India Pharma Outlook brings the biggest regulatory developments shaping safety, compliance, and growth in 2025.
The country’s pharmaceutical sector, long recognized for its manufacturing scale and innovation, is now benefiting from a more robust governance framework that aligns domestic practices with global benchmarks. This proactive regulatory approach is intended not only to safeguard patient health but also to enhance India’s reputation as a trusted supplier of high-quality medicines worldwide.
A major step in this direction is the government’s plan to reinforce WHO benchmarking for drug regulation, signaling its commitment to elevate domestic standards and align them with international expectations. Complementing this, the Central Drugs Standard Control Organization (CDSCO) has launched the ONDLS system to track high-risk pharmaceutical solvents, ensuring tighter oversight and improving compliance across manufacturing units. These measures enhance operational transparency, mitigate risks, and foster confidence among global stakeholders and domestic consumers alike.
Patient safety is further strengthened through mandatory QR codes on vaccines, anticancer medications, and narcotic drugs, providing traceability and reducing the risk of counterfeiting. In parallel, India has initiated a probe into anti-dumping practices related to TB drug ingredient imports, reflecting vigilance against unfair trade and protecting domestic manufacturers. Collectively, these regulatory interventions demonstrate a forward-looking, globally aligned approach, positioning India as a resilient and responsible pharmaceutical hub, capable of supporting long-term industry growth, innovation, and international trust.
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