In a key step to ensure drug safety, the government is preparing new rules to mandate barcodes on critical medicines to stop counterfeit sales and improve traceability.
The Union Health Ministry is preparing to amend the Drugs Rules, 1945, to make it mandatory for drug manufacturers to include barcodes or QR codes on labels of certain categories of medicines. This measure, aimed at improving authenticity verification and reducing the risk of counterfeit drugs, will cover antimicrobials, narcotics, vaccines, and psychotropic substances.
According to The Economic Times, this step comes after a series of incidents where expensive cancer drugs were found to be counterfeited and refilled by criminal networks working in collusion with hospital pharmacies. To address the issue, the drug regulator had earlier mandated barcodes for select cancer drugs. These barcodes provided access to batch details and manufacturing credentials, helping track products in the supply chain.
Following that model, barcoding was extended in 2023 to 300 of the most widely used medicine brands, including Dolo, Fabiflu, Saridon, Ecosprin, and Unwanted 72. These were selected based on data from Pharmatrac, a pharmaceutical market research firm. The goal was to ensure traceability across drugs with high retail turnover and wide patient use.
Despite years of delay due to resistance from some industry stakeholders, the Drugs Consultative Committee recently decided that the public interest outweighs industry concerns. The committee reviewed feedback during a consultation round held last month and has recommended moving forward with regulatory changes.
The barcoding system allows healthcare professionals and consumers to verify drug authenticity simply by scanning the code. Each code will provide data such as batch number, manufacturing license, and expiry details. Officials believe that this will help prevent fake drugs from entering hospital supply chains and pharmacies.
Although the proposal for barcode tracking has been in discussion since 2011, the renewed focus on drug security and patient safety has led to regulatory momentum. With these changes, India aims to strengthen drug traceability and protect patients from counterfeit risks in a more structured and technology-enabled way.
