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

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

Seizures included 282 cartons of "Wiscof" cough syrup containing Codeine Phosphate and Triprolidine Hydrochloride.

Petitioner Kamal Gupta, a Director of the logistics company, and petitioners Bimal Kumar and Rupesh Kumar, licensed pharmaceutical stockists, were charged 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.

The petitioners moved to quash the cognizance and charge-framing orders, contending the syrup was a licensed medicinal product containing codeine within legally permissible limits.

1. Whether the possession and transport of "Wiscof" cough syrup containing 10 mg of codeine per 5 ml dosage unit constitutes an offence under the NDPS Act.

2. Whether the continuation of criminal proceedings against licensed pharmaceutical stockists and transporters for such medicinal preparations amounts to an abuse of the process of law.

The court applied Section 8 of the NDPS Act, which prohibits certain operations involving narcotic drugs.

It relied on Central Government Notification S.O. 826(E) dated 14.11.1985 (Entry 35), which exempts methyl morphine (codeine) preparations from being treated as "narcotic drugs" if they contain not more than 100 mg of the drug per dosage unit and a concentration of not more than 2.5% in undivided preparations.

The court further followed the precedent set by the Allahabad High Court in *Vibhor Rana v. Union of India*, which held that Phensedyl/codeine-based syrups falling within these limits do not attract NDPS Act prohibitions.

The court found that "Wiscof" cough syrup contains 10 mg of codeine per 5 ml dose, significantly below the 100 mg threshold established in the 1985 Notification.

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.

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

Since the petitioners held valid drug licenses and the consignment was supported by invoices from a licensed manufacturer (M/s Windlas Biotech Pvt. Ltd.), the court reasoned that the technical standards for therapeutic exemption were met, rendering the NDPS and Excise Act charges unsustainable.

The court quashed the cognizance order dated 22.08.2022 and the charge-framing order dated 10.09.2024 passed by the Sessions Judge-cum-Special Judge, NDPS, Madhepura.

All criminal proceedings arising out of Singheshwar P.S. Case No. 228 of 2020 against the petitioners were set aside to prevent the abuse of the process of law.