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The Gujarat Food and Drug Control Administration has recently exposed a clandestine operation involving the inter-state distribution of counterfeit drugs using fake QR codes. The Gujarat FDCA’s investigation has revealed a sophisticated nexus of wholesalers and distributors engaged in illegal trade of fake medicines, camouflaged under seemingly legitimate QR codes on product packaging. The scale and method of the operation suggest the involvement of an organized cybercriminal network possessing advanced technical capabilities. The FDCA is now probing whether these fake QR codes were generated through data theft, illegally obtained from manufacturing units, or manipulated by cybercriminals with high-level expertise. The QR code on medicines was introduced by the Union Health Ministry some time back to boost the pharmaceutical industry’s efforts to maintain the authenticity of medicines in the country. The Ministry on June 16, 2022 had issued a draft Rule making QR code mandatory on the packaging of top 300 brands of life-saving medicines from August 1, 2023. The draft Rule introduced a new Schedule H2 with a list of 300 top brands, and inserted a new sub-rule under Rule 96, under the Drugs and Cosmetics Rules, 1945, after the sub-rule (5). As per the new sub-rule named as (5A), the manufacturers of drug formulation products specified in the Schedule H2 of the Rule, should print or affix barcode or QR code on its primary packaging label. In case of inadequate space in primary package label, it should be printed on the secondary package label that store data or information legible with software application to facilitate authentication.
Of course, distribution of counterfeit medicines has recently emerged as a global issue, and the Indian market was no exception. Under this backdrop, the Health Ministry’s move to introduce QR code was a well considered decision as it would help trace source and affirm authenticity of medicines while also improving patient health and safety. The ministry’s move in this regard was in line with the recommendation of the Drugs Technical Advisory Board (DTAB), which had recommended introduction of barcode or QR code on the top 300 brands of medicines available in the Indian market to help track and trace these brands. The QR code, which will prevent the sale of counterfeit drugs, will also verify whether a drug is genuine or counterfeit, and will include information such as the company, manufacturer, expiry date, and brand name, among other things. The QR code was introduced not only to identify misbranded or counterfeit pharmaceutical products but also to help to recall these products if there is a quality issue with the product. It is true that the pharmaceutical companies leave no stones unturned to maintain the authenticity of medicines and to make sure that counterfeit medicines are eradicated from the market. The introduction of QR code on medicine packages was to offer transparency about the manufacturing process, contents of the medicines and the expiry date. A QR code can allow easier access to information on the prescribed medicine by the patient. The patient does not need to solely rely on the information physically printed on the packaging of the medicine. Also, the information about the medicine can be easily shared to others if required. The information stored through a QR code is much more dynamic and engaging, and these codes can even allow for better data monitoring by a pharmaceutical company. Overall, it was a welcome move by the government. But, the Gujarat FDCA’s recent findings now raise serious concerns about the security of the QR code system and its vulnerability to tampering. The government should urgently intervene in the matter to plug the loopholes in the system.
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