Court distinguishes medicinal use from illicit trafficking, emphasizing adherence to Drugs and Cosmetics Act for licensed dealers; issues guidelines for bail and Drug Department’s FIR procedure.
In a landmark judgment dated September 1, 2026, the Allahabad High Court, presided by Justice Arun Kumar Singh Deshwal, delivered a detailed common verdict disposing of numerous bail applications related to cases involving codeine-based cough syrups such as New Phensedyl, Eskuf, Codectus, and others. These cases raised pivotal legal questions on whether codeine-containing cough syrups with permitted quantities of codeine fall within the ambit of the Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS Act).
The Court extensively analyzed the definitions and provisions under the NDPS Act and the Drugs and Cosmetics Act, 1940, alongside relevant notifications issued by the Central Government. The key findings clarify that codeine-based cough syrups containing codeine within the permitted limits set out in Entry 35 of the Notification dated 14.11.1985 (less than 100 mg per dosage unit and concentration below 2.5%), and which have been established in therapeutic practice, are not narcotic drugs under the NDPS Act when sold, stocked, or transported by license holders for medicinal purposes. Such preparations are regulated under the Drugs and Cosmetics Act, and violations in record-keeping or prescription requirements attract penalties under that Act rather than the NDPS Act.
However, the Court emphasized that if such codeine-based cough syrups are diverted for non-medicinal purposes like intoxication or transported without valid licenses, they lose the exemption and attract NDPS Act provisions, including strict penalties. The entire mixture quantity is to be considered for determining commercial quantities for offenses under the NDPS Act.
The Court also made important observations regarding the liability of transporters and helpers unaware of the contents, stating that such persons may not attract NDPS provisions and are generally entitled to bail, subject to conditions.
A significant aspect of the judgment involved scrutinizing the modus operandi in alleged diversion cases, where firms with licenses under the Drugs and Cosmetics Act were found to be fronts for illegal trafficking through forged documents, fictitious firms, and non-existent transactions. The Court held that bail in such cases would generally be denied due to prima facie evidence of trafficking for non-medical use.
Specific bail applications were addressed individually, with the Court granting bail to several accused persons who had limited or no direct involvement in illegal trafficking or whose involvement was based solely on confessional statements without corroborative material. Conversely, bail was denied to key accused involved in large-scale diversion and illegal trafficking, where evidence indicated deliberate violations of licensing conditions and misuse of codeine-based syrups.
The Court prescribed stringent bail conditions including prohibitions on tampering with evidence, cooperation in trial, prohibition on committing further offenses, mandatory court appearances, and restrictions on leaving the country without permission. Violation of these conditions may lead to cancellation of bail.
Expressing concern over procedural irregularities, the Court directed the Commissioner of Food Safety and Drug Administration (FSDA), Uttar Pradesh, to instruct Drug Inspectors to adhere strictly to the Drugs and Cosmetics Act while registering FIRs, especially in cases involving minor violations, to avoid unnecessary invocation of the NDPS Act. It emphasized the need for Drug Inspectors to allow license holders adequate opportunity to produce required documents before lodging FIRs.
The judgment is a comprehensive legal framework clarifying the distinction between medicinal and illicit use of codeine-based cough syrups, balancing the objectives of public health regulation and narcotics control.
Bottom Line:
NDPS - Codeine-based cough syrup with permitted quantity of codeine is not a narcotic drug under NDPS Act when sold or transported for medicinal purposes; however, if diverted for non-medicinal use such as intoxication, it attracts NDPS Act provisions.
Statutory provision(s): Narcotic Drugs and Psychotropic Substances Act, 1985 Sections 2(xi), 2(xiv), 2(xvi), 8(c), 21, 27A, 29; Drugs and Cosmetics Act, 1940; Drugs and Cosmetics Rules, 1945; Essential Commodities Act, 1955; Bharatiya Nyaya Sanhita, 2023; Bharatiya Nagarik Suraksha Sanhita, 2023; Bharatiya Sakshya Adhiniyam, 2023
Bhola Prasad v. State of U.P., (Allahabad) : Law Finder Doc id # 2971303
