India's pharmaceutical regulator is overhauling cold chain storage rules for vaccines and insulin. The government plans to classify medications as thermostable or thermolabile to prevent improper temperature storage that compromises drug efficacy. Currently, the Drugs and Cosmetics Act lacks specific classifications beyond vague instructions like "cold place." The new framework will define formulations requiring storage at or below 8 degrees Celsius as thermolabile drugs. CDSCO has identified 203 formulations including vaccines, insulin, and blood products needing strict oversight. This matters significantly for India's $12 billion biopharmaceutical market, which supplies 60% of global vaccines. Stronger enforcement during inspections will ensure consistent medicine quality across the supply chain.
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