Legal Classification of Stem Cells as Drugs Under the Drugs and Cosmetics Act

The definition of a drug under Section 3(b)(i) of the Drugs and Cosmetics Act, 1940 is comprehensive and incorporates not only conventional medicines but all corporeal substances intended to be used for or in the diagnosis, treatment, mitigation, or prevention of any disease or disorder in human beings or animals. Interpreting the statutory conjunction "and" disjunctively between medicines and substances, biological cellular matter possessing a specific composition and physical texture qualifies as a substance intended for therapeutic application. Therefore, even where autologous stem cells do not undergo substantial manipulation and fall outside the narrower definition of a "new drug" or a "stem cell derived product," they remain squarely within the overarching statutory definition of a drug under Section 3(b)(i) of the Act. As a consequence, the protective umbrella, regulatory safeguards, and prohibitions against unauthorized manufacture, distribution, and administration enacted under the statutory drug framework extend fully over stem cell preparations. (Yash Charitable Trust & Ors. Vs Union of India & Ors. | 2026 INSC 96).