Police Cannot Routinely Slap NDPS Act for Codeine Cough Syrups Within Permissible Limits: Patna High Court
The Patna High Court rebuked the police practice of routinely invoking the Narcotic Drugs and Psychotropic Substances (NDPS) Act in cases involving the seizure of codeine-based cough syrups. The court made these observations while hearing a bail petition filed by Bharat Kumar, who was arrested in May 2026 after authorities in Bihar’s Khagaria district seized 484 litres of codeine-containing cough syrup from a pick-up van.
Granting bail to the petitioner, a Single Judge bench headed by Justice Ashok Kumar Pandey held that medicinal preparations containing codeine within statutory threshold limits do not fall within the definition of a "manufactured drug" under the NDPS Act. The bench observed that the police are "invariably misusing the procedure" by registering NDPS cases rather than initiating action under the Drugs and Cosmetics Act, 1940.
Legal Topic
Area of Law: Criminal Law / Pharmaceutical Regulation
Sub-topic: NDPS Act vs. Drugs and Cosmetics Act / Statutory Classification of Manufactured Drugs
Core Legal Issue
The controversy centres on whether the possession, transportation, or sale of codeine-based cough formulations constitutes an offence under the NDPS Act when the codeine concentration falls below 2.5% and contains no more than 100 milligrams per dosage unit.
The primary legal question before the court was whether the stringent bail restrictions under Section 37 of the NDPS Act and the Supreme Court’s "mixture rule" in Hira Singh v. Union of India can be triggered when the seized therapeutic preparation is statutorily exempted from qualifying as a narcotic drug in the first instance.
What Did the Court Decide?
Justice Ashok Kumar Pandey granted regular bail to the accused, ruling that the rigorous bar against bail under Section 37 of the NDPS Act does not apply.
The court clarified that determining whether a seizure amounts to a "commercial quantity" under the Hira Singh doctrine arises only after the recovered material is legally established to be a narcotic drug or psychotropic substance. Since the formulation in question fell within the Central Government’s exempt concentration threshold, the court observed that there was no jurisdictional basis to treat the batch as contraband under the NDPS Act. The bench further emphasized that codeine cough syrup is a Schedule H prescription drug, and any unauthorized stocking, licensing lapses, or distribution breaches constitute violations punishable under the Drugs and Cosmetics Act, 1940, rather than the NDPS Act.
Key Legal Points
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Threshold Jurisdictional Test: A recovered substance must first satisfy the definition of a "narcotic drug" or "manufactured drug" under Section 2 of the NDPS Act before questions of quantity or statutory bail bars can be examined.
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Statutory Dosage Exception: Under Central Government Notification S.O. 826(E) (Entry 35), codeine preparations compounded with other ingredients containing not more than 100 mg per dosage unit and a concentration not exceeding 2.5% are exempted from being treated as manufactured drugs.
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Inapplicability of the Mixture Rule: The doctrine established in Hira Singh v. Union of India—which measures the entire weight of a neutral mixture containing a drug—cannot be deployed to convert an exempted medicinal formulation into an illicit commercial-quantity contraband.
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Procedural Misuse Under the NDPS Act: Violations related to Schedule H pharmaceutical drugs must be prosecuted under the Drugs and Cosmetics Act, 1940, and the routine registration of NDPS cases by police demonstrates procedural overreach.
Relevant Law
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Narcotic Drugs and Psychotropic Substances Act, 1985: Section 2(xi) (Manufactured Drug), Section 21 (Contravention in relation to manufactured drugs and preparations), and Section 37 (Stringent conditions for grant of bail).
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Drugs and Cosmetics Act, 1940 & Drugs Rules, 1945: Schedule H (Prescription drug licensing and sales register requirements).
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Central Government Notification No. S.O. 826(E) (dated November 14, 1985): Entry No. 35, defining permitted concentration limits for codeine formulations.
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Judicial Precedent: Hira Singh and Anr. v. Union of India and Anr. (2020).
Arguments of the Parties
Petitioner
Counsel for the petitioner submitted that the seized cough syrup contained codeine phosphate at a concentration of approximately 0.2%, well below the 2.5% threshold stipulated in Central Government Notification S.O. 826(E). The defence argued that because the preparation complied with the statutory exemption, it did not qualify as a "manufactured drug" under the NDPS Act, rendering the prosecution under the special statute legally unsustainable and entitling the applicant to regular bail.
The State
The Additional Public Prosecutor vehemently opposed the bail plea, citing the Supreme Court’s ruling in Hira Singh v. Union of India. The prosecution contended that the total weight and volume of the entire seized preparation—amounting to 484 litres—must be considered in aggregate. Under this calculation, the State asserted that the recovery constituted a commercial quantity, thereby triggering the stringent embargo of Section 37 of the NDPS Act and disqualifying the petitioner from receiving bail.
Why Does It Matter?
This ruling directly addresses a persistent jurisdictional conflict between police enforcement under the NDPS Act and regulatory enforcement under the Drugs and Cosmetics Act. Investigating agencies frequently leverage the NDPS Act’s non-bailable framework to bypass standard drug licensing inquiries, leading to severe pre-trial incarceration for transport workers, stockists, and retail pharmacists.
By explicitly holding that the Hira Singh mixture rule cannot be used backwards to transform an exempted therapeutic formula into a narcotic drug, the decision provides critical clarity for criminal trial courts. It restricts police overreach and reinforces that regulatory infractions concerning Schedule H prescription drugs belong under the Drugs and Cosmetics Act unless an unauthorized, illicit manufacturing or chemical alteration is proven.
Legal Takeaway
Before the harsh bail embargos of the NDPS Act can be triggered, the prosecution must establish that the seized formulation legally qualifies as a narcotic drug. Where a codeine-based syrup contains less than 2.5% concentration, it remains an exempted pharmaceutical preparation governed by the Drugs and Cosmetics Act, barring police from using the NDPS Act to prevent bail.
Sources
Primary Source:
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Patna High Court, Judgment/Order in Criminal Miscellaneous proceedings, Coram: Ashok Kumar Pandey, J. (delivered October 2026 / underlying notifications under S.O. 826(E)).
Additional Sources:
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Central Government Notification No. S.O. 826(E) (Entry 35).
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Hira Singh and Anr. v. Union of India and Anr. (2020) SCC OnLine SC 382.
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Litigation reporting by Bar and Bench on Patna High Court proceedings (October 2026).