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Issues: (i) Whether codeine-based cough syrup within the quantitative limits in Entry 35 of the notification dated 14.11.1985 attracts the NDPS Act when dealt with by a drug licence holder for medicinal use; (ii) Whether such cough syrup attracts the NDPS Act when stocked, sold or transported for intoxication or another non-medicinal purpose; (iii) Whether the respective applicants were entitled to bail on the material attributed to them.
Issue (i): Whether codeine-based cough syrup within the quantitative limits in Entry 35 of the notification dated 14.11.1985 attracts the NDPS Act when dealt with by a drug licence holder for medicinal use.
Analysis: Codeine is an opium derivative and ordinarily a manufactured drug, but Entry 35 excludes a preparation compounded with other ingredients, containing no more than 100 mg per dosage unit and no more than 2.5% concentration, which has been established in therapeutic practice. The expression concerns the established therapeutic character of the preparation, not the end-user's individual use. A codeine cough syrup satisfying these conditions and dealt with in the ordinary medicinal trade by a valid licence holder is outside the category of manufactured drug. A routine retail sale without a prescription may breach the Drugs and Cosmetics regulatory regime, but does not by itself invoke the NDPS Act absent material indicating knowledge of diversion to non-medicinal use.
Conclusion: A qualifying codeine-based cough syrup sold, stocked or transported by a licence holder for medicinal use is not a narcotic substance under the NDPS Act.
Issue (ii): Whether such cough syrup attracts the NDPS Act when stocked, sold or transported for intoxication or another non-medicinal purpose.
Analysis: The statutory exception is available only where the preparation is genuinely dealt with for medical or scientific purposes and consistently with the applicable licensing requirements. The NDPS Act operates in addition to the Drugs and Cosmetics Act; a licence does not protect dealings involving deliberate diversion of a codeine preparation for intoxication. Large-scale diversion, fictitious documentation or entities, absence of actual delivery or stock, forged transport records, and other material indicating non-medicinal trafficking may establish that the exemption is unavailable. Where the NDPS Act applies, the weight of the entire syrup mixture is considered in determining small or commercial quantity.
Conclusion: A qualifying codeine cough syrup knowingly stored, sold or transported for intoxication or another non-medicinal purpose is treated as a codeine preparation and manufactured drug attracting the NDPS Act.
Issue (iii): Whether the respective applicants were entitled to bail on the material attributed to them.
Analysis: Bail was assessed individually without deciding guilt. Bail was justified where the material did not prima facie establish conscious possession, knowledge of concealed contents, actual involvement in diversion, or participation in a trafficking conspiracy beyond unsupported confessional statements or weak circumstantial material. Bail was refused where the record prima facie disclosed organised diversion of very large quantities through fictitious firms, false invoices or transport records, unexplained financial routing, forged documentation, or other evidence of intended non-medicinal distribution.
Conclusion: Bail was granted to applicants against whom prima facie material of conscious involvement in non-medicinal trafficking was insufficient, and refused to applicants against whom such material was prima facie established.
Final Conclusion: The statutory exemption protects genuine medicinal dealings in qualifying codeine cough syrup, but cannot be used to shield its knowing diversion for intoxication; the individual applications were resolved according to the strength of the respective prima facie material.
Ratio Decidendi: A codeine preparation within Entry 35 remains outside the NDPS Act only while it is genuinely dealt with for medical or scientific purposes in accordance with the governing regulatory requirements; knowing diversion for intoxication defeats the exemption.
Medicinal Codeine Exemption: Qualifying cough syrup remains outside NDPS controls unless knowingly diverted for intoxication or non-medicinal trafficking.
Qualifying codeine cough syrup remains outside the NDPS Act when it meets the Entry 35 composition limits, has an established therapeutic character, and is genuinely dealt with by a licensed entity for medicinal or scientific purposes. A Drugs and Cosmetics regulatory breach, including retail sale without prescription, does not alone establish NDPS liability without material showing knowing diversion. The exemption is unavailable where stock, sales or transport are knowingly directed to intoxication or other non-medicinal use; in that event, the entire syrup mixture determines the relevant quantity. Bail depends on individual prima facie evidence of conscious possession, knowledge, diversion, or participation in trafficking, rather than unsupported confessions or weak circumstantial material.
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.