Pharmaceutical companies typically use a variety of factors to determine the price of their drugs, including: Development and production costs: Pharmaceutical companies invest significant amounts of money into the research, development, and production of new drugs. The cost of these activities, including clinical trials and obtaining regulatory approval, is factored into the price of the drug. Marketing and Distribution Cost: Marketing and distribution costs may also be considered by pharmaceutical companies when determining drug prices. These costs include expenses related to advertising, sales representatives, and distribution networks. Drug Uniqueness: If a drug is the first of its kind or represents a significant improvement over existing treatments, the pharmaceutical company may set a higher price for it. If a drug has many competitors or is like existing treatments, the company may have to set a lower price to remain competitive. Market demand: Companies also consider the dem
I. Particulars to be shown in the manufacturing records:
(1) Serial number.
(2) Name of the product.
(3) Lot or Batch size.
(4) Lot or Batch number.
(5) Date of commencement of manufacture and date when manufacture was completed.
(6) Names of all ingredients, quantities required for the lot/batch size, quantities actually used.
(7) Control reference numbers in respect of raw materials used in formulation.
(8) Reference to analytical report numbers or unique code.
(9) Actual production and packing particulars indicating the size and quantity of finished packings.
(10) Date of release of finished packing for distribution or sale.
(11) Signature of the expert staff responsible for the manufacture.
II. Records of raw materials: Records in respect of each raw material shall be maintained indicating the quantity received, control reference number, the quantity issued from time to time, the names and batch numbers of the products for the manufacture of which the said quantity of raw material has been issued and the particulars relating to the proper disposal of the stocks.
Notes: (1) The Licensing Authority may permit the licensee to maintain records in such manner as is considered satisfactory, provided the basic requirements laid down above are complied with.
(2) The Licensing Authority may direct the licensee to maintain records for such additional particulars, as it may consider necessary in the circumstances of a particular case.
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