India moves to bolster global trust in medicines with real-time tracking
Subscribe to enjoy similar stories. New Delhi: In a move to enhance transparency and curb corruption in India’s pharmaceutical regulatory process, the Union government is working on a plan to overhaul drug sampling and testing procedures, according to two officials and documents reviewed by Mint.
Aimed at eliminating human interference, the plan utilizes digital tools to map every step of a drug sample’s journey from the pharmacy shelf to the laboratory, with authentication via real-time mobile applications, unique QR codes, and mandatory videography. This comes against the backdrop of a growing realization that traditional manual inspection and testing methods were vulnerable to manipulation in India’s $50 billion pharmaceutical market.
The plan has been put in place on the recommendation of a high-level committee set up by India’s apex drug regulator, the Drugs Controller General of India (DCGI), after over a year of deliberation and site studies. The new guidelines applicable to India’s 2,000 drug inspectors (DI) state that an inspector is no longer permitted to simply bag a sample and fill out a manual ledger.
Instead, the DI must carry a portable printer for every site visit and, upon selecting a sample, open a dedicated mobile application to enter sample details, which then generates a unique QR code with an encrypted timestamp. Queries sent to the health ministry and DCGI office on Monday remained unanswered.
Also, the process does not end with paperwork, the inspector captures multiple images and videos of the sampling and sealing process through the app. This digital evidence is linked to the physical sample via the generated QR code, ensuring that the package cannot be tampered with or replaced without
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