The new rules will be applied to those medicines which have either high risk of side effects or are to be used strictly under medical supervision
NEW DELHI: The health ministry has stiffened the labelling norms for high-risk medicines to enhance consumer awareness and safety of drugs. Printing warnings prominently on such drug packs for pharmaceutical companies is goint to be mandatory from November 1.
The new rules will be applied to those medicines which have either high risk of side effects or are to be used strictly under medical supervision. The must-to-write medicines include cancer drugs, narcotics analgesics, sedatives, tranquillisers, steroids and anti-depressants etc.
The new rules also specify that if the medicine contains a drug substance specified in Schedule H, Schedule G or Schedule X, it will be labelled with symbol Rx. In case of substances specified under Schedule H1, which comes within the purview of the Narcotic Drugs and Psychotropic Substances Act, 1985, the packaging will be labelled with symbol NRx, in red colour with caution statement on the left top corner.
The government, through this norm, aims at bringing in more transparency while also preventing sale of prescription drugs over the counter (without doctor’s instructions). The Indian drug retail market is pegged at over Rs 1 lakh crore annually, of which 75-80% are prescription drugs. Currently, ‘OTC’ or over the counter has no legal recognition in India and all drugs not included in the list of ‘prescription-only’ drugs are legally allowed to be sold over the counter by pharmacists. However, several ‘prescription-only’ medicines, listed in Schedules H and X of the Drug and Cosmetics Rules, are easily available OTC without prescription. The new labelling norms will address this issue.