Vinay Kumar
At a time when the State proclaims its intent to decriminalise minor business lapses through the Jan Vishwas Bill, 2026 signalling a shift from punishment to trust, the ground reality appears to be telling a rather different story. While one arm of governance speaks the language of ease of doing business and regulatory reform, another seems determined to discover criminality where compliance exists. It is almost as if the law has developed a split personality, promising faith in enterprise on paper, while in practice, invoking the harshest penal provisions under the NDPS Act and the BNS with remarkable enthusiasm, even against those operating within licensed frameworks. The irony is difficult to miss: in the quest to build Jan Vishwas, enforcement on the ground risks replacing trust with suspicion and regulation with prosecution. A Dangerous Drift from Regulation to Criminalisation: In recent months, a deeply disquieting trend has begun to surface across multiple jurisdictions in India; the increasing invocation of the Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS Act) against licensed pharmaceutical stockists dealing in codeine-based cough syrups – Corex-T, Phensedyl, Tossex, Codistar, Ascoril-C etc. – typically containing 10mg of Codeine per 5ml of dosage. What was conceived as a stringent statutory weapon to combat drug trafficking is now, in multiple instances, being deployed against stockists operating within the framework of lawful medical commerce. This development is not merely a question of statutory interpretation; it raises a more fundamental concern about the boundaries of criminal law itself. When a regulated activity begins to attract penal consequences of the highest order, the distinction between illegality and irregularity becomes blurred. The question, therefore, is not whether the State must act against drug misuse, it unquestionably must, but whether, in doing so, it is beginning to criminalise what is essentially regulatory in nature. The law speaks of Jan-Vishwas, yet its enforcement risks scripting a tale of Jan-Avishwas. Codeine-based cough syrups such as Phensedyl are not inherently unlawful. Their manufacture, distribution and sale are recognised under the law, subject to conditions. The regulatory regime governing them is well-established under the Drugs and Cosmetics Act, 1940, which prescribes licensing requirements, storage conditions, documentation standards and oversight mechanisms. This framework reflects a legislative understanding that such substances, though capable of misuse, are legitimate medicines when handled within prescribed limits. Yet, enforcement practice increasingly departs from this statutory design. The Statutory Architecture and the Limits of NDPS A proper understanding of the issue must begin with the statutory scheme of the NDPS Act, particularly Section 8(c). This provision imposes a general prohibition on activities such as possession, sale, transport and use of narcotic drugs. However, the prohibition is not absolute. The proviso explicitly permits such activities when carried out for medical or scientific purposes and in accordance with the law. This proviso is not incidental, it is the controlling principle in cases involving medicinal preparations. It acknowledges that certain substances, though falling within the broader category of narcotic drugs, are nonetheless integral to healthcare and must be regulated, not prohibited. Once an activity falls within this permitted domain, the entire basis of criminality under Section 8(c) disappears. The consequence is straightforward. Section 21, which penalises contravention of Section 8(c), can be invoked only when there is a clear violation of the prohibition. If the activity itself is lawful, being undertaken under a valid licence for therapeutic purposes, there is no contravention, and therefore no offence. Similarly, Section 26(d), which addresses breach of licence conditions, applies only to licences granted under the NDPS framework. It cannot be extended to licences issued under the Drugs and Cosmetics Act, which operates as a distinct and self-contained regulatory regime. The legal position that emerges is unambiguous: a violation of licence conditions under the Drugs and Cosmetics Act does not, by itself, attract the penal consequences of the NDPS Act. Quantity as a Proxy for Guilt Despite this clarity, enforcement actions often proceed on a simplified and flawed premise that the recovery of large quantities of codeine-based syrup is, in itself, indicative of criminality. This assumption ignores the commercial realities of pharmaceutical distribution. Stockists and super-stockists function at scale. Their role is to procure large consignments from manufacturers and ensure their distribution across multiple licenced regions. Bulk possession is not an anomaly; it is a structural requirement. To treat quantity as evidence of illegality is to misunderstand the very nature of the trade. Criminal law does not operate on the basis of scale alone. It requires proof of unlawful conduct and more importantly, the intent. Where the stock is supported by valid licences, purchase records, tax documentation and traceable supply chains, the presumption of illegality cannot arise merely from volume. Mens Rea and the Imperative of Intent At the heart of criminal jurisprudence lies the principle of mens rea. The existence of a guilty mind is what distinguishes an offence from a mere act. Licensed pharmaceutical stockists operate within a structured and transparent framework. Their activities are documented, regulated and subject to periodic inspection. The presence of invoices, batch tracking, GST compliance and licence records collectively points toward legitimacy. In such circumstances, the absence of criminal intent is not merely arguable, it is apparent. The invocation of NDPS provisions, without establishing diversion into illicit channels or intent to misuse, effectively bypasses this foundational requirement. It results in a situation where lawful conduct is judged not by its nature, but by speculative possibilities of misuse. Judicial Trends and the Recognition of Overreach Courts have, in recent times, begun to grapple with this growing tension between regulatory compliance and criminal prosecution, though the judicial response remains far from uniform. A significant and binding articulation of the legal position emerges from the Division Bench judgment of the Allahabad High Court in Vibhor Rana case (2022). The Court was faced with an identical question, “Whether Phensedyl cough syrup, containing codeine, could attract the rigours of the NDPS Act?” Answering in the negative, the Court held that Phensedyl, containing 0.2% codeine, falls squarely within the exemption provided under the Central Government Notification dated 14.11.1985, being a compounded medicinal preparation within permissible limits. It was thus categorically held that such a formulation does not constitute a “narcotic drug” under the NDPS Act, and consequently, its possession, sale or distribution cannot attract NDPS provisions. The Court went further to hold that the search, seizure and prosecution initiated by the authorities were without authority of law. Importantly, the finding was premised on the presence of complete documentation – purchase records, sale invoices, tax compliance and valid licences; demonstrating lawful trade within a regulated framework. The ratio of Vibhor Rana case therefore firmly establishes that where pharmaceutical activity is duly licensed, documented and within statutory limits, the NDPS Act has no application, and any attempt to invoke it disregards binding precedent as well as the discipline of law. A similar articulation of the limits of NDPS in such cases emerges from the Patna High Court (2026), where anticipatory bail was granted by the Single Judge in a matter involving recovery of codeine-based cough syrup. The Court undertook a detailed examination of the Central Government notification governing codeine preparations and noted that the concentration of codeine in the seized syrup was well within the permissible limits. On that basis, it held that such medicinal formulations do not fall within the ambit of “contraband” under the NDPS Act. More importantly, the Court made a categorical and telling observation that law enforcement authorities are “invariably” invoking NDPS provisions in cases involving cough syrups, despite such substances being regulated as Schedule-H drugs under the Drugs and Cosmetics Act. It clarified that any infraction, in such circumstances, would at best constitute a violation of the Drugs and Cosmetics Act, and not attract the penal consequences of the NDPS regime. This reasoning goes to the root of the matter, namely that the jurisdictional threshold for invoking NDPS itself is absent where the substance is a permissible medicinal preparation handled within a valid regulatory framework. However, the judicial position is not entirely settled. The Allahabad High Court (Division Bench), in a series of proceedings including writ petitions seeking quashing of FIRs, has adopted a more expansive approach, permitting investigation and continuation of proceedings under NDPS provisions at the threshold stage. The reasoning in such cases reflects a degree of judicial deference to investigative processes, particularly where allegations of diversion, misuse or large-scale distribution are raised, even if the transaction originates within a licensed pharmaceutical framework. This divergence was carried to the Supreme Court in a recent Special Leave Petition arising from such proceedings, in which the issue of applicability of NDPS to licensed pharmaceutical trade was squarely raised. The matter, argued at length, culminated in an order of the Supreme Court, wherein the petition was permitted to be withdrawn with liberty to pursue appropriate remedies at the relevant stage. While the Court did not render a conclusive determination on merits, the grant of liberty is significant; it keeps the legal question open and underscores that the issue is far from settled at the highest level. Taken together, these developments reveal a jurisprudential crossroads. On one hand, some Court have emphasised the statutory exclusion, therapeutic use and regulatory character of such medicinal preparations, cautioning against the routine invocation of NDPS. On the other, certain decisions have allowed NDPS proceedings to continue at a preliminary stage, leaving the question of intent and misuse to be determined through investigation or trial. Yet, even within this divergence, a foundational principle remains clear: the applicability of NDPS cannot be presumed merely from the nature or quantity of the substance, but must be grounded in clear evidence that the statutory exemption does not apply. Where the material on record demonstrates that the substance is a regulated medicinal preparation, handled within permissible limits and under a valid licence, the invocation of NDPS begins to lose its legal foundation. Such judicial scrutiny is essential, not merely for granting individual relief, but for preserving the coherence of the statutory framework. Because when a penal statute of exceptional severity is invoked without first satisfying its own jurisdictional threshold, the issue transcends interpretation; it enters the realm of overreach, where the line between regulation and criminalisation is no longer merely blurred, but fundamentally compromised. The present uncertainty in judicial approach, coupled with the absence of a definitive pronouncement from the Supreme Court, has left the law in a state of uneasy suspension. While liberty to pursue remedies has been preserved, the core question, “Whether licensed pharmaceutical trade can be subjected to the rigours of the NDPS Act”, remains unanswered. This silence is not merely procedural; it has real and immediate consequences for those caught at the intersection of regulation and criminal law. In a statute as stringent as the NDPS Act, where liberty is curtailed at the threshold and the burden of proof is reversed, ambiguity itself becomes punitive. The need of the hour is not incremental clarification, but categorical delineation. Because when the law speaks in uncertain tones, enforcement grows louder and, in that imbalance, lies the risk that regulation will continue to be mistaken for crime, until the highest court draws the line where it was always meant to be. The Misapplication of DRI v Raj Kumar Arora (2025) A key factor contributing to the present confusion is the reliance placed on the Supreme Court’s judgment in Directorate of Revenue Intelligence v. Raj Kumar Arora; the factual matrix of which is fundamentally distinct. It dealt with substances that were precursors or raw materials capable of being used in the manufacture of narcotic drugs. The Court examined whether such substances could attract NDPS provisions when there was evidence of their intended use in illicit drug production. The emphasis was on potential transformation and intent. In contrast, codeine-based cough syrups are finished medicinal products, already formulated, standardised and regulated. They are not precursors. They are not capable of being converted into narcotic substances without entirely new processes and deliberate intent. Applying the ratio of Raj Kumar Arora to such cases is therefore a clear misapplication. It extends the principle beyond its intended scope and substitutes a contextual analysis with a blanket presumption. The judgment does not authorise the criminalisation of licensed pharmaceutical trade. To interpret it otherwise is to distort its ratio. The Expanding Role of BNS and the Risk of Layered Prosecution An emerging dimension of this issue is the increasing use of provisions under the Bharatiya Nyaya Sanhita (BNS) alongside NDPS. Allegations of conspiracy, cheating and fraudulent conduct are often added, creating a multi-layered prosecution. While such provisions may be justified in cases involving organised rackets, their routine application to pharmaceutical trade disputes raises serious concerns. This layering transforms what is essentially a regulatory issue into a criminal prosecution of the highest order, exposing individuals to severe legal consequences without a corresponding evidentiary foundation. Constitutional Dimensions of Articles 20 and 21 The implications of such prosecutions extend into the constitutional domain. Article 21 guarantees the right to life and personal liberty, which includes protection against arbitrary and excessive State action. The NDPS Act, with its stringent bail provisions and reverse burden of proof, significantly curtails this liberty. Its invocation must therefore be reserved for cases where its application is clearly warranted. Article 20 reinforces the principle that penal consequences must be based on clear legal authority and established wrongdoing. The extension of NDPS provisions to situations not contemplated by the statute risks violating this safeguard. When lawful business activity is subjected to the rigours of a penal statute without clear justification, the issue transcends statutory interpretation and enters the realm of constitutional infirmity. Systemic Impact Beyond Individual Cases The consequences of this trend are not confined to the individuals prosecuted. Pharmaceutical supply chains are disrupted, affecting the availability of essential medicines. Businesses face reputational harm, often irreversible. Employees lose livelihoods, and families bear the social and economic burden of prolonged litigation. More importantly, such actions create a climate of uncertainty within the regulated sector. When compliance does not guarantee protection, the incentive to operate within the law is weakened. A system that fails to distinguish between the compliant and the culpable risks undermining its own regulatory objectives. Conclusion – A Line That Must Not Be Crossed The law draws a clear and deliberate distinction between regulated medicine and illicit narcotics. That distinction is not determined merely by the nature of the substance, but by its purpose, context and adherence to the statutory framework. Pharmaceutical stockists and distributors operating under valid licences, maintaining records, and complying with regulatory norms form an integral part of the healthcare ecosystem, they are not offenders. Where violations occur, the response must be swift and appropriate within the regulatory domain, including suspension or cancellation of licences. However, any perceived weakness in enforcement under the Drugs and Cosmetics Act cannot justify the indiscriminate invocation of the NDPS Act or provisions of the BNS. Regulatory lapses cannot be elevated into criminal offences of the gravest kind merely to compensate for enforcement gaps; such an approach not only distorts the legislative scheme but risks undermining the rule of law itself, while violating the fundamental rights of such individuals.
