India is facing a perilous rise in counterfeit high-value medicines, from cancer immunotherapies like Keytruda (pembrolizumab) to fast-growing weight-loss injections such as tirzepatide and semaglutide. These are not routine quality lapses—they are organised criminal operations that put patients at immediate risk.
In today’s healthcare ecosystem, supply chain is no longer a support function—it is the engine of survival in the VUCA world. These demands have increased the need for organisational and government agility, resilience, and strategic flexibility. Even with AI tools embedded in our supply chain, despite latest technological tools such as IoT-enabled visibility, real-time data, predictive analytics, and connected ecosystems, we as a nation are still struggling to root out the foundational disruptors that threaten patient outcomes.
The counterfeit saga
Recent investigations have shown how counterfeiters exploit gaps in hospital waste disposal and supply chains. In the case of Merck’s Keytruda, a therapy which has shown promising results across several cancers, particularly in advanced or metastatic stages, used authentic vials were allegedly collected, refilled with ineffective or unrelated substances such as saline or antifungal medication, resealed, and resold as genuine therapy. For cancer patients, the consequence is devastating: no therapeutic benefit, delayed treatment, avoidable toxicity, and in some cases, fatality.
The same pattern is now appearing in the obesity and diabetes segment. In Gurugram, authorities recently uncovered a counterfeit injectable racket valued at over 70 lakh, involving fake versions of popular GLP-1 and GIP-based therapies.
Raw materials, including peptides, were allegedly sourced from vendors on the Chinese ecommerce platform Alibaba, while finished pens were sold online via IndiaMART at a 27 per cent discount to the genuine product’s price. Packaging labels mimicking the original were also recovered. The seized items were not stored under proper refrigeration, raising serious safety concerns. Pharma company Eli Lilly, which manufactures Mounjaro, welcomed the enforcement action by Haryana State FDA and stated that it is actively supporting investigations to safeguard patients from counterfeit medicines.
With the surging demand for these medicines, illegal sellers are targeting desperate buyers through discounted offers, informal channels, and unverified online listings.
For the pharma sector, this crisis highlights three urgent vulnerabilities.
- Packaging and vial recovery controls remain weak, allowing criminals to reuse genuine containers.
- Serialisation and QR-based authentication, while important, are only effective if they are implemented through the entire cycle upto the end-user.
- Public awareness is still low, especially when steep discounts make counterfeit products appear attractive.
Actions beyond AI
AI is emerging as a useful line of defense in all walks of life today. Computer vision tools can detect subtle packaging anomalies, handheld spectroscopy devices can help verify chemical identity in the field, and AIbased monitoring systems can flag suspicious supply-chain movements or illicit online sales.
However, technology alone will not solve the problem. Stronger destruction protocols for used primary packaging materials, tighter risk-based manufacturer distributor audits and enforcement, active market surveillance, and rapid batch-level reporting are absolutely essential.
What can pharma companies, healthcare providers and patients do?
For pharma companies, the priority is clear: build anticounterfeit protection across the full product lifecycle, not just at the point of manufacture.
For healthcare providers and hospitals, vigilance in procurement and disposal is critical. For patients, the safest route remains authorised pharmacies, verified invoices, and consultation with treating specialists especially before purchasing any high-cost, potent, life-saving therapies.
AI- Boon and bane?
How AI helped the regulators
- Supply chain surveillance: AI-driven “Track and Trace” proposals and the QR code mandate for India’s top 300 brands is a significant step to digitally monitor drug movement.
- Marketplace crawlers: Regulators used AI algorithms to scan platforms like IndiaMART and social media to find and shut down listings for unapproved and counterfeit weight-loss drugs.
The ‘AI-Generated’ threat
- Fake prescriptions: Recently, the All India Organisation of Chemists and Druggists (AIOCD) warned the Prime Minister in that AI-generated medical prescriptions were being used to illegally buy restricted drugs like opioids and psychotropics from e-pharmacies. Criminals used AI to fabricate hospital letterheads and doctor details that appeared authentic to automated verification systems.
- Static vs dynamic codes: Many current QR codes are “static,” meaning they contain fixed information that does not change. Counterfeiters have successfully replicated these codes on fake packaging (e.g., Levipil 500), which then scan as “genuine” because the system does not always detect if the same unique ID is being scanned in multiple locations simultaneously.
- Digital leakage: There have been instances where active QR codes were leaked from vendors or manufacturing plants before the genuine drugs even reached the market.
- Cost for SMEs: Small and medium-sized manufacturers face high costs for the specialised printing and IT infrastructure required, sometimes leading to compromised standards.
- Low consumer awareness: A lack of government-led public awareness campaigns means few patients actually scan the codes to verify their medicine.
Final thoughts
Counterfeit medicines are no longer a peripheral compliance issue. They are a direct threat to treatment outcomes, brand trust, and patient safety—and they demand an industry-wide action coupled with strict government enforcement.
By imparting and promoting shared knowledge at the grassroots level, it is an absolute must to educate and empower healthcare and industry professionals even at the grassroot level to embrace their responsibility, ensuring they take proactive and ethical actions to safeguard patient safety.
For patients, outreach programs to disseminate critical health information cannot be compromised. Tools such as visual aids, utilising , communityled workshops, and local language resources can unquestionably bridge the gap for the underprivileged patient pool. Lat but not the least, the success of our healthcare system is measured by a single standard: the safety and wellbeing of the patients we serve.