Regulation of Pharma Sector in India

Regulating India's pharmaceutical sector ensures drug safety, efficacy, and affordability. Challenges include combating counterfeit medicines, ensuring quality control, and balancing innovation with public health needs, requiring robust regulatory frameworks.

Need for Regulation

  • Quality Assurance: Ensuring the production of safe, effective, and high-quality drugs is crucial, especially given India's role as a major exporter of generic drugs and vaccines.
  • Affordability: Regulations help in maintaining drug prices, ensuring that essential medicines are affordable for the population.
  • Compliance with Global Standards: To maintain its status as the 'Pharmacy of the World', India must comply with international standards, which necessitates stringent regulatory frameworks.
  • Innovation and R&D: Regulations ....
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