Therapeutic codeine preparation within notified limits falls outside NDPS offence, leading to quashing of the FIR.

Phensedyl cough linctus, containing codeine phosphate within the notified limit and established in therapeutic practice, fell within the statutory exception to the definition of manufactured drug under the NDPS framework. Section 21 applied only to contraventions involving manufactured drugs and preparations, and the sample report showed codeine phosphate at 9.5 mg per 5 ml with 1.9 per cent concentration. Allegations of misuse by addicts, lack of purchase bills, or possible licence violations did not attract Section 21 and could at most raise issues under the Drugs and Cosmetics Act, 1940. Penal provisions were strictly construed, so the FIR and consequential proceedings were quashed.

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Issues: Whether Phensedyl cough linctus, containing codeine phosphate within the notified limit and established in therapeutic practice, fell within the exception to the definition of manufactured drug so that no offence under Section 21 of the Narcotic Drugs and Psychotropic Substances Act, 1985 was made out and the FIR was liable to be quashed.

Analysis: Section 21 of the Narcotic Drugs and Psychotropic Substances Act, 1985 applies only to contravention in relation to manufactured drugs and preparations. The statutory definition of manufactured drug under Section 2(xi) read with Notification No. 0.826(E), dated 14-11-1985 excludes preparations compounded with other ingredients containing not more than 100 milligrammes of codeine per dosage unit and not more than 2.5 per cent concentration in undivided preparations, provided they have been established in therapeutic practice. The sample report showed codeine phosphate at 9.5 mg per 5 ml and 1.9 per cent concentration, and Phensedyl was acknowledged to be used therapeutically for dry cough. Allegations regarding misuse by addicts, absence of purchase bills, or licence violations did not attract Section 21, as such matters could at best arise under the Drugs and Cosmetics Act, 1940. Penal provisions were to be strictly construed, and the preparation could not be brought within the mischief of the Act merely on apprehended misuse.

Conclusion: The preparation was covered by the notified exception, no offence under Section 21 was made out, and the petitioner succeeded in securing quashing of the FIR and consequential proceedings.

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