Case Background
The main case was a civil writ filed by a transportation and logistics company. It operates trucks to transport goods across States. In this matter, it had transported a consignment of Wiscof Cough Syrup containing Codeine Phosphate.
The cough syrup was manufactured by M/s Windlas Biotech Pvt. Ltd., Dehradun. According to the petitioner, this manufacturer had a valid licence under Rule 70 of the Drugs and Cosmetics Rules, 1945 to manufacture prescription drugs, including Codeine listed in Schedule H.
The goods were picked up from M/s Maa Durga Enterprises at Ranchi, Jharkhand. This consignor was stated to be an authorised distributor of the manufacturer and held wholesale drug licences in Form 20B and 21B under the Drugs and Cosmetics Rules, 1945. The consignment was destined for two licensed pharmacies at Madhepura, Bihar, namely M/s Bimal Medical Agency and M/s Yash Enterprises, both claimed to have valid Form 20B and 21B licences.
When the truck reached Madhepura, it was intercepted and the consignment seized. Singheshwar P.S. Case No. 228 of 2020 was registered. The FIR invoked several sections of the Narcotic Drugs and Psychotropic Substances Act, 1985 (Sections 8(c), 21(c), 22(c), 23, 24, 25, 27A and 29) and Section 30(a) of the Bihar Prohibition and Excise Act, 2016 against the driver, the consignor, the consignees and the company’s owner.
Separately, confiscation proceedings were initiated. By order dated 06.09.2021 in Excise Confiscation Case No. 32 of 2021, the Additional Collector-cum-Additional District Magistrate, Madhepura ordered confiscation of the truck and directed that it be auctioned.
In the civil writ, the transport company sought three main reliefs: quashing of State Government Notification No. 11 dated 18.10.2016 issued under Section 3 of the Bihar Prohibition and Excise Act, 2016; quashing of the confiscation order dated 06.09.2021; and release of the truck and the seized cough syrup consignment.
Alongside, a connected criminal writ (Criminal Writ Jurisdiction Case No. 558 of 2021) pertaining to the same police case was also heard, arising out of Singheshwar P.S. Case No. 228 of 2020. Both matters were heard together by a Division Bench headed by the Acting Chief Justice.
What the Court Examined and Decided
The central attack in the civil writ was on the validity and constitutionality of Notification No. 11 dated 18.10.2016. By this notification, the State of Bihar had, in exercise of powers under Section 3 of the Bihar Prohibition and Excise Act, 2016, declared all medicines and medicinal preparations containing Codeine and Dextropropoxyphene to be “intoxicants” for the purposes of the Act.
The petitioner argued that this notification was beyond the State’s legislative competence and repugnant to the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, especially Sections 26A and 26B of the 1940 Act and Entry 132 of Schedule H read with Rules 65, 75 and 97 of the 1945 Rules. It was contended that the central legislations, together with the NDPS Act, fully occupied the field of regulation of narcotic and psychotropic medicines, including Codeine.
On facts, the petitioner stressed that Codeine in therapeutic dosage is not treated as an illegal narcotic. The Central Government, by S.O. No. 826(E) dated 14.11.1985 under Section 2(xi)(b) of the NDPS Act, had declared Codeine (Methyl Morphine) and its salts, including Codeine Phosphate, with not more than 100 mg per dosage unit and a concentration not exceeding 2.5% in undivided preparations, and which are established in therapeutic practice, as “manufactured drugs”.
The petitioner pointed out that Wiscof Cough Syrup contained Codeine within this permitted limit. It was specifically noted by the Court that it was not the prosecution’s case that the cough syrup exceeded the Central Government’s notified Codeine limits so as to become a psychotropic substance.
On this basis, the petitioner had earlier argued before the authorities that transporting such cough syrup was a licensed and lawful activity and that cough syrup was not an “intoxicant” or “psychotropic substance” when manufactured and moved strictly within the regulatory framework of the Drugs and Cosmetics Act and Rules.
In the present writ, the petitioner took a broader constitutional stand. It argued that Entry 19 of the Concurrent List, which deals with “drugs and poisons”, is already covered in detail by Central laws, i.e., the NDPS Act, 1985 and the Drugs and Cosmetics Act, 1940. Sections 18, 27, 26A and 26B of the 1940 Act, read with the Rules, cover manufacture, distribution, sale, stocking, transport and prohibition or restriction, leaving no residual space for State legislation under Entry 8 of List II to re-classify centrally licensed medicines as intoxicants for prohibition purposes.
Further, the petitioner contended that the notification was ultra vires the Bihar Prohibition and Excise Act, 2016 itself. Section 2(40) defines “intoxicant” and Section 2(41) defines “intoxicating drug”. Under Section 2(41)(iv), the State can, by notification, declare any other intoxicating or narcotic substance to be an “intoxicating drug”, but expressly excludes “opium, coca leaf or a manufactured drug as defined in Section 2 of the NDPS Act, 1985”. Since Codeine has been treated by the Central Government as a “manufactured drug”, the petitioner argued it cannot be notified as an intoxicating drug or brought in as an intoxicant through Section 3.
The petitioner also attacked the workability of the notification. Sections 14, 15, 16 and 27 of the Bihar Prohibition and Excise Act, 2016 deal with movement of intoxicants, restrictions on vehicles, power to regulate transport of intoxicants and fees and conditions for licences, permits and passes. Section 27 requires rules to prescribe the form, particulars and conditions of licences and permits.
It was argued that, at the relevant time, no rules had been framed under Section 95 of the Act to give effect to Section 27, so no valid permit or licence format existed for transporting such notified intoxicants like codeine-based medicines within Bihar. A Division Bench of the Patna High Court in CTI Infrastructure Private Limited v. State of Bihar, 2019 SCC OnLine Pat 710 had earlier held that Section 14 was unworkable in the absence of rules. Therefore, according to the petitioner, the 2016 notification was practically inoperative and could not lawfully criminalise what was otherwise a licensed activity under central law.
On the other side, the State, through the Advocate General, emphasised its prohibition policy announced on 21.12.2015 and the constitutional directive in Article 47, which mandates the State to bring about prohibition of the consumption (except for medicinal purposes) of intoxicating drinks and of drugs injurious to health.
The State relied on Entry 8 of List II of the Seventh Schedule, which covers “intoxicating liquors, that is to say, the production, manufacture, possession, transport, purchase and sale of intoxicating liquors”. Relying heavily on the nine-Judge Bench judgment of the Supreme Court in State of U.P. v. Lalta Prasad Vaish, 2024 SCC OnLine SC 3029, the State argued that Entry 8 must be given a wide, purposive interpretation. Alcohol and intoxicants are considered res extra commercium, meaning the State can heavily regulate or prohibit their use in public interest, especially for health and morality.
The State contended that the notification did not clash with the central drug laws because it was aimed at misuse and non-medicinal abuse of codeine-based and dextropropoxyphene-based medicinal products. It pointed out that the notification itself carved out exceptions for licensed pharmacies and registered practitioners and that the Bihar Prohibition and Excise Rules, 2021 (published on 27.09.2021) had since put in place a structured licensing regime, especially through Rules 22 and 24(2), for medicinal and pharmaceutical preparations that might qualify as intoxicants when misused.
The Division Bench then undertook a detailed constitutional analysis. It examined Sections 2(40) and 2(41) of the Bihar Prohibition and Excise Act, 2016 and Section 3, which empowers the State Government to notify “commodities or chemical ingredients, which can be used as a substitute for alcohol, to be intoxicants” with specified conditions.
It reviewed the development of law concerning Entry 8 of List II, starting from Synthetics and Chemicals Ltd. v. State of U.P., (1990) 1 SCC 109, through several subsequent decisions, and culminating in the nine-Judge Bench decision in Lalta Prasad Vaish. The Court noted that the earlier narrow reading of “intoxicating liquor” in Synthetics, limiting State power essentially to potable alcohol, had been overruled.
Quoting and applying key conclusions from Lalta Prasad Vaish, the Patna High Court highlighted that Entry 8 of List II is both industry-based and product-based and covers regulation from raw material to consumption of intoxicating liquor and intoxicants. Alcohol and similar substances are inherently noxious and prone to misuse affecting public health. Entry 8 extends beyond potable alcohol to substances like rectified spirit, ENA and denatured spirit when they can be used for intoxication.
The Court also referred to Southern Pharmaceuticals and Chemical v. State of Kerala, (1981) 4 SCC 391, where the Supreme Court upheld State competence under Entry 8 to regulate use of rectified spirit in medicinal preparations if such products are capable of being misused for intoxication. The test laid down was whether the article can be used as a beverage or for noxious purpose.
Applying that test, the Division Bench recorded that “Codeine is capable of being used as an intoxicant. Therein lies the justification for the State to come out with the notification which has been impugned in the present petition.”
On the question of repugnancy and “occupied field”, the Court discussed the doctrine of pith and substance, the principle of “occupied field”, Article 246 and leading precedents like Hoechst Pharmaceuticals Ltd. v. State of Bihar, Committee for Protection of Democratic Rights, West Bengal, and M. Karunanidhi. It stressed that federal supremacy of Parliament under Article 246 is triggered only in case of irreconcilable conflict between Union and State entries.
The Bench held that the Drugs and Cosmetics Act, 1940 and NDPS Act, 1985 regulate manufacture, quality, licensing, and penalties for misuse of drugs, but the Bihar notification under Entry 8 targets a distinct field: preventing abuse of certain medicinal preparations as intoxicants within the State in furtherance of Article 47. The State was not re-licensing or re-defining Codeine as a drug; it was treating codeine-based medicinal preparations as “intoxicants” for the purpose of prohibition and control of intoxicant abuse.
Therefore, the Court concluded that there was no direct conflict or repugnancy. Both legal regimes – central drug regulation and State prohibition law – can co-exist. The central law did not exhaust the entire field so as to oust State power under Entry 8.
On the workability argument, the Court acknowledged that when the FIR in Singheshwar P.S. Case No. 228 of 2020 was registered, the Bihar Prohibition and Excise Rules, 2021 had not yet come into force. It observed that in such circumstances, criminal courts, when asked to quash FIRs or scrutinise charges, would have to consider the absence of implementing rules in assessing whether offences were actually made out at the relevant time.
However, this point went to the merits of the criminal prosecution and not to the constitutional validity of the notification itself. On that limited question, the Court upheld the notification.
Ultimately, the Division Bench held that:
(a) The impugned notification is a legitimate exercise of power under Entry 8 of List II, read with Section 3 of the Bihar Prohibition and Excise Act, 2016, and in line with the Supreme Court’s judgment in Lalta Prasad Vaish.
(b) There is no repugnancy with the Drugs and Cosmetics Act, 1940, as the State action targets abuse and non-medicinal use of codeine-based medicines.
(c) The notification is in furtherance of the State’s constitutional obligation under Article 47 to prevent intoxicating substance abuse.
(d) Intoxicants and intoxicating drugs, when misused, fall within the category of res extra commercium, allowing stringent State control.
Having so declared, the Court disposed of the civil writ (C.W.J.C. No. 20522 of 2021). The connected criminal writ (Cr.W.J.C. No. 558 of 2021) was directed to be placed before the learned Single Judge dealing with such criminal writ petitions so that the Single Judge can consider, in light of this judgment and the absence of rules at the relevant time, whether the offences alleged in the FIR are made out and whether any relief like quashing should be granted.
Why This Judgment Matters
This judgment is important for transporters, pharmaceutical distributors, and pharmacies operating in Bihar. It confirms that even medicines legally manufactured and licensed under Central drug laws can be treated as “intoxicants” by the State if they are capable of being misused for intoxication.
The Patna High Court has made it clear that Bihar can, under its prohibition law and Entry 8 of the State List, impose conditions, permits and controls on movement and possession of codeine-based cough syrups and similar medicinal preparations. The fact that a medicine complies with central standards does not, by itself, protect it from being brought under State prohibition controls.
At the same time, the Court has indicated that criminal courts must carefully examine, in each case, whether at the relevant time the necessary rules and licensing formats existed. If rules were absent, it may affect whether a particular FIR can stand. This gives an affected person a path to challenge individual prosecutions, even though the overarching notification has been upheld.
For lay readers, the takeaway is straightforward: in Bihar, transport or possession of codeine-based cough syrup is no longer just a routine commercial activity. It now falls into the category of an “intoxicant” under the State’s prohibition law. Those dealing with such products must strictly follow any permit or licence system prescribed by the Bihar Prohibition and Excise Rules, 2021 and any subsequent circulars, or risk serious criminal charges and confiscation.
Legal Issues and Answers
- Issue: Can the State of Bihar, under its prohibition law and Entry 8 of List II, notify all medicines and medicinal preparations containing Codeine as “intoxicants” despite central regulation of Codeine under the NDPS Act and Drugs and Cosmetics Act?
Answer: Yes. The Court held that Entry 8 of List II, as interpreted by the Supreme Court in Lalta Prasad Vaish and Southern Pharmaceuticals, allows the State to regulate and prohibit substances, including medicinal preparations, that are capable of being used as intoxicants. The Bihar notification is a valid exercise of this power and is not repugnant to central laws. - Issue: Is Notification No. 11 dated 18.10.2016 ultra vires the Bihar Prohibition and Excise Act, 2016, particularly in view of Sections 2(40), 2(41) and 3, and the exclusion of “manufactured drugs” from the definition of intoxicating drugs?
Answer: No. The Court held that the State can, under Section 3 read with the wide meaning of intoxicants in Section 2(40) and the constitutional scheme, treat codeine-based medicinal preparations as intoxicants. The fact that Codeine is a “manufactured drug” under the NDPS Act does not prevent the State from declaring its medicinal preparations as intoxicants for the limited purpose of prohibition and control of misuse. - Issue: Does the absence of rules under the Bihar Prohibition and Excise Act, 2016 at the time of the FIR automatically make the notification or prosecutions invalid?
Answer: No, the absence of rules does not invalidate the notification itself. However, the criminal courts must consider this factor while deciding individual cases, including petitions to quash FIRs, to see whether, in the absence of prescribed permits and procedures, the alleged offences were actually made out when the FIR was registered.
Cases Cited by the Court
- State of U.P. v. Lalta Prasad Vaish, 2024 SCC OnLine SC 3029 (Nine-Judge Bench)
- Synthetics and Chemicals Ltd. v. State of U.P., (1990) 1 SCC 109 (overruled on key aspects by Lalta Prasad Vaish)
- Shri Bileshwar Khand Udyog Khedut Sahakari Mandali Ltd. v. State of Gujarat, (1992) 2 SCC 42
- State of A.P. v. McDowell & Co., (1996) 3 SCC 709
- Vam Organic Chemicals Ltd. v. State of U.P., (1997) 2 SCC 715
- Bihar Distillery v. Union of India, (1997) 2 SCC 727
- Government of Haryana v. Haryana Brewery Ltd., (1997) 5 SCC 758
- State of Bombay v. R.M.D. Chamarbaugwala, 1957 AIR 699
- Khoday Distilleries Ltd. v. State of Karnataka, (1996) 10 SCC 304
- Southern Pharmaceuticals and Chemical v. State of Kerala, (1981) 4 SCC 391
- Tika Ramji & Others v. State of Uttar Pradesh & Others, 1956 AIR 676
- Deep Chand v. State of U.P., 1959 AIR 648
- M. Karunanidhi v. Union of India, 1979 AIR 898
- Zameer Ahmed Latifur Rehman Sheikh v. State of Maharashtra & Others, AIR 2010 SC 2633
- Hoechst Pharmaceuticals Ltd. & Others v. State of Bihar & Others, (1983) 4 SCC 45
- State of West Bengal & Others v. Committee for Protection of Democratic Rights, West Bengal & Others, (2010) 3 SCC 571
- CTI Infrastructure Private Limited v. State of Bihar, 2019 SCC OnLine Pat 710
Case Details
Case Number: Civil Writ Jurisdiction Case No. 20522 of 2021; with Criminal Writ Jurisdiction Case No. 558 of 2021 (arising out of Singheshwar P.S. Case No. 228 of 2020, District Madhepura)
Case Title: Om Logistics Limited v. The State of Bihar & Others; with Sooryamani Prasad Pandey @ Sooryamani Pandey @ Suryamani Pandey v. The State of Bihar & Others
Coram: Hon’ble the Acting Chief Justice Ashutosh Kumar and Hon’ble Mr. Justice Partha Sarthy
Citation: 2025(3) PLJR 187
Advocates:
In Civil Writ Jurisdiction Case No. 20522 of 2021:
- For the petitioner (transport company): Mr. Jitendra Kumar Singh, Senior Advocate; Mr. Harsh Singh, Advocate
- For the State: Mr. P.K. Shahi, Advocate General; Mrs. Shama Sinha, AC to SC 5
- For the respondents (other State functionaries): Mr. Nadim Seraj, G.P. 5; Mr. Asif Iqbal Niazi, AC to G.P. 5; Mr. Kumar Manish (SC 5)
In Criminal Writ Jurisdiction Case No. 558 of 2021:
- For the petitioner: Mr. Harsh Singh, Advocate
- For the respondents (State): Mr. Md. Nadim Seraj, G.P. 5
Nature of the Case: Civil writ petition challenging the validity of a State notification and consequential confiscation order under the Bihar Prohibition and Excise Act, 2016, heard along with a connected criminal writ arising from an NDPS and prohibition FIR.
Date of Judgment: 16.05.2025 (CAV judgment; CAV date 23.04.2025)
Result: Civil writ (C.W.J.C. No. 20522 of 2021) disposed of after upholding the validity and constitutionality of Notification No. 11 dated 18.10.2016; connected Criminal Writ (Cr.W.J.C. No. 558 of 2021) sent to Single Judge for consideration on merits of the criminal case.
Link to judgement ; https://patnahighcourt.gov.in/viewjudgment/MTUjMjA1MjIjMjAyMSMxI04=-z0QIeA54PwA=
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