Counterfeiting Pharmaceuticals: Challenges and Legal Response in India.

Keywords: Counterfeit drugs, Trademarks, Patents, Pharmaceuticals, Enforcement

Introduction

A pill is meant to heal, not harm. Yet, across India’s crowded markets and digital shelves, there exists a quieter, deadlier trade, counterfeit medicines that look genuine but carry no cure, sometimes even poison. Counterfeit medicines are tackled only indirectly under drug control laws, not by a specific statute. For instance, The Trademarks Act, 1999 prevents the unauthorized use of the registered trademark of a medicine; however, it doesn’t directly address the issue of counterfeit medicines.

To understand, “a counterfeit medicine is defined as one that either contains the wrong active ingredient, none of the specified active ingredient, or the correct active ingredient at the wrong dose.” According to the WHO, counterfeit in relation to pharmaceutical products implies the intentional and fraudulent mislabeling in relation to the identity, composition and /or source of a final and market-ready product, or any ingredient for the preparation or composition of a pharmaceutical product. The act of counterfeiting may be applicable to both classes of products i.e. generic and branded, as well as conventional remedies.

Counterfeit Pharmaceuticals in the Indian context

Over the past few decades, the Indian pharmaceutical industry has experienced enormous expansion, making it one of the top producers of medicines globally. The country's pharmaceutical industry has witnessed immense growth, however, both nationally and internationally, there exist serious concerns about the quality of the pharmaceuticals' formulations. The onset of the COVID-19 pandemic created the ideal conditions for counterfeiters to up their manufacturing and spread unlawful goods. Counterfeits are always inferior in terms of quality, safety and efficacy compared to original pharmaceuticals posing an unacceptable risk to public health and lead to loss of confidence in medicines, healthcare providers, and health systems. A new global supply chain, the urgent demand for medications, and recent legislative changes in India have all contributed to the growth of parallel supply lines that house counterfeit goods in the nation. In Walter Bushnell Pvt. Ltd. v. Miracle Life Sciences (Delhi High Court, 2014) the court reinforced for more cautious and pro-consumer approach when dealing with pharmaceutical disputes, and held that plaintiffs, in such cases, need not meet the same high evidentiary threshold as in ordinary commercial trademark battles.

The counterfeiting of medicinal drugs is no new phenomenon, and in India, it has attained great levels, which only proves its continuance in harboring such practices and the failure of the government in regulating it. While the Trademarks Act, 1999, does provide a route to sue for the practice of infringement and passing off against deceptively similar packaging, the issue of counterfeiting medicines often intersects with patent law as well. A counterfeit product may not only mimic a brand but also violate the Patents Act, 1970, by illegally manufacturing a patented Active Pharmaceutical Ingredient (API). This creates a dual-front legal battle for legitimate manufacturers, fighting to protect both their brand identity and their core invention from fraudulent replication. A study by OECD/EUIPO database corroborates the fact that during the period of 2014 to 2016, India has been the top economy for counterfeiting pharmaceuticals and no doubt it continues to be so, highlighting the existence of the vacuum in existing framework enforcement. At present, Indian Pharmaceutical market has an estimate value of INR 40,000 crore and 20% of the market is of counterfeit medicines.

Legal measures against Counterfeit Pharmaceuticals

In Indian law, the value of intellectual property is acknowledged at all levels: legislative, administrative, and judicial, however, the issue arises when it is not properly put into practice. Trademark law, for instance, is a powerful shield for pharmaceutical companies. Under Section 29 of the Trade Marks Act, 1999, the use of identical or deceptively similar marks amounts to infringement, and when it comes to medicines, such confusion can be fatal rather than merely commercial. Counterfeit drugs often masquerade under deceptively similar brand names or packaging, and protecting trademarks in this sector is not merely about safeguarding corporate identity; it is directly tied to patient safety, because a forged label can translate into a compromised medicine.

Patent law, too, plays a vital role in protecting innovation. Under Section 48 of the Patents Act, 1970, patentees are granted the exclusive right to prevent third parties from making, using, or selling the patented product without consent. In the pharmaceutical industry, this exclusivity is the reward for years of research and massive investment. However, when counterfeit versions enter the market, they erode not only profits but also the incentive to innovate. Stronger enforcement of patent rights, supported by remedies under Sections 108–111 of the Patents Act, can therefore serve as a deterrent, ensuring that innovation continues to thrive while patients receive medicines that are both safe and effective.

Despite their presence, these laws have yielded only limited success in curbing the menace. In reality, it is those small-scale industries and factories, operating solely on substandard or falsified medicines, that spread the menace to every corner, penetrating deep into the system and making it hollow from within. Moreover, as these products are available at nominal prices, they often become the first choice for poor and middle-class families, who in turn become the prime targets of such industries. The judiciary has recognised the delicacy that needs to be considered when dealing with matters in a pharmaceutical context. In Cadila Health Care Ltd. v. Cadila Pharmaceuticals Ltd., (2001), the Supreme Court ruled that questions of trade mark similarity and confusion in the pharmaceutical sector should be treated with special care because any confusion may lead to disastrous and even life-threatening consequences. Additionally court clarified that drug authorities, while approving brand names invoking Section 17- B of Drugs and Cosmetic Act should do a trademark search as a prerequisite to avoid later disputes and public risk. The Court laid down that while the usual tests for infringement apply, the application of the judicial mind must be on the overall impression created on the ordinary layman purchaser, and in the case of medicines, that includes prescribers and patients for whom even a slight mistake may turn out fatal. Yet, even with this nuanced judicial guidance, the reality on the ground unfortunately remains grim: courts’ pronouncements have not translated into consistent detection, interdiction, or speedy conviction.

Although many pharmaceutical manufacturers have established internal mechanisms to curb counterfeiting, counterfeiters have simultaneously refined their methods. This underscores the need for a comprehensive legal framework capable of anticipating such tactics and effectively addressing the crime at a systemic level.

Challenges

Counterfeiters have increasingly grown adept at methods of mimicking legitimate drugs. The use of sophisticated packaging, holograms, and printing techniques, which even doctors and patients are not able easily distinguish from genuine pharmaceuticals. Detecting a fake usually requires laboratory analysis which is a slow & costly process as on visual inspection the pills can look identical to the real thing. Meanwhile, the rise of online sales through e-commerce platforms have given counterfeiters new, hard-to-police channels. Unlicensed medications by rogue operators are sold via e-commerce or dark web sites, shipping small quantities directly to consumers. By the time authorities trace and seize one batch, several others have already entered the market.

India’s sprawling supply chain and global trade further lead to the exacerbation of the problem as the country heavily relies on imports of raw materials and APIs from other nations. When COVID-19 disrupted global supply chains, the export deficit on medical inputs created supply shortages, an unfortunate opening that counterfeiters quickly exploited. Supply of spurious drugs surged into the market, filling gaps left by supply disruptions. As per data, the World Health Organisation notes that only about 20% of countries worldwide have truly effective drug-control systems. That means poor-quality imports from less-regulated regions easily find their way into India’s market. Free trade zones and untracked shipments also allow illegal drugs to slip in under the radar. Lacking a unified track-and-trace system, authorities struggle to pinpoint where each batch of medicine originated or travelled. As a result, counterfeit medicines can spread across states and even cross international borders unchecked.

Enforcement and regulatory mechanisms in India continue to face significant hurdles. Although the Trade Marks Act, 1999 and the Patents Act, 1970 provide strong remedies against infringement and counterfeiting, their practical enforcement in the pharmaceutical sector remains uneven. A recent analysis observes that “low public awareness, lax enforcement of laws, and flexibility in the current legal system” have fueled the expansion of the counterfeit drug industry. Regulatory agencies are chronically understaffed, making routine factory inspections and market raids rare, especially in rural areas. Court cases drag on for years, so even when authorities seize counterfeit drugs, convictions are rare. Corrupt practices at checkpoints and among some local officials can further allow illicit products to escape detection. Compounding these challenges is the absence of a single, comprehensive statute targeting counterfeit drugs; instead, enforcement relies on a patchwork of provisions drawn from the Drugs and Cosmetics Act, trademark law, and related regulations. Such fragmentation creates legal loopholes that unscrupulous manufacturers exploit, knowing that prosecution is often slow or avoided entirely.

Socio-economic factors give further momentum to the fake drug trade. India’s high patient load and uneven healthcare access reciprocate that many citizens turn to the most affordable option rather than the safest one. Limited access to doctors and clinics, especially in rural areas, drives self-medications often with over, the, counter purchases or online orders of dubious origin. A recent review highlights that high drug costs and restricted health access are major drivers of fake medicine sales in India. Poor and middle-income families, aiming to stretch their budgets, may fall prey to cheaper generics sold through unregulated vendors. Even pharmacists, struggling to compete on price, might inadvertently dispense counterfeit pills because of lack of tools or training to verify authenticity. In such a market, demand itself helps sustain the counterfeiters: they simply supply an already eager consumer base.

Together, these challenges create a vicious cycle: as counterfeiters adapt and expand, public trust in medicines erodes, leaving people increasingly uncertain about what is truly safe to consume. Breaking this cycle is daunting and requires not just tougher laws or harsher penalties, which already exist on paper, but also vigilant enforcement, better technology, and widespread public awareness. The technological arms race between counterfeiters and regulators is relentless. Each time a safeguard such as tamper proof holograms or quick response codes is introduced, criminals devise ways to bypass it. At the same time, border control and customs inspections intercept only a fraction of illicit consignments. Without broader literacy and awareness campaigns, many patients will continue to rely on price or packaging as their measure of authenticity, rather than safety or accreditation.

Conclusion

Counterfeit pharmaceuticals pose a grave and distinct threat to India’s healthcare system, simultaneously endangering patients and eroding public confidence in medicines. While statutory laws prescribe stringent penalties for the manufacture of spurious drugs, including imprisonment and heavy fines, their impact has been inconsistent. The deterrent effect envisioned by these provisions has, in practice, remained largely absent. A long-term solution needs to be multi-faceted including stronger field enforcement, drug-tracking technology, coordinated international cooperation, and consumer education over counterfeit products. For instance, implementing robust supply chain tracking so that every tablet’s journey can be logged and verified could help authorities intercept fakes more quickly. At the same time, public awareness campaigns can alert patients to purchase medicines only from licensed pharmacies and to verify packaging. In this sense, the fight against counterfeit drugs must mirror law enforcement efforts against other serious crimes: it demands not only punishment, but prevention through education and systemic change.

Ultimately, preserving the integrity of India’s pharmaceutical supply is not solely a matter of stronger laws on paper but of proactive vigilance across every level of the drug ecosystem.