The Union health ministry has come out with the much awaited notification adding a new provision, Schedule H1, to the Drugs & Cosmetics Act a few days ago to curb the indiscriminate use of antibiotics and some other vital drugs in the country. The notification placed 46 such drugs under the restricted category consisting of mainly third and fourth generation antibiotics, certain anti TB drugs and a few habit forming drugs. The formulation packs of these drugs should have a warning printed in a box with a red border on the label. These specified list of drugs can only be sold by chemists after retaining a copy of the prescription and maintaining a separate register by them. The ministry had originally planned to include 91 drugs under the Schedule H1 but in the wake of strong objections from different sections especially from the trading community the list was pruned to 46. With the notification already gazetted, the CDSCO has the responsibility to enforce the order in the days to come.
Drug resistance, mainly to antibiotics, has been one of the most serious public health problems of today in the world with some of the infectious diseases becoming untreatable with the existing drugs. Resistance to drugs occurs due to both improper and excessive use of drugs by patients. The emergence of multi drug resistant TB in India and several other Asian and African countries is due to improper use of TB drugs by the poor patients. And today, no drug is available to treat such deadly form of TB spreading in these countries. Similarly repeated use of antibiotics for common ailments make these drugs ineffective in patients when some serious infections take place. 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 prescription practices of doctors in public hospitals and private clinics. Antibiotics need to be prescribed in optimal doses, regimens and should be stopped when the infection is under control. It is important that the use of last line antibiotics should be restricted to serious infections and only when simpler drugs do not work. Similarly prescribing of codeine containing cough syrups to patients having even mild cough is a very common practice amongst general practitioners. This needs to be checked as uncontrolled consumption of cough syrups containing codeine and sugar by diabetic patients can push up their sugar level. Now, as in case of any rules implementation of Schedule H1 is going to be a tough job as the enforcement has be carried out by the state drug authorities. Inspection of more than 6 lakh pharmacies across the country and monitoring prescriptions of doctors countrywide is a massive task for the state authorities and the existing machinery is not fully equipped for that. Apart from the private hospitals and clinics, a large number of government hospitals and primary health centres are probably a much bigger frontier where prescriptions are generated on a big scale.