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 The deaths of children due to diethylene glycol (DEG) contaminated medication, such as those traced to the operations of Sresan Pharma in Tamil Nadu, serve not as isolated incidents but as damning evidence of a catastrophic, nationwide failure in India's public drug procurement and regulatory framework, according to regulatory expert Sumanta Kumar Tiwari of Jharkhand FDA.
The crisis exposes a healthcare system riddled with inconsistencies, absence of accountability, and a dangerous over-reliance on administrative rather than criminal responses to mass fatalities, he says.
In a telephonic interview with Pharmabiz, Tiwary said the specific failure at the manufacturing level, such as the Kancheepuram-based Sresan Pharma, highlights a profound lapse in local regulatory vigilance. Records show that the regulator had previously issued 51 adverse observations to the company, all of which were ignored, yet the response to the subsequent deaths was purely administrative. This systemic unwillingness to pursue criminal prosecution against company directors, opting instead for show-cause notices and administrative action, effectively shields those responsible and guarantees that lethal quality lapses will be repeated, said the JDC of Jharkhand, who is known for actively pursuing violators.
“This local tragedy transitions into a larger, national scandal, driven by the absence of a unified, technology-driven national procurement policy. Despite central funding, there is no uniform standard or consistent pricing mechanism across states, leading to an environment where patient safety is compromised by market inefficiencies,” he told Pharmabiz.
Tiwari argues that only an aggressive adoption of technology and a stringent overhaul of enforcement can secure the lives of patients dependent on public health schemes.
The fragmentation of procurement models, from centralized systems in Kerala and Tamil Nadu to decentralized systems in Maharashtra and Jharkhand, creates inconsistent standards and immense supply chain inefficiencies. Furthermore, Comptroller and Auditor General (CAG) audits repeatedly expose substandard medicine quality, poor recordkeeping, and a failure to conduct mandatory pre-dispensing tests across major government supply chains, including CGHS and Ministry of Defense institutions.
Compounding the problem, drug distribution suffers from poor IT enablement, manual documentation, and a complete lack of real-time inventory management, leaving no standard method for enforcing quality checks or tracking expiry dates effectively. To solve this crisis, Tiwari advocates for a seven-point technology-driven reform roadmap, centered on enforcing a ‘One India One L1 Rate’ policy for bulk procurement via a single, unified digital portal. Key to this is mandatory implementation of 7-layered QR code verification for every consignment, integrating e-Governance and AI-powered supply chain analytics to minimize bottlenecks and predict shortages, ensuring NSQ drugs are flagged instantly.
According to him, these suggested reforms are essential to address India's recurring public procurement failures. Continuous learning and technology upgradation must be institutionalized across all government health procurement agencies, supported by stringent quality control and citizen oversight, to ensure tragedies involving contaminated medicines do not repeat.
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