Medical experts world over have been expressing serious concern over the marketing of increasing number of drug combinations by pharmaceutical companies particularly in the developing countries. They are right in holding the view that a drug combination being a new drug entity its marketing can be allowed only after its safety and efficacy are adequately established. A combination, in effect, is a new drug as while combining two drugs, the efficacy and bioavailability of the two drugs undergo a change on account of the reactions between these chemicals. For ailments like TB, patients' intake of more than one drug at a time for longer treatment period is a critical factor and drug combinations are justified for the sake of compliance. But, most of the fixed dose combinations currently marketed in India are not at all rational as their clinical benefits are in doubt but the licenses were issued for their manufacture and marketing. The state drug controllers in India have been either not looking into the aspect of drug safety or have been issuing licenses under the influence of other considerations. The office of the DCGI had often cautioned the state drug controllers against this practice in the past but with no result. Such excesses on the part of the state drug controllers have been, in fact, a contravention of the provisions of the Drugs and Cosmetics Act. The Act clearly states that permission for the manufacture and marketing of any new drug has to be obtained from the DCGI.
Perhaps the sole reason for the presence of thousands of irrational and harmful combinations in the Indian pharmaceuticals market is this irresponsible conduct of state drug controllers. Fixed dose combinations of ciprofloxacin with tinidazole, amlodipine with lozarten and nifedipine with atenolol are in hundreds in the market with no therapeutic rationale. In the case of nimesulide, there are as many as 130 combinations. Many more such drug combinations are getting approved in various parts of the country and getting into the market. It is significant to note, in this context, that DCGI, last week asked the state drug controllers to withdraw all manufacturing licenses issued by them for drug combinations after May 2002. The DCGI action comes in the wake of a recommendation in this regard by the Drug Consultative Committee to the Central government. It is certainly a bold move and the office of DCGI should put maximum pressure to get it enforced in the states this time. It is to be recalled that DCGI had prohibited the state drug controllers from issuing any more licenses for new combinations in a directive in November 2001. But this directive was more ignored than followed by the state drug controllers.