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Pharma Sector Quality Issues - Coggle Diagram
Pharma Sector Quality Issues
Context
This is not the first time that Indian pharma companies have faced allegations of exporting contaminated or substandard drugs
Indian pharma companies have been under constant international scrutiny for exporting allegedly contaminated drugs
India’s Pharma Sector: A Backgrounder
The second stage covers 1970 to 1990 when several domestic companies began operations
1990 to 2010 is the third stage, where liberalization led Indian components to launch operations in foreign countries
At that time, the Indian market was dominated by foreign companies
The introduction of the patent bill was one of the first advancements in the pharma industry.
The time before 1970 is considered as the first stage of the pharma industry
Market Size
India’s domestic pharmaceutical market is at US$ 42 billion in 2021 and likely to reach US$ 65 billion by 2024 and further expand to reach ~US$ 120-130 billion by 2030
India’s biotechnology industry comprises biopharmaceuticals, bio-services, bio-agriculture, bio-industry, and bioinformatics
According to the Indian Economic Survey 2021, the domestic market is expected to grow 3x in the next decade
Who regulates Indian Pharma Sector?
This also established the Central Drugs Standard Control Organization (CDSCO)
It establishes the regulatory control over the manufacture and sale of drugs.
It clearly defines the spurious drugs, adulterated drugs and mis-branded drugs.
State Health department has to regulate the manufacturing, sales and distribution of drugs
Drugs and Cosmetics Act, 1940 was the central legislation
Drug Inspectors will control the implementation at ground level
Various govt. policies
Bulk Drug Parks Scheme 2020
Production Linked Incentive Scheme
Bhartiya Janaushadhi Pariyojana
Strengthening of Pharmaceutical Industry (SPI) Scheme, 2022 Budget
100% FDI in Greenfield projects and 74% FDI in brownfield projects
Various challenges
Dependence on China for API
Plagiarism
Hostile competition
Domestic drug price control
FDA mandate in US
Burden of new diseases
Low spending on R&D
Way forward
Quality Control Measures
Promote Ethical Practices
Increased Pharmacovigilance
Strengthen Post-Marketing Surveillance
Enhance Regulatory Capacity
Strengthen Regulatory Framework
Consequences of
Ineffective Regulations
Antibiotic Resistance
Lack of Drug Innovation
Increased Healthcare Burden
Unsafe Clinical Trials
Public Health Risks
Erosion of Public Trust
Substandard or Counterfeit Medicines