By Dipak Kurmi
India, proudly bearing the title of the “pharmacy of the world,” stands at a troubling crossroads. The nation that supplies affordable medicines to millions across the globe is grappling with an insidious domestic threat: the rampant proliferation of counterfeit and substandard drugs. The tragic deaths of children across multiple states from adulterated cough syrups serve as a grim reminder that this is not a series of isolated incidents but rather a symptom of profound systemic failure. Behind the veneer of India’s pharmaceutical prowess lies a disturbing reality where investigative and prosecutorial machinery remains woefully inadequate to combat the sophisticated, organized networks orchestrating this criminal enterprise.
The numbers tell a damning story. The conviction rate for counterfeit drug cases in India languishes at a dismal 5.9 percent, and when procedural adjustments are factored in, the effective conviction rate barely scrapes past 3 percent. These statistics expose more than mere inefficiency; they reveal the fundamental inadequacy of investigative processes governed by the Drugs and Cosmetics Act of 1940, a legislative framework conceived in a vastly different era and ill-equipped to address the complexities of modern transnational pharmaceutical crimes. The absence of critical investigative tools such as data analytics, forensic mapping, and inter-agency intelligence sharing has created an environment where counterfeiters operate with near-total impunity, confident that the odds of facing meaningful consequences remain vanishingly small.
The legal landscape governing pharmaceutical enforcement underwent a significant shift following the Supreme Court’s 2020 verdict in the Ashok Kumar case. This landmark decision restricted the registration of offences under the Drugs and Cosmetics Act exclusively to Drug Control Officers, effectively barring police from directly registering cases under the Act. While the Court’s intention was to prevent the misuse of police powers and protect legitimate pharmaceutical businesses from harassment, the judgment inadvertently created a critical enforcement vacuum that counterfeiters have been quick to exploit. The restriction effectively paralyzed law enforcement capability at a time when coordinated, aggressive action was most needed.
Recognizing the severity of this constraint, the Indian Pharmaceutical Alliance has filed a Public Interest Litigation challenging this restriction, a case that currently awaits adjudication before the Supreme Court. The central concern is straightforward: while Drug Control Officers possess extensive knowledge about regulatory compliance, licensing procedures, and pharmaceutical standards, they fundamentally lack the field intelligence capabilities, investigative training, and forensic resources necessary to penetrate and dismantle large-scale counterfeit networks. Consequently, most investigations remain superficial exercises confined to physical seizures without ever uncovering the elaborate criminal ecosystems that sustain the counterfeit trade.
However, a more nuanced legal analysis reveals that the police are not entirely powerless in this fight. The Bharatiya Nyaya Sanhita of 2023, India’s reformed criminal code, provides viable avenues for police to initiate investigations using general criminal provisions. Section 318, which addresses cheating, and Sections 336 through 338, which cover forgery and falsification of records, offer legal pathways that circumvent the restrictions imposed by the Ashok Kumar verdict. The sale of counterfeit or adulterated medicines inherently involves systematic deception of consumers who believe they are purchasing genuine therapeutic products. Similarly, the production and distribution of fake medicines invariably requires forged labels, fabricated invoices, counterfeit manufacturing licenses, and falsified quality certificates, all of which constitute forgery under criminal law.
This dual-track approach has already demonstrated its effectiveness in several jurisdictions. In cities including Meerut, Agra, Delhi, and Dehradun, coordinated efforts between the Indian Pharmaceutical Alliance and local police departments have successfully led to the registration of First Information Reports under these general criminal provisions, allowing investigations to proceed under both regulatory and criminal statutes simultaneously. The Delhi High Court has explicitly affirmed this convergent approach, holding that cases involving elements of cheating and forgery can indeed be investigated by police even when the underlying predicate offence arises under the Drugs and Cosmetics Act. This judicial validation ensures that enforcement efforts need not stop at compliance checks but can extend to the complete dismantling of criminal enterprises.
To achieve meaningful deterrence and protection of public health, India must adopt what can be termed a “Best of Both Worlds” model, one that fuses the technical precision and domain expertise of the Drug Control Department with the investigative acumen, operational capabilities, and prosecutorial experience of police and forensic agencies. The Drug Control Department brings invaluable specialized knowledge to the table, including expertise in licensing procedures, formulation standards, pharmacovigilance protocols, and regulatory compliance. The police, by contrast, offer operational capability, extensive experience in intelligence gathering, expertise in surveillance and interrogation, and familiarity with criminal prosecution procedures.
Joint investigations structured around this collaborative framework would enable the simultaneous enforcement of specific pharmaceutical legislation through the Drugs and Cosmetics Act while also pursuing charges under general criminal laws including the Bharatiya Nyaya Sanhita, the Prevention of Money Laundering Act, and other relevant statutes. This creates a dual layer of accountability that not only broadens the investigative scope but also substantially enhances the admissibility and credibility of evidence in court through scientific validation and multi-agency corroboration.
It is crucial to recognize that counterfeit medicine networks are rarely standalone operations. They represent sophisticated economic crimes intricately intertwined with money laundering schemes, systematic tax evasion, and organized criminal syndicates. Therefore, the fight against pharmaceutical counterfeiting must expand far beyond the jurisdiction of drug inspectors to encompass financial and enforcement authorities with specialized expertise in tracking illicit financial flows.
The Enforcement Directorate can invoke the Prevention of Money Laundering Act to identify, track, and freeze assets derived from the counterfeit drug trade, following the money trail that sustains these operations. The Income Tax Department and GST authorities can investigate the shell entities, fake billing structures, and complex financial arrangements used to legitimize and launder illegal profits. By systematically targeting the financial infrastructure that supports counterfeiters, the government can effectively neutralize their operational capacity and make the enterprise economically unviable.
This comprehensive approach, combining fiscal scrutiny with forensic science and criminal investigation, transforms enforcement from reactive raids triggered by complaints into proactive, comprehensive economic-crime investigations. It ensures that counterfeit medicine operations are not merely prosecuted but permanently dismantled, with their financial resources seized and their operational networks destroyed.
A robust forensic framework constitutes the essential backbone of successful prosecution in counterfeit medicine cases. Every investigation must transition from the mere physical seizure of spurious drugs to comprehensive scientific evidence collection using modern analytical techniques. Chemical and toxicological analysis can identify harmful substances and establish deviation from approved formulations. Packaging and ink forensics can trace manufacturing sources and distribution chains. Digital footprint mapping can reveal online sales networks and communication patterns. Call Detail Record analysis can establish connections between conspirators and map organizational hierarchies.
These sophisticated investigative methods allow law enforcement to identify entire distribution networks, uncover international linkages, and build irrefutable evidence chains that withstand judicial scrutiny. A forensic-driven investigative system dramatically enhances credibility in court proceedings and ensures substantially higher conviction rates. India’s existing infrastructure, including Forensic Science Laboratories across the country and the National Forensic Sciences University, can play a pivotal role in capacity building, laboratory certification, standardization of protocols, and providing expert witness support for prosecutions.
Section 111 of the Bharatiya Nyaya Sanhita provides the necessary statutory foundation for declaring large-scale counterfeit medicine operations as organized criminal enterprises, triggering enhanced penalties and expanded investigative powers. Building on this legal framework, Special Investigation Teams should be constituted, incorporating officers from police departments, drug control authorities, the Enforcement Directorate, and forensic units to create truly integrated task forces capable of addressing the multifaceted nature of pharmaceutical crime.
India’s counterfeit drug challenge represents both a law enforcement crisis and a legislative gap that demands urgent attention. The solution lies not in replacing one enforcement system with another but in intelligently integrating regulatory specialization with criminal investigative capability. The Drugs and Cosmetics Act provides the essential scientific and procedural framework for pharmaceutical regulation, while the Bharatiya Nyaya Sanhita and Prevention of Money Laundering Act provide the investigative tools and punitive strength necessary to dismantle criminal networks.
Achieving effective synergy between these legal frameworks requires concrete action across multiple fronts. First, the Drugs and Cosmetics Act must be amended to explicitly permit joint jurisdiction between Drug Control Officers and police, removing current ambiguities and legal obstacles to collaboration. Second, national and state-level Special Investigation Teams must be constituted specifically to probe counterfeit medicine crimes, with clear mandates and adequate resources. Third, forensic analysis must be mandated in every major counterfeit drug case to ensure scientific rigor and evidentiary strength. Fourth, financial investigations through the Enforcement Directorate, Income Tax Department, and GST authorities must be enabled and coordinated with pharmaceutical enforcement efforts. Fifth, comprehensive training programs must be institutionalized to promote inter-agency cooperation and develop forensic awareness among all enforcement personnel.
The fight against counterfeit medicines demands nothing less than the best of both worlds: the precision of pharmaceutical science combined with the full power of criminal law. A coordinated, forensic-led, multi-agency investigation model, firmly anchored in thoughtful legislative reform, has the potential to transform India’s currently reactive enforcement posture into a proactive shield protecting public health. When regulatory insight meets criminal investigation, when data analytics meets deterrence, when forensic science meets judicial accountability, India can finally provide its citizens with meaningful protection from the epidemic of counterfeit medicines that currently threatens both individual lives and national credibility on the world stage.
(The writer can be reached at dipakkurmiglpltd@gmail.com)
