Codeine Cough Syrup With Permitted Codeine Attracts NDPS If For Intoxication: Allahabad High Court

In a significant ruling clarifying the legal status of codeine-based cough syrups, the Allahabad High Court has held that while such syrups containing the permitted quantity of codeine are not narcotic drugs when used medicinally, they attract the stringent provisions of the Narcotic Drugs and Psychotropic Substances (NDPS) Act if stocked, sold, or transported for the purpose of intoxication.

Justice Arun Kumar Singh Deshwal, presiding over a batch of over 100 connected bail applications, delivered the common judgment on September 1, 2026 , after hearing extensive arguments from senior counsel for the applicants and the State of Uttar Pradesh.

The Core Legal Question

The central issue before the court was whether codeine-based cough syrups—such as New Phensedyl, Eskuf, Codectus, and Lykarex-T—containing codeine within the limits prescribed by Entry 35 of the Central Government's notification dated November 14, 1985 , would fall under the NDPS Act when dealt with outside medicinal channels. The applicants argued that since the syrups contained only 0.2% codeine (well below the 2.5% threshold), they were merely drugs under the Drugs and Cosmetics Act and not manufactured drugs under the NDPS Act.

The court framed two distinct questions for determination: first, whether such syrups attract the NDPS Act when sold or transported by a licensed drug holder to another for medicinal purposes; and second, whether they attract the NDPS Act when sold, transported, or stored for purposes other than medicinal use, such as intoxication.

Arguments From Both Sides

Senior Advocates G.S. Chaturvedi , Nipun Singh , and Sushil Shukla , representing the applicants, contended that the codeine-based cough syrup in question had a codeine concentration of 0.2%, far below the limit specified in Entry 35. They relied heavily on the Division Bench decision of the same High Court in Vibhor Rana v. Union of India , which had held that Phensedyl cough syrup with 0.2% codeine does not fall under the definition of a narcotic drug. They also pointed to a 2009 clarification from the Central Drug Authority stating that Phensedyl is regulated by the Drugs and Cosmetics Act .

Opposing the bail applications, Additional Advocate General Anoop Trivedi submitted that the exemption under Entry 35 requires satisfaction of twin conditions—the permitted quantity of codeine and establishment in therapeutic practice . He argued that when huge quantities of such syrup are transported without valid documentation or for non-medicinal purposes, the exception is lost. The State relied on Supreme Court judgments in Mohd. Sahabuddin v. State of Assam , Union of India v. Sanjeev V. Deshpande , Hira Singh v. Union of India , and Revenue Intelligence Directorate v. Raj Kumar Arora .

Court's Analysis: A Fine Distinction

The High Court undertook a detailed examination of the statutory framework, particularly Section 2(xi)(b) of the NDPS Act , which defines manufactured drugs, and Section 8(c) , which prohibits dealing in narcotic drugs except for medical or scientific purposes. The court interpreted the expression " established in therapeutic practice " in Entry 35 to mean a preparation that has been fully proven and widely accepted for treating diseases based on long-term medical evidence.

The court held that codeine-based cough syrup with the permitted quantity of codeine satisfies both conditions under Entry 35 when intended for medicinal use, and therefore does not qualify as a manufactured drug or narcotic drug. However, the court drew a critical distinction: the moment such syrup is dealt with for purposes other than medicine—particularly for intoxication—the exemption evaporates.

"Similarly, even if a person has a license to deal with codeine-based cough syrup having a permitted quantity of codeine, if he possesses, sells, or transports the same for the purpose of intoxication because of its codeine content, then that person will also not be entitled to get the benefit of the exemption given under Entry 35 of the notification dated 14.11.1985."

The court declined to follow the Delhi High Court 's decision in Mohd. Ahsan v. Customs , which had declared Vibhor Rana per incuriam , noting that the Delhi High Court had incorrectly interpreted the notification of May 5, 2015 , and Rule 52A of the NDPS Rules . The court also distinguished the observations in Mohd. Sahabuddin , noting that the Supreme Court in that case had interpreted the term " therapeutic practice " rather than " established in therapeutic practice ," and those observations were obiter dicta made on different facts.

Applying the Law to Individual Cases

After laying down the legal principles, the court proceeded to decide each bail application on its own merits. In cases where the material prima facie showed that the cough syrup was being diverted for intoxication through layered business arrangements and fictitious firms, bail was refused. For instance, the court rejected the bail application of Bhola Prasad, proprietor of Saili Traders, finding evidence of a syndicate that sold over 7.5 lakh bottles of Phensedyl to non-existent firms, with the consignments ultimately recovered in Bihar and West Bengal during illegal transportation.

Conversely, bail was granted to applicants whose involvement appeared peripheral or where there was insufficient evidence of conscious possession or knowledge of the illicit purpose. Truck drivers and cleaners who were found transporting sealed cartons without awareness of the contents were among those granted bail.

The Verdict

Answering the two framed questions, the court declared:

Question No. 1: Codeine-based cough syrup having the permitted quantity of codeine will not be treated as a narcotic substance so long as it is sold or transported for medicinal use.

Question No. 2: Codeine-based cough syrup, if stocked, sold, or transported for purposes like intoxication instead of medicinal use, would be treated as a codeine preparation under the category of manufactured drug and would attract the provisions of the NDPS Act. The entire mixture of syrup shall be treated as codeine for determining commercial quantity , in view of the Supreme Court 's judgment in Hira Singh .

The court also expressed concern over the tendency of the Drug Department to invoke the NDPS Act for minor violations that properly fall under the Drugs and Cosmetics Act , directing the Commissioner of Food Safety and Drug Administration to issue appropriate guidelines to Drug Inspectors .