Codeine Cough Syrup Is Not Narcotic Only When Sold for Medicinal Use: Allahabad HC

New Delhi: The Allahabad High Court has ruled that codeine-based cough syrup containing codeine within the legally permitted concentration will remain outside the ambit of the Narcotic Drugs and Psychotropic Substances Act, 1985, only when it is stocked, sold, or transported for genuine medicinal use.

However, if such cough syrup is diverted, stored, sold or transported for intoxication or any purpose other than medicinal use, it will be treated as a “manufactured drug” and attract prosecution under the NDPS Act.

Justice Arun Kumar Singh Deshwal delivered the judgement on September 1, 2026, after reserving it on August 25, 2026. The ruling came in Bhola Prasad v. State of Uttar Pradesh, Criminal Miscellaneous Bail Application No. 418 of 2026, along with 75 other connected bail applications involving the stocking, sale and transportation of codeine-based cough syrups such as New Phensedyl, Eskuf, Codectus, Lykarex-T, Phencypink-T and Rexley-T.

The common legal issue before the Court was whether codeine-based cough syrup containing codeine within the limit permitted under Entry 35 of the Central Government notification dated November 14, 1985, could attract the NDPS Act when it was stocked, sold or transported in violation of the conditions of a licence issued under the Drugs and Cosmetics Act and the corresponding Rules.

The Court framed two principal questions for consideration. The first was whether codeine-based cough syrup containing the permitted quantity of codeine would attract the NDPS Act when sold or transported by a licensed drug dealer to another licence holder or any other person for medicinal purposes. The second was whether the same cough syrup, although manufactured as a cough suppressant, would attract the NDPS Act if it was stocked, sold or transported for intoxication or another non-medicinal purpose.

The specific bail application filed by Bhola Prasad arose from Case Crime No. 1191 of 2025, registered at Robertsganj Police Station in Sonbhadra district under Sections 318(4), 338, 336(3), 340(2) and 61(2)(a) of the Bharatiya Nyaya Sanhita, 2023, along with Sections 27A and 29 of the NDPS Act. Prasad sought release on bail during the pendency of the trial.

According to the case background recorded in the judgment, drug authorities inspected the premises of M/s Maa Kripa Medical and M/s Shivichha Pharma in Sonbhadra after receiving information concerning the supply of New Phensedyl cough syrup. Although both firms held licences under the Drugs and Cosmetics Act, they allegedly failed to produce documents relating to the purchase of the cough syrup from Saili Traders, Ranchi, a proprietorship concern owned by Bhola Prasad.

The authorities were reportedly informed by neighbours that the two shops were opened only occasionally. The proprietors of Maa Kripa Medical and Shivichha Pharma stated that they had purchased a total of 7,53,000 bottles of New Phensedyl cough syrup, each containing 100 ml, from Saili Traders between April 1, 2024, and August 23, 2025.

Appearing for Bhola Prasad, Senior Advocate G.S. Chaturvedi argued that Saili Traders was a licensed super stockist under the Drugs and Cosmetics Act and was legally authorised to sell, purchase, stock and distribute medicines, including codeine-based cough syrup. The applicant maintained that there was no prescribed limit on the quantity of cough syrup that a super stockist could purchase, stock or sell.

The applicant further referred to Rule 28A of the Drugs (Prices Control) Order, 2013, to contend that a super stockist could not refuse to supply drugs to a licensed stockist or dealer. It was submitted that an August 15, 2022 office memorandum issued by the State Government, which prescribed limits for the storage and sale of certain medicines by dealers and stockists, did not prescribe any corresponding limit for super stockists. In any case, the operation of the memorandum had reportedly been stayed by the Allahabad High Court on February 15, 2023, in Writ Petition No. 3749 of 2023.

The applicant argued that codeine itself may be a narcotic drug under the NDPS Act, but New Phensedyl cough syrup could not be classified as a narcotic or manufactured drug because its codeine concentration was only 0.2 per cent. Relying on Entry 35 of the November 14, 1985 notification, the applicant contended that a preparation containing not more than 100 mg of codeine per dosage unit and having a concentration not exceeding 2.5 per cent, when established in therapeutic practice, stood excluded from the definition of a manufactured drug.

It was further argued that the cough syrup was covered by drug licences issued in Form 21-B and Form 20-B and that the applicant’s licence remained valid from October 6, 2023, to October 5, 2028. The licence was cancelled by the Drug Department only on November 12, 2025, after the FIR had already been registered. Therefore, the applicant contended that the transactions conducted before the cancellation were legally valid.

The applicant also claimed that proper GST invoices had been issued for the sales and that responsibility for transporting the consignments rested with the purchasing firms. Statements from truck owners allegedly showed only that medicines had been transported from the Saili Traders warehouse in Ranchi to a warehouse in Varanasi, without identifying the exact medicines loaded. On this basis, the applicant argued that there was no direct evidence proving that he had diverted New Phensedyl or supplied it for intoxication.

It was also submitted that no cough syrup allegedly supplied by the applicant had been recovered from Maa Kripa Medical, Shivichha Pharma or the firms to which they claimed to have made subsequent sales. The applicant disputed allegations concerning the use of different Aadhaar addresses, explaining that the address was changed after he shifted from Ranchi to Varanasi, while his name and father’s name remained unchanged. The blank signed cheques recovered from his premises were described as security cheques received in the ordinary course of business.

The State, represented by Additional Advocate General Anoop Trivedi, opposed the bail application and argued that a licence under the Drugs and Cosmetics Act did not authorise the open-market diversion of codeine-based cough syrup for non-medicinal purposes. The State maintained that such medicine could be supplied only on prescription or to another licensed drug dealer for legitimate medicinal distribution.

The State alleged that Maa Kripa Medical and Shivichha Pharma were paper entities that did not conduct any genuine pharmaceutical business. They allegedly failed to produce purchase documents or records establishing physical receipt of the consignments. The firms further claimed that the cough syrup was sold to three other entities—Dileep Medical, Ayush Enterprises and Sanaya Medical—but those firms allegedly neither possessed the stock nor maintained records showing its subsequent sale.

The prosecution claimed that money deposited into the accounts of the three downstream firms originated from several individuals who were not involved in the pharmaceutical trade, including persons dealing in flowers, plastic articles and beauty-parlour activities. After the funds were transferred to Maa Kripa Medical and Shivichha Pharma, almost the entire amount was allegedly remitted to Saili Traders.

The State further submitted that the Enforcement Directorate recovered blank signed cheques belonging to 63 medicine firms, including Maa Kripa Medical and Shivichha Pharma, from the applicant’s office. According to the prosecution, this suggested that the applicant exercised actual control over the intermediary firms, even though they were registered in the names of other persons.

It was also alleged that e-way bills showed the consignments as destined for Sonbhadra, whereas toll-plaza records indicated that the medicines had not reached the stated destination. Instead, the cough syrup was allegedly transported to Varanasi and thereafter diverted to other locations. A truck driver’s statement was cited to allege that cough syrup moved from Ranchi to Varanasi and subsequently to Dhanbad, after which the truck was loaded with scrap for its return journey.

The State informed the Court that bottles forming part of consignments purchased by the applicant’s firm and purportedly sold to firms in Sonbhadra were recovered in Purnia district of Bihar, Siliguri and Agartala. The prosecution also relied upon a statement alleging that the syrup was being supplied to Bangladesh for use as an intoxicant. In addition, the experience certificate and other documents used for obtaining the drug licence of Saili Traders were alleged to be forged.

While examining the wider legal question, the Court held that the phrase “established in therapeutic practice” in Entry 35 of the November 14, 1985 notification had to be interpreted in conjunction with Section 8(c) of the NDPS Act. The Court explained that the phrase refers to a preparation that has been medically proven, widely accepted and routinely used by doctors for treating a disease or health condition. Codeine-based cough syrup within the permitted concentration fulfils this requirement because it has been accepted as a treatment for cough through clinical trials and long-standing medical practice.

At the same time, the Court held that this exemption is conditional and cannot be claimed by a person who diverts the medicine for intoxication or any other non-therapeutic use. Applying the mischief rule of statutory interpretation, the Court observed that the NDPS Act was enacted to control and prevent the misuse and illegal trafficking of narcotic drugs and psychotropic substances. Its provisions must consequently be interpreted in a manner that suppresses the mischief of drug abuse and advances the statutory remedy.

The Court rejected the proposition that compliance with the Drugs and Cosmetics Act would automatically exclude prosecution under the NDPS Act. Referring to Section 80 of the NDPS Act and the Supreme Court’s decision in Directorate of Revenue Intelligence v. Raj Kumar Arora, the High Court observed that the NDPS Act operates in addition to, and not in derogation of, the Drugs and Cosmetics Act. Therefore, where the facts warrant it, offences under both enactments may arise simultaneously.

The Court clarified that the Drugs and Cosmetics Act primarily seeks to prevent substandard, adulterated and spurious drugs from entering the medical market and to maintain standards in medical treatment, whereas the NDPS Act regulates narcotic drugs and psychotropic substances and penalises their diversion or use for intoxication. Consequently, violation of drug-licence conditions involving a narcotic drug or psychotropic substance may also constitute a violation of Section 8 of the NDPS Act.

On the determination of quantity, the High Court relied upon the Supreme Court’s decision in Hira Singh v. Union of India and held that the weight of the entire mixture or preparation, rather than only the actual narcotic content, must be considered. Therefore, when a codeine preparation loses the benefit of the therapeutic-use exemption, the entire cough-syrup mixture must be taken into account for determining whether the recovered quantity is small, intermediate or commercial. If the total quantity is above one kilogram, the restrictions contained in Section 37 of the NDPS Act concerning the grant of bail would apply.

Answering the first legal question, the Court ruled:

“Codeine-based cough syrup having permitted quantity of codeine as per Notification dated 14.11.1985 and Notification dated 02.05.2001 of the Central Government will not be treated as a narcotic substance, so long as it is sold or transported for medicinal use.”

On the second and central question, the Court ruled in the following exact terms:

“Codeine-based cough syrup having permitted quantity of codeine, manufactured or produced as a cough suppressant, if stocked, sold or transported for other 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 in view of the judgment of the Hon’ble Apex Court in Hira Singh’s case (supra).”

The Court also drew an important distinction concerning routine retail sales without a prescription. It clarified that an isolated sale of codeine-based cough syrup by a medical store without a prescription would ordinarily amount to a violation of the Drugs and Cosmetics Act rather than the NDPS Act. However, the position may change where a retailer sells a huge quantity within a very short period, indicating knowledge that the medicine was intended for a purpose other than medicinal or scientific use.

Applying these principles to Bhola Prasad’s case, the Court noted that Saili Traders had admittedly sold 3,66,000 bottles of New Phensedyl to Maa Kripa Medical and 3,87,000 bottles to Shivichha Pharma. Although e-way bills were generated for transporting the consignments to Sonbhadra, the purchasing firms allegedly failed to produce documents proving physical receipt of the stock.

The Court further considered the statements of the landlords, transporters and other persons, the alleged routing of consignments to Varanasi and Dhanbad, recovery of bottles in other states, the financial trail involving layered firms, and the recovery of blank signed cheques. These materials, according to the Court, prima facie indicated that the firms existed only on paper and that the cough syrup had been diverted for a purpose other than medicinal use.

The Court also noted that the applicant had failed to explain four cases forming part of his criminal history. It emphasised that, at the bail stage, it was neither necessary nor appropriate to undertake a meticulous examination of every commercial transaction or record final findings on disputed claims that would ultimately have to be tested during the trial. In cases involving alleged diversion through layered business entities or intermediary firms, the Court said a cautious approach was necessary because organised narcotics operations frequently employ structured transactions or shell arrangements to distance principal actors from the physical recovery of the substance.

Concluding that the material disclosed a prima facie case of large-scale diversion of codeine-based cough syrup for non-medicinal purposes, the Court refused to grant Bhola Prasad the benefit of the exemption under Entry 35 of the November 14, 1985 notification.

Rejecting the bail application, the Court passed the following operative order:

“In view of above, this Court is not inclined to grant bail to the applicant. Therefore, his bail application is rejected.”