Drug Schedules (Drugs & Cosmetics Act)

Introduction & legislative framework

• Parent statute — The Drugs and Cosmetics Act, 1940 regulates the import, manufacture, distribution and sale of drugs & cosmetics in India; operational detail sits in the subordinate Drugs and Cosmetics Rules, 1945 (notified 21 Dec 1945).
• What a "Schedule" is — an appendix to the Rules. The Act/Rules carry the enabling sections; the Schedules (A–Y) carry the substantive lists, standards, forms, fees & conditions those rules point to — the "lookup tables" of Indian drug law.
• Amendable by notification — schedules can be added/amended by gazette notification (G.S.R.) without amending the parent Act — this is how Schedule H1 was inserted in 2013 (G.S.R. 588(E)).
• Who enforces — CDSCO under the Drugs Controller General of India (DCGI) is the central authority (import, new-drug approval, standards); State Drugs Control Authorities licence & inspect manufacture and retail/wholesale sale.
• Why a schedule system exists — graded control keyed to a drug's potential for harm, abuse or need for professional supervision — the domestic analogue of the US Food, Drug & Cosmetic Act (1906 → 1938 safety after "elixir sulfanilamide" → 1962 Kefauver efficacy proof after thalidomide).