India moves to bolster global trust in medicines with real-time tracking

India is digitizing its drug regulatory framework by replacing manual ledgers with a QR-code-based tracking system and mandatory videography to eliminate corruption in sample testing. News India moves to bolster global trust in medicines with real-time tracking Priyanka Sharma 5 min read 17 Feb 2026, 05:10 am IST The plan utilizes digital tools to map every step of a drug sample’s journey from the pharmacy shelf to the laboratory. Summary India is digitizing its drug regulatory framework by replacing manual ledgers with a QR-code-based tracking system and mandatory videography to eliminate corruption in sample testing. Gift this article This is a Mint Premium article gifted to you. Subscribe to enjoy similar stories. Subscribe now 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. Also Read | Regulator plans to increase risk-based inspection to check spurious drugs 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. Key Takeaways Drug inspectors must transition to a 100% digital reporting system via a dedicated mobile app and the SUGAM portal. Mandatory videography and photography will document every stage, from shelf-sampling to lab-weighing, to prevent sample swapping. Every sample will carry an encrypted QR code with a timestamp, ensuring a transparent chain of custody during transit. Laboratories will adopt forensic-level SOPs, requiring two-person verification for critical testing steps like weighing and dilution. The move is expected to reduce legal disputes between pharma companies and regulators over mishandled samples during transport. 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 immediate detection. Documentation in the required format will be e-signed on-site, and the digital form will be forwarded to the laboratory in real time via the SUGAM portal, eliminating the risk of data manipulation during transit. SOPs laid downThese guidelines have been prepared by a high-level sub-committee of the DCGI, which submitted its report in the Drugs Consultative Committee meeting held in November, proposing the total digital transformation of drug sampling and testing procedures across the country. The sub-committee—constituted in September 2023—was headed by Dr Saroj Kumar Gosh, director, Central Drugs Laboratory (CDL) Kolkata. CDL is the primary institution responsible for quality control of drugs in India. The sub-committee noted that digital platforms could be leveraged to prevent “corruption" by reducing the scope for arbitrary decision-making. The main objective of the drug sampling is to check the quality and efficacy of drugs and cosmetics available in the market against their approved specifications. 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 immediate detection. Also Read | India looks to harden drug law to curb opioid abuse Documentation, in the requisite format, will be e-signed on-site, and the digital form will be forwarded to the laboratory in real-time via the SUGAM portal—a government platform, leaving no room for data manipulation during transit. Upon arrival at the testing facility, the process becomes even more rigorous following stringent evidence-handling procedures found in forensic laboratories. The sub-committee has recommended that laboratory heads visit Central Forensic Laboratories (CFL) to study their standard operating procedures (SOPs) for evidence preservation. When a parcel is received at the lab, it must be opened under the supervision of a technical manager in the samples section. The QR code must be scanned to verify i