Cough syrup containing Codeine Phosphate within prescribed therapeutic limits is not a narcotic drug under the NDPS Act.

In brief

The question

1. Whether cough syrup containing codeine phosphate within prescribed therapeutic limits qualifies as a "narcotic drug" under the NDPS Act.

The court held

The Court held that the continuation of criminal proceedings would amount to an abuse of the process of law.

It also directed

It answered the issues in favor of the petitioners, ruling that the cough syrup did not qualify as a narcotic drug under the circumstances.

The Court allowed the applications and quashed the cognizance order dated August 22, 2022, the charge-framing order dated September 10, 2024, and the entire criminal proceedings in Singheshwar P.S. Case No. 228 of 2020 against all petitioners.

01Facts

On September 27, 2020, police intercepted a container truck and a Tata Magic vehicle in Madhepura, alleging the illegal transport of codeine-based intoxicants.

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They seized 282 cartons of "Wiscof" cough syrup.

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Petitioner Kamal Gupta is a Director of the logistics company transporting the goods, while the other petitioners are licensed pharmaceutical proprietors who had ordered the stock.

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The police registered an FIR under Sections 8(c), 21(c), 22(c), 23, 24, 25, 27(A), and 29 of the NDPS Act, 1985, and Section 30(a) of the Bihar Prohibition and Excise Act, 2018.

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The petitioners sought to quash the cognizance order dated August 22, 2022, and the framing of charges dated September 10, 2024.

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02Issues

i.1. Whether cough syrup containing codeine phosphate within prescribed therapeutic limits qualifies as a "narcotic drug" under the NDPS Act.

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ii.2. Whether the criminal proceedings against the petitioners constitute an abuse of the process of law given the medicinal nature of the seized substance.

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03Law Applied

The Court applied Section 2(xi)(b) of the NDPS Act and Central Government Notification S.O. 826(E) dated 14.11.1985 (Entry 35), which exempts preparations containing not more than 100 mg of Codeine per dosage unit and a concentration not exceeding 2.5% in undivided preparations from being treated as "narcotic drugs".

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The Court relied on the precedent set by the Allahabad High Court in *Vibhor Rana vs. Union of India (2021)*, which held that such medicinal preparations falling within the therapeutic exception do not attract NDPS Act prohibitions.

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Provisions in the judgment · 10 · Linked ones open on LawLens

Narcotic Drugs and Psychotropic Substances Act, 1985 10 provisions

Section 2 Section 8 Section 21 Section 22 Section 23 Section 24 Section 25 Section 27 Section 29 Section 60

04Reasoning

The Court found that "Wiscof" cough syrup contains 10 mg of Codeine Phosphate per 5 ml dosage unit, which is significantly below the 100 mg threshold established by the 1985 Notification.

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Consequently, the preparation is classified as a "manufactured drug" for therapeutic use rather than a prohibited narcotic drug under Section 8 of the NDPS Act.

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The Court noted that the prosecution failed to verify if the seized items were legitimate medicinal products before initiating criminal action.

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Since the petitioners held valid drug licenses or were legitimate transporters of licensed drugs, and the concentration of the substance fell within legal limits, the statutory prohibitions of the NDPS Act and the Bihar Prohibition and Excise Act were not applicable.

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