UNION OF INDIA vs PFIZER LIMITED

The Supreme Court interpreted Section 26A of the Drugs and Cosmetics Act, 1940, affirming that prior consultation with the Drugs Technical Advisory Board (DTAB) is a mandatory condition before the Central Government exercises its power under this section. The Court distinguished this position from earlier judgments of the Karnataka and Madras High Courts, which held that such consultation was not necessary. The ruling emphasizes the importance of regulatory oversight in ensuring the safety and efficacy of Fixed Dose Combinations (FDCs) in the Indian market.