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The Union Health Ministry issued a draft gazette notification on 8 September 2026 amending Rule 65 of the Drugs Rules, 1945.
Medical premises supplying prescription drugs, other than wholesale dealers, would have to install CCTV and keep recordings for at least three months.
The aim is tighter oversight of Schedule H, H1 and X drugs, which may be sold only on a registered medical practitioner's prescription.
The proposal went through the Drugs Consultative Committee and was recommended by the Drugs Technical Advisory Board; objections are invited for 30 days.
| Schedule | Covers | Control |
|---|---|---|
| H | Prescription drugs | Sale only on a registered medical practitioner's prescription |
| H1 | Selected 3rd/4th-generation antibiotics, anti-TB drugs, certain habit-forming drugs | Prescription plus a separate register (prescriber, patient, drug, quantity) kept 3 years |
| X | Narcotic and psychotropic drugs | Strictest sale, storage and record-keeping controls |
Parent law regulating import, manufacture, distribution and sale of drugs; the Drugs Rules, 1945 are framed under it.
Conditions of retail and wholesale sale licences; the draft inserts sub-rule (2A) mandating CCTV.
Added by G.S.R. 588(E) of 30 August 2013 to curb over-the-counter sale of antibiotics and habit-forming drugs.
Statutory body under the Drugs and Cosmetics Act, 1940 advising the Centre and states on technical matters; recommended this draft.
Statutory committee under the same Act, of central and state drug regulators, securing uniform enforcement across the country; examined the proposal first.
National drug regulator under the Directorate General of Health Services, Ministry of Health and Family Welfare.
Drugs and Cosmetics Act enacted.
Drugs Rules framed under the Act.
Schedule H1 inserted.
High-alcohol medicinal products (>12% v/v, >30 mL) moved to Schedule H1.
Draft notification proposes CCTV at prescription-drug outlets under Rule 65.
GS Paper II > Health - regulation of drugs; statutory bodies
General Awareness > Polity - Acts and regulators
Drugs Rules schedule (2013) for antibiotics, anti-TB and habit-forming drugs needing a separate sales register.
Drugs Technical Advisory Board - top technical advisory body under the 1940 Act, chaired by the DGHS.
Proposed rules published for public objections before they are finalised.