The Union Health Ministry is all set to come out with a national antibiotics policy by incorporating a new Schedule namely, HX, in the Drugs & Cosmetics Act in a bid to prevent large scale misuse of antibiotics in the country. The ministry has identified a group of 70 antibiotics to be included in this restricted category of drugs. Currently, antibiotics are placed under the Schedule H of the D&C Act. The Drugs Consultative Committee had already given its go-ahead to the proposal. The new Schedule will require doctors and chemists to retain prescriptions so that the abuse of antibiotics could be checked from now onwards. Once the policy takes effect, doctors, while prescribing antibiotics, will have to issue two prescriptions to every patient and one copy should be kept for a period of two years by the chemists. The officials from the DCGI office or state regulatory authorities can, thus, audit these prescriptions at any time. Violations under the new Schedule may be punished with a fine of Rs. 20000 or up to two years of imprisonment. The new policy will be applicable to practitioners both in public and private sector establishments. Antibiotics would be categorised as non-restricted, restricted and very restricted. Each category would have a distinct colour code for the benefit of consumers.
Growing antibiotic resistance is a serious public health problem world is facing today due to its irrational use by the patients. Repeated and improper use of antibiotics are two main causes for increase in resistant bacteria world over. It is estimated that up to 50 per cent of antibiotic prescriptions given in the community settings are not actually needed. Patients contribute to antibiotic resistance by requesting physicians to prescribe antibiotics even if they do not have a bacterial infection. Non compliance of patients to the antibiotic treatment regimen is another contributory factor for resistance which has become a significant patient safety concern today. In India, scientific debate on antibiotic resistance started in the wake of a recent controversy over a reference made in the medical journal, Lancet, regarding the superbug called New Delhi metallo-beta-lactamase 1 (NDM-1). The superbug is stated to be resistant to the most powerful antibiotics and the circulation of the Lancet report did hit the image of India as a destination for medical tourism. And it is in this background, the Union health ministry had set up a task force to review the current situation regarding manufacture, use and misuse of antibiotics in the country. The task force was also asked to initiate studies documenting prescription patterns and establish a monitoring system for the same. The report has been already placed before the Drug Consultative Committee several weeks ago for action. Now AIOCD, representing in the country, has taken serious objection to the ministry’s move to introduce the new schedule on the ground that it will affect the survival of 7.5 lakh chemists in the country. AIOCD's contention is that it is the doctors who prescribe the antibiotics without any checks and chemists just provide the drugs. This may be true in a number of cases. But, a large number of retail chemists do also indulge in selling antibiotics without prescriptions throughout the country. No one deny this fact. Therefore, some regulatory intervention is called for to fix this public health problem.