A Prescription for Peril, How India’s Fight Against Counterfeit Drugs Demands a Multi-Agency Overhaul

A Prescription for Peril, How India’s Fight Against Counterfeit Drugs Demands a Multi-Agency Overhaul

India, celebrated globally as the “pharmacy of the world” for its prolific production of affordable generic medicines and vaccines, is grappling with a sinister shadow that threatens to undermine its hard-earned reputation and, more critically, the lives of millions. The nation faces a growing and insidious crisis: the unchecked proliferation of counterfeit and substandard drugs. The heart-wrenching tragedies of children in Gambia, Uzbekistan, and within Indian states like Jammu and Gujarat, who lost their lives to adulterated cough syrups, are not mere isolated accidents or unfortunate industrial mishaps. They are the most visible and tragic symptoms of a profound and systemic failure in the country’s regulatory and law-enforcement machinery. This machinery, as it stands today, remains dangerously ill-equipped to combat the sophisticated, organized, and often transnational criminal networks that profit from the trade in fake medicines.

The scale of this failure is starkly illuminated by a single, damning statistic: the conviction rate for counterfeit drug cases in India is a paltry 5.9 per cent. Even more alarming, after procedural adjustments and legal delays, the effective conviction rate rarely exceeds a negligible 3 per cent. This statistic is not just a number; it is an indictment of the entire investigative and judicial process governing pharmaceutical crime. It reveals an environment where the risk of serious legal consequence is so low that it functions as a de facto license for criminal enterprises to operate with near impunity. At the heart of this failure lies the Drugs and Cosmetics Act, 1940 (D&C Act), a legislation conceived in a different era, now hopelessly outmatched by the complexities of modern, organized crime.

The Legal Straitjacket: How a Well-Intentioned Verdict Paralyzed Enforcement

A significant and often overlooked turning point in this crisis was the Supreme Court’s 2020 verdict in the Ashok Kumar case. In an effort to prevent the potential misuse of police powers and to ensure that regulatory technicalities were handled by experts, the Court limited the registration of offences under the D&C Act exclusively to drug control officers. While the intention was to bring specialization to the forefront, the consequence was catastrophic. It inadvertently created a massive enforcement vacuum.

Drug control officers are regulatory experts, skilled in assessing manufacturing compliance, checking for proper documentation, and ensuring quality control within a known supply chain. However, they are not equipped—nor were they ever trained—to function as criminal investigators. They lack the field intelligence networks, the forensic tools, the powers of inter-state jurisdiction, and the experience in unearthing complex financial rackets that are the stock-in-trade of modern police forces. Consequently, as authors Kumar and Opal point out, most investigations led by drug inspectors remain confined to surface-level seizures. They successfully intercept a batch of fake drugs but fail to trace the operation back to its source—the clandestine labs, the printing presses forging labels, the shell companies laundering money, and the kingpins orchestrating the entire network. The “criminal ecosystems,” as the authors term them, remain largely untouched.

This procedural impediment has been recognized by the industry itself. The Indian Pharmaceutical Alliance (IPA), a body representing leading research-based pharmaceutical companies, has challenged this restriction through a Public Interest Litigation (PIL) currently pending before the Supreme Court. The industry understands that a weak enforcement regime not only endangers public health but also inflicts severe reputational damage on the entire “Made in India” pharmaceutical brand, jeopardizing exports and global trust.

A Path Through the Legal Labyrinth: The Bharatiya Nyaya Sanhita as a Potential Key

Despite the constraints of the Ashok Kumar verdict, a careful and strategic reading of the law reveals a potential pathway to reinvigorating enforcement. The recently enacted Bharatiya Nyaya Sanhita (BNS), which replaces the Indian Penal Code, provides critical avenues for police intervention. The police are not entirely powerless. They can, and must, initiate investigations under general criminal provisions that are inherently violated in the trade of spurious medicines.

Key among these are:

• Section 318 (Causing Death, Etc., by Negligence): This applies directly to cases where adulterated drugs cause fatalities, as seen in the cough syrup tragedies.

• Sections 336–338 (Acts Endangering Life or Personal Safety of Others): The very act of manufacturing and selling counterfeit medicines is a reckless endangerment of public health on a massive scale.

• Provisions on Cheating and Forgery: The sale of spurious medicines inherently involves cheating the consumer, who purchases a product that is not what it claims to be. Furthermore, the use of forged labels, invoices, and manufacturing licences to make these fake products appear genuine constitutes a clear case of forgery.

Therefore, the police can legally register a First Information Report (FIR) under these relevant sections of the BNS. This strategy is not merely theoretical; it has already shown promise in the field. The article cites coordinated efforts between the IPA and local police in Meerut, Agra, Delhi, and Dehradun, which led to the successful registration of FIRs and allowed investigations to proceed under both regulatory and criminal statutes. This dual-track approach has received judicial validation from the Delhi High Court, which affirmed that cases involving cheating and forgery can indeed be probed by the police, even when the underlying product is a drug regulated by the D&C Act.

Beyond the Pill: Targeting the Financial and Organized Crime Nexus

The most critical evolution needed in India’s strategy is the recognition that counterfeit medicine is not just a regulatory violation; it is a highly lucrative financial crime run by organized syndicates. The individuals mixing toxic solvents in a makeshift warehouse are merely the foot soldiers. The real engine of this criminal enterprise is the financial infrastructure that funds it, launders its profits, and allows it to scale.

To dismantle this engine, the fight must expand far beyond the mandate of drug inspectors. A multi-agency offensive is essential:

• Enforcement Directorate (ED): The ED can invoke the Prevention of Money Laundering Act (PMLA) to track, seize, and freeze the assets derived from the counterfeit drug trade. Hitting the criminals where it hurts most—their wallets—is one of the most effective ways to cripple their operations permanently.

• Income Tax Department and GST Authorities: These agencies are uniquely positioned to investigate the complex web of shell companies, bogus billing, and fake invoicing used to legitimize illegal profits and integrate them into the formal economy. By dismantling these financial facades, they can expose the entire supply chain.

By targeting the financial backbone, the government can move beyond simply arresting low-level operatives and begin neutralizing the operational and financial capacity of the entire network. This ensures that counterfeit medicine racks are not just temporarily disrupted but are permanently dismantled.

The Forensics Imperative: Building Irrefutable Cases for Conviction

The abysmally low conviction rate of 3-5.9% points to a fundamental weakness in the evidence presented in court. Too many cases rely on seizure memos and basic chemical analysis, which are often successfully challenged by defense lawyers. A robust, scientific, and forensic framework is the missing backbone of successful prosecution.

Every investigation into counterfeit medicine must make the crucial transition from being a mere “seizure” case to a “scientific evidence collection” operation. Modern forensic tools can provide the irrefutable evidence chain needed to secure convictions:

• Chemical and Toxicological Analysis: Going beyond identifying the absence of an active ingredient to precisely identifying the harmful contaminants and their sources.

• Packaging and Ink Forensics: Analyzing the packaging material, printing inks, and holograms to match them to specific printing presses and paper suppliers, creating a physical evidence trail.

• Digital Footprint Mapping and CDR Analysis: Using the digital trails from mobile phones and computers to map the communication between conspirators, track the movement of goods, and establish the hierarchy within the criminal network.

These methods allow investigators to move up the chain, identifying entire distribution networks and even international linkages. A forensic-driven system not only enhances the credibility of the case in court but also serves as a powerful deterrent. India’s Forensic Science Laboratories (FSLs) and the National Forensic Sciences University (NFSU) must be centrally integrated into this fight, playing a leading role in capacity building, laboratory certification, and providing expert witness testimony.

A Legislative and Operational Prescription for a Healthier Future

The solution to India’s counterfeit drug challenge is not to replace one system with another, but to intelligently integrate regulatory specialisation with the formidable power of criminal investigation and financial forensics. The authors propose a comprehensive five-point reform agenda:

1. Legislative Amendment: Amend the D&C Act to explicitly permit joint jurisdiction between Drug Control Officers and the police, formalizing the collaborative model and ending the current ambiguity.

2. Constitute Special Investigation Teams (SITs): Establish national and state-level SITs, mandated to probe major counterfeit medicine crimes. These teams should be composed of officers from the police, drug control department, ED, Income Tax, and forensic units, creating a single, powerful entity with all the necessary tools.

3. Mandate Forensic Analysis: Make a comprehensive forensic audit and analysis compulsory in every major counterfeit drug case, ensuring that evidence meets the highest standards of judicial scrutiny.

4. Enable Concurrent Financial Probes: Create formal protocols for the automatic triggering of parallel investigations by the ED, Income Tax, and GST authorities whenever a significant counterfeit drug racket is uncovered.

5. Institutionalize Training: Develop and implement rigorous training programs to foster inter-agency cooperation and build forensic awareness among drug inspectors, police officers, and financial investigators.

The fight against counterfeit drugs is a battle for India’s public health, its global standing, and its moral conscience. It requires the best of both worlds: the precision of scientific regulation and the formidable power of criminal law. By embracing a coordinated, forensic-led, multi-agency investigation model anchored in decisive legislative reform, India can transform its reactive and feeble enforcement apparatus into a proactive, intelligent, and unbreachable shield for its citizens and for the world that depends on its pharmacy.

Q&A: Deepening the Understanding of India’s Counterfeit Drug Crisis

1. The article argues that the Supreme Court’s Ashok Kumar (2020) verdict, while well-intentioned, created an “enforcement vacuum.” What specific capabilities do the police have that drug control officers lack, making their exclusion so detrimental?

Drug control officers are essentially regulatory auditors. Their expertise lies in ensuring that licensed manufacturers and distributors comply with predefined rules regarding manufacturing practices, storage conditions, and documentation. They operate within the formal, known supply chain. In contrast, the police are equipped for criminal investigation. Their critical capabilities include:

• Field Intelligence Networks: Police have informants and intelligence-gathering mechanisms that can penetrate criminal underworlds, which are completely outside the purview of drug inspectors.

• Powers of Inter-State Raids and Arrests: A drug racket often operates across multiple states; while a drug inspector’s jurisdiction is typically limited, police can coordinate nationwide raids and arrests.

• Experience with Organized Crime: Police forces are trained to dismantle hierarchical criminal syndicates, map their networks, and target kingpins, rather than just seizing the end-product.

• Access to Specialized Tools: They can legally employ techniques like wiretapping, surveillance, and forensic analysis of digital devices to build a case.
  By excluding the police, the system lost its primary weapon for proactive, deep-rooted criminal investigation, leaving only the regulatory capacity for reactive checks.

2. How does the invocation of the Prevention of Money Laundering Act (PMLA) by the Enforcement Directorate (ED) change the dynamics of fighting counterfeit drug networks?

Invoking the PMLA is a game-changer because it shifts the focus from the commodity (the fake drugs) to the proceeds of the crime (the money). This has several powerful effects:

• Attacks the Motivation: The primary driver of this crime is profit. By freezing and seizing assets—including bank accounts, properties, and luxury goods purchased with illicit funds—the ED directly attacks the incentive for the crime.

• Dismantles Operational Capacity: Without liquid funds, criminal networks cannot pay operatives, rent warehouses, bribe officials, or purchase raw materials. It cripples their ability to function.

• Creates a Powerful Deterrent: The fear of losing accumulated wealth is a far stronger deterrent for kingpins than the relatively low risk of a drug-related conviction. It also allows the government to hit back at those who may otherwise remain insulated from direct prosecution.

• Provides Investigative Leads: Following the money trail often leads investigators to the masterminds and reveals the full scale of the operation, including international hawala transactions and other sophisticated laundering techniques.

3. The authors propose “mandating forensic analysis in every major counterfeit drug case.” Beyond basic chemical testing, what specific forensic techniques could be deployed, and what evidence could they uncover?

A sophisticated forensic go beyond simply identifying a substance and can reconstruct the entire criminal process:

• Packaging and Material Forensics: Analysis of the cardboard, plastic, and foil used in blister packs can trace the materials to specific batch suppliers. The chemical composition of the inks and the microscopic wear and tear on the printing plates can link the packaging to a specific printing press.

• Digital Device Forensics: Seizing and analyzing the mobile phones and computers of suspects can reveal communication logs (planning), transaction records (financial trails), and even GPS data linking them to clandestine manufacturing units.

• Call Detail Record (CDR) Analysis: Mapping the locations and interactions of suspects’ phone numbers over time can visually chart the network, identify key nodes (leaders), and establish connections between manufacturers, distributors, and transporters.

• Stable Isotope Analysis: This advanced technique can sometimes trace the geographical origin of the raw materials (like the solvents or sugars) used in the fake drugs, potentially pointing to a specific source region or supplier.

4. The low conviction rate (3-5.9%) is a central problem. How would a dual-track approach—using both the D&C Act and the Bharatiya Nyaya Sanhita (BNS)—help improve this rate in court?

A dual-track approach strengthens the prosecution’s case by presenting it on multiple, mutually reinforcing legal foundations, making it harder for the defense to create reasonable doubt.

• Broader Evidence Base: The D&C Act provides the technical, regulatory violation (e.g., the drug does not meet standard specifications). The BNS charges (cheating, forgery, endangering life) allow for the inclusion of a much wider array of evidence, including witness statements from cheated consumers, forensic evidence of forged documents, and expert testimony on the public health danger.

• Overcoming Technicalities: If a defense lawyer successfully challenges a procedural aspect of the D&C Act case (e.g., the chain of custody of the sample), the charges under the BNS, which are based on general criminal law, may still stand. It provides a safety net for the prosecution.

• Demonstrating Criminal Intent: The D&C Act can sometimes be framed as a compliance failure. Charges under the BNS for cheating and forgery unequivocally establish a mens rea (criminal intent), which is crucial for securing stronger convictions and sentences.

5. What are the potential risks or challenges in implementing the proposed multi-agency model involving police, ED, and drug inspectors, and how can they be mitigated?

The primary challenges are:

• Inter-Agency Rivalry and Turf Wars: Different agencies may compete for credit, control over the investigation, or resources.

• Lack of Shared Understanding: A police officer may not understand pharmaceutical nuances, while a drug inspector may not grasp criminal procedure or financial investigation techniques.

• Increased Bureaucracy and Slower Pace: Coordinating between multiple agencies can lead to delays and procedural bottlenecks.

Mitigation Strategies:

• Clear Mandates via SITs: Establishing formal Special Investigation Teams (SITs) with a clear leadership structure and defined roles for each agency can minimize conflict.

• Joint Training Programs: As the authors suggest, mandatory training where police, drug inspectors, and financial investigators learn about each other’s domains is crucial for building a shared vocabulary and operational trust.

• Unified Digital Platforms: Creating a shared, secure digital platform for case management and evidence sharing can streamline coordination and ensure all agencies are working from the same information in real-time.