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
After these provisions and requirements, Drug and Cosmetic act prescribes the annexure for medical devices.
Annexure A: The manufacturer shall prepare a succinct document in the form of Device Master File containing specific information about the device manufacturing in the premises
Annexure B: The manufacturer shall prepare a succinct document in the form of Plant Master File containing specific information about the production and/or control of device manufacturing carried out at the premises.
Annexure C: Environmental requirement for Notified medical devices and in-vitro diagnostics
For more detail refer Drug and Cosmetic Act
Schedule M-III (Rule
69,69A, 75,75A and 76):
Schedule M-III describes the quality management system for
notified medical devices and in vitro diagnostics.
1.
General Requirements
2.
Applicability
3.
Term and definitions
§
Active implantable medical device
§
Active medical device
§
Advisory Notice
§
Customer Complaint
§
Implantable medical device
§
Component means any raw material, substance,
piece, part, software, firmware, labeling, or assembly
§
Design inputs means
§
Design output means
§
Design review means
§
Finished device means
§
In-vitro Diagnostic means
§
Management with executive responsibility means
§
Medical device referred
§
Quality audit means
§
Quality policy means
§
Quality system means
§
Rework means
§
Specification means
§
Validation means i)Process validation means ii) Design
validation means
§
Verification means
4.
Quality management system
§
General
§
Documentation requirements
·
General
·
Quality Manual
·
Control of documents
·
Control of records
5.
Management responsibility
§
Management commitment
§
Customer focus
§
Quality policy
§
Planning
·
Quality objectives
·
Quality management system planning
§
Responsibility, authority and communication
·
Responsibility and authority
·
Management representative
·
Internal communication
§
Management review
·
General
·
Review input
·
Review output
6.
Resource management
·
Provision of resources
·
Human resources
¨
General
¨
Competence, awareness and training
·
Infrastructure
·
Work environment
7.
Product
Realisation
·
Planning of product realization
·
Customer-related processes
¨
Determination of requirements related to the
product
¨
Review of requirements related to the product
¨
Customer communication
·
Design and development
¨
Design and development planning
¨
Design and development inputs
¨
Design and development outputs
¨
Design and development review
¨
Design and development verification
¨
Design and development validation
¨
Control of design and development changes
·
Purchasing
¨
Purchasing process
¨
Purchasing information
¨
Verification of purchased product
·
Production and service provision
¨
Control of production and service provision
Ø
General requirements
Ø
Control of production and service provision-Specific
requirements
§
Cleanliness of product and contamination control
§
Installation activities
§
Particular requirements for sterile medical
devices
Ø
Particular requirements for sterile medical
devices
§
General
§
Particular requirements for sterile medical
devices
Ø
Identification and traceability
§
Identification
§
Traceability
§
Status identification
Ø
Customer property
Ø
Preservation of product
¨
Control of monitoring and measuring devices
1.
Measurement, analysis and improvement:
·
General
·
Monitoring and measurement
¨
Feedback
¨
Internal audit
¨
Monitoring and measurement of processes
¨
Monitoring and measurement of product
·
Control of nonconforming product
·
Analysis of data
·
Improvement
¨
General
¨
Corrective action
¨
Preventive action
After these provisions and requirements, Drug and Cosmetic act prescribes the annexure for medical devices.
Annexure A: The manufacturer shall prepare a succinct document in the form of Device Master File containing specific information about the device manufacturing in the premises
Annexure B: The manufacturer shall prepare a succinct document in the form of Plant Master File containing specific information about the production and/or control of device manufacturing carried out at the premises.
Annexure C: Environmental requirement for Notified medical devices and in-vitro diagnostics
For more detail refer Drug and Cosmetic Act
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