Buprenorphine hydrochloride under NDPS law: psychotropic status accepted, but Chapter VII restrictions held inapplicable.

Buprenorphine hydrochloride is treated as a psychotropic substance because buprenorphine is listed in the NDPS Schedule and the material described it as a salt of that substance; its status as a Schedule H medicine under the Drugs and Cosmetics Rules did not exclude NDPS coverage. The note also states that Chapter VII of the NDPS Rules applies only to psychotropic substances in Schedule I to those Rules, and buprenorphine hydrochloride is not included there. On that basis, the general Chapter VII restrictions were said to be inapplicable, and liability under the NDPS Act was not attracted on the facts described.

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Issues: (i) Whether buprenorphine hydrochloride is a psychotropic substance within the meaning of the Narcotic Drugs and Psychotropic Substances Act, 1985. (ii) Whether the manufacture, possession, sale and transport of buprenorphine hydrochloride injections are governed and prohibited by Chapter VII of the Narcotic Drugs and Psychotropic Substances Rules, 1985 so as to attract liability under the Narcotic Drugs and Psychotropic Substances Act, 1985.

Issue (i): Whether buprenorphine hydrochloride is a psychotropic substance within the meaning of the Narcotic Drugs and Psychotropic Substances Act, 1985.

Analysis: Section 2(ixia) of the Narcotic Drugs and Psychotropic Substances Act, 1985 defines psychotropic substance to include any salt or preparation of a substance included in the Schedule. Buprenorphine is expressly listed in the Schedule, and the material on record showed that buprenorphine hydrochloride is a salt of buprenorphine. It was not treated as a preparation in the statutory sense, but the expert material established its chemical nature as a salt. The fact that it is also a Schedule H medicine under the Drugs and Cosmetics Rules, 1945 did not exclude it from the NDPS regime.

Conclusion: Buprenorphine hydrochloride is a psychotropic substance under the Narcotic Drugs and Psychotropic Substances Act, 1985.

Issue (ii): Whether the manufacture, possession, sale and transport of buprenorphine hydrochloride injections are governed and prohibited by Chapter VII of the Narcotic Drugs and Psychotropic Substances Rules, 1985 so as to attract liability under the Narcotic Drugs and Psychotropic Substances Act, 1985.

Analysis: Section 8 of the Narcotic Drugs and Psychotropic Substances Act, 1985 prohibits dealings in psychotropic substances except for medical or scientific purposes and in the manner provided by the Act or the rules. Section 9 authorises regulation by rules. Chapter VII of the Narcotic Drugs and Psychotropic Substances Rules, 1985, particularly Rules 64 to 67, applies only to psychotropic substances specified in Schedule I to those Rules. Buprenorphine hydrochloride does not appear in Schedule I to the Rules. On that basis, the general prohibition in Rule 64 and the connected rules in Chapter VII were held inapplicable to it. Consequently, dealings in that medicine remained governed by the Drugs and Cosmetics Act and Rules, and the alleged contraventions under Section 8 and Section 22 of the NDPS Act were not made out.

Conclusion: Buprenorphine hydrochloride injections were held not to fall within Chapter VII of the Narcotic Drugs and Psychotropic Substances Rules, 1985, and the NDPS offences alleged against the applicants were not attracted.

Final Conclusion: The common legal issue was answered in favour of the applicants, and the bail applications were granted on the footing that the NDPS Act was not attracted on the facts found.

Ratio Decidendi: A psychotropic substance listed in the Schedule to the NDPS Act attracts penal consequences under the NDPS Act only when its possession or dealing is in contravention of the Act or rules made thereunder, and the Chapter VII restrictions in the NDPS Rules apply only to substances specifically included in Schedule I to those Rules.

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