The notification in this regard is in final stages with the Drug Controller General of India (DCGI) writing to the Union Health Ministry, which, in turn, will send it to the Law ministry for its nod, a Health Ministry official said.
"The classification of 91 new generation antibiotics will be labelled 'Rx' in red and also prominently display warnings that the drug is not to be administered without medical advice," the official said.
He, however, said such a notification is likely after the current monsoon session of Parliament.
The Schedule H-1 drugs will prominently carry a warning "it is dangerous to take this preparation except in accordance with medical advice" in red colour on the left corner, along with another advice of "not to be sold by retail without the prescription of a registered medical practitioner".
The Drug Controller General of India has already written to all state drug controllers for strengthening of regulatory control at retail sale outlets to ensure drugs are dispensed by retail chemists in compliance to the provisions of the Drugs and Cosmetics Rules.
The DCGI directive also seeks to ensure that drug inspectors make surprise checks on chemists in their areas so that restricted Schedule X and Schedule H drugs are not sold without medical prescription.
Sources said the availability of these third and fourth generation antibiotics which are habit-forming, including some anti-tuberculosis drugs which are prone to have resistance, need to be restricted.
