(MENAFN- Live Mint)

New Delhi: India is set to tighten rules on the sale and distribution of four crucial life-saving medicine categories-vaccines, antimicrobials, narcotic and psychotropic drugs, and anti-cancer drugs-to safeguard public health, according to two government officials aware of the matter and documents reviewed by Mint.

As part of the plan, the government has proposed a major overhaul aimed at securing the pharmaceutical supply chain and protecting patients from counterfeit and substandard medicines.

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This revamp involves inserting a new section under Schedule H2 of the Drugs and Cosmetics Rules, 1945, which currently requires certain drug formulations to carry a bar code or quick response (QR) code on their packaging. The move aims to make product-level traceability mandatory for these four critical drug categories.

The move is vital for a country that is the largest global supplier of generic drugs, accounting for 20% of the world's supply by volume, and whose pharma market is projected to swell from its current $50 billion to $130 billion by 2030.

“The government is considering an amendment to the Drugs Rules, 1945, which will make product-level traceability mandatory for four of the most critical drug categories: all vaccines, all antimicrobials, all narcotic and psychotropic drugs, and all anti-cancer drugs. The move is set to focus on areas where the risk of fraud, diversion, or treatment failure poses the most significant threat to public health," said the first of the two government officials cited earlier, both of whom spoke on the condition of anonymity.

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Queries sent to the health ministry on Saturday remained unanswered till press time.

Notably, the initiative is seen as essential given the high-stakes nature of these medications.

Vaccines and anti-cancer drugs, for instance, are expensive, life-saving products where sub-standard quality can lead to dangerous consequences, including failure of treatment and high mortality rates. Furthermore, mandating traceability for narcotic and psychotropic drugs is a decisive action to prevent their diversion and illegal sale, curbing their potential for abuse. For antimicrobials, the measure is expected to boost the government's effort against antimicrobial resistance (AMR), as counterfeit or poor-quality antibiotics are known to accelerate the development of drug-resistant infections.

“The primary goal is to combat the menace of spurious products in India's pharmaceutical supply chain. The implementation of unique QR codes on each pack enables tracking and tracing of these critical medications from the manufacturer right up to the consumer," the official explained.

The health ministry, following consultations with the expert Drugs Technical Advisory Board (DTAB), has proposed amending the Drugs Rules, 1945, to mandate strict packaging for highly sensitive, high-value drugs under Schedule H2.

While public health experts welcome the intent behind the plan, they also highlight the need for continuous vigilance against evolving criminal tactics.

Dr. Rajeev Jayadevan, a public health expert and past president of the Indian Medical Association (IMA), Cochin Chapter, said that fake and substandard medicines put lives at risk.

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“Beyond tighter regulations and enforcement, the public must also be empowered to fight them. That's why expanding QR codes is a crucial step. Although they have been mandatory on India's top 300 drug brands since 2023, extending QR codes to all vaccines, antimicrobials, anti-cancer, and psychotropic drugs closes important gaps," he said.

Dr. Jayadevan emphasised that QR codes give each pack a unique ID, allowing real-time verification against a central database.“This lets consumers and pharmacists spot duplicates and track suspicious supply chain patterns. For example, even if some counterfeiters copy a few QR codes, when these duplicate codes are scanned at different pharmacies, they get flagged as duplicates. This immediately exposes the counterfeit operation, making large-scale fraud much harder."

However, industry experts stressed that the focus should extend beyond the final product packaging. Namit Joshi, director at Centrient Pharmaceuticals, said, "The problem involves both fake and substandard drugs. While track and trace helps limit fake drugs, even the barcoding can be imitated." Joshi suggested that the government should extend regulation to packaging material suppliers and conduct audits, restricting them from selling packaging material to non-licensed manufacturers. This measure, he said, is essential to effectively tackling the root of the counterfeiting problem.

Rajiv Singhal, general secretary at the All India Organisation of Chemists and Druggists (AIOCD) that represents over 1.2 million chemists, welcomed the government decision to mandate barcoding and QR code–based traceability for vaccines, antimicrobials, narcotic & psychotropic drugs, and anti-cancer medicines under Schedule H2.

“This progressive step will greatly strengthen the fight against counterfeit and substandard medicines and enhance patient confidence in the supply chain. Ensuring traceability from manufacturer to consumer is essential to protect public health and uphold the integrity of the pharmaceutical sector," Singhal said.

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