Codeine cough syrup within permitted limits is outside the NDPS Act for medicinal sale, but diversion for intoxication attracts prosecution, Allahabad High Court rules

The High Court heard 76 connected bail applications involving the alleged stock, sale, transport and diversion of codeine-based cough syrups, including New Phensedyl, Eskuf, Codectus, Lykarex-T, Phencypink-T and Rexley-T.

The applicants included licensed pharmaceutical wholesalers and retailers, proprietors of medical firms, transporters, drivers, helpers, godown caretakers and alleged intermediaries.

In the lead matter, Bhola Prasad was alleged to have sold 7,53,000 bottles of New Phensedyl through his firm, Saili Traders, to two licensed firms which allegedly existed only on paper; the consignments were said to have been diverted through layered firms and transported for non-medical use.

The Court separately assessed each applicant’s alleged role, the available documentary and testimonial material, the existence of conscious possession or knowledge, the filing of charge-sheets, criminal history and the applicability of the statutory bar under Section 37 of the NDPS Act.

Whether codeine-based cough syrup containing the permitted quantity of codeine under Entry 35 of the Notification dated 14 November 1985 attracts the NDPS Act when sold or transported by a drug-licence holder to another licensed dealer or person for medicinal purposes.

Whether such codeine-based cough syrup, although manufactured as a cough suppressant and containing the permitted quantity of codeine, attracts the NDPS Act when stocked, sold or transported for non-medicinal purposes, such as intoxication.

Whether the entire weight of the cough-syrup preparation, rather than merely the quantity of codeine contained in it, is relevant for determining whether the recovered quantity is commercial under the NDPS Act.

Whether the individual applicants were entitled to bail on the basis of their specific roles, the nature of the evidence, absence of conscious possession or knowledge, filing of the charge-sheet and other bail considerations.

The Court applied Sections 2(xi), 2(xiv), 2(xvi), 2(xx), 8(c), 9(1)(a)(va), 21, 27A, 29, 37 and 80 of the NDPS Act.

Codeine is an opium derivative and a manufactured drug under Sections 2(xi) and 2(xvi)(c), while a preparation includes a mixture or solution containing a narcotic drug.

However, Entry 35 of the Notification dated 14 November 1985 excludes from the definition of manufactured drug a preparation compounded with another ingredient, containing not more than 100 mg of codeine per dosage unit and not more than 2.5% concentration, provided it has been established in therapeutic practice.

Relying on Mohd. Sahabuddin v. State of Assam, (2012) 13 SCC 491, the Court held that the therapeutic-use requirement must be satisfied where the preparation is transported or dealt with without valid authority or in circumstances indicating non-medical use.

Under Union of India v. Sanjeev V. Deshpande, (2014) 13 SCC 1, the NDPS Act operates in addition to, and not in derogation of, the Drugs and Cosmetics Act.

The Court also relied on Hira Singh v. Union of India, (2020) 20 SCC 272, for treating the entire mixture as relevant to quantity determination.

The Court held that the codeine concentration and dosage limits under Entry 35 are necessary but not sufficient by themselves. A compliant cough-syrup preparation remains outside the NDPS Act when dealt with in the ordinary course of licensed pharmaceutical business for medicinal use.

Conversely, where the material prima facie showed fictitious firms, non-existent premises, absence of stock or delivery, forged invoices, implausible vehicle details, rapid movement of very large quantities, unexplained cash deposits, or recovery of the same batches in other States during illegal transport, the Court inferred possible diversion for intoxication.

The Court nevertheless differentiated between principal or intermediary actors allegedly involved in diversion and persons such as drivers, cleaners, caretakers and licensed dealers against whom there was no material showing knowledge, conscious possession or involvement in non-medical trafficking.

In contrast, applicants connected with layered transactions and allegedly fictitious firms, unexplained financial transfers, non-delivery of consignments and recovery of corresponding batches at trafficking destinations were found prima facie involved and were denied bail.

It answered Question No. 2 in the affirmative: the same preparation, if stocked, sold or transported for intoxication or another non-medical purpose, is treated as a codeine preparation falling within the category of manufactured drug and attracts the NDPS Act; the entire mixture is relevant for quantity determination.

Bhola Prasad’s bail application was rejected because the material prima facie indicated diversion of a very large quantity through fictitious or paper firms, layered transactions, unexplained financial transfers and transportation for non-medical use; his unexplained criminal history also weighed against bail.

Bail was granted to several applicants whose involvement was limited, whose knowledge or conscious possession was not established, or against whom only co-accused statements were relied upon, subject to personal bonds, two sureties, non-tampering, cooperation with trial, abstention from criminal activity, attendance before the court and a prohibition on leaving India without permission.

The Court further directed the Commissioner of Food Safety and Drug Administration, Uttar Pradesh, to guide Drug Inspectors to proceed under the Drugs and Cosmetics Act for licensing violations and to obtain legal advice before registering NDPS FIRs in appropriate cases.