New Delhi: In an attempt to improve supply-chain transparency and curb circulation of falsified and substandard medicines, the Union health ministry Thursday expanded its QR code-based drug traceability framework to cover vaccines, anti-cancer medicines, antimicrobials, and narcotic and psychotropic drugs.
The ministry notified the amendments to the Drugs Rules, 1945 bringing these categories under Schedule H2, which mandates the use of barcodes or QR codes on medicine packaging for authentication and verification.
Until now, the requirement largely applied to the country’s top 300 pharmaceutical brands by sales. The latest amendment significantly widens the framework’s scope by covering entire categories of medicines considered critical from a public health perspective.
According to the notification, manufacturers will be required to print or affix a barcode or QR code on the primary packaging label of these medicines, or on the secondary packaging where space is inadequate. The code must contain information that can be accessed through software applications to facilitate authentication and verification throughout the supply chain.
The QR code will carry details including the product’s unique identification code, generic and brand names, manufacturer details, batch number, manufacturing and expiry dates, manufacturing licence number, and information of non-reactive components wherever applicable.
The government said the measure is intended to improve tracking and verification of medicines and strengthen regulatory oversight. The health ministry has also linked the move to efforts to tackle antimicrobial resistance (AMR), saying enhanced traceability could help identify poor-quality and falsified antimicrobial products in circulation.
The rollout will take place in a phased manner. Provisions relating to vaccines, anti-cancer medicines, and narcotic and psychotropic drugs will come into force from 1 July 2027, while antimicrobials will be brought under the framework from 1 July 2028.
The move comes amid continued concerns over medicine quality in India. According to the health ministry’s monthly drug alert for May, the Central Drugs Laboratories identified 46 drug samples as Not of Standard Quality (NSQ), while State Drugs Testing Laboratories flagged another 113 samples as NSQ.
Jyotsna Govil, Chairperson of the Indian Cancer Society, Delhi, welcomed the inclusion of cancer medicines under the traceability framework. “Counterfeit and substandard medicines can have devastating consequences for cancer patients, whose treatment depends on timely access to genuine, quality-assured drugs. QR-based traceability will help improve transparency across the supply chain and enable patients, caregivers and healthcare providers to verify the authenticity of medicines more easily,” she told ThePrint.
However, she stressed that implementation will require strong enforcement, industry compliance, and widespread public awareness.
Meanwhile, senior researcher and legal advisor at Third World Network K.M. Gopakumar, who works on medicine access issues, told ThePrint that one should be cautious about viewing QR codes as a complete solution to the problem of falsified medicines. “QR codes may strengthen traceability but are not foolproof because they can be copied and replicated,” he said.
According to Gopakumar, the technology primarily improves tracking and verification rather than guaranteeing authenticity. “Batch number also gives you track and trace. These are not foolproof,” he said.
Authentication confirms a medicine’s identity and origin, while verification confirms it meets required quality standards.
He further argued that policymakers should also address the conditions that create demand for medicines sold outside regulated channels. He attributed the problem largely to affordability concerns. “Medicine prices are very high, so therefore many people cannot buy it,” he said, adding that patients often turn to heavily discounted products when genuine medicines are beyond their reach.
“The government should address the root causes which create a favourable environment for circulation of these types of products,” he said. “If I go to a government hospital, I should get free medicine there. If I go to a private hospital, medicines should be available at an affordable price.”
(Edited by Vidhi Bhutra)
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