Narcotic-Cased Medicines And NDPS Act: Limits Of Therapeutic Practice Defence

In recent years, the misuse of narcotic based medicines, particularly codeine containing cough syrups, has posed a serious challenge to criminal law enforcement in India. Though such substances have been recognised as having legitimate medicinal value, courts are increasingly confronted with cases involving their illegal stocking, transportation, and sale in a manner wholly divorced from therapeutic use. This recurring issue has again come to the fore in a recent order of the Allahabad High Court^[1], where the Court was called upon to examine whether such large-scale illegal dealing in narcotic-based medicines could be insulated from the rigours of the Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS Act) merely because such substances are regulated under the Drugs and Cosmetics Act, 1940 (Drugs and Cosmetics Act). In such prosecutions, a common defence is raised that since these formulations are governed by the Drugs and Cosmetics Act, the alleged illegality can only amount to a regulatory violation under that statute, thereby excluding the application of the NDPS Act. This argument, if accepted mechanically, would undermine the very object of the NDPS Act and provide a ready shield for organised diversion of pharmaceutical narcotics. Courts have therefore consistently emphasised that therapeutic recognition of a substance is not the same as therapeutic legality of conduct, and that misuse cannot be legitimised merely by regulatory classification.

The statutory framework itself makes this position clear. The NDPS Act is a special penal legislation enacted to control and prohibit unauthorised dealings in narcotic drugs and psychotropic substances, and to combat abuse and illicit trafficking through stringent provisions (Sections 8, 21 to 29, NDPS Act). In contrast, the Drugs and Cosmetics Act is primarily a regulatory statute, concerned with licensing, quality control, record maintenance, and lawful manufacture and sale of drugs for medical purposes (Sections 18 and 18A, Drugs and Cosmetics Act). Significantly, the legislature has consciously avoided any exclusionary overlap between the two enactments. Section 80 of the NDPS Act expressly provides that its provisions shall be in addition to, and not in derogation of, the Drugs and Cosmetics Act. Correspondingly, Section 32(3) of the Drugs and Cosmetics Act clarifies that prosecution under that Act does not bar prosecution under any other law. The legislative intent is therefore unambiguous. Regulatory control under the Drugs and Cosmetics Act does not eclipse penal control under the NDPS Act.

The concept of therapeutic practice under the NDPS regime is itself a limited and conditional exception. Section 8(c) of the NDPS Act prohibits all dealings in narcotic drugs and psychotropic substances except for medical or scientific purposes and in the manner provided by the Act or the Rules made thereunder. In relation to codeine or methyl morphine, reliance is often placed on Notification S.O. 826(E) dated 14 November 1985, particularly Entry 35, which excludes certain preparations containing codeine from the definition of manufactured drugs. However, this exclusion operates only when specific cumulative conditions are satisfied, including prescribed concentration limits, compounding with other therapeutic ingredients, and the requirement that the preparation is established in therapeutic practice. Courts have consistently held that failure to meet even one of these conditions revives the prohibition under Section 8 of the NDPS Act, and the burden of establishing entitlement to the exemption lies squarely on the accused.

This approach is firmly rooted in Supreme Court jurisprudence. In Md. Sahabuddin v. State of Assam^[2], the Court rejected the presumption that cough syrup containing codeine must necessarily be treated as therapeutically exempt merely because it is a pharmaceutical product. Emphasising the huge quantity involved and the absence of documents explaining lawful destination or purpose, the Court held that therapeutic use cannot be assumed and that exemption under the notification cannot be claimed unless all statutory conditions are demonstrably satisfied. Similarly, in Union of India v. Sanjeev V. Deshpande^[3], the Supreme Court clarified that the NDPS Act is a special statute dealing with a distinct class of controlled substances, while the Drugs and Cosmetics Act operate in a broader regulatory field. The Court recognised that where conduct falls within the mischief of the NDPS Act, regulatory classification under the Drugs and Cosmetics Act cannot dilute or neutralise penal consequences.

The Supreme Court further reaffirmed this position in The State of Punjab v. Rakesh Kumar^[4], where it expressly relied upon Section 80 of the NDPS Act to hold that offences under the NDPS Act may coexist with violations under the Drugs and Cosmetics Act. The Court rejected the argument that regulatory governance of drugs automatically excludes NDPS prosecution. The Constitution Bench decision in Hira Singh v. Union of India^[5], though rendered in the context of quantity determination in mixtures, reinforced the principle that NDPS provisions must be construed strictly and purposively, and that interpretative dilution which frustrates the object of the Act must be avoided.

The most recent and authoritative reaffirmation of this legal position is found in Directorate of Revenue Intelligence v. Raj Kumar Arora^[6]. The Supreme Court in this decision clearly delineated the distinct objectives of the NDPS Act and the Drugs and Cosmetics Act, observing that while the latter regulates legitimate medical trade, the former is aimed at curbing abuse and illicit trafficking of controlled substances. The Court held that the two statutes operate concurrently, and that the absence of a substance from Schedule I of the NDPS Rules or its regulation under the Drugs and Cosmetics framework does not, by itself, exclude NDPS prosecution when the conduct complained of attracts Section 8 of the NDPS Act.

Considerable reliance is often placed on Union of India v. Ashok Kumar Sharma^[7] to argue that police authorities lack competence to prosecute cases involving drugs governed by the Drugs and Cosmetics Act. Such reliance is misplaced. The judgment in Ashok Kumar Sharma is confined to the procedural requirement under Section 32 of the Drugs and Cosmetics Act regarding who may institute prosecution for offences under that Act. It does not create any immunity from prosecution under other statutes. On the contrary, Section 32(3) of the Drugs and Cosmetics Act itself preserves prosecution under any other law if the act complained of constitutes an offence thereunder. Courts have therefore rightly held that Ashok Kumar Sharma cannot be invoked to bar NDPS proceedings where the ingredients of NDPS offences are independently disclosed.

High Court jurisprudence, including that of the Allahabad High Court, reflects a consistent and fact sensitive application of these principles. In Vibhor Rana v. Union of India^[8], relief was granted only after a careful examination of the composition, dosage, and statutory compliance of the preparation in question. The decision did not lay down a blanket proposition excluding NDPS applicability to codeine-based medicines. In Hemant Kumar Saini v. Union of India^[9] and similar matters, the Allahabad High Court declined to quash NDPS proceedings where the material on record indicated large scale stocking, unexplained transport, or absence of documentation consistent with therapeutic distribution. The emphasis has consistently been on the nature of conduct rather than the nomenclature of the substance.

This approach finds resonance across other High Courts as well. The Delhi High Court in Mohd. Ahsan v. Customs^[10] upheld applicability of the NDPS Act where codeine-based syrups were dealt with outside lawful medical channels. The Jammu & Kashmir and Ladakh High Court in Azhar Javaid Rather v. UT of J&K^[11] rejected the claim of therapeutic exemption where quantities and surrounding circumstances pointed towards misuse. Recent decisions of the Patna High Court have similarly relied on Raj Kumar Arora, Rakesh Kumar, and Sanjeev V. Deshpande to reaffirm that NDPS law operates in addition to, and not in exclusion of, the Drugs and Cosmetics regime.

Treating such conduct as a mere regulatory breach under the Drugs and Cosmetics Act would significantly dilute the legislative intent behind the NDPS Act. The Drugs and Cosmetics Act is not designed to address the scale, intent, and societal impact of narcotic diversion. Its penal provisions are corrective and regulatory in nature. The NDPS Act, on the other hand, is a deterrent statute aimed at preventing abuse and illicit trafficking. Where the facts disclose illegal stocking, smuggling, or sale of narcotic based medicines beyond lawful therapeutic use, confining prosecution to regulatory offences would defeat the purpose of narcotics control and render Section 80 of the NDPS Act redundant.

Therefore, the therapeutic recognition of a medicine cannot be stretched to legitimise conduct that is illegal in substance and effect. Illegal stocking, smuggling, and sale of narcotic based medicines cannot be exempted under the Drugs and Cosmetics Act in the garb of therapeutic practice. Once the conditions of exemption fail, the prohibition under Section 8 of the NDPS Act is attracted, and the rigours of the NDPS Act apply in addition to the penal provisions of the Drugs and Cosmetics Act. This interpretation alone preserves the balance intended by the legislature, protecting genuine medical use while firmly addressing abuse and diversion, and ensures that the law does not become complicit in the very mischief it seeks to prevent.

Vaibhav Sahu is a practicing Advocate at Allahabad High Court. Sneha Arora is a Faculty-cum-Mentor at LiveLaw Academy and a visiting faculty at Jamia Hamdard. Views are personal.

1. https://www.livelaw.in/high-court/allahabad-high-court/codeine-cough-syrup-racket-allahabad-high-court-rejects-quashing-pleas-alleged-kingpin-co-accused-513950 ↑

2. Criminal Appeal No. 629 of 2010, Supreme Court ↑

3. Criminal Appeal No. 660 of 2007, Supreme Court ↑

4. 2018 INSC 1131 ↑

5. 2020 INSC 348; also at: https://www.livelaw.in/top-stories/ndps-quantity-neutral-substances-mixture-taken-into-account-along-actual-drug-weight-small-or-commercial-quantity-155647 ↑

6. 2025 LiveLaw (SC) 434 ↑

7. 2020 INSC 517 ↑

8. 2021: AHC: 171222-DB ↑

9. MISC BENCH no. 11190 of 2021, Lucknow Bench, Allahabad High Court ↑

10. 2022 LiveLaw (Del) 878 ↑

11. Bail Application No. 138/2022, High Court of Jammu & Kashmir and Ladakh at Srinagar