As part of the plan, the government proposed a major overhaul aimed at securing the pharmaceutical supply chain and protecting patients from counterfeit and substandard medicines.
This amendment involves the insertion of a new section in Schedule H2 of the Drugs and Cosmetics Rules 1945, which currently requires certain dosage forms to bear a barcode or quick reaction (QR) code on the packaging. The aim of this step is to introduce a product-level traceability obligation for these four critical categories of medicines.
The move is vital for the country, which is the world’s largest supplier of generic drugs, accounting for 20% of the world’s supply by volume, and whose pharmaceutical market is expected to grow from the current $50 billion to $130 billion by 2030.
“The government is considering an amendment to the Drug Rules 1945 that will make product-level traceability mandatory for the four most critical categories of drugs: all vaccines, all antimicrobials, all narcotic and psychotropic drugs and all cancer drugs. The move is intended to target areas where the risk of fraud, misuse or treatment failure poses the most significant first threat to public health,” the official said. cited earlier, both spoke on condition of anonymity.
Inquiries sent to the Department of Health on Saturday remained unanswered as of press time.
In particular, this initiative is considered essential given the high nature of these drugs.
Vaccines and cancer drugs, for example, are expensive, life-saving products where substandard quality can lead to dangerous outcomes, including treatment failure and high mortality. In addition, the regulation of the traceability of narcotic and psychotropic drugs is a decisive measure to prevent their abuse and illegal sale and to limit their potential for abuse. For antimicrobials, the measures are expected to boost the government’s efforts against antimicrobial resistance (AMR), as counterfeit or low-quality antibiotics are known to accelerate the development of drug-resistant infections.
“The primary objective is to combat the menace of counterfeit products in India’s pharmaceutical supply chain. The implementation of unique QR codes on each package enables tracking and tracing of these critical drugs from the manufacturer to the consumer,” the official explained.
The Ministry of Health, in consultation with the Drugs Technical Advisory Board (DTAB), proposed an amendment to the Drugs Rules, 1945 to mandate strict packaging for highly sensitive, high value drugs under Schedule H2.
While public health experts welcome the intent of the plan, they also stress the need for continued vigilance against evolving criminal tactics.
Dr. Rajeev Jayadevan, public health expert and former president of the Indian Medical Association (IMA), Cochin Chapter, said fake and substandard medicines are putting lives at risk.
“Apart from stricter regulation and enforcement, the public must also be empowered to fight against them. Therefore, the expansion of QR codes is a crucial step. Although they are mandatory for India’s top 300 drug brands from 2023, the expansion of QR codes to all vaccines, antimicrobials, anticancer and psychotropic drugs closes important gaps,” he said.
Dr. Jayadevan emphasized that QR codes give each pack a unique ID, allowing for real-time verification against a central database. “This allows consumers and pharmacists to detect duplicates and track suspicious supply chain patterns. For example, even if some counterfeiters copy several QR codes, when these duplicate codes are scanned at different pharmacies, they are flagged as duplicates. This immediately detects counterfeit operations, making large-scale fraud much more difficult.”
However, industry experts emphasized that the focus should extend beyond the packaging of the final product. Namit Joshi, director of Centrient Pharmaceuticals, said: “The problem is both fake and substandard drugs. While tracking and tracing helps curb fake drugs, barcodes can also be imitated.” Joshi suggested that the government extend regulation to packaging material suppliers and conduct audits to restrict them from selling packaging material to unlicensed manufacturers. According to him, this measure is essential to effectively address the root of the counterfeiting problem.
Rajiv Singhal, general secretary of the All India Organization of Chemists and Druggists (AIOCD), which represents more than 1.2 million chemists, welcomed the government’s decision to mandate barcode and QR code-based traceability of vaccines, antimicrobials, narcotics and psychotropics and cancer drugs under Schedule H2.
“This progressive step will significantly strengthen the fight against counterfeit and substandard drugs and strengthen patient confidence in the supply chain. Ensuring traceability from manufacturer to consumer is essential to protect public health and maintain the integrity of the pharmaceutical sector,” Singhal said.
