An order to curb the unrestricted use of antibiotics is finally coming after years of deliberations by the medical experts and officials in the health ministry. A notification adding Schedule H1 to the Drugs & Cosmetics Act is expected to be announced in a few days from now. It is understood that the new Schedule will cover only 40 drugs, mainly third and fourth generation antibiotics. This specified list of drugs should be sold by chemists only after retaining a copy of the prescription by them. The packs of these drugs should have a warning in a box with a red border on the label. The health ministry had initially planned to put 91 drugs under the Schedule H1 but the proposal raised strong objections from different sections especially from the trading community which raised concerns of losing business. Some of the third and fourth generation antibiotics to be included in the list are imipenem, meropenem, cefaclor, tigecycline and some pain-killers like tramadol. After the notification, the CDSCO is expected to take steps to enforce the order by conducting surprise inspections in the pharmacies.
Resistance to drugs, mainly to antibiotics, has emerged as one of the world's most pressing public health problems of today with some of the infectious diseases becoming untreatable with the existing drugs. The main reason for this trend is the tendency of the physicians to prescribe this class of drugs as an easy option even for a minor infection. And there has been no control over the prescriptions by doctors as it is considered to be a technical work and the authorities left that decision entirely to the medical profession. Ideally, antibiotics need to be prescribed in optimal doses, regimens and should be stopped when the infection is treated. It is important that the use of last line antibiotics should be restricted to serious infections and only when simpler drugs do not work. Whenever used for prophylaxis, antibiotics should be used for short courses and at appropriate times. As in case of any rules, enforcement of the new provision in the D&C Act is going to be tough job for the drug regulators. Inspection of 6 lakh pharmacies across the country and monitoring prescriptions of doctors countrywide may turn out to be a massive task for the government and the existing machinery is not equipped for that. Apart from the private hospitals and clinics, large number of government hospitals and primary health centres are probably a much bigger frontier where antibiotic prescriptions are currently generated on a big scale. Office of the DCGI and the state drug control administrations have to seriously think about how to check this practice at these levels. Formation of antibiotics committees with adequate powers in district and taluk level hospitals and PHCs could be one effective way to implement Schedule H1.