Often called the “pharmacy of the world,” India’s pharmaceutical industry faces a growing crisis that threatens both public health and national credibility — the unchecked proliferation of counterfeit and substandard drugs. The tragic deaths of children in multiple states due to adulterated cough syrups are not isolated accidents but symptoms of a systemic failure. India’s investigative and prosecutorial machinery remains ill-equipped to combat the complex, organised networks behind counterfeit medicines.
The conviction rate for counterfeit drug cases in India is a mere 5.9 per cent, and after procedural adjustments, the effective conviction rate rarely exceeds 3 per cent. This statistic exposes the inadequacy of investigative processes under the Drugs and Cosmetics Act, 1940 (D&C Act), a law ill-suited for modern transnational crimes. The absence of data analytics, forensic mapping, and inter-agency intelligence has created an environment where counterfeiters flourish with near impunity.
A significant procedural impediment stems from the Supreme Court’s Ashok Kumar (2020) verdict, which limited the registration of offences under the D&C Act exclusively to Drug Control Officers. While this decision aimed to prevent misuse of police powers, it inadvertently paralysed law-enforcement capability. Excluding the police from directly registering cases under the Act created an enforcement vacuum that is exploited by counterfeiters.
The Indian Pharmaceutical Alliance (IPA) has challenged this restriction through a Public Interest Litigation (PIL), which is pending before the Supreme Court. Drug Control Officers are knowledgeable about regulatory compliance, but they lack the field intelligence and forensic tools needed to unearth large-scale counterfeit networks. Consequently, most investigations remain confined to seizures without uncovering the criminal ecosystems.
A careful legal reading, however, reveals that the police are not entirely powerless. The Bharatiya Nyaya Sanhita (BNS), 2023, provides avenues for initiating police investigations under general criminal provisions such as Section 318 (Cheating) and Sections 336–338 (Forgery and Falsification of Records). The sale of fake or adulterated medicines inherently involves deception of consumers, while forged labels, invoices, and manufacturing licenses amount to forgery.
The police can, therefore, register cases under these BNS provisions. This strategy has shown promise: In Meerut, Agra, Delhi, and Dehradun, coordinated efforts between the IPA and local police led to the successful registration of FIRs and allowed investigations to proceed under both regulatory and criminal statutes. The Delhi High Court has affirmed this dual approach, holding that cases involving cheating and forgery can indeed be probed by police even when the predicate offence arises under the D&C Act. This convergence of regulatory and criminal law ensures that enforcement does not stop at compliance checks but extends to dismantling criminal enterprises.
To achieve tangible deterrence, India must embrace a “Best of Both Worlds” model — one that fuses the technical precision of the Drug Control Department with the investigative acumen of the police and forensic agencies. The Drug Control Department possesses domain knowledge—licensing, formulation standards, and pharmacovigilance, while the police offer operational capability, intelligence gathering, and prosecutorial experience.
Joint investigations would enable simultaneous enforcement of specific legislation (D&C Act) and general criminal laws (BNS, PMLA, IPC-equivalents), creating a dual layer of accountability. This framework not only broadens investigative scope but also enhances the admissibility of evidence in court through scientific validation and multi-agency corroboration.
Counterfeit medicine networks are rarely standalone operations — they are economic crimes intertwined with money laundering, tax evasion, and organised syndicates. The fight must expand beyond drug inspectors to include financial and enforcement authorities.
The Enforcement Directorate (ED) can invoke the Prevention of Money Laundering Act (PMLA) to track and freeze assets derived from the counterfeit drug trade. The Income Tax Department and GST authorities can investigate shell entities and fake billing structures used to legitimise illegal profits. By targeting the financial backbone of counterfeiters, the government can neutralise their operational capacity.
This approach — combining fiscal scrutiny with forensic science — turns investigations from reactive raids into comprehensive economic-crime probes. It ensures that counterfeit medicine rackets are not just prosecuted but permanently dismantled.
A robust forensic framework is the backbone of successful prosecution. Every counterfeit medicine case must transition from mere seizure of the spurious drugs to scientific evidence collection. Modern tools such as chemical and toxicological analysis, packaging and ink forensics, digital footprint mapping, and Call Detail Record (CDR) analysis provide irrefutable evidence chains.
These methods allow investigators to identify entire distribution networks and international linkages. A forensic-driven system enhances credibility in court and ensures higher conviction rates. India’s Forensic Science Laboratories (FSLs) and the National Forensic Sciences University (NFSU) can play a central role in capacity building, laboratory certification, and expert witness support.
Section 111 of the BNS provides the statutory foundation for declaring large-scale counterfeit medicine operations as organised criminal enterprises. So, Special Investigation Teams (SITs) that include officers from the police, drug control department, ED, and forensic units can be constituted to fight medical crime.
India’s counterfeit drug challenge is both a law-enforcement crisis and a legislative gap. The solution lies not in replacing one system with another but in integrating regulatory specialisation with criminal investigation. The D&C Act provides the scientific and procedural framework; the BNS and PMLA provide the investigative and punitive strength.
The following needs to be done to achieve synergy between the D&C Act and the BNS and PMLA:
One, amend the D&C Act to permit joint jurisdiction between Drug Control Officers and police.
Two, constitute national and state-level SITs to probe counterfeit medicine crimes.
Three, mandate forensic analysis in every major counterfeit drug case.
Four, enable financial probes through ED, Income Tax, and GST units.
Five, institutionalise training for inter-agency cooperation and forensic awareness.
The fight against counterfeit medicines requires the best of both worlds—the precision of science and the power of law. A coordinated, forensic-led, multi-agency investigation model anchored in legislative reform will transform India’s reactive enforcement into a proactive shield for public health. When regulatory insight meets criminal investigation, when data meets deterrence, and when science meets justice, India can finally safeguard its citizens from the epidemic of counterfeit medicines.
Keshav Kumar is a retired IPS officer and Advisor to Indian Pharmaceutical Alliance. Mumbai and Nikita Opal is an advocate
Varanasi court declares Shubham Jaiswal, prime accused in a multi-crore codeine racket, a proclaimed offender and orders the seizure of his assets. (File) 
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