Self-Verification Cannot Be the Last Line of Defence Against Counterfeit Cancer Drugs

Every 21 days, I sit in an infusion chair and receive targeted therapy for my cancer. When I am advised to photograph the package before each infusion, I do so, assuming it is a routine procedure. It never occurred to me to verify the batch and serial number or enquire about the distributor. As a patient, I followed instructions and trusted the system because when you are ill, exhausted, and dependent, trust is not really a choice. 

I say this as someone who has spent three decades working on women’s health, access to medicines and the politics of healthcare. I knew counterfeit drugs existed. Yet, in that infusion chair, I never thought of questioning the vial in front of me. That gap between professional knowledge and the vulnerability that illness creates. This is what illness does. And that is precisely the point.

It wasn’t until I read a recent investigation by a newspaper into the black market for a cancer immunotherapy drug priced at over Rs 1.5 lakh per vial, that I understood the significance of that photograph and how little protection it actually offered. According to the newspaper reports, a highly organised network of pharmacists, middlemen, and hospital insiders were collecting used or empty vials, refilling them with other substances, resealing them with authentic batch numbers, and selling them to desperate patients at a discount across some of India’s most trusted hospitals. I am not on that particular infusion, but the report was not about a single drug. It revealed vulnerabilities that extend to patients across oncology wards in India.

Counterfeit drug networks

In March 2024, Delhi Police uncovered an alleged counterfeit cancer-drug network involving fake versions of expensive immunotherapy medicines. Used vials were allegedly refilled with an antifungal substance, and thousands of doses were distributed across India and abroad through illicit supply chains. 

The ICIJ investigation mapped eleven points in the journey of a single vial from prescription to delivery to disposal, where it could slip into the grey market. Hospital procurement departments, pharmacists, and delivery intermediaries were all implicated. In December 2024, a joint operation by the Central Drugs Standard Control Organisation (CDSCO) and West Bengal drug authorities seized counterfeit anti-cancer and anti-diabetic drugs worth Rs 6.60 crore from a wholesale firm in Kolkata. 

The cost of targeted cancer infusions is unaffordable for most families, and counterfeit networks profit from that desperation. This raised questions I had never considered before: How could any patient know whether what was being administered was genuine? If a drug is diluted or substituted, what trace exists? Who monitors the mixing process: the hospital, its internal systems, or the patient's attendant?

If I, with all my years in this field, did not think to ask these questions in that chair, what are we expecting from a first-generation hospital user, a woman alone in a busy oncology ward, or someone who cannot read the labels on the vials? These are not exceptional cases. They are the majority of people receiving cancer care in this country. They cannot be the last line of quality control. Yet the burden has quietly shifted onto those least equipped to bear it. 

There is no meaningful mechanism through which hospitals involve patients in verifying what is being administered. I am not implying that all hospitals or oncology departments are complicit. My experience may reflect a hospital with standards and safeguards. But individual good practice is not the same as systemic protection. The real question is whether procurement and regulatory systems are robust enough to prevent harm across India’s cancer-care settings, particularly in overstretched public hospitals where most patients have no choice.

Where the system breaks down

What the investigation describes is not an isolated criminal opportunism. It reflects a larger failure of accountability in which adulteration and falsification become profitable within weakly regulated supply chains. Steep prices drive desperate families toward unregulated suppliers, while distribution chains create opportunities for tampering. A BMJ Global Health study found that medicine quality in India is compromised by weak oversight across manufacturing and distribution.

Authorised distributors are bypassed for grey-market suppliers, pharmacies offer steep discounts on drugs worth lakhs with little scrutiny, and online platforms continue to list Schedule H medicines that require prescription-only dispensing, despite regulatory restrictions. High prices and supply shortages push families outside supply chains, creating entry points for falsifiers. 

When procurement is opaque, traceability weak, regulatory bodies understaffed, and patients poorly informed, the counterfeit ecosystem exploits vulnerability inside hospitals, and procurement chains. The failure lies in the diffusion of responsibility and the absence of accountability when the system breaks down. 

The law exists. Enforcement does not.

As India's apex drug regulator, CDSCO oversees the licensing of thousands of pharmaceutical companies across the country. Such a scale requires both capacity and political commitment. The laws already exist. Under Section 27 of the Drugs and Cosmetics Act, 1940, manufacturing or selling a spurious drug that causes serious harm can lead to life imprisonment and a fine of not less than Rs 10 lakh. But the problem is not the absence of law; it is weak and uneven enforcement. 

In 2024, the Delhi high court denied bail to the alleged kingpin of a counterfeit anti-cancer drug racket, noting that spurious injections had compromised efficacy and could lead to cancer progression, relapse or death. Yet, by May 2026, several co-accused were granted bail after the court pointed to lapses in the investigation. 

In the same proceedings, the Delhi high court described a leading newspaper's front-page coverage during the bail hearings as 'deeply disturbing,' raising concerns that such reporting could influence judicial proceedings. The larger issue is that individual court cases cannot compensate for a system that struggles to trace where counterfeit medicines enter the supply chain. Part of the problem is fragmentation: while CDSCO functions as the national regulator, much of the actual licensing and enforcement rests with State Drug Controllers. In practice, this creates uneven oversight and coordination gaps that counterfeit networks can exploit.

Systemic change

The frameworks already exist – the Drugs and Cosmetics Act, Schedule H restrictions, CDSCO oversight, and barcode and QR code requirements for pharmaceutical packaging. The problem is enforcement. Extending serialisation and track-and-trace requirements currently mandated for pharmaceutical exports to the domestic market, alongside digital audit trails for procurement, dispensing, and vial destruction in oncology settings, would reduce opportunities for malfeasance. CDSCO’s monthly alerts on drugs classified as “Not of Standard Quality” (NSQ) underscore the scale of the challenge. 

Restricting procurement to licensed suppliers with verifiable cold-chain records, mandatory documentation and destruction of used vials, and establishing a real-time reporting mechanism for oncologists to flag unusual non-response patterns should be baseline requirements, not exceptions. Treatment failure is often attributed to disease progression rather than potentially compromised medicines. Pharmaceutical companies also bear responsibility for what happens after a product leaves the manufacturing facility. Given the exceptionally high prices charged for many oncology drugs, manufacturers should be required to maintain end-to-end traceability, actively monitor distribution channels, and investigate patterns suggestive of diversion, counterfeiting, or quality compromise. Responsibility for patient safety cannot stop at the point of sale.

Ensuring drug integrity is a systemic responsibility. It cannot be shifted onto people undergoing treatment. Neither a patient in an understaffed public hospital nor one in a well-equipped private oncology centre can function as a quality-control mechanism for a failed supply chain. Health systems are meant to guarantee protection regardless of literacy, class, caste or institutional setting. When they fail to do so, it is a failure of system design. 

Cancer already strips people of certainty, savings, time, mental wellbeing, and dignity. The least a health system can do is ensure people can trust the medicine entering their bloodstream. Yet, until accountability becomes central to regulation, procurement, and clinical care, that trust will remain out of reach. This dynamic plays out across public and private hospitals alike, but its consequences are not evenly distributed. Those with privilege – information, connections, resources, and the confidence to navigate medical institutions can question what they are given, verify what they receive, and seek alternatives when something seems wrong. Those without these advantages have no such recourse. 

A person undergoing cancer treatment deserves a system that takes their life seriously – not as a privilege, but as a guarantee from the moment they sit in that infusion chair.

Sarojini Nadimpally is a public health researcher. She works on women's health, ethics, reproductive and biotechnologies from an intersectional and reproductive justice lens. 

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