Introduction
The illicit trade of counterfeit pharmaceutical products poses severe risks to public safety, commercial reputation, and healthcare integrity. When spurious medicines flood the market, legal questions frequently arise regarding which investigating agency possesses the jurisdiction to prosecute the offenders and under what specific statutory framework. A crucial aspect of this debate is whether the specialised statutory mechanism governing drugs exclusively bars traditional law enforcement agencies from investigating penal offences under general criminal codes or intellectual property statutes. In a significant judicial ruling, the High Court examined these overlapping statutory frameworks, addressing the balance between drug regulatory laws, penal provisions against cheating, and copyright protections extended to proprietary product packaging.
Factual and Procedural Background
The origin of the case traces back to widespread detection of counterfeit medicines across several regions in India, including Maharashtra, Rajasthan, Delhi, West Bengal, Telangana, and Uttar Pradesh.
A leading pharmaceutical firm, Sun Pharma Laboratories Limited, owning established registered trademarks for several well-known drug formulations such as Rosuvas, Ranozex, Montek, Rozavel, Levipil, and Gemer, uncovered a widespread distribution network dealing in fake versions of its products.
Enquiries indicated that key supply operations were linked to facilities located in Puducherry, where storage and production units were allegedly functioning under the guise of fake pharma entities.
Consequently, an FIR was lodged in Puducherry under Sections 276, 318(4), and 61 of the Bharatiya Nyaya Sanhita, 2023, along with Sections 27(d) and 17B(b) of the Drugs and Cosmetics Act, 1940.
Simultaneously, other FIRs had already been registered in cities such as Agra, Muzaffarnagar, and Delhi. During the pendency of the matter, the investigation of the Puducherry FIR was formally transferred to the Central Bureau of Investigation.
The individuals named as key players in the Puducherry supply chain invoked the inherent jurisdiction of the High Court under Section 528 of the Bharatiya Nagarik Suraksha Sanhita, 2023, seeking to quash the FIR.
Dispute Before the Court
The core legal question presented before the Court was whether a police officer or specialised investigating agency has the legal authority to register an FIR and conduct an investigation when the allegations predominantly involve spurious or adulterated drugs.
The petitioners contended that under Section 32 of the Drugs and Cosmetics Act, 1940, only a designated Drugs Inspector is authorised to institute legal proceedings for offences under Chapter IV of the Act. Relying on binding judicial precedents, they argued that police officers are barred from registering FIRs or conducting searches and seizures for drug-related offences, making the entire police action illegal and devoid of jurisdiction.
The petitioners further asserted that no offence of cheating under Section 318(4) of the Bharatiya Nyaya Sanhita, 2023, was made out since there was no direct dishonest inducement of any specific individual to deliver property.
They also argued that copyright law applies strictly to traditional literary, dramatic, musical, or artistic works and cannot be extended to pharmaceutical products or drug packaging.
Lastly, they submitted that registering multiple FIRs across different states for the same overarching set of allegations amounted to an abuse of the legal process.
In response, the investigating agency and the pharmaceutical company argued that Section 32(3) of the Drugs and Cosmetics Act contains an explicit saving clause preserving the right to prosecute offenders under other existing laws.
They contended that the unauthorised replication of distinctive packaging designs, logos, and 3D security strips violates copyright in artistic works, which exists independently of trademark or drug regulatory statutes.
They also argued that deceiving distributors and the general public into purchasing fake medicines under the guise of genuine products clearly satisfies the elements of criminal cheating.
Reasoning and Analysis of the Court
Jurisdiction Under the Drugs and Cosmetics Act
The Court undertook an analytical evaluation of the statutory provisions, inter- statutory harmony, and established legal principles.
Addressing the jurisdictional challenge under the Drugs and Cosmetics Act, 1940, the Court acknowledged that while Chapter IV offences are meant to be prosecuted through formal complaints filed by Drugs Inspectors, this restriction does not create an absolute bar against police investigation under general penal statutes.
The Court emphasised Section 32(3) of the Drugs and Cosmetics Act, 1940, which explicitly provides that nothing in Chapter IV shall be deemed to prevent any person from being prosecuted under any other law for an act or omission constituting an offence.
Therefore, general police powers to register cases under Section 173 of the Bharatiya Nagarik Suraksha Sanhita, 2023, for offences under the Bharatiya Nyaya Sanhita, 2023, remain fully intact.
Copyright Protection for Pharmaceutical Packaging
Examining the applicability of the Copyright Act, 1957, the Court applied the doctrine of overlapping remedies.
The Court clarified that copyright protection operates as an independent statutory framework that can be invoked concurrently alongside other commercial and penal remedies.
Under Section 2(c) read with Section 13(1)(a) of the Copyright Act, 1957, original artistic work embodied in product labels, packaging layouts, and specialised graphic designs enjoys distinct copyright protection.
When counterfeiters fraudulently copy and reproduce these distinctive labels, color schemes, and specialized 3D security strips, their actions go beyond mere drug contamination and constitute a direct criminal infringement of copyright under Section 51, punishable under Sections 63 and 65 of the Copyright Act, 1957.
Cheating Under the Bharatiya Nyaya Sanhita
Regarding the charge of cheating under Section 318(4) of the Bharatiya Nyaya Sanhita, 2023, the court rejected the defence that no direct deception was proven at the threshold stage.
The Court observed that by placing spurious medicines bearing identical brand names, artwork, and fraudulent packaging into the commercial supply chain, the accused intentionally induced distributors, retailers, and end consumers to pay money for fake drugs under the belief that they were buying genuine pharmaceutical products.
This systematic misrepresentation directly establishes dishonest inducement to part with money, satisfying the statutory ingredients of cheating and causing wrongful loss to both consumers and the genuine manufacturer.
Multiple FIRs and Quashing Principles
On the issue of multiple FIRs, the Court reviewed the factual record and noted that the present FIR was not a duplicate registration for the same specific occurrence.
Instead, it was based on distinct seizures, specific local storage facilities uncovered in Puducherry, manipulated e-way bills, fraudulent purchase invoices, and separate batch codes.
Reaffirming settled legal principles on the exercise of inherent powers to quash criminal proceedings, the Court observed that an FIR is not meant to be an exhaustive encyclopedia of every detail.
Citing Supreme Court rulings including Sau. Kamal Shivaji Pokarnekar vs. State of Maharashtra, (2019) 14 SCC 350, and M/s. Neeharika Infrastructure Pvt. Ltd. vs. State of Maharashtra, 2021 SCC OnLine SC 315, the Court reiterated that criminal proceedings should not be scuttled at the initial stage when the allegations prima facie disclose the commission of cognizable offenses.
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Final Decision of the Court
The Court declined to quash the First Information Report and dismissed the criminal original petition along with all connected miscellaneous petitions.
Recognising the need for a prompt investigation into the counterfeit drug operation, the Court directed the Central Bureau of Investigation to complete its investigation in Crime No. 27 of 2025 and submit its final report before the jurisdictional Magistrate within twelve weeks.
Point of Law Settled
This decision clarifies the legal relationship between specialised regulatory statutes and general criminal laws.
It reaffirms that the presence of specialized enforcement mechanisms under the Drugs and Cosmetics Act, 1940 does not oust police jurisdiction to investigate penal offenses such as cheating under the Bharatiya Nyaya Sanhita, 2023 or copyright violations under the Copyright Act, 1957.
Furthermore, the ruling confirms that original artistic elements on drug packaging, labels, and anti-counterfeiting security features qualify as protected artistic works.
Consequently, their unauthorised replication constitutes an independent criminal offence, allowing brand owners to pursue multi-pronged legal remedies against counterfeiters.
Key Legal Principles
- Police retain jurisdiction to investigate offences under the Bharatiya Nyaya Sanhita, 2023, notwithstanding the Drugs and Cosmetics Act, 1940.
- Section 32(3) of the Drugs and Cosmetics Act preserves prosecution under other applicable laws.
- Original artistic elements on pharmaceutical labels and packaging are capable of copyright protection.
- Counterfeit drug packaging may attract independent criminal liability under the Copyright Act, 1957.
- Cheating under Section 318(4) of the Bharatiya Nyaya Sanhita, 2023, may arise from the sale of counterfeit medicines through deceptive branding.
- Separate FIRs are maintainable where they relate to distinct transactions, locations, seizures, and evidence.
Statutory Provisions Considered
| Statute | Relevant Provisions | Purpose in the Case |
|---|---|---|
| Bharatiya Nyaya Sanhita, 2023 | Sections 276, 318(4), 61 | Counterfeit medicine-related offences and cheating allegations. |
| Drugs and Cosmetics Act, 1940 | Sections 17B(b), 27(d), 32, and 32(3) | Regulation of spurious drugs and prosecution mechanism. |
| Bharatiya Nagarik Suraksha Sanhita, 2023 | Sections 173 and 528 | Police investigation powers and inherent jurisdiction of the High Court. |
| Copyright Act, 1957 | Sections 2(c), 13(1)(a), 51, 63, 65 | Protection of artistic works embodied in pharmaceutical packaging. |
Case Details
| Title of the Case | Vivek Venkatesan and Another vs. The State of Puducherry and Others |
|---|---|
| Date of Judgement | 21.07.2026 |
| Case Number | Crl.O.P.No.35020 of 2025 and Crl.M.P.Nos.24577 of 2025 & 3904 of 2026 |
| Name of Court | High Court of Judicature at Madras |
| Hon’ble Judge | Hon’ble Mr Justice G.K. Ilanthiraiyan |
| Written By | Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi |
Important Links
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