Super Speciality medicines (like cancer drugs, biologics, vaccines, insulin, monoclonal antibodies, and other advanced therapies) require cold chain packaging because their effectiveness and safety depend on maintaining a strict temperature range during storage and transport.
Here’s why:
🔹 1. Temperature Sensitivity
• Many speciality drugs are biological molecules (proteins, enzymes, antibodies).
• These molecules lose their structure and activity if exposed to heat, freezing, or temperature fluctuations.
🔹 2. Stability & Shelf Life
• If the medicine is not stored in its recommended range (commonly 2°C to 8°C), its potency reduces.
• Even short exposure to wrong temperatures can make the drug ineffective or harmful.
🔹 3. Patient Safety
• A degraded medicine may not only lose efficacy but could also cause adverse reactions.
• For example, chemotherapy drugs and biologics can become toxic if denatured.
🔹 4. Regulatory Compliance
• Agencies like WHO, US FDA, CDSCO (India) strictly mandate cold chain logistics for certain medicines.
• Pharmacies, hospitals, and distributors must prove that temperature was maintained until delivery.
🔹 5. High Cost & Critical Use
• These drugs are often life-saving and very expensive (₹10,000 to ₹5 lakh per dose).
• Any wastage due to poor storage means huge financial and patient loss.
🔹 6. Global Distribution
• Super speciality medicines are often imported or shipped long distances.
• Cold chain ensures the medicine reaches the patient in the same quality as manufactured.
Cold chain packaging = Protects potency, ensures patient safety, reduces wastage, and complies with law.