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Issues: (i) Whether genuine licensed medicinal dealings in permitted-strength codeine cough syrup, including routine prescription or record-keeping breaches, attract the NDPS Act. (ii) Whether stocking, selling or transporting such syrup for intoxication attracts the NDPS Act despite permitted codeine content or a drug licence. (iii) Whether the entire syrup mixture determines commercial quantity and the applicability of statutory bail restrictions. (iv) Whether the individual evidence of conscious possession, diversion or conspiracy warranted granting or refusing regular bail. (v) Whether retirement from a partnership before the relevant transactions justified bail for the firm's subsequent drug dealings. (vi) Whether a woman who occasionally received consignments for her husband's medicine business was entitled to bail under the statutory provision applicable to women.
Issue (i): Whether genuine licensed medicinal dealings in permitted-strength codeine cough syrup, including routine prescription or record-keeping breaches, attract the NDPS Act.
Analysis: Sections 2(xi), 2(xiv), 2(xvi)(c) and 2(xx) of the Narcotic Drugs and Psychotropic Substances Act, 1985 govern the classification of codeine and its preparations. Entry 35 of the Central Government Notification dated 14.11.1985 exempts preparations compounded with other ingredients, containing not more than 100 milligrams of codeine per dosage unit and a concentration not exceeding 2.5% in undivided preparations, which are established in therapeutic practice. Such permitted medicinal preparations are also excluded from the essential narcotic drug regime under the notification dated 05.05.2015 and Rule 52A of the NDPS Rules. Their licensed medicinal trade remains regulated under the Drugs and Cosmetics Act, 1940 and the prescription and record requirements associated with Schedules H and H-1 of the Drugs and Cosmetics Rules, 1945. Routine retail sales without prescriptions or complete records do not, without material indicating non-medicinal diversion, establish a narcotics offence.
Conclusion: Permitted-strength codeine cough syrup sold or transported by a drug licence holder for medicinal use does not attract the NDPS Act. Ordinary prescription or record-keeping breaches alone fall within the drugs regulatory regime. Drug inspectors must obtain the specified prosecutorial legal advice before registering an NDPS FIR for licence violations.
Issue (ii): Whether stocking, selling or transporting such syrup for intoxication attracts the NDPS Act despite permitted codeine content or a drug licence.
Analysis: Sections 8(c) and 21 prohibit and punish dealings in covered narcotic preparations outside the permitted medicinal or scientific framework. Applying the mischief rule, the medicinal exemption cannot protect diversion for intoxication merely because the product is capable of therapeutic use or its dealer holds a drug licence. The licence holder claiming exemption must demonstrate substantial compliance with the requirements governing medicinal use. Abnormally large unrecorded sales over a short period may indicate knowledge of non-medicinal use, unlike ordinary retail irregularities. Section 80 establishes the concurrent operation of statutes: an offence under the Drugs and Cosmetics Act does not exclude prosecution under the NDPS Act where its ingredients are established.
Conclusion: Yes. Permitted-strength codeine syrup stocked, sold or transported for intoxication is treated as a codeine preparation falling within manufactured drugs and attracts the NDPS Act. A drug licence does not preserve the exemption for such dealings, and prosecution under both enactments is permissible where applicable.
Issue (iii): Whether the entire syrup mixture determines commercial quantity and the applicability of statutory bail restrictions.
Analysis: Once a preparation falls within the NDPS Act, Note 4 of the notification dated 19.10.2001 requires the whole mixture, including neutral ingredients, to be considered when determining quantity. The isolated weight of codeine cannot be substituted for the weight of the offending preparation. The applicable commercial-quantity threshold for codeine was identified as a quantity exceeding one kilogram, attracting the restrictions under Section 37. This calculation does not itself remove the exemption applicable to genuine medicinal dealings.
Conclusion: The entire offending syrup mixture must be weighed, rather than only its codeine content. Where that quantity exceeds one kilogram, the commercial-quantity restrictions under Section 37 apply.
Issue (iv): Whether the individual evidence of conscious possession, diversion or conspiracy warranted granting or refusing regular bail.
Analysis: Regular bail required an individualised prima facie assessment, not a definitive adjudication of disputed commercial transactions or guilt. Recovery from sealed containers did not by itself establish conscious possession by a transporter, driver or helper unaware of their contents. Employment, ownership of premises, familial association, ordinary cash deposits, telephone contact or cash recovery likewise did not automatically establish participation in illicit trafficking or criminal conspiracy. A matching manufacturing batch number alone was insufficient to identify the recovered bottles as those supplied by a particular accused. Co-accused confessions, if proved, were treated as relevant to conspiracy under Section 30 of the Indian Evidence Act, but the absence of corroborating material materially favoured release in several applications.
Analysis: In contrast, fictitious intermediary firms, implausible vehicle details, toll and transporter evidence contradicting declared deliveries, missing stock and business records, unexplained layered money transfers, and common digital access provided corroborating material of organised diversion in other applications. Knowing, exceptionally large unaccounted supplies also supported refusal of bail. Completed investigation, the need for further custody, criminal antecedents, jail overcrowding and trial pendency informed the assessments where applicable.
Conclusion: Regular bail was directed for applicants whose conscious involvement or participation was not sufficiently supported. Bail was refused to applicants prima facie linked by corroborating material to organised diversion or knowing bulk supply for intoxication. These findings did not determine criminal liability at trial.
Issue (v): Whether retirement from a partnership before the relevant transactions justified bail for the firm's subsequent drug dealings.
Analysis: Section 38 governed the asserted vicarious criminal liability arising from the partnership's activities. The reconstituted partnership deed and GST records supported retirement before the purchases under investigation, while another person was identified in the drug licence as responsible for the firm's day-to-day affairs. Those circumstances supported release without finally determining liability for the firm's transactions.
Conclusion: The retired partner was entitled to regular bail concerning the firm's transactions occurring after his retirement.
Issue (vi): Whether a woman who occasionally received consignments for her husband's medicine business was entitled to bail under the statutory provision applicable to women.
Analysis: The discretion concerning women under Section 480(1) of the Bharatiya Nagarik Suraksha Sanhita, 2023 was applied to an applicant whose alleged role was occasional receipt of consignments for her husband's business. No cough syrup was recovered from the shop, and her limited alleged role, absence of criminal antecedents and completed investigation supported release.
Conclusion: The woman applicant was entitled to regular bail with the benefit of Section 480(1) of the Bharatiya Nagarik Suraksha Sanhita, 2023.
Final Conclusion: Permitted codeine content supports a conditional medicinal exemption, not immunity for illicit diversion. Narcotics liability requires attention to the actual purpose of the dealings and the individual's evidenced role, while ordinary drug-regulatory infractions must not automatically be converted into narcotics offences. Ultimate criminal responsibility remains for determination at trial.
Ratio Decidendi: A codeine preparation satisfying the prescribed compositional limits and established in therapeutic practice remains exempt from narcotics regulation when dealt with for genuine medicinal use; knowing diversion for intoxication defeats that exemption notwithstanding a drug licence.
Codeine cough syrup loses medicinal exemption when diverted for intoxication, with total mixture weight governing bail restrictions.
Codeine cough syrup compounded with other ingredients, containing at most 100 milligrams of codeine per dosage unit and 2.5% in undivided preparations, and established in therapeutic practice remains exempt from narcotics regulation for genuine licensed medicinal dealings. Ordinary prescription or record-keeping breaches alone remain subject to drugs regulation, without establishing an NDPS offence. Diversion for intoxication defeats the exemption despite a drug licence, and concurrent prosecution under the NDPS Act and Drugs and Cosmetics Act is permissible where their ingredients are established. Once the NDPS Act applies, the entire syrup mixture determines quantity; quantities exceeding one kilogram attract Section 37 commercial-quantity bail restrictions. Bail requires an individualised prima facie assessment of conscious involvement and corroborated diversion or conspiracy; employment, family links or transport alone do not establish participation. Retirement before relevant partnership transactions and statutory discretion for women may support bail.
Stock, sale and transport of codeine-based cough syrups- stock, sale and transport of codeine-based cough syrups (like New Phensedyl, Eskuf, Codectus, Lykarex-T, Phencypink-T, Rexley-T) -narcotic drug v/s simply a drug - diversion for intoxication - Whole-mixture rule for narcotic preparations - applicants entitlement to bail on the material attributed to them Codeine cough syrup - medicinal use exemption - Therapeutic practice - Whether the codeine-based cough syrup having permitted quantity of codeine as mentioned in Entry 35 of Notification dated 14.11.1985 would attract the provisions of the NDPS Act, if the same has been sold or transported by the drug licence holder to another drug licence holder or any person for medicinal purposes? - HELD THAT: - Entry 35 of the notification requires that the codeine preparation be compounded with other ingredients, contain codeine within the prescribed dosage and concentration limits, and be established in therapeutic practice. The expression "established in therapeutic practice" concerns a preparation accepted and routinely used for treatment of disease, and not its particular use by an end consumer. Codeine cough syrup satisfying these conditions is exempt from the category of manufactured drugs when dealt with in the ordinary course of medicinal business. A routine sale without medical prescription or other ordinary breach of drug-licence conditions is actionable under the Drugs and Cosmetics Act, unless the circumstances establish non-medicinal diversion. Hon’ble Apex Court in the case of Raj Kumar Arora’s case [2025 (4) TMI 1179 - SUPREME COURT] observed that unnecessary benefit of exception under NDPS Act should not be given to a person who misuses the narcotic drugs or psychotropic substances merely because drugs can potentially be used for medicinal or scientific purposes. Also it is clear that the violation of the condition of license issued under Drugs and Cosmetics Act and its rule regarding the narcotic drug or psychotropic substance would amount to contravention of Section 8 of NDPS Act itself. In such circumstances, apart from proceeding under Drugs and Cosmetics Act, prosecution under NDPS Act will also be permissible.[Paras 27, 28, 34, 55, 56] Permitted-quantity codeine cough syrup dealt with for medicinal use does not attract the NDPS Act merely because of a breach of drug-licence conditions. Codeine cough syrup-non-medicinal diversion - Compliance with drug-licence conditions - Whole-mixture rule - whether Codeine-based cough syrup containing the permitted quantity of codeine, when stocked, sold or transported for intoxication or another non-medicinal purpose, loses the benefit of the Entry 35 exemption and attracts the NDPS Act? - HELD THAT: - The statutory exemption is conditional upon the preparation being dealt with for medicinal use and in substantial compliance with the applicable licence and statutory requirements. A person without authority to deal in the syrup, or a licence holder who diverts it for intoxication, cannot claim that exemption. The NDPS Act operates in addition to the Drugs and Cosmetics Act; hence, circumstances may give rise to offences under both enactments. Once the exempt preparation is diverted for a non-medicinal purpose, it is to be treated as a codeine preparation falling within manufactured drugs. For determining small or commercial quantity, the whole syrup mixture, and not merely the actual codeine content, is to be reckoned. [Paras 49, 51, 52, 54, 55] Diversion of permitted-quantity codeine cough syrup for intoxication attracts the NDPS Act, and its entire mixture is relevant for quantification. Regular bail - prima facie involvement in codeine cough syrup diversion - Conscious possession - whether connected bail applications arising from alleged illegal dealing in codeine-based cough syrup were decided according to the prima facie material showing knowledge, conscious possession, or participation in non-medicinal diversion? - HELD THAT: - At the regular-bail stage, the Court declined to make definitive findings upon disputed commercial transactions. Bail was granted where sealed consignments, mere employment, ownership of premises or vehicles, or uncorroborated statements did not prima facie establish conscious possession, trafficking, or conspiracy. Bail was declined where the material prima facie indicated diversion through fictitious firms, false transport records, non-delivery of consignments, forged documents, unexplained transactions, or sale on a scale indicating non-medicinal use. [Paras 57, 58] The applications were allowed or rejected on their respective prima facie facts, without expressing a final opinion on the merits. Final Conclusion: The Court held that permitted-quantity codeine cough syrup remains outside the NDPS Act when lawfully dealt with for medicinal use, but its diversion for intoxication attracts the Act. The connected bail applications were allowed or rejected according to the respective prima facie material.