India Pharma Outlook Team | Wednesday, 16 July 2025
An appeal has been made to the Prime Minister by Sumanata Kumar Tiwari, the joint director-cum-drug controller of Jharkhand, for a significant overhaul of the current regulatory framework to combat the escalating menace of counterfeit medicines in India. In a letter, the severe health hazards posed by spurious drugs and their detrimental impact on national tax collection were highlighted by Tiwari.
The government's previous efforts, such as the mandatory QR/ barcode requirement for the top 300 drug brands, were acknowledged by Tiwari, as stipulated in the ministry of health and family welfare's Notification No. G.S.R.823 ( E). He emphasized, the current standards have serious flaws that counterfeiters are taking advantage of, making them essentially useless. He drew attention to the lack of clarity surrounding the usage of bar codes or straightforward QR codes, which are readily copied, as well as the fact that these codes can be applied to secondary packaging, making it impossible for customers to confirm authenticity at the time of use.
A major concern raised in the letter is the absence of a mandatory serialization requirement for individual customer-facing units (CUs). it was explained by Tiwari that without a unique serial number on each blister pack, vial, or bottle, individuals products cannot be authenticated by buyers, making it difficult for fake drugs to be detected within a batch. Given that manufacturers frequently lose track of items once they leave their C& F agents and travel through distributors, retailers, and end users, the letter further emphasized the absence of a strong system for batch recalls.
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Frustration was also expressed by Tiwari over the perceived lack of accountability and action from key governmental bodies despite mounting evidence and repeated complaints regarding the proliferation of fake medicines.
