India faces a growing concern over the compromised safety, quality, and authenticity of medicines during their transit from manufacturers to consumers. The major problems include:
• Drug degradation due to poor handling, high temperatures, or improper storage.
• Mix-ups in hospital supplies, including wrong or expired medicines.
• Entry of substandard and spurious drugs into the supply chain.
• Lack of mandatory enforcement of transit-related quality controls.
Such risks pose a serious threat to patient health, erode public trust in healthcare systems, and weaken India’s position in the global pharmaceutical trade.
• Patients may receive medicines that have lost efficacy or become unsafe.
• Economic losses for manufacturers, pharmacies, and hospitals.
• India supplies over 20% of the global generic drug market.
• The Indian pharmaceutical industry is valued at over $50 billion and ranks third globally by volume.
Failure to address drug quality issues during transportation could affect both domestic healthcare and export credibility.
• Voluntary industry practices for secure packaging and storage.
• Cold chain systems for temperature-sensitive drugs used by large pharma firms.
• Internal audits in hospitals to track expired or damaged stocks.
• Limited barcoding and digital tracking by private pharmacy chains.
• No uniform legal requirement for maintaining drug quality during transit.
These measures remain fragmented and lack consistent implementation across the pharmaceutical sector.
The Central Drugs Standard Control Organisation (CDSCO) is introducing a nationwide initiative to enforce safe and transparent medicine transit through new regulatory measures.
• Every secondary drug pack must include:
• Product code
• Manufacturing and expiry dates
• Batch number
• Manufacturer’s license number
• This will enable complete end-to-end product traceability.
• Clear roles and digital records at every stage—from manufacturing to final sale.
• All stakeholders (transporters, distributors, retailers, and stockists) must comply with traceability standards.
• To be made legally binding under the Drugs Rules, 1945.
• Will define acceptable storage conditions, packaging standards, and stakeholder responsibilities.
• Aims to ensure uniform quality control during storage and transport.
• CDSCO is consulting with:
• Pharmaceutical manufacturers and trade associations
• Logistics and transport companies
• Hospital procurement officials and retail pharmacy chains
• The final policy will integrate multi-sectoral inputs for effective implementation.
• A cleaner and safer drug supply chain with reduced counterfeit and degraded medicines.
• Stronger regulatory infrastructure and greater compliance.
• Enhanced international confidence in Indian pharmaceuticals.
• A step forward toward ensuring universal access to safe and quality medicines.
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