Unauthorized possession of low‑codeine cough syrups falls under the NDPS regulatory net: Patna High Court applies Hira Singh mixture rule and Section 37 bail bar

Case: Nilendra Kumar Karan @ Nilendra v. The State of Bihar

Court: Patna High Court | Coram: Hon’ble Mr. Justice Jitendra Kumar | Date: 27 August 2025

Proceeding: Criminal Miscellaneous No. 54100 of 2025 (Regular Bail under Sections 483 and 484 of the Bharatiya Nagarik Suraksha Sanhita, 2023)

Introduction

This commentary examines the Patna High Court’s decision refusing regular bail to the petitioner in an NDPS case arising from the seizure of 40 bottles of 100 ml each of a codeine phosphate and triprolidine hydrochloride cough syrup (“Oxerex”) from a vehicle at the Indo–Nepal border (Harlakhi, Madhubani). The petitioner, a Nepal resident, and a co-accused were apprehended by SSB personnel while allegedly transporting the consignment from India to Nepal.

The case squarely raises recurring issues in “cough syrup” prosecutions under the Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS Act):

• Whether low‑dose codeine cough syrups (less than 2.5% codeine and not more than 100 mg per dosage unit) are outside the NDPS Act and covered only by the Drugs and Cosmetics Act, 1940;
• Whether the “mixture rule” in Hira Singh v. Union of India applies to determine “commercial quantity” for such preparations;
• How the stringent bail embargo in Section 37 NDPS Act operates in these cases;
• Whether alleged non‑compliance of Section 42 NDPS Act (information, recording and reporting before search) can be a decisive factor at the bail stage.

The petitioner relied on Vibhor Rana v. Union Of India (Allahabad High Court), arguing that therapeutic low‑codeine cough syrup is not a “manufactured drug” and thus not punishable under the NDPS Act, at best inviting consequences under the Drugs and Cosmetics Act. The State cited contrary high court views (Mohd. Ahsan, Delhi HC; Azhar Javad Rather, J&K HC) and emphasized the applicability of Chapter VA of the NDPS Rules, 1985 regulating “essential narcotic drugs,” the non‑derogation clause in Section 80 NDPS Act, and the bail bar in Section 37.

Summary of the Judgment

• The Court refused regular bail, holding that:
  • Even low‑codeine cough syrups are within the regulatory fold of the NDPS Act and the NDPS Rules (Chapter VA) when possessed, transported, sold, or used without authorization; the NDPS Act is not displaced by the Drugs and Cosmetics Act (Section 80 NDPS Act);
  • The “mixture rule” in Hira Singh v. Union of India applies; therefore, for determining “commercial quantity,” the entire weight/volume of the seized preparation is reckoned, not merely the pure codeine content;
  • Given the quantity (40 bottles × 100 ml = 4 liters), the seizure qualifies as “commercial quantity,” triggering the twin conditions under Section 37 NDPS Act—conditions that were not satisfied in the petitioner’s favor;
  • Alleged non‑compliance with Section 42 NDPS Act is a fact‑intensive issue better examined at trial; at the bail stage, it is not decisive (relying on Karnail Singh and subsequent Supreme Court authorities).
• The Court distinguished Vibhor Rana on the ground that it did not consider Section 9 NDPS Act and Chapter VA of the NDPS Rules, 1985.
• Result: Bail rejected.

Analysis

Statutory scheme and interplay of laws

The Court foregrounded four pillars of the statutory framework:

• Section 8 NDPS Act: Prohibits production, manufacture, possession, sale, purchase, transport, import/export inter‑State, etc. of “narcotic drugs or psychotropic substances,” except for medical or scientific purposes, and “in the manner and to the extent” provided by the Act/Rules/orders and relevant licences/permits.
• Section 9 NDPS Act: Empowers the Central Government to “permit, control and regulate,” inter alia, the manufacture, possession, transport, sale, purchase, consumption and use of essential narcotic drugs and psychotropic substances, and to prescribe licences/permits and conditions.
• NDPS Rules, 1985 – Chapter VA (2015): A comprehensive code for “essential narcotic drugs” (ENDs), including codeine (methyl‑morphine) and ethyl morphine and their salts and preparations, with specific exceptions for certain therapeutic low‑dose combinations. Rule 52A(1) states that no person shall possess any essential narcotic drug otherwise than in accordance with the Rules; Rule 52A(2) fixes permitted quantities; subsequent rules allocate licensing/permit responsibilities to designated authorities (controller of drugs, etc.).
• Section 80 NDPS Act: The NDPS Act’s provisions are “in addition to, and not in derogation of” the Drugs and Cosmetics Act, 1940 and Rules. Thus, compliance with the D&C Act does not immunize an accused from NDPS obligations; both regimes may apply concurrently, with NDPS imposing additional controls on narcotics/psychotropics and ENDs.

On quantity, the Court invoked the Central Government’s notifications specifying “small” and “commercial” quantities and the post‑2009 Note 4, as interpreted by the Supreme Court in Hira Singh, which requires counting the whole mixture/preparation (including neutral substances) for determining the threshold.

Precedents cited and how they shaped the outcome

• Hira Singh v. Union of India, (2020) 20 SCC 272
  • Held valid the 2009 notification adding Note 4 to the 2001 quantity notification;
  • For mixtures/preparations of narcotic/psychotropic substances with neutral substances, the entire mixture weight is considered for “small” or “commercial” quantity—not merely the pure drug content;
  • Applied here to cough syrup preparation to conclude “commercial quantity.”
• E. Michael Raj v. NCB, (2008) 5 SCC 161
  • Earlier view that only pure drug content counts; effectively limited/overruled by Hira Singh in the context of the 2009 Note 4.
• Union of India v. Sanjeev V. Deshpande, (2014) 13 SCC 1
  • Section 8’s embargo remains unless the dealing is for medical/scientific purposes and “in the manner and to the extent” prescribed by the Act/Rules/orders. The mere therapeutic character of a product does not place it outside NDPS control; authorization/licence pathways matter.
• Mohd. Sahabuddin v. State of Assam, (2012) 13 SCC 491
  • Denied bail in a large seizure of codeine cough syrup where the accused could not demonstrate lawful possession/transit; relied upon to underscore that therapeutic formulations can attract NDPS consequences when misused or diverted.
• Section 37 bail line of authorities:
  • State of M.P. v. Kajad, (2001) 7 SCC 673: “Negation of bail is the rule and its grant an exception” for offences carrying minimum ten‑year sentences; twin conditions in Section 37 are cumulative and mandatory.
  • NCB v. Mohit Aggarwal, (2022) 18 SCC 374: At bail stage, courts do not try guilt or weigh evidence but must be satisfied there are reasonable grounds to believe the accused is not guilty and will not reoffend; mere charge‑sheet filing or custody length is insufficient to overcome Section 37.
  • NCB v. Kashif, (2024) 11 SCC 372: Reaffirms the mandatory, cumulative nature of Section 37’s twin conditions.
• Search and seizure compliance:
  • Karnail Singh v. State of Haryana, (2009) 8 SCC 539; Union of India v. Mohd. Nawab Khan, AIR 2021 SC 4476; Buta Singh v. State of Haryana, AIR 2021 SC 1913: Adequacy of Section 42 compliance is a fact question, and substantial compliance may suffice depending on circumstances. At the bail stage, such issues are flagged for trial rather than dispositively adjudicated.
• Interplay with Drugs and Cosmetics Act and END framework:
  • DRI v. Raj Kumar Arora, 2025 SCC OnLine SC 819; State of Punjab v. Rakesh Kumar, (2019) 2 SCC 466: Cited to delineate distinct aims of the D&C Act (drug quality, safety, standards) and NDPS (control, regulation, penalization of narcotics/psychotropics), emphasizing Section 80’s non‑derogation principle.
• Competing high court approaches on codeine cough syrups:
  • Mohd. Ahsan v. Customs, 2022 SCC OnLine Del 2910; Azhar Javad Rather v. UT of J&K, AIR Online 2023 J&K 270: Held that even low‑codeine cough syrups are within the NDPS regulatory regime; unauthorized possession/transport attracts NDPS.
  • Vibhor Rana v. Union Of India, 2021 SCC OnLine All 908: Took a contrary view that such therapeutically established low‑dose codeine syrups are excluded as “manufactured drugs,” hence outside NDPS, and governed by the D&C Act. The Patna High Court distinguished this case noting that Section 9 NDPS Act and Chapter VA of the NDPS Rules were not considered there.

Legal reasoning applied by the Court

1. NDPS Act applies concurrently with D&C Act: Section 80 NDPS Act ensures the NDPS framework overlays and supplements the D&C Act. Thus, even if a product is a therapeutic cough syrup, its possession/transport/sale is controlled under NDPS if it contains a narcotic/psychotropic substance or is an essential narcotic drug within the Rules’ remit.
2. Regulatory pathway matters more than therapeutic label: Relying on Sanjeev V. Deshpande, the Court emphasized that dealings in such substances must be “for medical or scientific purposes” and “in the manner and to the extent” permitted—i.e., with appropriate licence/permit, within prescribed quantities, and by authorized persons. The petitioner did not assert or demonstrate any licence/permit.
3. Mixture rule for quantity: By applying Hira Singh, the Court treated the entire 4 liters (40 × 100 ml bottles) as the relevant quantity for deciding whether the seizure amounted to “commercial quantity,” thereby triggering the stringent bail bar in Section 37 NDPS Act.
4. Section 37 bail embargo is decisive: With “commercial quantity” implicated, the Public Prosecutor’s opposition was to be considered and the Court had to be satisfied that there are reasonable grounds to believe that the accused is not guilty and will not reoffend. On the available material (the seizure, statements in the case diary, border interception, absence of authorization), such satisfaction could not be recorded.
5. Section 42 compliance reserved for trial: Alleged non‑compliance with Section 42 was held to be a fact‑dependent issue, aligned with Supreme Court precedent, unsuitable for definitive determination in a bail proceeding.

Impact and implications

For NDPS jurisprudence and enforcement in Bihar:

• The decision crystallizes within the Patna High Court’s jurisdiction that low‑dose codeine cough syrups, though therapeutically established, invite NDPS regulation when possessed or transported without authorization. This aligns Bihar with the Delhi and J&K High Courts’ approach and dissuades reliance on Vibhor Rana as a bail‑stage shield.
• Hira Singh’s mixture rule is expressly applied to cough syrup prosecutions, making “commercial quantity” easier to establish in bulk seizures of liquid preparations—thereby activating Section 37’s stringent bail thresholds.
• At the border context (India–Nepal), the judgment endorses active SSB/State enforcement against diversion of therapeutic narcotics under NDPS, not merely the D&C Act.

For medical and pharmaceutical stakeholders:

• Registered medical practitioners, medical institutions, chemists, dealers, and manufacturers must adhere strictly to the Chapter VA licensing and quantity controls for ENDs.
• Even when formulations meet the “low‑dose” exemption criteria under specific notifications, possession/transport in bulk without proper authorization may still attract NDPS consequences in this jurisdiction.

For bail practice under BNSS 2023:

• Though the bail power was invoked under Sections 483/484 BNSS, Section 37 NDPS Act—with its non‑obstante and cumulative twin conditions—continues to constrain judicial discretion powerfully. BNSS recodification does not dilute NDPS special constraints.

Wider doctrinal note: The decision contributes to resolving a persistent divergence among High Courts on whether low‑dose codeine cough syrups are outside NDPS. By emphasizing Section 9, Section 80, and Chapter VA, it reinforces the view that NDPS oversight persists notwithstanding therapeutic status, at least where authorization/permits and quantity controls are not complied with.

Complex concepts simplified

• Manufactured drug vs. essential narcotic drug (END): A “manufactured drug” is a narcotic substance/preparation notified as such (Section 2(xi)). “Essential narcotic drugs” are notified for medical/scientific use and are regulated under Chapter VA of the NDPS Rules. Codeine and ethyl morphine are treated as ENDs, subject to certain exceptions for specific low‑dose therapeutic combinations.
• Therapeutic exemption does not mean no NDPS oversight: Even if a product is a medically accepted cough syrup with low codeine content, the NDPS Act still controls who may possess/transport/sell it, in what quantities, and under what licences. Being “medicine” does not automatically remove NDPS compliance duties.
• Mixture rule (Hira Singh): When a narcotic/psychotropic is part of a mixture or preparation (like syrup), the whole mixture’s weight/volume counts toward deciding “small” or “commercial” quantity.
• Section 37 bail bar: For “commercial quantity” cases, bail can be granted only if the Court finds reasonable grounds to believe the accused is not guilty and will not commit an offence if released. Both conditions must be met; they are cumulative, not alternative.
• Section 42 compliance at bail stage: Whether officers complied with pre‑search reporting requirements is typically assessed at trial. Courts avoid resolving such fact‑heavy disputes at the bail stage unless the non‑compliance is glaring and undisputed.

Key takeaways

• Patna High Court affirms that low‑dose, therapeutically established codeine cough syrups remain subject to NDPS control when possessed/transported without authorization, notwithstanding the D&C Act.
• Hira Singh applies to liquid cough syrups: the entire preparation is counted to determine “commercial quantity.”
• Section 37 NDPS Act continues to be a formidable barrier to bail in “commercial quantity” cases; generalized pleas of innocence or medicinal character are insufficient.
• Challenges based on Section 42 NDPS Act compliance are reserved for trial on facts; they rarely carry the day at the bail stage.
• The decision narrows the persuasive space for reliance on Vibhor Rana in Bihar and aligns the State with stricter high‑court precedents on codeine cough syrup cases.

Conclusion

The Patna High Court’s ruling in Nilendra Kumar Karan consolidates a robust, regulation‑forward approach to low‑dose codeine cough syrup cases under the NDPS Act. By foregrounding Section 8’s “manner and extent” clause, the empowering scheme of Section 9, the comprehensive END controls in Chapter VA of the NDPS Rules, and the supremacy of Section 80’s non‑derogation principle, the Court makes clear that therapeutic status does not immunize narcotic‑bearing cough syrups from NDPS oversight. The application of the Hira Singh mixture rule to cough syrups further means that bulk seizures are likely to cross “commercial quantity” thresholds quickly, activating Section 37’s stringent bail impediments.

With bail denied, the decision signals a legally coherent and enforcement‑friendly paradigm for addressing diversion/misuse of narcotic‑bearing medicines in Bihar, especially in border districts. It also accentuates the compliance obligations of the healthcare supply chain and narrows the defensive reliance on contrary high‑court authority. Going forward, the judgment will likely shape both bail outcomes and trial strategies in NDPS prosecutions involving therapeutic narcotic preparations.