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The menace of counterfeit medicines has been a major issue the world has been facing for a long time now, and the Indian market was no exception. The front pages of the Indian newspapers have very often been carrying the reports of distribution of counterfeit drugs in the Indian pharmaceutical market. The menace became so rampant that the Union Health Ministry was forced to introduce QR code on medicines to boost the pharmaceutical industry’s efforts to maintain the authenticity of medicines in the country. The Ministry on June 16, 2022 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 formulations 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. No doubt, the Ministry’s move to introduce QR code was a well considered decision to 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.
Of course, it was a welcome move by the government. But, the heartless counterfeiters have gone one step further as recent investigations by the drug authorities have exposed a clandestine operation involving the inter-state distribution of counterfeit drugs using fake QR codes. The Gujarat FDCA’s recent investigation is a case in point as it 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 confiscation of spurious Levipil 500 mg tablets by the drug authorities in Telengana during raids in Hyderabad and Karimnagar is yet another case in point. What makes this situation particularly dangerous is that all seized counterfeit Levipil products possess active QR codes that, upon scanning, falsely authenticate the drugs as genuine. This alarming loophole provides a false sense of security to both the consumers and inspectors, allowing potentially harmful fake medicines to be circulated undetected. These cases may not isolated incidents. There is lack of accountability and action from governmental despite mounting evidence and repeated complaints regarding the proliferation of fake medicines. There can be no difference of opinion, this is an alarming public health crisis. The government should urgently intervene in the matter to plug the loopholes in the system.
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