The Union health ministry is ready with the draft of a national antibiotics policy by inserting a new Schedule called HX under the Drugs and Cosmetics Act with a view to preventing the misuse of drugs numbering about 70 antibiotics.


Sources in the Ministry said the draft has been sent for vetting by the Law Ministry before forwarding it for further steps including getting the approval of the Drugs Technical Advisory Board (DTAB). The Drugs Consultative Committee had already given its go-ahead to the proposal. Currently the antibiotics are placed under the Schedule H of the D&C Act.


The new Schedule will require doctors and chemists to retain prescriptions so that the abuse of antibiotics could be checked. Doctors will have to give two prescriptions to every patient and one copy should be kept for a period of two years by the chemists. The Drug Control General of India (DCGI) office or its representatives can audit it any time. Violations will be punished with a fine of Rs.20000 or upto two years imprisonment, according to the draft policy.


The new policy would apply to both public and private health sectors. Antibiotics would be categorised as non-restricted, restricted and very restricted. Each category would have a distinct colour code for the benefit of consumers. The policy would include a list of antibiotics that cannot be sold without doctors’ prescription. The norms of the policy were framed as per the recommendations of a Task Force set up by the DCGI.


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.


The new policy is also likely to have curbs on doctors. The practitioners are expected to follow standard treatment guidelines. They would be allowed to prescribe only selected antibiotics. If needed, the doctors will have to justify the prescription of these drugs to hospital committees and drug and therapeutic committees that will monitor them. Stringent penalties will be imposed on errant doctors.