The Schedule H1 of the Drugs & Cosmetics Rules has come into effect from March 1, 2014 in the country after years of deliberations among the medical experts and government officials. Under this Schedule, a total of 46 drugs including mostly antibiotics, some anti TB drugs and a few habit forming psychotropic drugs are included. The Union health ministry amended the Drugs and Cosmetics (D&C) Rules in September 2013 to insert Schedule H1 for this purpose but enforcement of the same took some more time because of the stiff resistance from the pharmaceutical trade. The objective of bringing this new Schedule to the D&C Rules is to keep a tab on indiscriminate and irrational use of antibiotics in the wake of growing resistance to many of these drugs in recent years. The new Schedule requires every chemist to ensure that medicines under the Schedule are dispensed only on prescriptions of registered medical practitioners and records are maintained on sale of such drugs. The prescriptions for these drugs should be maintained for a period of three years from the date of its sale and the same should be made available for verification at any inspection conducted by the regulatory officials.
Resistance to drugs, mainly to antibiotics, is one of the world's most challenging 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. In an environment where very few new drugs are coming out into the market and diseases like malaria, TB and some kind of infections are becoming incurable, available drugs have to be used rationally. The inclusion of Schedule H1 in D&C Rules is, therefore, very much required and needs to be enforced in the country in the interest of patient community. The pharmaceutical trade has been objecting to the implementation of the new Schedule from the beginning. Now, most of the 7 lakh retail chemists in the country are yet to comply with the new rule although the Schedule is effective from March 1. Their contention is that a proper healthcare infrastructure should be in place to implement Schedule H1 and the onus of complying with the new rule should be not only on the trade but also on physicians. That stand is quite right considering the fact that the issue originates from physicians. They have to be made accountable in the whole exercise by directing them to follow right prescription practices and mandating them to maintain records of prescriptions for these drugs. For this active involvement of Medical Council of India and Indian Medical Association will be necessary.