Codeine Cough Syrup and the NDPS Act: Allahabad HC Draws a Line Between Medicine and Intoxicant

Justice Arun Kumar Singh Deshwal resolved 76 bail applications to settle when codeine-based cough syrup crosses from the Drugs and Cosmetics Act into NDPS Act territory — and when it does not.

The High Court of Judicature at Allahabad has, in a common judgment running to over 220 pages, disposed of 76 bail applications that all turned on a single legal question: does codeine-based cough syrup — sold widely under brand names such as New Phensedyl, Eskuf, Codectus, Lykarex-T, Phencypink-T and Rexley-T — attract the stringent provisions of the Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS Act), or does it fall only under the Drugs and Cosmetics Act? Justice Arun Kumar Singh Deshwal, sitting singly, answered that the syrup remains outside the NDPS Act when it contains the permitted quantity of codeine and is dealt with for medicinal purposes; once it is diverted for intoxication, the exemption falls away and the NDPS Act applies in full. The judgment reserved on 25 August 2026 was delivered on 1 September 2026.

Why 76 Bail Applications Were Heard Together

The Hon'ble Chief Justice nominated all 76 applications to the same bench on account of the common legal issue running through each of them. The accused persons ranged from super stockists and wholesale drug dealers to truck owners, drivers and alleged handlers of shell firms. They were arrested in cases registered across districts including Sonbhadra, Chandauli, Ghazipur and Varanasi, with police invoking Sections 8, 21, 27A and 29 of the NDPS Act alongside various provisions of the Bharatiya Nyaya Sanhita, 2023.

Counsel for the applicants — led by Senior Advocates G.S. Chaturvedi, Nipun Singh and Sushil Shukla — jointly submitted that cough syrups such as New Phensedyl contain only 0.2% codeine (10 mg per 5 ml dose), well within the permitted ceiling. The NDPS Act, they argued, simply had no application; any licence violation should be prosecuted under the Drugs and Cosmetics Act alone. The State was represented by Additional Advocate General Anoop Trivedi, assisted by several Additional Government Advocates.

The Statutory Landscape: Codeine, Manufactured Drugs and the 1985 Notification

The court walked through the definitional chain in the NDPS Act. Section 2(xiv) defines “narcotic drug” to include all manufactured drugs. Section 2(xi) defines “manufactured drug” to include, under clause (a), opium derivatives — and Section 2(xvi)(c) expressly lists codeine as a phenanthrene alkaloid falling within opium derivatives. Codeine is therefore a manufactured drug, which is a narcotic drug.

However, Section 2(xi)(b) empowers the Central Government, by notification, to declare a narcotic substance or its preparation not to be a manufactured drug. It exercised that power through a notification dated 14 November 1985. Entry 35 of that notification declares codeine and its preparations to be manufactured drugs, but carves out an exception for preparations that satisfy two cumulative conditions:

• The preparation is compounded with one or more other ingredients and contains not more than 100 mg of codeine per dosage unit, with a concentration of not more than 2.5% in undivided preparations; and
• The preparation has been established in therapeutic practice.

The court confirmed that the cough syrups in every one of the 76 cases contain 10 mg codeine per 5 ml dose unit (0.2% concentration), satisfying the first condition without dispute. The real contest was over the second condition.

What “Established in Therapeutic Practice” Means

The applicants relied heavily on the Division Bench decision of the same court in Vibhor Rana v Union of India, 2021 SCC OnLine All 908, which held that the phrase “established in therapeutic practice” refers to the drug's standing in the medical world, not to any particular transaction. The Division Bench had observed that the expression cannot be altered to read “used for therapeutic purposes”, and that misuse by an end consumer does not pull the drug into the NDPS Act.

The State countered by pointing to the Supreme Court's decision in Mohd. Sahabuddin v State of Assam, (2012) 13 SCC 491, where the apex court held that a person transporting a huge quantity of cough syrup without a valid licence cannot claim the benefit of therapeutic practice. The State also invoked the more recent Supreme Court ruling in Revenue Intelligence Directorate v Raj Kumar Arora, (2026) 2 SCC 401, which held that violation of a licence condition under the Drugs and Cosmetics Act can itself constitute a contravention of Section 8 of the NDPS Act, and that section 80 of the NDPS Act makes its provisions additional to, not in substitution of, the Drugs and Cosmetics Act.

Justice Deshwal drew on dictionary meanings and the context of Section 8(c) of the NDPS Act to hold that “established in therapeutic practice” means a preparation that has been fully proven, widely accepted, and routinely used by doctors to treat or cure a disease, based on long-term medical proof. Codeine-based cough syrup, he held, satisfies this test: it has been established through clinical trials and long-term clinical practice to treat cough. The second condition is therefore met as a matter of the drug's character, not the accused's intent in any individual transaction.

The court respectfully disagreed with the Delhi High Court's view in Mohd. Ahsan v Customs, 2022 SCC OnLine Del 2910, which had declared Vibhor Rana to be per incuriam on the ground that codeine cough syrup became an essential narcotic drug under the Central Government's notification dated 5 May 2015. Justice Deshwal found that the 2015 notification and Rule 52A of the NDPS Rules, read carefully, continued to exclude the permitted-quantity preparation from the category of essential narcotic drugs rather than including it.

The Two Questions Answered

The court formally framed and answered two questions.

Question 1: Does codeine-based cough syrup with permitted codeine attract the NDPS Act when sold or transported by a drug licence holder to another licence holder or to any person for medicinal purposes?

Answer 1: No. Such syrup will not be treated as a narcotic substance so long as it is sold or transported for medicinal use, in compliance with the Central Government's notifications dated 14 November 1985 and 2 May 2001.

Question 2: Does the same syrup attract the NDPS Act when transported, sold or stored for a purpose other than medicinal use — such as intoxication?

Answer 2: Yes. When stocked, sold or transported for intoxication rather than medicinal use, the syrup ceases to enjoy the Entry 35 exemption. It is treated as a codeine preparation within the category of manufactured drug, attracting the NDPS Act. The entire weight of the mixture is to be treated as codeine for the purpose of determining small or commercial quantity, following Hira Singh v Union of India, (2020) 20 SCC 272.

The court added a specific clarification: a drug retailer who sells codeine cough syrup without a medical prescription in routine sales commits a violation of the Drugs and Cosmetics Act, not the NDPS Act — unless the quantity sold in a very short span of time clearly reveals the retailer's knowledge that the syrup is being procured for intoxication rather than medicine.

It also noted that for claimants who do hold a valid licence, any violation of licence conditions is ordinarily to be prosecuted under the Drugs and Cosmetics Act. However, following Raj Kumar Arora, a licence-holder who diverts the syrup for intoxication loses the benefit of the exemption entirely and can be prosecuted under the NDPS Act as well. A person with no licence at all, transporting huge quantities without documents, cannot invoke the Entry 35 exemption and stands exposed to the NDPS Act directly.

Where the total quantity of codeine recovered in syrup form exceeds 1 kg — the commercial quantity threshold in the NDPS Act schedule — the bar under Section 37 of the NDPS Act against bail applies.

Applying the Law: How Individual Applications Fared

Armed with the legal framework, the court turned to the specific facts of each bail application. The outcomes differed sharply.

Bhola Prasad (main applicant, Case Crime No. 1191 of 2025, PS Robertsganj, Sonbhadra): Bhola Prasad is the proprietor of Saili Traders, Ranchi, a licensed super stockist. His firm sold 3,66,000 bottles of New Phensedyl to M/s Maa Kripa Medical, Sonbhadra, and 3,87,000 bottles to M/s Shivichha Pharma, Sonbhadra, between 1 April 2024 and 23 August 2025. The State placed on record that neither firm could produce any purchase or receipt documents; the landlord confirmed both shops were occasionally open and no medicine was ever unloaded there; the toll plaza traceability showed the consignment never reached Sonbhadra; bottles were recovered in Purnia district, Bihar during illegal transportation; Enforcement Directorate officers recovered signed blank cheques of both firms from the applicant's office; and a co-accused, Jubai Hussain, stated in a confessional statement that he received consignments from the applicant's firm for transport to Bangladesh for intoxication. The court found prima facie evidence that 7,53,000 bottles were diverted for purposes other than medicinal use. The applicant had also not explained the criminal history in four other cases against him. Bail was rejected.

Brijmohan Shivhare and Ram Gopal Dhakad (Case Crime No. 1054 of 2025, PS Robertsganj, Sonbhadra): Both trucks carrying cough syrup (Eskuf, 1,19,675 bottles) were intercepted at Sonbhadra. The bottles were concealed inside sealed cartons of chips and namkeen. The truck owner and driver had valid e-way bills and invoices showing the consignment as chips and namkeen. On viewing the recovery video, the court held that the transporter could not be presumed to know the cartons contained codeine syrup bottles. Conscious possession was not established. Bail was granted.

Vinod Verma and Sanskar Verma (Case Crime No. 1054 of 2025): Their firm, Om Sai Pharmaceutical, Prayagraj, purchased 1,14,850 bottles of Eskuf. Some bottles of the same batch numbers were recovered at Sonbhadra. The court noted that a single batch can have up to 90,000 bottles, and recovering bottles of the same batch number is insufficient to presume those specific bottles belonged to the applicants. The State produced no other material showing diversion for intoxication. Bail was granted.

Devesh Jaiswal @ Divesh Jaiswal (Case Crime No. 571 of 2025, PS Mughalsarai, Chandauli): The allegation was that the applicant operated as a handler for Saili Traders and created fake pharma firms. Beyond the statement of one Kishan Lal, the court found no independent material showing the exact amount deposited by the applicant or his active involvement in illegal trafficking. Bail was granted.

Several other applicants in the Ghazipur cases (Amit Kumar Singh, Shubham Singh, Sarvansh) faced rejection. In each case, toll plaza traceability reports showed the consignments purchased on paper from Saili Traders were never actually delivered to the applicants' firms; the firms to which the applicants allegedly on-sold the syrup were found fictitious, with no stock and no sale documents; yet crores of rupees flowed through those firms back to Saili Traders; and bottles of the same batch numbers surfaced in Tripura and West Bengal during illegal transportation for intoxication. Bail was rejected in each of those cases.

The Court's Concern About Drug Department Practices

Beyond the individual disposals, Justice Deshwal expressed concern about the manner in which drug inspectors have been lodging FIRs. The court found that, in several cases, the Drug Department had invoked the stringent NDPS Act even for relatively minor licence violations that should have been prosecuted under the Drugs and Cosmetics Act. It further observed that drug inspectors had in many instances failed to give licence holders adequate time to produce documents before filing FIRs, which later altered the version of the FIR when documents were placed before the investigating officer during investigation.

The court directed the Commissioner of Food Safety and Drug Administration (FSDA), Uttar Pradesh, Lucknow to look into the issue and to apprise drug inspectors of the correct method of lodging FIRs, distinguishing between violations attracting the Drugs and Cosmetics Act and those attracting the NDPS Act.

Order

The court disposed of all 76 bail applications by a common judgment dated 1 September 2026. Bail was granted in a number of applications — including those of Brijmohan Shivhare, Ram Gopal Dhakad, Vinod Verma, Sanskar Verma and Devesh Jaiswal — subject to standard conditions including no inducement or tampering with evidence, cooperation in trial, no leaving the country without permission of the trial court, and verification of Aadhaar and surety details. Bail was rejected in the application of the lead applicant Bhola Prasad and in several other applications where the material in the case diary disclosed prima facie diversion of large quantities of codeine syrup for intoxication.

The Commissioner of FSDA, U.P., Lucknow was directed to receive a copy of the order and take corrective steps regarding the practice of FIR registration by drug inspectors.