DRAP Act, who has the authority to remove the difficulty?
95. What is the consequence of violating the conditions of a license to import drugs or the provisions of the Act?
96. When does an Inspector need to divide a sample into three portoons instead of four?
97. What does the term "Advertise" mean under Schedule-II?
98. Which of the following actions related to therapeutic goods is PROHIBITED under Schedule-II?
99. What are "Medicated Cosmetics" under Schedule-I?
100. What is the definition of "Biological Drugs (Ready-to-fill form)" under Schedule-I?
