With a view to giving sharper teeth to the Drugs and Magic remedies (Objectionable Advertisements) Act, the Health Ministry may amend the Drugs and Cosmetic Rules by incorporating a provision to ban the advertisements of drug formulations containing drugs falling in the Schedule H category.
The move comes in the wake of the recent instances of manufacturers advertising prescription drugs and the scathing reference on the practice by the Parliamentary Standing Committee on Health in its 59th report which assessed the working of the Central Drugs Standard Control Organisation (CDSCO).
The CDSCO has also taken note that some manufacturers advertise prescription drugs (Schedule H) in the lay press. The Parliamentary panel apprehended that based on incomplete information, patients tend to self medicate more so because such medicines are generally available without prescription. Such practices can adversely impact not only the health of individuals but even communities and countries.
The panel had recommended stringent implementation of the Drugs and Magic remedies (Objectionable Advertisements) Act and incorporating a provision in the Drugs and Cosmetics Rules, ban such practices and penalize offenders.
The DTAB recently took up the matter and opined that even though advertisements of drugs do not come under the purview of the Drugs and Cosmetics Act, 1940, it is however, necessary in public interest that the manufacturers do not indulge in advertisement of drugs included in Schedule H, H1 and X of the Drugs and Cosmetics Rules as self medication may lead to dangerous side effects.
“The DTAB after deliberations recommended that a condition under the licence to manufacture drugs may be incorporated under the Drugs and Cosmetics Rules to the effect that the advertisement of drugs covered under Schedule H, H1 (proposed) and X are not permitted, except otherwise as permitted by the Government of India in public interest,” sources said.