During the late evenings of 2024, inspectors commissioned by MANI Inc.—the Japanese firm whose stainless-steel and files dominate root-canal procedures worldwide—quietly purchased assorted K-Files and rotary instruments from distributors in the Asian region, including India. Laboratory testing told a grim story. Almost one in every three files, about 30 percent, was either an outright fake or so poorly machined that MANI’s engineers classified it as counterfeit. The discovery offered a chilling reminder that India’s dental renaissance—fueled by rising incomes, medical tourism and a new aspirational middle class—now sits squarely in the cross-hairs of global counterfeiters.
India’s appetite for modern oral care explains the attraction. According to a report by the Indian Dental Association, say that the potential size of India’s dental market is vast and is expected to become one of the largest single-country markets for overseas dental products and materials. This analysis is based on the fact that there are more than 2,92,000 dental professionals in India, 317 dental institutes and over 5,000 dental laboratories. The overall market size of the Indian Dental market has been approximated to be over USD 2 billion. Such numbers promise opportunity for innovators; they also spotlight a margin-rich niche that illicit manufacturers are eager to exploit.
Counterfeit dental products are not simply “cheaper copies.” They are precision instruments built without precision, syringes moulded from plastics that leach toxins, or implants milled from metal alloys that snap under bite pressure. When a fake bur overheats or a curing light emits the wrong wavelength, the failure is not cosmetic—it is clinical. When dentists unknowingly place counterfeit implants, the devices may not fuse with the bone, leading to costly corrective surgery and damaging patient trust. Material failures are common enough that the British Dental Industry Association has labelled counterfeit handpieces “among the most dangerous devices ever seized.”
The ethical dimension is unambiguous. Practitioners in India take the same professional oath as their colleagues worldwide; the duty of primum non nocere cannot be reconciled with products of uncertain lineage. The Central Drugs Standard Control Organisation now publishes monthly “Not of Standard Quality” alerts and is drafting track-and-trace rules that would extend the Unique Device Identification regime to Class B and C dental devices. Penalties under the Drugs & Cosmetics Act have been stiffened and enforcement raids have become more frequent, signalling that ignorance will no longer be a viable defence.
Beyond the clinic, counterfeits corrode the broader health-care economy. The World Health Organization estimates that falsified or sub-standard medical goods siphon between USD 200 billion and USD 432 billion every year—more than twice the organisation’s own annual budget. Those lost revenues translate into forgone R&D, weaker tax receipts and a climate of suspicion that can extend to genuine brands. In low- and middle-income markets such as India, where affordability pressures are acute, the damage is multiplied: patients pay twice, first for the defective item and again for its correction.
Yet the industry is not without answers. Digital provenance, tamper-evident packaging, and real-time analytics are already turning the tide in pharmaceuticals; dentistry can follow suit. Policy can accelerate this momentum. Harmonised bar-coding across all dental consumables, fiscal incentives for clinics that source exclusively through CDSCO-certified portals, and public-awareness campaigns that make “Buy Original” as familiar a slogan as “Wear a Mask” were during the pandemic, would shift the conversation from price to provenance.
Ultimately, counterfeiting in dentistry is not an isolated act of economic opportunism; it is a breach of the social contract that underpins clinical practice. India’s oral-care boom will realise its full promise only when every impression tip, implant screw and composite syringe is traceably authentic. Dentistry, after all, is a covenant of trust: between clinician and patient, between industry and science, between the present and the future of public health. Upholding that covenant in India’s fast-evolving market will demand an unflinching commitment to transparency. In a developing market, ethics and commercial success are not rivals but partners. The message to dentists is clear: choose originality not because regulators demand it, but because professional integrity—and your patient’s wellbeing—leave no alternative. In a country where 1.3 billion smiles are poised to benefit from modern oral health, that choice is nothing short of transformational—and it is ours to make, every single day.
This article is attributed to Dr Vikas Agarwal, CEO & Founder, Dentalkart