6 min readNew DelhiJun 26, 2026 07:00 AM IST
First published on: Jun 26, 2026 at 07:00 AM IST
Manufacturers of all vaccines, antimicrobials, addictive medicines and cancer drugs will be required to affix a QR-code on the package that can identify each unit of a drug, thereby helping regulators trace its complete journey from the manufacturing unit to the market.
The change in packaging will be slowly implemented over the next two years — by July 2027 for vaccines, narcotics, and anticancer drugs and by July 2028 for antimicrobials, according to the gazette notification June 22 published on Thursday.
This QR-code based tracking is already applicable to top 300 brands of medicines at present. This sort of granular tracking of every vial or strip of every product reduces the likelihood of counterfeit drugs entering the market. This is significant considering the drug regulator was aware — and an Indian Express investigation revealed — how unscrupulous players were refilling empty vials of expensive cancer-drugs with other products such as antifungal medicine and selling it to unsuspecting cancer patients.
What is QR-code based tracking?
Manufacturers of all medicines listed under the Schedule H2 of the Drugs Rules are required to affix a unique barcode or QR code on the primary package of the medicine — or in case of dearth of space on the secondary packaging of the product. What this means is the unique identification code should be ideally on the packaging in contact with the drug — the bottle, the blister pack, or the vial in which the drug is present. Only if that is not possible, the companies can affix the code on the outer boxes.
In addition to the unique identification number for each unit, the QR code will also contain information such as name and address of the manufacturer, manufacturing and expiry dates, and batch number.
Specialised track and trace platforms will be able to access this information and verify the journey of each single unit of the product to the market. Usually, drug packages only carry a batch number that can easily be copied by counterfeiters.
“The enhanced traceability mechanism will facilitate authentication of medicines at various stages of the supply chain and enable improved tracking and verification of drug products. The measure is expected to strengthen regulatory oversight and support efforts to curb the distribution of spurious medicines in the market. It will also contribute to the national fight against Antimicrobial Resistance (AMR) by enabling better identification and monitoring of counterfeit and substandard antimicrobial products,” the Health Ministry said.
An industry expert explained how “with each unit of the drug carrying a unique code, counterfeiting will become difficult. Of course, sometimes counterfeiters may use the same packaging to beat the system. But even then, it would only work if the fake product is purchased and logged into the system before the genuine product. This is a good move towards ensuring that only genuine products enter the market — it helps the industry because counterfeiting is a real challenge.”
Importantly, the government has given enough time for implementing the changes, so companies should be able to exhaust the current stock before the new packaging becomes mandatory.
Counterfeiting and cancer drug
An Indian Express investigation earlier this year revealed that a counterfeiting ring in Delhi-NCR was buying empty and used vials of a very expensive cancer drug called Keytruda. They were refilling it with anti-fungal medicine and reselling it for cheaper to desperate cancer patients. While the immunotherapy drug can work wonders for certain types of cancers — sometimes dissolving the tumours completely — it remains largely inaccessible in India owing to its high cost.
The drug costs around Rs 2 lakh per cycle, with patients usually administered anywhere between 12 and 17 cycles. Even with patient assistance provided by the company, patients would have to shell out around Rs 10 lakh for the drug, on top of other costs associated with cancer treatment.
This matter was first discussed in 2024 by the Drug Technical Advisory Board under the country’s apex drug regulator. The board said, “These anti-cancer drugs must be issued under strict directives to implement mandatory QR codes and rigorous track and trace mechanisms on every vial and strip of medication that are marketed in India…. DTAB deliberated the matter and agreed for the proposed amendment to include all Anticancer Medicines under Schedule H2.”
Regulatory maturity
This measure is also geared towards improving the maturity level of India’s drug regulator. One of the requirements by a drug regulator for achieving the highest ranking as per the WHO classification is the implementation of such track and trace mechanism.
The sub indicator mandates “legal provisions and regulations …for placement of a product’s unique identification number on its outer packaging.”
In another meeting held in January 2024, the DTAB said: “to fulfil the requirements of sub indicator 1.05 … for Maturity Level 4, it is required to make legal provision or regulations for affixing of unique identification number on outer packaging of each vaccine product.” India is already at maturity level 3 for vaccine products.
The expert body further deliberated and said: “the same may be extended to all antimicrobials, narcotic and psychotropic substances in a phase wise manner.”
According to a gazette notification dated June 22, the change in packaging will be implemented over the next two years -- by July 2027 for vaccines, narcotics and anti-cancer drugs, and by July 2028 for antimicrobials.
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