The drug controller general of India (DCGI) has secured the nod of the Drug Consultative Committee (DCC) to introduce new rules to regulate the sale of antibiotics and add separate schedule under the Schedule H of the Drugs and Cosmetics Act and Rules, in the wake of recent controversies around superbug scare.

Sources at the DCGI office have confirmed that the new rules mandating the patients to get two copies of a prescription to buy the antibiotics. One of the copies should be given to the chemist who has to keep it for audit up to one year.

To implement the new rules, a new Schedule HX will be added to the Drugs and 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 up to two years imprisonment. The whole purpose of the move is to check the abuse of antibiotics, sources said.

The DCGI had set up a panel to study the matter in the wake of the recent controversies of superbug and the report of the committee was placed before the DCC meeting last week. The meeting gave a go ahead to the proposal following with the rules are being introduced.

Despite repeated assurance and denials by the health ministry, 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.

A meeting presided over by Director General of Health Services (DGHS) Dr R K Srivastava and attended by experts from the All India Institute of Medical Sciences (AIIMS), National Centre for Communicable Diseases (NCDC), Hinduja Hospital, Mumbai, and other institutes, a range of measures were discussed to regulate the use of antibiotics in the country. One of them was to put in place new set up of laws to regulate the sale of antibiotics.