Diagnostic Kits Classified as Devices, Not Drugs, Unless Notified; Tax Implications Depend on Official Gazette Notification.

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....The case involved the classification of Diagnostic Kits as "drugs" under the Drugs and Cosmetics Act, 1940. The court held that devices used for diagnosis fall under the definition of "drug" only if specified by the Central Government in the Official Gazette. Diagnostic Kits were deemed more akin to "devices" than "medicines" and would be considered as "drugs" under sub-section (iv) of Section 3 (b) if notified by the Central Government. The court noted the absence of evidence showing Diagnostic Kits are considered "medicines" or "drugs" by medical practitioners. If the Kits are notified as "drugs," they would be charged at 4% under Entry 48 of Schedule C; otherwise, they would fall under Entry 165 of Schedule D and be taxed at 12.5%. The court disposed of the petition accordingly.....