The Health Ministry has almost finalised norms and rules to introduce a new Schedule under the Drugs and Cosmetics Rules to exclusively regulate the antibiotics and it may go to the Drug Technical Advisory Board soon, sources said.

As per the draft regulations, a new Schedule HX will be added to the Drugs & Cosmetics Act to make it compulsory to carry duplicate prescriptions. About 70 drugs including antibiotics will come under the new Schedule HX. Violations will be punished with a fine of Rs.20,000 or upto 2 years imprisonment. The whole purpose of the move is to check the abuse of antibiotics. Currently, the antibiotics are included in the Schedule H of the Act.

Based on the recommendations of the Task Force set up by the DCGI in this regard, a system of colour coding of 3rd generation antibiotics and all newer molecules like Carbapenem will be introduced. Besides, all types of surveillances will be done for antimicrobial resistance, sources said.

Apart from this, the Task Force had also called for conducting a study on prescription patterns, setting up of an Antibiotic Management Team (AMT) with experts from different clinical and pharmaceutical streams, and conducting environmental surveillance as an interface between veterinary, industrial and human health, etc. The Ministry is also considering some of these recommendations to streamline the antibiotics sector.

Sources in the DCGI office said, the Drug Consultative Committee had already given its approval to the proposal and the draft is almost ready to go to the DTAB. The apex body for clearing the regulatory changes may take up the matter in the forthcoming meeting.

The DCGI had set up a panel to study the matter in the wake of the controversies of superbug and the report of the committee was placed before the DCC. The meeting gave a go ahead to the proposal. The panel was set up after the Superbug called New Delhi Metallo-beta-lactamase 1 (NDM1), which was alleged to be resistant to the most powerful antibiotics, had hit the image of the country as a destination for medical tourism and cheaper treatment facilities.