Pharmaceutical Regulation

Why it matters

• Protects public health by preventing the circulation of substandard, spurious, or adulterated drugs that pose risks to patient safety.
• Ensures equitable access to affordable essential medicines while maintaining a balance between innovation and generic drug availability.
• Maintains international credibility for the domestic pharmaceutical industry, facilitating global trade and compliance with international quality benchmarks.
• Establishes accountability mechanisms for manufacturers and distributors to ensure ethical practices and transparency in the supply chain.

How it is asked

Focus on the role of statutory bodies in drug licensing, the balance between intellectual property rights and public health, the challenges of regulating the digital pharmacy sector, and the implementation of Good Manufacturing Practices (GMP) to ensure quality control.