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 L (Omitted)
Schedule L-1 (Rule 74,78 and 150E):
Schedule L and Schedule L1:
Schedule L (Omitted)
Schedule L-1 (Rule 74,78 and 150E):
Schedule L describes the good laboratory practices and requirements of premises and equipments.
- General Requirements
- Premises
- Personnel
- Equipments
- Chemical and Reagents
- Good Housekeeping and Safety
- Maintenance, calibration, and validation of equipments
- Reference materials
- Microbiological Cultures
- Quality System
- Internal Quality system audit
- Management Review
- Standard Operating Procedures
- Protocols and specifications archive
- Raw Data
- Storage and archival
For more detail refer Drug and Cosmetic Act
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