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What is the extent of counterfeiting in India’s pharma supply chain?
Counterfeit medicines continue to pose a significant risk to patient safety and the integrity of India’s pharmaceutical supply chain. According to the CRISILASPA State of Counterfeiting in India 2025 Report, 28 per cent of consumers reported encountering a counterfeit healthcare product at least once during the last 12 months. The report uses the broader category “healthcare products,” which includes pharmaceuticals, OTC medicines, nutraceuticals, and medical devices following a nomenclature update.
ASPA believes the threat extends beyond economic losses. Counterfeit medicines directly endanger patient safety, undermine treatment outcomes, erode consumer confidence, and damage the reputation of legitimate pharmaceutical manufacturers.
What are the common modus operandi of such counterfeit operations?
ASPA observes that counterfeiters have become increasingly sophisticated. Rather than producing obvious imitations, they now:
Closely replicate genuine packaging and labels.
Attempt to imitate certain security features.
Exploit fragmented distribution networks.
Use online marketplaces and e-pharmacies to reach consumers.
Introduce products containing incorrect ingredients, substandard formulations, harmful substances, or sometimes no active pharmaceutical ingredient at all.
These evolving tactics make visual inspection alone insufficient and reinforce the need for authentication combined with end-to-end traceability.
What has been the reaction of pharma companies to such incidents? Has it been adequately addressed to prevent future incidents?
Pharma companies are increasingly strengthening their anti-counterfeiting efforts. ASPA cites examples such as Mankind Pharma, which has adopted authentication and traceability solutions to enhance product security and consumer trust.
Manufacturers are increasingly viewing authentication not merely as a compliance requirement but as a strategic investment in patient safety and brand protection.
That said, ASPA’s position is that more needs to be done. Counterfeiters continue to evolve, making isolated security measures insufficient. The association advocates integrated authentication ecosystems combining serialisation, traceability, physical security features, digital verification, and stakeholder collaboration.
What has been the reaction from policymakers like the CDSCO?
ASPA welcomes the Government of India’s efforts to strengthen oversight within the pharma packaging ecosystem, including initiatives aimed at improving accountability and traceability. This is a step in the right direction and reflects growing regulatory recognition of the problem.
At the same time, ASPA believes oversight measures need to evolve into enforceable standards. The association is advocating for the next phase of policy to include mandatory adoption of multi-layered Authentication and Traceability Solutions (ATS) for high-risk drug categories, stricter penal action against counterfeiters and those enabling them, and a national track-and-trace mandate that gives visibility across the entire supply chain, not just at the point of packaging.
The CDSCO has mandated expansion of QR codes to vaccines. What are ASPA’s views, given that QR codes have proven unsuccessful in preventing counterfeiting?
ASPA welcomes this as a step in the right direction. Extending QR code requirements to vaccines shows the regulator’s intent to improve traceability in a high stakes category.
However, the solution is complete only when QR codes are combined with other visible and invisible security features. A standard QR code, on its own, carries the risk of being copied or reprinted by counterfeiters just as easily as the genuine one, since it does not by itself authenticate the product. Layering it with tamper-evident features, holograms, and covert or nonclonable markers is what actually closes that gap and gives both regulators and consumers a way to verify authenticity with confidence.
At the 69th Drugs Consultative Committee (DCC) meeting, held virtually on last month on June 24, it was recommended to constitute a subcommittee to evaluate the feasibility of the proposal to introduce an online registration framework for manufacturers/suppliers of printed pharma packaging materials used for drugs. Why does ASPA feel that the printer registration initiative is a meaningful first step, but insufficient on its own?
ASPA sees printer registration as a welcome and meaningful first step. It strengthens oversight, accountability, and transparency at the packaging stage of the supply chain, an area that has traditionally seen limited scrutiny. However, registration of printers does not, by itself, authenticate a product or track it once it leaves the printing facility. Counterfeiters operating outside registered networks can still replicate packaging design. ASPA’s ask is for this initiative to be paired with clear enforcement mechanisms, such as periodic audits of registered printers and a defined compliance timeline, alongside a broader push for product-level authentication so that oversight extends beyond who printed the packaging to whether the product itself can be verified as genuine.
Where are the gaps even after printer registration is in place?
The real gap lies beyond the printing stage. Once a product moves through manufacturing, warehousing, distribution, and retail, visibility drops sharply. There is currently no reliable way to confirm that the medicine reaching a patient at the last mile is the same one that left the manufacturing facility.
This is a supply chain visibility problem as much as a packaging problem. Diverted stock, parallel distribution channels, and unregulated online sellers can all introduce counterfeit or tampered products at any point after packaging, well outside the reach of printer oversight. Closing this gap requires giving every product a verifiable identity that can be checked at each handoff, not just at the point of origin.
What kind of authentication technology is essential to close those gaps?
ASPA’s position is that no single technology can eliminate pharma counterfeiting on its own.
What is needed is a multilayered Authentication and Traceability Solution (ATS): serialisation for unique product identity, secure or non-clonable QR codes, tamper-evident packaging, holograms and covert security features, RFID/NFC for automated tracking, cloud based verification, and AI-enabled monitoring for anomaly detection.
This “phygital” approach, combining physical security with digital verification, is what allows a product to be authenticated and tracked through its entire lifecycle, rather than relying on any single checkpoint.
What do such counterfeiting operations mean for India’s credibility as a global pharma exporter?
Counterfeiting poses a serious threat to India’s reputation as one of the world’s largest pharmaceutical manufacturers and exporters. Even isolated incidents can undermine confidence among international regulators, healthcare providers, and global buyers, leading to increased scrutiny and affecting trust in the country’s pharmaceutical supply chain.
As the Pharmacy of the World, India must continue strengthening supply chain integrity through robust product authentication, end -to-end traceability, and advanced anti-counterfeiting technologies. These measures will not only safeguard patient safety but also reinforce India’s credibility as a trusted global supplier of high-quality medicines and support seamless international trade.
viveka.r@expressindia.com
viveka.roy3@gmail.com
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