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Pharmacentical Regulatory Affairs

  1. Briefly mention the objective and elements of National Drug Policy (NDP) 2005
  2. Explain the considerations for fixing price of raw materials of pharmaceutical finished products. Calculate the trade price (TP), VAT and Chemist Benefit for a pharmaceutical finished products having Maximum Retail Price (MRP) of 325.00 Taka.
  3. Write down the requirements for registration of a drug which is neither introduced as monograph in BP/USP/BPC/USP-NF and nor introduced in Bangladesh.
  4. Write down the drug situation in Bangladesh before the drug control ordinance of 1982.
  5. Name the registers and the particulars for pharmacists and apprentice prepared and maintained by Pharmacy Council of Bangladesh. Who will be qualified for registration as pharmacist according to The Pharmacy Ordinance 1976?
  6. Briefly describe the Code of Ethics for pharmacists. Why are they necessary?
  7. Define the terms 'Drugs' and 'Misbranded Drugs' from the view point of Drug Act 1940.
  8. Describe the composition and functions of Pharmacy Council of Bangladesh according to The Pharmacy Ordinance 1976.
  9. Mention the rules and regulations for controlling narcotic materials in Bangladesh.
  10. Define the poisons according to Poison Act, 1952. Write down the penalty for unlawful important of poisons according to The Poison Act, 1919.
  11. Write down the composition and function of the National Intoxicant Control Board.
  12. Make a category of intoxicants according to the schedule of The Intoxicant Control Act, 1990. How this Act provide the cure and rehabilitation of intoxicated persons?

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