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
Schedules: Schedule A, Schedule B, Schedule C, Schedule D, Schedule E1, Schedule F, Schedule G, Schedule H, Schedule H1, Schedule I, Schedule J, Schedule K, Schedule L1, Schedule M, Schedule M1, Schedule M2, Schedule M3, Schedule N, Schedule O, Schedule P, Schedule Q, Schedule R, Schedule S, Schedule T, Schedule U, Schedule V, Schedule W, Schedule X, Schedule Y
Schedule F:
Schedule F (Rule 78 and Part X) describes requirements related to Blood and Blood Components. We are describing general heading about schedule. This will give you Idea about schedule structure and matter.
Part XIIB: Requirements for the functioning and operation of a blood bank and / or for preparation of blood components.
I. This section describes details about Blood Bank and Blood Components
Part XIIC:
I. Requirements for manufacturing of blood products
Part XIID: Requirements for collection, processing, testing, storage, banking and release of umbilical cord blood derived stem cells
i. General Requirements
ii. Collection and storage of processed umbilical cord blood component
iii. Personnel
iv. Air Handling System
v. Quality Control
vi. Screening Test
vii. Storage
viii. Reference Samples
ix. Labelling
x. Record or Documents
xi. Cord Blood Release
Part XIII:
I. General
I. Provisions applicable to the production of bacterial vaccines
Part II: Antisera
I. Provisions applicable to the production of all Sera from Living Animals
Part III: Diagnostic Antigens
I. Provisions Applicable to the Manufacture and Standardisation of Diagnostic Agents (Bacterial Origin)
Part IV: General
Part XIIB: Requirements for the functioning and operation of a blood bank and / or for preparation of blood components.
I. This section describes details about Blood Bank and Blood Components
- General
- Accommodation for a Blood Bank
- Personnel
- Maintenance
- Equipment
- Supplies and Reagents
- Good Manufacturing Practices (GMP’s) and Standard Operating Procedures (SOP’s)
- Criteria for Blood Donation
- General equipments and Instruments
- Special Reagents
- Testing Whole Blood
- Records
- Labels
II. This section describes the details about Blood Donation Camps
- Premises, personnel etc
- Personnel for Out-door Blood Donation Camp
- Equipments
- Accommodation
- Equipment
- Personnel
- Testing Facility
- Category of blood components
- Plasmapheresis, plateletpheresis, leucapheresis, using a cell separator
Part XIIC:
I. Requirements for manufacturing of blood products
- General Requirements
- Collection and storage of plasma for fractionation
- Personnel
- Production Control
- Viral Inactivation Process
- Quality Control
- Testing of Blood Products
- Storage of finished products
- Labelling
- Record
- Master Formula Records
Part XIID: Requirements for collection, processing, testing, storage, banking and release of umbilical cord blood derived stem cells
i. General Requirements
ii. Collection and storage of processed umbilical cord blood component
iii. Personnel
iv. Air Handling System
v. Quality Control
vi. Screening Test
vii. Storage
viii. Reference Samples
ix. Labelling
x. Record or Documents
xi. Cord Blood Release
Part XIII:
I. General
Schedule F(I):
Part I: VaccinesI. Provisions applicable to the production of bacterial vaccines
Part II: Antisera
I. Provisions applicable to the production of all Sera from Living Animals
Part III: Diagnostic Antigens
I. Provisions Applicable to the Manufacture and Standardisation of Diagnostic Agents (Bacterial Origin)
Part IV: General
Schedule F (II) (Rule 124-C):
- Standards for Surgical Dressings
Schedule F(III) (Rule 124-D):
- Standards for Umbilical Tapes
Schedule FF (Rule 126-A):
- Standard for Ophthalmic preparations
- Part A: Ophthalmic Solutions and suspension
- Part B: Ophthalmic Ointments
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