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

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 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 down

These 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.

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 its identity, and the unsealing must be video-recorded. This ensures that the laboratory receives exactly what the inspector sent, with no possibility of "sample swapping" behind closed doors.

The integration of these technologies into the SUGAM portal ensures that the entire lifecycle of a drug test is tracked digitally.

Documenting procedure

The report suggested that after the sample is approved for testing, it is allotted to a government analyst. Even the internal movement of the sample within the lab is digitized. If a sample is divided into different sections—such as chemical analysis and microbiology—each sub-sample is assigned its own QR code to maintain a log of used and unused portions.

The sub-committee’s report stresses that the most important potential failure points are the preparation stages.

Consequently, the weighing of standard samples and the preparation of test solutions must be witnessed by a second official and recorded on video. These dilution records must be signed both digitally and on physical raw datasheets by the analyst and the witness, providing a dual layer of accountability.

The report said that after the analyst completes the testing, the results are submitted through the SUGAM portal for a thorough review by the government analyst, who then releases the final test report within the strict timelines mandated.

Even the storage of remaining samples as control units will be documented via videography to prevent unauthorized disposal.

The framework is intended to be mandatory for both the Central Drugs Standard Control Organisation (CDSCO) and State Drug Control administrations to ensure a uniform, pan-India standard for drug surveillance.

“This comprehensive digital trail creates a permanent, auditable record that higher authorities can access at any time to verify the validity of a drug test. The government is seeking to make the system more transparent using digital technology," said one of the two officials.

Ritesh Shah, joint managing director, Anuh Pharma Ltd, a listed bulk drug company, said, “In practice, a significant proportion of quality-related disputes arise not from manufacturing deficiencies but from questions around sampling conditions, storage, transportation, and handling of samples collected from the market."

Shah further said that if implemented with clear protocols and adequate transition time, QR-coded sampling and videography can significantly strengthen the credibility, traceability, and fairness of the drug quality surveillance system.

Removing fakes

GL Singhal, former Haryana drug controller, stated, “Drug sampling is essential; without it, a drug inspector is incomplete and cannot truly perform his duty. He is a ‘toothless tiger’ without the dual weapons of sampling and inspection. However, sampling is only as good as the laboratory."

Medical experts said that transparency will bring improvement

Dr Sanjay Rai, professor at community medicine department at AIIMS, said, “Now, suppose we picked up any sample and sent it from there, but in between—during transport or after reaching the laboratory—if there is an influential person, they can have the sample changed. So, if all this documentation is done properly, it is better." Dr Rai further added that counterfeit medicines can be easily weeded out thanks to transparency.