The government has released a preliminary draft for public feedback over the next 45 days
concerning potential restrictions on advertisements for anti-diabetes medications, sex
hormone treatments, and various oncology drugs. The aim is to curb misleading claims by
amending the Drugs and Cosmetics Rules, 1945, to encompass regulations for medicines
containing Schedule G substances. Schedule G drugs, though not requiring a prescription, are
critical and necessitate medical supervision.
Currently, drugs categorized under Schedule H, Schedule H1, and Schedule X already
mandate prior government approval for advertising. The proposed amendments align with
existing regulations that mandate warning labels on Schedule G medicines for internal use,
stating “Caution: it is dangerous to take this preparation except under medical supervision,”
in a prescribed format.
Additionally, the Ministry of Health and Family Welfare underscored provisions in the Drugs
and Magic Remedies Act, 1954, which prohibit advertisements claiming to cure specific
diseases. This reinforces the framework governing drug promotions.
The initiative follows consultations with the Drugs Technical Advisory Board (DTAB),
India’s foremost drug advisory body, prompted by a presentation from Goa’s Directorate of
Food and Drugs Administration. DTAB recently recommended restricting advertisements for
Schedule G drugs, continuing discussions that have been ongoing for several years.
