Electronic nicotine delivery systems held prima facie outside the Drugs Act definition of drug, with impugned circular stayed.

Electronic nicotine delivery systems were found, prima facie, not to fall within the definition of "drug" under Section 3(b) of the Drugs and Cosmetics Act, 1940, because they were not shown to be therapeutic devices, medicines, or substances having medicinal value. The materials before the Court, including the view of the Drugs Consultative Committee, supported the conclusion that e-cigarettes were outside the statutory definition. On that basis, the respondent was held to lack jurisdiction to issue the impugned communication and circular, and both were stayed until the next date of hearing.

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Issues: Whether electronic nicotine delivery systems and similar devices fall within the definition of "drug" under the Drugs and Cosmetics Act, 1940, and whether the impugned communication and circular could be issued under that Act.

Analysis: The definition of "drug" in Section 3(b) of the Drugs and Cosmetics Act, 1940 extends to medicines and substances intended for diagnosis, treatment, mitigation, or prevention of disease, as well as certain notified devices. On a plain reading, the devices in question were not shown to be therapeutic devices or products having medicinal value, nor were they established as medicines for internal or external use. The materials placed before the Court, including the view of the Drugs Consultative Committee constituted under Section 7 of the Drugs and Cosmetics Act, 1940, supported the position that e-cigarettes were not covered by the statutory definition of "drug".

Conclusion: The Court held, prima facie, that the products did not fall within Section 3(b) of the Drugs and Cosmetics Act, 1940, and therefore the respondent lacked jurisdiction to issue the impugned communication and circular; both were stayed until the next date of hearing.

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