Buyer beware: On the QR code-based drug traceability framework

The Health Ministry’s notification to expand Schedule H2 drugs to entire therapeutic classes now from a curated list of brands earlier is a commendable change from regulating based on revenue to regulating based on risk. The government had introduced Schedule H2 in 2022-23, which required a barcode or QR code on each pack of specific drugs to verify the pack’s authenticity. It is part of a framework that also touches on regulating active pharmaceutical ingredients and export-oriented pharmaceutical compliance. Now, with the additional symbols encoding a product identifier, the manufacturing licence number, batch number, and other details, authorities hope to better track down defective batches. Counterfeit networks have long targeted vaccines, cancer medicines and antimicrobials, with WHO flagging high volumes of fake antimicrobials in low- and middle-income countries. India has one of the world’s highest antimicrobial resistance rates, and substandard antimicrobials can lead to sub-therapeutic dosing, exerting selection pressure on resistant strains. The Narcotics Control Bureau has also expressed concerns about medicinal opioids and psychotropic substances ‘leaking’ into illicit markets. The government will hope that the new system addresses the U.S. FDA’s and the European Medicines Agency’s recurring concerns about quality control, an issue on which India has found itself on the back foot over contaminated cough syrups. The U.S. Trade Representative has also repeatedly identified India as a leading source of counterfeit medicines, with many fake pharmaceuticals seized at the U.S. border originating from or transiting through India.