DR. (MISS) ALETTA GRACE BELL vs DR. (MISS) S. TIRKEY AND ANR.

The Supreme Court upheld the Patna High Court's decision that Dr. Alette Grace Bell's hospital was required to obtain a license under Section 18(c) of The Drugs and Cosmetics Act, 1940 for the manufacture and distribution of I.V. Solutions. The Court clarified that the amendment to the Act, effective from 1-2-1983, combined the activities of manufacture for sale and distribution into a single composite activity requiring a license. The Court emphasized that regardless of the nature of the activity, compliance with licensing requirements is mandatory under the Act.