DCGI Asks States To Mandate Display Of PvPI QR Code At All Pharmacies

In a move aimed at strengthening drug-safety ecosystem in the country, the Drugs Controller General of India (DCGI) has directed all State and Union Territory drug regulators to ensure that a Quick Response (QR) code for reporting adverse drug reactions is prominently displayed in every retail and wholesale pharmacy across the country.

The directive follows the recommendations of the 16th Working Group Meeting of the Pharmacovigilance Programme of India (PvPI), held a few months ago.

The initiative is expected to significantly boost patient participation in reporting adverse events, an area where under-reporting has long been a challenge.

According to the circular issued by DCGI Dr. Rajeev Singh Raghuvanshi, drug licensing authorities must ensure that the designated QR code—shared by the Central regulator—is placed at a clearly visible location in all pharmacy premises. Alongside the QR code, the toll-free helpline number (1800 180 3024) of PvPI must also be displayed to enable easy reporting.

“This measure will facilitate seamless reporting of Adverse Events and Adverse Drug Reactions (AE/ADRs) by the public and healthcare professionals through PvPI’s indigenous Adverse Drug Reaction Monitoring System (ADRMS),” Dr. Raghuvanshi noted in the communication to stakeholders.

The DCGI has also instructed State and UT regulators to widely disseminate the directive among license holders and strictly monitor compliance.

Kamal Ranjan Chawla, Deputy Drugs Controller DCGI in a similar advisory to the pharmacy associations said, “…in the public interest, it is hearby instructed to retail/pharmacy/chemist stores to display QR Code and the PvPI toll-free number in their premises at a prominent place open to public, so as to facilitate consumer participation in reporting ADRs and further submission of AEs/ADRs through the indigenous software, ADRMS.”

The Indian Pharmacopoeia Commission (IPC)—which serves as the National Coordination Centre for PvPI—has developed the online reporting platform ADRMS linked to the QR code.

The first-of-its-kind system aims to simplify reporting by allowing consumers and healthcare workers to instantly upload information through their mobile devices. The IPC has already advised that the QR code and toll-free number be displayed in all pharmacy outlets nationwide.

In September, the pharma sector had organised the National Pharmacovigilance Week under the theme “Your Safety, Just a Click Away: Report to PvPI,” with an aim to sensitise healthcare professionals, regulators, researchers and the public to proactively report ADRs through user-friendly digital platforms.

India’s pharmacovigilance capacity received a major upgrade last year with the launch of PvPI’s indigenous ADRMS software—unveiled by Union Health Minister JP Nadda on August 19, 2024.

The system serves as the country’s first medical product safety database tailored to Indian requirements and enables real-time collection and analysis of adverse events linked to medicines and medical devices.

Officials say that the data generated through ADRMS will play a pivotal role in strengthening regulatory decision-making. Insights derived from the system will assist the Indian Pharmacopoeia Commission in submitting evidence-based recommendations to the Central Drugs Standard Control Organisation (CDSCO), helping ensure safer and more rational use of medicines across the country.